12.05.2020

Liquid patches (skin adhesives). Technology of finished medicines The process of manufacturing mustard plasters includes the stage


Mustard plasters are rectangular sheets of paper measuring 8X12.5 cm, coated on one side with a layer of powder of defatted mustard seeds 0.3-0.55 mm thick. The raw material is the seeds of Sarepta (Semina sinapis junceae) and black (Semina sinapis nigrae) mustard. Seeds after shelling are subjected to grinding to medium fineness and fat is squeezed out of them in hydraulic presses. oil. The remaining fatty oil from the cake is then extracted in Soxhlet-type apparatuses. The presence of fatty oil adversely affects the quality of mustard plasters - it slows down the therapeutic effect and reduces their storage stability (mustard powder goes rancid and peels off the paper). A paste is prepared from the obtained defatted mustard cake powder by mixing it with a solution of rubber in gasoline. Spreading is done using a patching machine. There is another way: the paper tape is first lubricated with an adhesive solution (rubber solution). Upon exiting from under the funnel, mustard powder is sifted onto the paper, covering the freshly smeared adhesive surface with a thin l even layer. The paper is passed between rollers that compact the mustard layer and then through a long box with heating coils and strong exhaust ventilation.

At a specialized enterprise (in Volgograd), mustard plasters are produced according to the first method. Technological process consists of five stages: 1) glue preparation; 2) preparation of mustard mass; 3) spreading the mass on paper, drying, cutting the roll and laying the mustard plasters in the foot; 4) packaging; 5) gasoline recovery (Fig. 185).

Glue preparation. A bale of natural rubber from the warehouse is fed into the steaming chamber 6, where, with the help of a deaf steam, the rubber is steamed out for 24-36 hours. The steamed rubber is cut with a mechanical knife 7 into plates 60 mm wide, which are then cut with a circular knife 8 cut into cubes measuring 60X60X60 mm. Cut rubber is fed into the glue mixer 10.

Gasoline from storage by 1 petrol dispenser 2 fed into the petrol tank 3, from which through a water separator 4 and counter 5 gasoline flows by gravity into the glue mixer 10. Turn on the paddle mixer for 30-60 minutes; a 1.35-2% solution of rubber in gasoline is obtained. Glue from the glue mixer is fed by pump 11 into tanks with a filter 12, where the separation of undissolved pieces of rubber from the adhesive occurs. The undissolved rubber is returned to the glue mixer.

Preparation of mustard mass. Mustard mass is a mixture of rubber glue and mustard powder in a ratio of 1: 1 - 1.1: 1. The content of essential oil in the cake must be at least 1.11% - Rubber glue from the tank 12 flows by gravity into the mass mixer 13. Mustard powder from the hopper 14 augers serve on a sieve 15 for cleaning from large particles and impurities and further into the mass mixer 13, where it's mixed together With rubber glue to a uniform mass. Ready mustard mass pump 16 served on the table with a bath 18 for smearing.

Coating roll paper with mustard mass, drying, cutting into sheets and stacking. The spreading, drying and cutting process is carried out in a continuous plant. A roll of butter paper is fixed in roll holders 17. The edge of the paper is pulled into the gap between the tabletop and the bathtub. Bath 18 for mustard mass has a device that allows you to adjust the gap depending on the thickness of the spread. Bathtub and stove are made of brass. The edge of the paper is attached to the conveyor located in the dryer chamber 19, after which the installation is put into operation. The paper, passing under the bath, is covered on top with a layer of mustard mass 0.3-0.5 mm thick. Enrolling in drying chamber, the tape is heated by radiant heaters and is blown with hot air coming out of the slots of the blower perpendicular to the sheet surface. Drying time 45 min, temperature 80°C. With more high temperature the enzyme myrosin is destroyed and mustard plasters lose their qualities. The fuel-air mixture constantly formed in the chamber is gradually sucked off and fed to recovery. The productivity of one chamber of the drying plant is 74,000 mustard plasters per hour.

The dried paper web from the dryer chamber is sent to the sheeter 20, where it is cut into sheets 75x76X90 cm in size. Mustard plaster sheets are cooled for 24 hours, after which they are served on the table 21 for transferring sheets with labels and further to the paper cutting machine 23, where the sheets are cut into individual mustard plasters. After cutting, incorrectly cut and for other reasons unusable mustard plasters are rejected.

Packing. Suitable mustard plasters are sent for packaging or packaging in vending machines (24). Mustard plasters are produced in cellophane bags or paraffin paper bags of 10 pcs. Every tenth mustard plaster on one side has a label indicating the method of application. Mustard plasters are packed in packs of 600 pieces. For shipment to consumers, they are packed in paper bags of 15 packs (9000 pcs.).

Gasoline recovery. The absorption of gasoline vapors from the air-fuel mixture is carried out by adsorbers, the absorber in which is activated charcoal of the AR-3 brand. Gasoline vapors are extracted with coal from the gas mixture until the breakthrough of gasoline vapors is detected. After that, the coal is treated with live steam (100-105°C). Hot steam entering the adsorber raises the temperature of the coal and displaces gasoline vapors, taking their place. The condensed vapors of gasoline and water enter the separator, where the gasoline is separated from the water and sent to the gasoline storage.

At the end of desorption, to remove water from the coal, it is blown with hot air at a temperature of 100 ° C until the moisture content of the coal is 5%. By blowing out atmospheric air, the coal in the adsorbers is cooled, and the adsorbers are ready for new cycles. Usually there are several adsorbers to ensure the continuity of the process.

The use of mustard plasters as an irritant is based on the hydrolysis of the glycoside sinigrin, which is found in the seeds of Sarepta and black mustard, and the release of mustard essential oil, which consists entirely of allyl isothiocyanate. This hydrolysis proceeds only under the condition that the emulsion enzyme (mi- rosin):

Grade The quality of mustard plasters is made according to the content of allyl isothiocyanate, which in 1 mustard plaster (100 cm 2) should be at least 0.0119 g. In addition, mustard plasters are dipped for 5-10 seconds in water at a temperature of 37 ° C, after which they are tightly applied to the skin of the hand. Mustard must cause severe burning and redness of the skin no later than 5 minutes.

Packs of mustard plasters must be stored in a dry place. Shelf life 8 months. In the presence of moisture, hydrolysis of sinigrin occurs and mustard plasters lose their activity.

The manufacture of ointments in large-scale industries is based on the same theoretical foundations as in pharmacies. The specificity lies only in the equipment used. It is also obvious that the control over the technological process and the quality of raw materials, semi-finished products and finished ointments at plants and factories can be organized in a more versatile way.

The main operations for the manufacture of ointments are carried out in hemispherical cast-iron-enamelled double-walled cauldrons, between which heating steam circulates. To drain the molten mass, the boilers are made overturning or have drain valves at the bottom. Ointment boilers are equipped with powerful anchor agitators suitable for operation in very viscous media. However, with the help of agitators alone, it is impossible to ensure the proper dispersion of suspension ointments. Therefore, ointments need additional rubbing (grinding), which is carried out mostly with the help of three-roll mazeters.

A three-roller lube consists of three parallel and horizontally arranged rotating smooth metal shafts (Fig. 26.1). Shaft III rotates at a higher speed (38 rpm) than shaft II (16 rpm) and shaft I (6.5 rpm), and, in addition, it oscillates along shaft II. different speed the rotation of the shafts ensures the transition of the ointment from the shaft to the shaft. The grinding effect is enhanced by the additional rubbing action of shaft III, which oscillates. It is very important that the gaps between shafts I, II and between shafts II, III are correctly adjusted.

Ointments on hydrophobic bases

Alloy ointments. The production consists of two operations: the fusion of the constituent parts and the filtration of the melt. As in pharmacies, it is considered a rule that the constituent parts do not undergo excessive overheating. Therefore, melting starts with the high-melting ingredient, after which the remaining constituents are added in order of descending melting points. Homogenization is achieved by continuous stirring in the boiler until it is completely cooled. Typical alloy ointments are diakhil, naftalan, ichthyol, linetol, etc. According to the type of alloy ointments, all ointment bases are also produced, which are alloys, for example, paraffin and vaseline oil.

Ointment solutions. The manufacture is divided into two operations: the manufacture of the base and the dissolution of medicinal substances in it. If necessary, the ointment is still hot, filtered through the canvas, and then mixed until completely cooled. Typical ointments of this group are camphor ointment, Psoriasin ointment (containing mustard gas), Bom-Bengue ointment, Antipsoriaticum ointment, etc.

Suspension ointments. The production consists of three operations: base production, suspension preparation and homogenization. Medicinal substances in a finely ground state are introduced in small portions into the molten base with a continuously operating stirrer. Complete homogenization is achieved by passing the solidified mass through a three-roller. The nomenclature of this group of ointments is extensive: boric, butadiene, dermatol, nystatin, sulfur-naftalan, solid (according to Rybakov's prescription), streptocid, zinc, etc.

Ointments-emulsions. The production is divided into the following operations: preparation of the base, preparation of the aqueous phase - an aqueous solution of medicinal substances, emulsification and homogenization. The stability and degree of dispersion depend on the properties and amount of the emulsifier used and the methods of mechanical processing of the ointment. In the case of the preparation of ointments-emulsions of the M / B type, the emulsifier (monovalent metal soaps) is dissolved in the aqueous phase. When preparing ointments-emulsions of the W / O type, emulsifiers lanolin, polyvalent metal soaps and others are always introduced into the fatty phase. Emulsification is carried out in mixers that provide the necessary degree of dispersion. The dispersible liquid phase is introduced in small portions and only after the previous portion is completely emulsified. If there is not much emulsifiable liquid, then thorough mixing directly in the ointment boiler is sufficient. As an example of emulsion ointments, one can cite those produced by the industry: ointment for the prevention of frostbite (Unguentum contra congelationem) and Konkov's ointment.

Combined ointments. The manufacture of suspension-emulsion ointments and more complex disperse systems consists of operations: preparation of the base, preparation of the aqueous phase, emulsification, introduction of solid medicinal substances and homogenization. The solids are added to the finished emulsion in the agitated kettle without interrupting its operation. Homogenization is carried out on a three-roller.

Ointments such as Sunoref and Efkamon are also multiphase.

Ointments on emulsion bases

The production of ointments on emulsion bases consists of three stages: the manufacture of an emulsifier (in necessary cases), the manufacture of an emulsion ointment base and the preparation of the ointment itself. The technology of the last stage depends on the solubility of the incoming medicinal substances.

As emulsifiers in industry, emulsifier T-2 and emulsifier No. 1 VNIHFI are most often used.

Ointments on the T-2 emulsifier. With the help of this emulsifier, a consistency emulsion of the V / O type is easily obtained with the following composition (parts): vaseline - 60, emulsifier - 10 and water - 30. Sulfur ointment (Unguentum sulfuratum in emulso consistenti) is prepared on this basis according to the prescription: purified sulfur 100 parts consistency emulsion 200 parts.

Ointments on emulsifier No. 1 VNIHFI. The emulsifier is an alloy of sodium salts of sulfuric acid esters and synthetic fatty alcohols of the C16 - C21 fraction with the same free alcohols. The emulsifier is soluble in water, forms W / O type emulsions, is used in an amount of 10-25%. With the help of this emulsifier, the industry produces Undecin ointments, colhamic, gramicidin paste.

Ointments on hydrophilic bases

Of the ointments on non-greasy bases produced by the industry, Teimurov's paste (Pasta Teimurovi) can be cited as an example. Composition (parts): boric acid - 7, sodium tetraborate - 7, salicylic acid - 1.4, zinc oxide - 25, talc - 25, hexamethylenetetramine - 3.5, formalin - 3.5, lead acetate - 0.3, glycerin - 12, mint oil - 0.3, water - 12, emulsifier - 3. A thin mixture is prepared from the indicated crystalline substances, which is then introduced into the powder base (a mixture of zinc oxide and talc) according to the rules of complex powders. Glycerin is diluted with water and formalin. The powder composition is added in parts to the resulting liquid with continuous grinding. In this case, boric acid, sodium tetraborate, hexamethylenetetramine, lead acetate will partially pass into the solution. Essential oil is added to the finished paste and thoroughly homogenized. When dispersed, the essential oil covers the particles of the solid phase with thin films. Apply with sweating, diaper rash, some fungal diseases.

Protective pastes are also usually made with hydrophilic bases. For example, HIOT-6 paste on a gelatin-glycerin base.

Liniments

The widespread use of liniments as rubbing for the relief of rheumatic and other pains caused their popularity and great demand for them. In this regard, the vast majority of liniments enter the pharmacy network in finished form. The preparation of liniments - emulsions and suspensions - at the factory required the use of such emulsifiers as VNIHFI emulsifier No. 1 and T-2 emulsifier, since the emulsifiers used in pharmacy practice did not provide proper preservation during their long-term storage and transportation.

Liniments are made mainly in two ways: by mixing and grinding in a liquid medium. The choice of preparation method depends on the type of liniment, the expected degree of dispersion of medicinal substances and the characteristics of the starting substances, including the emulsifier. By mixing, liniments-solutions and liniments-emulsions are obtained. Grinding in a liquid medium - suspension liniments and more complex dispersed systems.

Private technology of liniment-solutions and liniment-emulsions

The simplest method of mixing is to use propeller mixers for this part, with the help of which homogeneous mixtures of liquid components that are mutually soluble in each other are obtained. This group includes liniments: pepper-ammonia, pepper-camphor, saliniment, complex turpentine, capsatrine, Sanitas.

Ammonia liniment(Linimentum ammoniatum). One of the most widely prescribed liniment emulsions, manufactured both in pharmacies and in the factory. In order to increase the durability of the liniment, sunflower oil is replaced with Esilon-4 polyethylsiloxane liquid. This replacement led to an increase in the shelf life of the liniment at room temperature up to 4 years.

aloe liniment(Linimentum Akes). Composition (parts): canned juice from biostimulated leaves of aloe vera - 78, castor oil - 10.1, emulsifier No. 1 - 10.1, eucalyptus oil - 0.1, sorbic acid - 0.2, sodium CMC - 1, 5. Biostimulated aloe leaves are finely chopped and juice is squeezed out under pressure. The juice is heated to 70°C and 95% ethanol is added in an amount of 25% of the juice volume, 0.2% sorbic acid, and after cooling and settling for 15-16 hours, it is filtered. Preheated (up to 70°C) castor oil is added to the melted emulsifier (at 70°C). Aloe juice heated to the same temperature is poured into the resulting base. The mixture is cooled while stirring with a propeller stirrer and eucalyptus oil is added while continuing to stir.

Private technology of slurry liniments and multiphase liniments

Grinding in a liquid medium is carried out using colloid mills and other designs of dispersing apparatus (rotary-pulsation apparatus, etc.).

Liniment balsamic(Linimentum balsamicum) according to Vishnevsky. The composition of the suspension (parts): tar - 3, xeroform - 3 and castor oil - 94. The initial ingredients are loaded into a heated boiler, mixed, and then passed through a colloid mill or a rotary-pulsation apparatus.

Liniments-emulsions-suspensions. A typical example multiphase liniment is synthomycin liniment (Linimentum Synthomycini) 1.5 and 10%. This liniment is a combination of emulsion and suspension. Prepared according to the prescription (parts): synthomycin - 1.5 or 10, castor oil - 20, emulsifier VNIHFI No. 1-5, preservative (salicylic acid) - 0.125, sodium CMC - 2, water up to 100 parts. Synthomycin and a preservative are mixed with part of the castor oil, after which the suspension is diluted with the rest of the oil and triturated in a colloid mill. The emulsifier is dissolved in water in a boiler with steam heating and a turbine agitator, after which sodium CMC (stabilizer) is introduced into the emulsifier solution. A creamy mass is formed. It is heated to 60-70 ° C, a suspension of synthomycin in castor oil is added, mixed and quickly cooled without stopping stirring. Packed in sterile jars. According to the same scheme, streptocide and tesan liniments are made.

Packaging and packaging of ointments and liniments. Storage

Ointments and liniments are supplied to the pharmacy network in packaged form. Packaging is carried out using screw and piston dosing devices. For ointments, the most hygienic, convenient, guaranteeing ointment from the harmful effects of atmospheric air and pollution is packaging in metal tubes (aluminum) or tubes made of plastics. Divisions can be applied to the tubes, allowing dosing of the ointment. Tubes can also be attached to nozzles (made of plastic) with holes on the top and side surface, which facilitate the introduction of ointments into the cavity. Tube filling machines are used to fill tubes.

Ointments and liniments in all types of packaging should be stored in a cool, dark place. Ointments containing mercury, iodine, tannins should not come into contact with metal objects. Emulsion ointments and liniments, as well as ointments on emulsion bases, should be stored in filled containers (to avoid dehydration of the upper layers) and at a temperature not lower than zero and not higher than 30-40 ° C (to avoid violation of homogeneity). Ointments and liniments on fatty bases must be stored at a low temperature (rancidity is prevented). An increase in temperature is unacceptable for ointments and liniments containing thermolabile medicinal substances.

plasters

Patches - a dosage form for external use, which has the ability to stick to the skin after softening at body temperature. At room temperature, the patch masses are dense, but at body temperature they become soft and sticky. With a further increase in temperature, the patches begin to melt, turning into thick liquids. For ease of use, spread the patches on cloth or paper. According to the dispersion classification, plasters should be attributed to free comprehensively dispersed systems with an elastic-viscous dispersion medium that allows formation (rolling out or extrusion of sticks, pouring into molds).

Plasters are one of the oldest dosage forms. They can be used to protect any part of the body from harmful external influences; to hide skin imperfections; to bring together the edges of wounds; for fixing dressings on the surface of the skin. The patches used for these purposes are called epidermal. Various medicinal substances are introduced into the patch masses for the purpose of therapeutic effects on diseased skin. Such patches are called endermatic. Patches with medicinal substances that penetrate the skin and affect deep-lying tissues are called diadermatic.

Epidermal patches should be sufficiently sticky, adhere tightly to the skin and not irritate it. Endermatic and diadermatic patches are made softer in consistency, they should ensure the action of drugs, facilitating their penetration to a known depth.

Plasters have long been a factory-made dosage form. The functions of the pharmacy include only sometimes spreading on fabric or paper those plasters that are produced in the form of masses. Plasters are classified: by composition - into ordinary and rubber ones and by preparation - into plasters in bulk and plastered plasters.

Plasters ordinary

Depending on the substances prevailing in the plaster base, ordinary plasters are divided into lead, lead-resin, lead-wax and resin-wax plasters.

Plain lead plaster (Emplastrum Plumbi simplex). Chemically, it is a mixture of lead salts of oleic, palmitic and stearic acids with a significant predominance of the former. It is made according to the recipe (part): sunflower oil - 10, purified lard - 10, lead oxide - 10 and water in sufficient quantities. Fats are melted in a steam-heated boiler. Then the steam inlet is stopped and lead oxide is added in the form of a fine suspension in 2 parts of water. A stirrer is put into operation and after 15 minutes at a temperature of 100-110 ° C, hot water is added in small portions to the boiler every 5 minutes, making sure that it does not completely boil away. A saponification process takes place, which lasts about 2 hours; the initially red mixture gradually turns into a whitish-gray, and at the end of cooking - into a whitish mass.

The cooking of the patch is considered complete when a small sample, poured into cold water, gives a plastic mass, which, when crushed, is not easily soiled and does not stick to the fingers. Next, the patch is freed from glycerin formed during the hydrolysis of triglycerides of fats, for which the still hot mass is poured through a thick metal sieve into warm water, where it solidifies in the form of threads. This significantly increases the contact surface of the mass with water, which facilitates the washing of glycerin. Then the plaster mass is transferred to a steam-heated kneader, where it is mixed with warm water. The water is drained, after which mixing with water is carried out several more times. The patch washed in this way is again transferred to the boiler and heated to 105-110 ° C until the water is completely removed. The finished patch mass is rolled out or squeezed out using a suppository press into sticks, which are wrapped with parchment paper.

A simple lead plaster, in addition to direct use in medicine (for purulent-inflammatory processes of the skin, boils, carbuncles), serves as the basis for the preparation of all other types of ordinary plasters.

Lead-resin patches. This includes a complex lead plaster (Emplastrum Plumbi compositum), which is an alloy of simple lead plaster (85 parts) with rosin (13.75 parts) and turpentine (1.25 parts). Produced in the form of sticks, it is used as a mild irritant.

Lead-wax patches. This includes epilin plaster (Emplastrum Epilini), which is an alloy of simple lead plaster (54 parts), yellow wax (5 parts), anhydrous lanolin (22 parts), into which 4 parts of epilin dissolved in 15 parts of water are introduced.

Resin-wax patches. This includes corn plaster (Emplastrum ad clavos). Prescription (parts): salicylic acid - 20, rosin - 27, paraffin - 26 and petrolatum - 27. Salicylic acid is dissolved in a still warm alloy with stirring, and then poured into molds of 3 g.

Rubber plasters

Rubber patches are mixtures of unvulcanized (natural) rubber with resins, balms, fat-like and other substances (anti-aging agents, etc.). The presence of rubber in these patches, which makes them highly sticky, makes them widely used as an epidermal patch. The addition of rubber to the adhesive mass is carried out by preliminary dissolving it in special closed boilers in aviation gasoline. The remaining substances are added to the resulting rubber body, after which the mass is mixed until completely homogeneous. Then the mass enters the patching machine, with which it is applied to the fabric. The solvent must be removed, so the tape, on which the plaster is applied, is enclosed in a cabinet through which warm air is sucked. The cabinet is divided into a number of compartments with different temperatures (20, 30, 35, 45°C). The patch, passing successively through these compartments, is freed from the solvent, and so that it can harden, it is finally passed through the compartment in which cold air circulates. The solvent (gasoline) is recovered.

Sticky plaster rubber smeared. Adhesive plaster (Emplastrum adhaesivum elasticum extensum). The plaster mass is applied to the chiffon. Its layer should be of such thickness that a piece of chiffon with a spread mass measuring 5x5 cm weighs 0.64-0.65 g. This is achieved as a result of 6-7 spreads. The tape standardized in this way is well dried over hot plates, cooled by blowing air and unwinded into rolls 5, 2 and 1 m long using an unwinding machine. Next, the rolls are cut into coils 1, 2, 3, 4, 5 and 6 cm in size. in waxed paper and stacked in cardboard boxes, 1 spool. The adhesive plaster, in addition, is produced in the form of strips 4x10 cm and 6x10 cm in size on a cream-colored staple fabric, covered with a protective layer of cellophane and packed in bags of 1 piece. Adhesive plaster in strips is designed for a wide range of consumers.

Adhesive plaster can be used for applying medicinal substances. Such, in particular, is a bactericidal patch (Emplastrum adhaesivum bactericidum), which consists of a gauze pad impregnated with an antiseptic solution, having the following composition (%): furatsilina - 0.02, synthomycin - 0.08, brilliant green - 0.01 in 40 % ethanol. The impregnated gasket is applied to the fixing adhesive tape. From above, the patch is covered with a protective layer of starch gauze and cellophane. The bactericidal patch is an excellent tool that prevents the occurrence of pustular skin diseases, is used for microtrauma of the fingers, hands and is convenient for first aid in everyday life, at work and in medical institutions. The patch is available in different sizes.

Medicinal substances can also be included in the adhesive mass of the adhesive plaster. These include pepper patch (Emplastrum Capsici) containing 8% capsicum thick extract, 0.6% belladonna thick extract and 0.6% arnica tincture, 22% natural rubber, 21% pine rosin, 18% anhydrous lanolin, 2% oil vaseline. It is produced in the form of rectangular pieces of paper measuring 12x18, 10 and 8x18 cm. Each package contains two pairs of such pieces lined with cellophane.

A corn plaster (Emplastrum adhaesivum ad clavos) is also produced on the basis of the adhesive plaster.

Release of patches from pharmacies

In addition to dispensing in finished form, patches in some cases also pass through the prescription department of a pharmacy. Patches can be prescribed in mass (piece, stick), or smeared on cloth or paper. The amount of patch mass needed to prepare a spread patch depends on the size of the surface indicated by the doctor. If there is no special indication in the recipe about the amount of mass to cover a certain area, then it is taken so much that the layer thickness does not exceed 1 mm. To spread the adhesive mass on a piece of material of a certain shape, in pharmacy practice, templates are used, i.e. frames made of thin tin.

The frame is applied to the material and with the help of a spatula, the heated plaster mass is smeared into shape. When the layer of patch mass reaches the required thickness, the surface of the patch is trimmed with a heated knife, then the edges are trimmed and wrapped in paraffin paper. Release the adhesive in the box. Standard sizes of templates for spreading plasters are in the form of a brush, palm, ear, playing card.

Liquid patches (skin adhesives)

Skin adhesives are liquids that leave a sticky, elastic, durable film on the skin when the solvent evaporates. Skin adhesives are thus liquid patches (Emplastra liquida). They are relatively widely used as epidermal and endermatic patches. Most often, the adhesive film is formed with the help of substances such as rosin or collodion. To give greater elasticity, vegetable oils are added to the mixture. The industry produces the following types of liquid plasters.

Collodion(Collodium). 4% solution of nitrocellulose in a mixture of ethanol and ether (20 + 76 parts). It is used to secure surgical dressings and cover small wounds and abrasions. Elastic collodion (Collodium elasticum) contains 3% castor oil.

On the basis of collodion, they produce: corn liquid (Liquor ad clavos), containing salicylic acid and brilliant green, and Novikov liquid (Liquor Novicovi), containing tannin and brilliant green, used to treat abrasions and cracks.

cleol(Cleolum). It is used to fix surgical dressings, obtained by dissolving 40 parts of rosin in an alcohol-ether mixture (33 + 15 parts) with the addition of 1 part of sunflower oil for film elasticity. All collodion and resin adhesives should be stored in a cool place away from fire.

mustard plasters

Mustard plasters are rectangular sheets of paper measuring 8x12.5 cm, coated on one side with a layer of powder of defatted mustard seeds 0.3-0.5 mm thick. The raw material is the seeds of Sarepta mustard (Semena Sinapis junceae). After removing the seed coat and grinding, the fatty oil is first squeezed out of the seeds. The remaining fatty oil from the cake is first extracted with gasoline, and then in Soxhlet-type apparatuses. The presence of fatty oil adversely affects the quality of mustard plasters - the therapeutic effect slows down, and during storage, the mustard powder turns rancid and peels off the paper. A paste is prepared from the obtained defatted mustard cake powder by mixing it with a solution of rubber in gasoline. Spreading is done using a patching machine. The technological process consists of five stages: 1) glue preparation (2% rubber solution in gasoline); 2) preparation of mustard mass (a mixture of equal parts of mustard powder and glue); 3) spreading the mass on paper and drying the roll; 4) cutting the roll and packing mustard plasters; 5) gasoline recovery.

Mustard plasters are produced in cellophane bags or paraffin paper bags of 10 pieces. Every tenth mustard plaster on one side has a label indicating the method of application.

The use of mustard as an irritant is based on the hydrolysis of the glycoside sinigrin, which is in the seeds, and the release of mustard essential oil, which consists entirely of allyl isothiocyanate. This hydrolysis proceeds only if the emulsion enzyme (myrosin) is preserved in the cake.

The quality of mustard plasters is assessed by the content of allyl isothiocyanate. In addition, mustard plasters are dipped for 5-10 seconds in water with a temperature of 37 ° C, after which they are tightly applied to the skin; while the mustard must cause a strong burning sensation of the skin no later than 5 minutes. Packs of mustard plasters must be stored in a dry place; shelf life 8 months. In the presence of moisture, hydrolysis of sinigrin occurs and mustard plasters lose their activity.

1 stage. Preparation of LP and VV.

1 operation. Seed degreasing.

Mustard seeds are weighed (scales), after removing the shells, they are crushed (possibly on roller crushers by crushing - one roller is fixed in a fixed bearing, the other in a movable one, thus the gap is regulated) and cold pressing is used to press fatty oil on a hydraulic press (reduces stability when storage, inhibits the breakdown of glycosides, worsening the therapeutic effect). The rest of the fatty oil is removed by extracting the cake with defatted chloroform (carbon tetrachloride, gasoline) in a Soxhlet circulation apparatus.

2 operation. Preparation of rubber glue.

2.1. rubber (does not irritate the skin, is indifferent, has great elasticity, air and moisture resistance) is kneaded on rollers, cut into pieces, dissolved in nephrase, kept for 20 hours.

2.2. rosin solution (for stickiness), stabilizers (akidol-1 in gasoline - to protect against "aging" and loss of elasticity) are added to the solution in the mixer reactor (for example, with anchor, paddle and turbine mixers).

2.3. mix until a homogeneous viscous mass. Viscosity is controlled by the amount of gasoline that will evaporate during the drying process.

2 stage. Preparation of mustard plaster mass.

From 2% rubber glue and mustard powder 1:1, a suspension is prepared by mixing (due to the turbine mixer of the reactor).

3rd stage. Getting mustard plasters.

The mustard mass is transferred to the hopper of the gluing machine.

Paper is wound on a roller (2); the end is pulled through the upper drying chamber with steam-heated hollow plates (1), returned back through the lower cooling chamber and fixed on the take-up roller (3). A knife (5) is lowered onto the filled paper, setting a gap of 0.3-0.5 mm. The mustard mass from the hopper is applied to the paper in front of the knife; when moving the paper, the knife evenly distributes the mass over the entire width. Travel speed 7.5-8.5m/min. When passing over a heated stove, gasoline evaporates, its vapors are sucked out through a pipe (6) and fed to recovery.

4th stage. The dried paper tape is cut on a sheet-cutting machine into sheets 75*76*90 cm in size, which are cooled for 24 hours.

Stage 5 Packing.

They are cut into smaller ones and packaged in 10 pieces, marking (possibly on the packaging and marking line).

Quality control.

2.soaked 5-10sec. Mustard must cause redness and burning no later than 5 minutes.

A) Make a description, characteristics of the drug.

Mustard plasters are a kind of rubber patches. On the one hand, they are covered with rubber glue and powder of defatted mustard seeds with a thickness of 0.3-0.55 mm.


The powder is obtained from the seeds of black and sarep mustard, which contain the glycoside singirin, which breaks down under the action of the enzyme myrosin into glucose, potassium hydrosulfate, mustard oil (allyl isothiocyanate), which causes irritation and flushing of the skin.

B) Justify the composition of excipients.

3. The distillery released 860 liters of anhydrous ethanol in the form of a solution with a strength of 90%. What is the weight of the dispensed ethanol? What volume does it occupy at 26°C?

Vbezv \u003d V26 solution * Mt5; Vp-ra=Vbezv/Mt5=860\.........=

V20 bezv \u003d M20 solution * Mt6; Mr-ra \u003d Vbezv / Mt6 \u003d 860: ... ... .. \u003d kg.

Mt5, Mt6 see table. GOST table 5

No. 33. 1. Draw up a technological scheme for the production of an aerosol preparation ("Ingalipt") of the following composition: streptocide 0.75, norsulfazol 0.75, thymol 0.015, eucalyptus oil 0.015, mint oil 0.015, ethanol 1.8, sugar 1.5, glycerin 2, 1, twin-80 0.9, water up to 30.0, gaseous nitrogen 0.3-0.42.

Production scheme:

1) Preparation of the concentrate. It is carried out in a reactor. Drugs are dissolved or dispersed in solvents (ethanol, glycerin, vegetable oils) using excipients (tween-80) - to impart aggregative stability. Ready concentrate - in the collections, from where it is fed to the automatic line for filling cylinders.

2) Preparation of propellant: providing a working pressure under which nitrogen is supplied to the aerosol can. Transportation of propellants is carried out using a pump or under pressure created by a gas.

3) Filling aerosol cans: because propellene is a compressed gas, then filling is carried out only under pressure. Gas is injected in the amount of 50-85%, providing the necessary internal pressure (manometer control). The concentrate is dosed into the balloon, air is removed from it (an inert gas is introduced or evacuated), sealed with a valve, and a propellant is injected through it through a pipeline under pressure.

Criteria for choosing the type of aerosol can: capacity, material (should not interact with the contents; must have high chemical and thermal resistance). In our country, glass cylinders (NS-1, NS-3) are produced. 15-80 ml. The valve is selected depending on the propellant: when using nitrogen, a special spray device is required that mechanically crushes the jet of the sprayed liquid, because nitrogen does not interact with solvents and water.

4) Evaluation of the quality of aerosol packaging. Check for strength (must withstand pressure, 1.5-2.5 times higher than operating pressure at T 45+/-5); tightness (immersed in a bath of water at T 45-50 for 20-25 minutes - no gas bubbles should be released); net weight - control weighing; checking for flammability of the spray mixture; qualities. and quantity component content. The maximum volume of filling with concentrate and propellant is regulated.

B) Tank design

The package consists of a cylinder (3), hermetically sealed with a valve, a siphon tube (4), a valve-spray device (1), (2) and the contents of the cylinder (5), (6), into which the siphon tube is immersed, designed to supply the solution , emulsion or suspension of the medicinal substance and propellant "to the hole in the valve stem for spraying. Above the layer of the liquid phase in an equilibrium state with it is a layer of saturated vapor of the propellant (compressed or liquefied gas), with the help of which the content is dispensed and dispersed in the air.

C) Hardware diagram:

1.Cylinders on the conveyor belt

2. Washing machine (washing, rinsing, steaming, drying)

3. Storage table (for performance leveling)

4.Automatic purging with sterile air

5. Automatic dosing device (concentrate filling, air removal)

6.Automatic valve fixing (sealing)

7.Dispenser (propellant injection)

8. Analyzer (water bath) (Quality control of filling, pressure)

9. Drying tunnel

10. Control scales (rejection)

11. Manometer (gas pressure control) rejection.

12. Automatic spray gun.

13. Packing machine.

2. Draw up a technological scheme for obtaining a liquid extract by countercurrent extraction.

Technology system. (for example get Chl)

1 stage. Preparatory.

1 operation. extractant preparation:

1.1. extractant calculation: 1:1, means X + X * K of ethanol absorption

1.2. calculation of strong alcohol, measuring

1.3. bringing strong alcohol to the calculated volume of extractant

1.4. concentration check (e.g. hydrometer)

2 operation. preparation of raw materials (1: 1) weighed (scales) Xkg of crushed raw materials,

2 stage. Extraction.

2.1. in a battery of 5-15 extractors (for large-scale production) interconnected by means of fittings and pipelines.

Raw materials are loaded in equal parts. Pure extractant is continuously fed to raw materials in 1 extractor. At the time of receipt of the finished product from the last extractor, the first one is turned off and a spare one is loaded. The pure extractant is supplied to the raw material in the 2nd extractor, the finished product is obtained from the spare, etc. That. the finished product is obtained from the least depleted raw materials. A significant difference in concentrations is maintained throughout the battery. The method allows you to deplete the raw materials as much as possible. The number of extractors and the speed of the extractant are calculated so that when the finished extract is obtained from the last extractor, the raw material is completely depleted in 1.

2.2. in continuous extractors.

2.2.1. disk (two pipes at an angle of 30 degrees, inside a cable with perforated disks)

extractant through the right branch pipe, raw materials are supplied from the feeder on the left. The finished product after 2-3 hours (for 1 turn of the cable) flows out of the pipe under the feeder.

2.2.2. spring-vane extractor - the body is divided into sections, in each drum with 2 arcuate spring blades, which immerse the raw material in the extractant, wring it out and transfer it to the next section; a heater is located under the bottom and extraction can be carried out in a wide temperature range).

2.2.3. vertical screw extractor in the body 2 vertical and 1 horizontal screws that move the raw material.

3rd stage. Recovery of ethanol from spent raw materials.

Distillation with water vapor (it is heated into a percolator with a steam jacket by steam entering the jacket; live steam is supplied through the bubbler, which passes through the entire thickness of the raw material and entrains ethanol, which, passing through a surface condenser (tubular or coiled p. 56), turns into a distillate and enters collection).

4 stage. Cleaning.

a) settling (T=8gr)

b) filtration (through a press filter)

Stage 5 Standardization

b) ethanol (by distillation) (n.m. 54%)

c) hMe (nb 0.001%)

d) dry residue

6 stage. Packing, capping, marking.

A) Give a comparative description of the methods of extraction upon receipt

liquid extract.

The method is determined by the efficiency of the production of the finished product and depends on the properties of the extractant and plant material, as well as the structure of the latter.

B) Make a hardware production scheme.

Situational calculation problem. What is the volume of 290 kg of a water-alcohol solution at 20°C if it contains 110 kg of anhydrous alcohol? What is the concentration of this alcohol in percent by volume?

Vc (by volume) = (110*100%)\290=37.9%

According to the type of formation of a suspension dispersion system, all of the listed substances are introduced into the composition of ointments on lipophilic bases EXCEPT 1 sulfadimesine 2 zinc oxide 3 zinc sulfate 4 camphor 5 bismuth nitrate basic ...


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  1. Technology of finished medicines
  2. The completeness of the extraction of active substances from medicinal plant materials is affected by:
  3. application of concentrate extracts
  4. the ratio of raw materials and extractant
  5. percolator shape
  6. all of the above factors
  7. The completeness of the extraction of active substances from medicinal plant materials is affected by
  8. applied volume of extract-concentrate
  9. order of adding ingredients
  10. extraction temperature
  11. Excipients
  12. all of the above factors
  13. Ultrasound is used in pharmacy to
  14. analysis of the chemical composition of the medicinal product
  15. drug drying
  16. ionization of molecules of active substances
  17. accelerating the impregnation of raw materials with an extractant
  18. changes in the properties of substances
  19. The main stages of the extraction process are
  20. reverse osmosis
  21. dialysis
  22. absorption
  23. During extraction, the following physicochemical processes take place
  24. diffusion
  25. desorption
  26. dissolution
  27. dialysis
  28. all of the above

6. According to the type of dispersion system, ointments can be

1) gels

2) extraction

3) homogeneous

4) resorptive

5) pastes

7. The components of the lipophilic bases of ointments belonging to the group of hydrocarbons are all EXCEPT

1) ceresin

2) paraffin

3) ozokerite

4) petrolatum

5) spermaceti

8. Fatty lipophilic bases include

1) polyethylene oxide bases

2) spermaceti

3) petrolatum

4) lard

5) gelatin-glycerin

9. The type of hydrophilic bases are

1) gels of cellulose derivatives

2) butyrol

3) vaseline/lanolin water

4) silicone

5) base for antibiotic ointments

10. The group of hydrophilic bases containing proteins and polysaccharides includes gels

1) collagen

2) lard

3) polyvinylpyrrolidone

4) bentonite

5) butyrol

11. The type of amphiphilic emulsion bases includes

1) glycerin ointment

2) starch

3) basis of ammonia liniment

4) bentonite clay gels

5) Rosenthal liniment base

12. The type of amphiphilic absorption bases includes

1) alloy of vaseline with anhydrous lanolin and sunflower oil

2) consistent base "water / petroleum jelly"

3) vaseline/lanolin water

4) gelatin

5) gels of acrylic acid derivatives

13. Homogeneous dispersed systems are ointments

1) furacilin

2) mercury amidochloride

3) ophthalmic mercury oxide

4) turpentine

5) ichthyol

14. Heterogeneous dispersed systems are ointments

1) ophthalmic mercury oxide

2) ichthyol

3) turpentine

4) extraction

5) camphor

15. According to the type of formation of a suspension dispersion system, all of the listed substances are introduced into the composition of ointments on lipophilic bases, EXCEPT

1) sulfadimesine

2) zinc oxide

3) zinc sulfate

4) camphor

5) bismuth nitrate basic

16. Absorption-based emulsion ointment forms

1) xeroform

2) dermatol

3) novocaine

4) bismuth nitrate basic

5) streptocide

17. Suspension ointments include

1) synthomycin liniment

2) Pasta Lassar

3) Vishnevsky stabilized liniment

4) ammonia liniment

5) Naftalan oil ointment

18. Emulsion ointments include

1) extraction

2) ichthyol

3) Naftalan oil

5) Vishnevsky stabilized liniment

19. Foundation for ointment does not meet the following requirements:

  1. smearing ability;
  2. absorbent capacity;
  3. chemical resistance;
  4. not indifference in pharmacological terms;
  5. resistance to microbial contamination

20. What is the industrial method for preparing suppositories fromthermolabile substances

1) pouring;

2) drip;

3) pressing;

4) dispersion;

5) rolling out

21. Unlike the bases for ointments, the bases for suppositories should

1) release drugs, be solid at room temperature, dissolve at body temperature

2) dissolve at body temperature, be solid at room temperature, melt at body temperature

3) be soft consistency, dissolve at body temperature, be storage stable

4) drug release, drug release, melt at body temperature

5) be solid at room temperature, melt at body temperature, release drugs

22. Lipophilic bases for suppositories include

1) cocoa butter, fatty

2) soap-glycerin, fatty

3) fatty, witepsol

4) gelatin-glycerin, witepsol

5) witepsol, cocoa butter

23. The type of amphiphilic bases for suppositories includes

1) hard fat type A

2) cocoa butter

3) witepsol

4) polyethylene glycol

5) soap-glycerin

24. Hydrophilic bases for suppositories are

1) lanol

2) witepsol

3) cocoa butter

4) polyethylene glycol

5) hard fat type A

25. The replacement factor differs from the inverse replacement rate in that

1) shows what mass of medicinal substance is equivalent in volume to 1.0 bases

2) shows the amount of the base, equivalent in volume to 1.0 of the substance

3) calculated for the amount of medicinal substances

4) shows what volume of the medicinal substance is equivalent in volume to 1.0 bases

5) shows the density of the base, equivalent to the density of 1.0 of the substance

26. When conducting research on a base intended for the manufacture of suppositories by pouring into molds, you will determine the solidification temperature as the temperature

1) the beginning of hardening

2) end curing

3) medium

4) remaining constant for a short time of the transition of a substance from a liquid state to a solid state

5) there are no correct answers

27. When a solution of adrenaline hydrochloride is introduced into the composition of the suppository mass in a volume exceeding the water-absorbing capacity of the base, a technological method is used

1) emulsification

2) evaporation to a minimum volume

3) resuspension

4) dispersion

5) layering

28. In suppositories on lipophilic and amphiphilic bases

DO NOT administer by type of suspension

1) chloramphenicol

2) sulfadimezin

3) belladonna extract

4) streptocide

5) xeroform

29. In lipophilic suppositories, DO NOT administer as an emulsion

1) zinc oxide

2) protargol

3) ichthyol

4) epinephrine hydrochloride

5) collargol

30. Does not dissolve in hydrophilic bases for ointments and suppositories

1) anestezin

2) epinephrine hydrochloride

3) tannin

4) novocaine

5) protargol

31. Amphiphilic bases for the manufacture of suppositories include

1) soap-glycerin

2) gelatin-glycerin

3) cocoa butter

4) lazupol

5) PEG alloys

  1. The absorption bases are

1) water/Vaseline consistency emulsion, eye ointment base, witepsol

2) witepsol, base for antibiotic ointments, base for eye ointments

3) base for eye ointments, fat base for suppositories, witepsol

4) fatty suppository base, eye ointment base, antibiotic ointment base

5) base for ointments with antibiotics, fat base for suppositories, witepsol

  1. When controlling the quality of suppositories in accordance with the Global Fund, all indicators are checked EXCEPT

1) deviations of the mass of the suppository from the average mass

2) dissolution time

3) disintegration

4) full deformation time

5) uniformity

  1. The dissolution time is determined

1) for pills

2) for hydrophilic suppositories

3) for boluses

4) for suppositories on lipophilic and amphiphilic bases

5) for granules (homeopathic grains)

35. In accordance with the classification for medical purposes, plasters are:

1) resin-wax

2) epidermal

3) lead

4) rubber

5) mustard plasters

36. Adhesive masses include the following groups of excipients

1) antioxidants that impart stickiness, aggregation

2) sliding, plasticizers, antioxidants, stickiness

3) imparting stickiness, neutralizing resin acids, lubricating

4) plasticizers, anti-oxidants, tackifiers, neutralizing resin acids

5) plasticizers, antioxidants, softeners, neutralizing resin acids

37. The initial components for the preparation of a simple lead patch include

1) sunflower oil, rubber, lead oxide

2) gasoline, lanolin, lead oxide, zinc oxide

3) lanolin, rosin, lead oxide

4) sunflower oil, pork fat, lead oxide, water

5) gasoline, rubber, lead oxide

38. Does not apply to liquid patches

1) collodion

2) perigel

3) furoplast

4) glue BF-6

5) pepper plaster

39. Does not apply to ordinary patches

1) mercury

2) pepper

3) acrychin

4) complex lead

5) epiline

40. The initial components for the preparation of the adhesive plaster are

1) rubber, rosin, lanolin, liquid paraffin, neozone, gasoline, sulfur

2) rubber, zinc oxide, lanolin, liquid paraffin, neozone, gasoline

3) rosin, zinc oxide, lanolin, liquid paraffin, neozone, salicylic acid

4) rubber, rosin, neozone, zinc oxide

5) rubber, rosin, gasoline, zinc oxide, lanolin, liquid paraffin, neozone

41. The substance used as a film-forming element in liquid patches is not

1) collodion

2) rosin

3) polyethylene glycol

4) ethyl cellulose

5) polymethacrylates

42. The process of making mustard plasters does not include the stage

1) seed pressing

2) oil cake degreasing

3) cake hydrolysis

4) preparation of mustard mass

5) application of mustard mass on paper tape

43. What compounds provide the therapeutic effect of mustard plasters

1) fatty oil, myrosin, sinetrin

2) aliisothiocyanate, myrosin, sinetrin

3) emulsions, fatty oil, myrosin

4) synethrin, aliisothiocyanate, emulsions

5) myrosin, sinetrin, emulsions

44. Medicinalphytofilms are not classified according to their area of ​​application:

  1. dental;
  2. ophthalmic;
  3. otorhinolaryngological;
  4. therapeutic;
  5. gynecological.

45. The composition of transdermal therapeutic systems (TTS) cannot contain substances that meet the following requirement:

  1. good permeability through the skin;
  2. neutrality of molecules;
  3. sufficient solubility in hydrophobic and hydrophilic media;
  4. high efficiency in small doses;
  5. molecular weight exceeds 1000 Daltons;

46. ​​In the production of transdermal therapeutic systems (TTS), excipients of the following group are not used:

  1. penetrators;
  2. propellants;
  3. adhesives;
  4. plasticizers;
  5. prolongators

47. As the main (film-forming) excipients in the production of transdermal therapeutic systems (TTS), the following are not used:

  1. Twin-80;
  2. Collagen;
  3. Dextran;
  4. Polyvinylpyrrolidone;
  5. Methylcellulose

48. In production , molecules of active substances with a carrier, notconnect by type:

  1. the medicinal product is included in a spherical or cylindrical shell for the purpose of implantation or oral administration (no chemical bonding with the polymer);
  2. drug molecules are included in the main chain of the polymer;
  3. drug suspension added to polymer solution
  4. the drug substance is attached by a covalent bond to the side chain of the polymer;
  5. the drug is uniformly distributed in the polymer solution or in the polymer block as a solid solution, or dissolved in the polymer solution (no covalent bond)

49. Phytofilms can be subdivided according to their design features:

  1. on monolayer;
  2. on multilayer;
  3. on bilayer;
  4. on monolithic;
  5. into dispersed

50. Biodegradationtransdermal therapeutic systems (TTS)does not flow through the following mechanism :

  1. destruction under the influence of temperature;
  2. enzymatic degradation;
  3. dissociation of polymer-polymer complexes (PPC);
  4. dissolution or non-specific hydrolysis of polymers in tissue fluids;
  5. intermolecular catalysis of PPK cleavage or intramolecular cleavage of water-insoluble polymers to form soluble fragments

51. Ravioli are called:

  1. matrix ;
  2. phytofilms;
  3. membrane transdermal therapeutic systems (TTS);
  4. medical glue;
  5. film-forming substances

52. What the auxiliary substance, from the above, has the properties of a plasticizer:

  1. water;
  2. glycerin;
  3. dimexide;
  4. polyacrylic acids;
  5. Sodium carboxymethyl cellulose

53. What functions do penetrators perform in transdermal therapeutic systems (TTS):

  1. co-solvent of the active substance;
  2. The solvent of the active substance;
  3. Substances that improve stickiness;
  4. Substances that improve the plasticity of the adhesive mass;
  5. Substances that improve the permeability of the active substance

54. In the production of tablets, the stages follow in sequence

1) granulation, dusting, mixing, pressing, coating, packaging

2) mixing, dusting, granulating, pressing, coating, packaging

3) granulation, mixing, dusting, pressing, coating, packaging

4) mixing, granulating, dusting, pressing, coating, packaging

5) mixing, granulating, dusting, coating, pressing, packaging

55. Disintegration of uncoated tablets in distilled water must be completed

1) in 15 min.

2) in 30 minutes

3) in 10 min.

4) in 45 minutes

5) in 60 minutes

56. The amount of the medicinal substance released from the tablets in terms of "Dissolution" should be

1) 30% in 45 minutes

2) 10% in 15 minutes

3) 100% in 60 minutes

4) 75% in 45 minutes

5) 50% in 30 minutes

57. Powdered granulate for all listed qualities, EXCEPT

1) improve compressibility

2) prevent delamination

3) improve flowability

4) prevent adhesion to punches

5) there is no correct answer

58. Mixers are used to mix powdered materials.

1) with rotating body

2) with rotating blades

3) pneumatic

4) with fluidization

5) all answers are correct

59. Tableting conditions on a rotary tablet press

1) dosing of bulk masses by volume, creation of bilateral gradually increasing pressure on the pressed material

2) tableting due to one-sided impact with the upper punch, the creation of a two-sided gradually increasing pressure on the pressed material

3) tableting due to one-sided impact with the upper punch, dosing of bulk masses by volume

4) the formation of a moistened mass in special forms, the creation of a bilateral gradually increasing pressure on the pressed material

5) formation of a moistened mass in special forms, dosing of bulk masses by volume

60. The analysis of the granulate is carried out according to the following indicators, EXCEPT

1) the average weight of the granule and the deviation from it in order to determine the uniformity

2) particle size distribution

3) bulk density

4) flowability

5) moisture content

61. Direct compression tablets medicinal substances

1) with a crystalline isometric shape, with good flowability

2) included in the tablets in in large numbers

3) pretreated surfactants

4) coloring

5) hydrophobic

62. Equipment for wet granulation of tablet masses

1) dryer-granulator, comiactor

2) dryer granulator, universal granulator

3) universal granulator, rotary beater machine

4) rotary beater machine, comiactor

5) comiactor, universal granulator

63. Double-compression tablet machines produce

1) dry pressed coating on tablets

2) trituration tablets

3) matrix tablets

4) pills with risk

5) there is no correct answer

64. The technological properties of powders include

1) bulk mass

2) fluidity

3) compressibility

4) porosity

5) all answers are correct

65. The bulk density of powders depends on all indicators, EXCEPT

1) particle shapes

2) particle size

3) moisture content

4) true density

5) wettability

66. Dosing accuracy depends on the technological properties of powders, EXCEPT

1) flowability

2) fractional composition

3) compressibility

4) bulk density

5) there is no correct answer

67. Powder moisture affects

1) flowability, particle shape

2) fractional composition, flowability

3) particle shape, compressibility

4) compressibility, flowability

5) particle size, flowability

68. Tablets are obtained by direct compression from the following substances, EXCEPT

1) calcium lactate

2) bromocamphor

3) hexamethylenetetramine

4) sodium chloride

5) potassium iodide

69. The technological cycle of tableting on RTM consists of the following operations

1) crushing, tablet ejection, pressing

2) dosing, pressing, ejection of the tablet

3) pressing, grinding, dosing

4) tablet ejection, dosing, packing into concurrencies

5) packing into concurrencies, pressing, grinding

70. Excipients introduced into the tableted mass in an amount of not more than 1% all, EXCEPT

1) stearic acid

2) twin-80

3) calcium stearate

4) starch

5) magnesium stearate

71. Set the correct sequence of technological operations for the manufacture of tablets

1) screening, powder grinding, mixing, granulating, granulate drying, pressing, tablet filling and packaging

2) granulation, powder grinding, screening, mixing, granulate drying, pressing, tablet filling and packaging

3) powder grinding, sieving, mixing, granulating, granulate drying, pressing, tablet filling and packaging

4) powder grinding, screening, mixing, pressing, granulating, granulate drying, tablet filling and packaging

5) mixing, powder grinding, sifting, granulating, granulate drying, pressing, tablet filling and packaging

72. The requirement is not presented by the Global Fund XI to tablets

1) mechanical strength

2) dosing accuracy

3) localization of the action of medicinal substances

4) disintegration

5) there is no correct answer

73. Excipients used in the manufacture of tablets

1) binding

2) fillers

3) baking powder

4) promote slip

5) all answers are correct

74. DO NOT use as binders in the production of tablets.

1) twin-80

2) water

3) sugar syrup

4) alginates

5) ethyl alcohol

75. Antifriction agents have all effects EXCEPT

1) prevent particles from sticking

2) remove electrostatic charges

3) provide slip

4) reduce the mechanical strength of tablets

5) have a lubricating effect

76. Granulation in the tableting process does NOT allow

1) improve the flowability of powders

2) improve dosing accuracy

3) ensure the release rate of drugs

4) prevent delamination of multicomponent tablet masses

5) ensure even distribution active ingredient

77. Apparatus not used in granulation

1) centrifugal mixer-granulator,

2) SP-30

3) SG-30

4) rotary pulsation apparatus

5) there is no correct answer

78. Set the correct wet granulation sequence

1) mixing medicinal and excipients, dusting, mixing powders with granulating liquid, rubbing the wet mass, drying the granulate

2) mixing medicinal and excipients, mixing powders with granulating liquid, rubbing the wet mass, drying the granulate, dusting

3) mixing medicinal and excipients, mixing powders with granulating liquid, wiping the wet mass, dusting, drying the granulate

4) mixing of powders with granulating liquid, mixing of drugs and excipients, rubbing wet mass, drying of granulate, dusting

5) mixing medicinal and excipients, mixing powders with granulating liquid, dusting, rubbing the wet mass, drying the granulate

79. Methods for obtaining trituration tablets

1) pressing

2) granulation

3) rolling out

4) panning

5) molding

80. Evaluation of the quality of tablets is carried out according to indicators

1) dissolution

2) disintegration

3) average weight

4) deviation from the average mass

5) all answers are correct

81. The strength of tablets does not depend on the specified factor

1) pressing pressure

2) tablet mass

3) the amount of binders

4) properties of active substances

5) the amount of loosening agents

82. Disintegration of tablets does not depend on the following factor

1) the amount of binders

2) pressing pressure

3) powder particle shapes

4) physical and chemical properties of substances

5) properties of active substances

83. Coating tablets with shells does not provide

1) accuracy of dosing of medicinal substances

2) impact protection external environment

3) localization of action

4) improvement of organoleptic properties of tablets

5) prolongation of action

84. The quality of the coating is not affected by the factor

2) the form of tablets-cores

3) coating time

5) the composition of the applied coating

85. What is a spray

  1. airborne spray
  2. powders for inhalation
  3. aerosol, where the drug substance is introduced as an emulsion
  4. drug-free aerosol
  5. all options are possible
  6. According to GF XI aerosols “is a dosage form in which drugs and excipients are under the pressure of a propellant gas”
  7. right
  8. add “dosage form representing solutions, emulsions, suspensions of medicinal substances in which…”
  9. should add "...propellant in a sealed package"
  10. add "... propellant, equipped with a valve-spray system (dosing and non-dosing)"
  11. wrong
  12. Inhalers are
  13. aerosols with a liquid dispersed phase
  14. foam aerosols
  15. type of inhalation aerosol
  16. variety of rectal aerosols
  17. everything is wrong
  18. The advantage of aerosols is
  19. ease of use
  20. increasing the stability of medicinal substances to the effects of light, air, etc.
  21. preservation of sterility
  22. all of the above
  23. The disadvantages of aerosols are
  24. psychological impact on the body
  25. toxic effect of a number of propellants on living organisms
  26. poor transportability
  27. decreased drug stability
  28. all of the above
  29. used as solvents in aerosols.
  30. pentol
  31. trilon B
  32. cellulose derivatives
  33. mineral oils
  34. nipagin
  35. According to the method of application, aerosols are
  36. for inhalation
  37. film-forming
  38. suffocating
  39. foamy
  40. all of the above
  41. used as film formers.
  42. ethanol
  43. acrylic acid derivatives
  44. sodium benzoate
  45. twin-80
  46. thymol
  47. Pharmaceutical propellants are required to
  48. chemical inertness
  49. ease of balloon filling
  50. speed of therapeutic effect
  51. possibility of precise dosing
  52. everything is wrong
  53. The advantages of freons include
  54. not hydrolyzed
  55. cheap
  56. at a slight excess pressure and low temperature, they easily pass from a gaseous state to a liquid
  57. has a prolonging effect
  58. improves drug penetration
  59. Aerosol cans are filled
  60. when heated
  61. at low temperatures in freezers
  62. at low pressure
  63. with stirring
  64. with stirring and heating
  65. The disadvantage of chlorinated hydrocarbons is
  66. toxicity
  67. hydrolyze in the presence of moisture
  68. flammable
  69. harmful effect on the environment
  70. all of the above
  71. The technological process for the production of aerosols includes
  72. preparation of concentrates of medicinal and excipients
  73. filling aerosol cans
  74. obtaining a mixture of propellants
  75. everything is right
  76. everything is wrong
  77. For transportationpropellants on the filling line apply
  78. method of supplying propellant with the help of overpressure
  79. propellant delivery method using natural pressure
  80. method of propellant supply with increasing temperature
  81. mixing propellant supply method
  82. everything is wrong
  83. Standardization of aerosols is carried out according to indicators
  84. cylinder leak test
  85. valve assembly test
  86. determination of the output of the contents of the package
  87. microbiological purity
  88. all of the above
  89. Depending on the nature of the medicinal substance (substance) and dosage, check
  90. particle size of the dispersed phase;
  91. amount of water;
  92. foreign impurities (related compounds);
  93. dosing uniformity
  94. all of the above
  95. Prospects for the development of aerosols
  96. ensuring highly economical production
  97. expanding the range of excipients and propellants that increase the bioavailability of drugs
  98. creation of environmentally friendly aerosols
  99. introduction of aerosol packages that do not contain propellants and carry out mechanical evacuation of the contents
  100. all of the above
  101. Aerosol cans are subject to the following requirements:
  102. ease of use
  103. sufficient strength
  104. heat resistance
  105. maintaining sterility
  106. all of the above
  107. Aerosol cans are not tested for
  108. transparency
  109. strength
  110. uniform wall thickness
  111. chemical resistance
  112. checked for all indicators
  113. Aerosol cans are not made from
  114. plastics
  115. glass
  116. become
  117. aluminum
  118. white sheet with internal varnishing

105. X-ray diffraction analysis used in the development of new drugs provides information

  1. O qualitative composition sample
  2. about the quantitative composition of the sample
  3. about the ability to adsorb
  4. about distances between crystallographic planes
  5. about the refractive index of light

106. What machines are used for medium grinding

  1. roller crusher
  2. dismembrators
  3. jet mills
  4. colloid mills
  5. ball mills

107. According to the method of obtaining a mesh, sieves are distinguished:

  1. drilled
  2. grate
  3. slotted
  4. cast
  5. all of the above

108. What machines are used for ultrafine grinding

  1. jet mill
  2. drum grass cutter
  3. disintegrator
  4. rod mill
  5. vertical ball mill

109. For mixing hard materials mixers are used

  1. with rotating body
  2. worm-bladed
  3. with fluidization of bulk material
  4. centrifugal action
  5. all of the above

110. On what principle do machines for grinding vegetable raw materials work

  1. crushing
  2. impact and shatter
  3. abrasion and crushing
  4. cutting and sawing
  5. breaking and crushing

111. What is the principle of operation of machines for grinding amorphous raw materials

  1. crushing
  2. abrasion and breakage
  3. impact and shatter
  4. impact and crush
  5. cutting and sawing

112. K positive features injection route of administration include

  1. speed of therapeutic effect
  2. possibility of shifting osmotic pressure
  3. injection with violation of the integrity of the skin
  4. the need for qualified medical personnel
  5. possibility of embolism

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The system of requirements for the production and quality control of drugs - "Good Manufacturing Practices" (GMP). The main sections of GMP: introduction, terminology, personnel, buildings and premises, equipment, production process, functions of the quality control department (QC), registration and reporting. GLP, GCP rules.

Legislative acts regulating the quality and conditions of drug production in the Republic of Belarus. Technological regulations, State Pharmacopoeia, FSP. Pharmacopoeia standardization of production and quality of pharmaceutical substances, excipients and dosage forms. GF RB, Pharmacopoeias: European, International, USA, Great Britain, etc. Indicators and quality standards of pharmaceutical substances and drugs.

Differentiation and profiling of pharmaceutical enterprises. The structure of pharmaceutical enterprises. Workshop principle of organizing the production of drugs.

Development industrial production drugs in the Republic of Belarus. Expansion of the nomenclature of drugs for industrial production.

A set of measures for quality assurance, preparation of production, personnel, premises, equipment, materials, documentation, production rules and quality control.

Technological process, its components: stages and operations. Periodic, continuous and combined technological process. Types of technological processes. General concepts: raw materials, ingredients, semi-finished product, finished product, by-product, waste and production waste.

Production regulations as the main technological document. Types of regulations: laboratory, pilot, start-up, industrial and standard industrial. Contents of the regulation: characteristics of the final product of production; chemical scheme of production; technological scheme of production; hardware scheme of production and specification of equipment; characteristics of raw materials, materials and semi-finished products; presentation of the technological process; material balance; processing and disposal of production waste; production control; safety engineering, fire safety and industrial sanitation; environmental protection ; list of production instructions; technical and economic standards; information materials.

Material and energy balance. Technical and economic balance. Technological output, waste, consumption coefficient and consumption rates.

General concepts of machines and devices. The machine as a unity of the engine, transmission and actuators. Characteristics of engines, receiving-transfer and actuators. Characteristics of the devices. Reactors. Control and measuring devices and devices.

2.2. Energy in production processes. Thermal processes. Water vapor as a coolant. Heat exchangers

Characterization of the main processes of pharmaceutical technology: mechanical, hydromechanical, thermal, mass transfer. The role and relationship of technological processes in the production of drugs.

General characteristics of thermal processes. Energy in production processes. Thermal processes in pharmaceutical production. Mechanisms of heat transfer: thermal conductivity, convection, radiation. Joint heat transfer.

Heat carriers. Water vapor as the main coolant. Wet, dry, saturated and superheated steam. Heat content of water vapor, communication and reduction of water vapor. Heating with sharp and deaf steam. Steam consumption during heating. The direction of movement of heat carriers (forward flow, counterflow, cross flow, mixed current), and its effect on the intensity of heat transfer.

Heat exchangers. Classification and characteristics of heat exchangers: surface, mixing, regenerative and with internal heat generation (coil, shell and tube, pipe in pipe, ribbed, steam jackets, scrubbers, refrigerators, boilers, heaters, etc.).

Condensation. Condensation mechanisms. Characteristics of condensers: surface and mixing (co-current and counter-current).

Cryoprocesses. Freezing. Application of refrigeration and freezing in pharmaceutical technology.

2.3. Powders and fees. Grinding and classification of powders. Technological schemes for the production of complex powders and charges. Equipment

The degree of grinding, its dependence on the strength, hardness, elasticity and brittleness of the material. Theoretical basis grinding. Surface and volume theory of grinding. Unified Rehbinder Theory. Grinding methods: crushing, splitting, impact, abrasion, etc. Grinding machines, principle and mode of operation. Dismembrators, disintegrators, Excelsior mills, hammer mills, ball mills, vibratory mills, jet mills. Basic rule of thumb. Features of grinding plant materials. Appointment and use of grinding in pharmaceutical technology.

Cryogrinding, its influence on the quality of the crushed material. Grinding in liquid and viscous media.

Classification of solid materials. Types of classification. Fundamentals of air and hydraulic classification of crushed material. Mechanical classification (screening). Sieve and sieve analysis. Materials and types of nets (woven, stamped, grate). Standards and numbering of sieves. The device and principle of operation of mechanized sieves: swinging, rotating, vibrating. Safety engineering.


Mixing. Production of powder mixtures. Factors affecting the homogeneity of mixtures in the process of obtaining, transporting and storing powders.

Mixers of solid, liquid and pasty materials. Types, devices and principles of operation of mixers: drum, screw, circulation, centrifugal action, gravity, fluidized bed mixers. Powders for external and oral use. Powders are "effervescent". Nasal powders. Powders for the preparation of oral solutions and suspensions, syrups.

Technological and instrumental schemes for the production of powders in a pharmaceutical enterprise. Dosing, packing and packaging of powders in industrial production. Storage: terms and conditions. Powder quality assessment: fineness, content uniformity, mass uniformity, dose mass uniformity in multi-dose containers, etc. Improvement of powder technology. Nomenclature. Carlsbad salt.

Fees. Characteristics of industrial production charges. Technological scheme of production. Nomenclature and private collection technology. Anti-asthma collection. Briquetted charges. Standardization: fineness, mass uniformity for dosed raw materials, mass uniformity for non-dosed raw materials, quantitative determination of pharmacologically active substances.

2.4. Pills. Characteristic. Types of tablets. Requirements of the State Pharmacopoeia of the Republic of Belarus. Equipment. Theoretical foundations of tableting. Characteristics of tablet machines. Study of the physicochemical and technological properties of powders and granulates

Pills. Characteristic. Types and nomenclature of tablets for internal, external, sublingual, implantation and parenteral use.

Technological properties of pharmaceutical substances and excipients: flowability, compressibility, granulometric composition, bulk density, etc. Theoretical foundations of tableting. Mechanical theory, capillary, pressure fusion. Manifestation of forces of cohesion and adhesion during pressing.

Pressing. Tablet machines KTM and RTM. Characteristics and principle of operation. Matrices and punches. Feeders: frame, stirrer, vacuum, vibrating. Tablet machines of double pressing.

2.5. Excipients used in the manufacture of tablets. Technological scheme for the production of tablets

Excipients used in the production of tablets: diluents, disintegrating, sliding, gluing, anti-adhesive (lubricating), dyes, corrigents, prolongators. Characteristic. Nomenclature.

Influence of excipients on the therapeutic efficacy of active substances in tablets.

Stages of the technological process for the production of tablets. Preparation of pharmaceutical substances and excipients. Mixing the ingredients that make up the tablets.

2.6. Direct pressing. Production of tablets without granulation. Trituration tablets

Technological schemes for the production of tablets. Direct tableting and with the use of granulation. Preparation of pharmaceutical substances and excipients. Grinding of pharmaceutical substances and excipients. Screening. vibrating sieves. Mixing the ingredients that make up the tablets. Drum mixers, worm-blade, belt, centrifugal mixers, SPM-200 installations. Production of trituration tablets by molding.

2.7. Production of tablets using granulation

Granulation. Granulation methods: wet, dry, structural. Granulators and mashers: model 3027 granulator, dry granulator, SG-30, SG-60, SG-100 fluid bed granulator, etc.

Drying of the granulate. Fluidized bed dryers SP-30, SP-60, SP-100, ITMO, etc.

Spheronization of granules. Assessment of granulate quality: granulometric composition, moisture content, flowability, compressibility.

Dusting of granules with sliding and release agents.

2.8. Coating of tablets. Granules. Dragee. Evaluation of the quality of tablets. Release of drugs from tablets

Coating of tablets. Purposes and methods of coating: building and pressing. The range and characteristics of auxiliary substances for coating tablets: sugar, sugar syrup, basic magnesium carbonate, dyes, glosses, film formers, plasticizers. Coating extension technology (drying): running-in, testing, polishing, polishing.

Obductors. Application of film coatings. Press coating technology. Production of granulate for pressed coatings.

Multilayer tablets. Extended-release tablets. Retard tablets, film tablets, durules, etc.

Standardization of tablets: average weight of tablets; standards for the content of auxiliary and active substances; dosing uniformity, strength (in compression, brittleness, abrasion), disintegration, solubility (release of medicinal substances). Devices: dynamometers (spring and hydraulic), pendulum pile driver, attritors (friabilators), swinging basket. Characteristics of devices for determining the rate of release of medicinal substances from tablets: simulating the process of absorption, flow type, stirrer type and rotating type.

Package. Semi-automatic packaging machines for tablets. Storage.

Granules. Technological scheme for obtaining granules. Evaluation of the quality of granules. Granules of furazolidone, sand immortelle flowers, etc.

Dragee. Production of pills by the method of building up in dragee boilers (obductors). Nomenclature. Dragee undevit, ferroplex. Package. Storage. Standardization: content uniformity, mass uniformity, disintegration, dissolution.

2.9. Bioavailability of drugs from tablets

The concept of bioavailability. Pharmacodynamic methods for determining bioavailability. Pharmacokinetic methods for determining bioavailability: with a single injection; at repeated appointments; by excretion of the substance in the urine. Principles of bioavailability calculations.

Endogenous and exogenous factors affecting bioavailability.

2.10. Drawing up regulatory documentation for the production of tablets

General characteristics and principles for compiling regulatory documentation for the production of tablets. Technical code of established practice TKP 123-2, pharmacopoeia articles, development and approval procedure. Technical Code of Practice TKP 030-2 Good Manufacturing Practice. Guidance Document Belbiopharm RD 0408.2-96 “Pharmaceutical and microbiological industry products. Technological regulations of production. Development order".

2.11. drugs for parenteral use. Requirements for medicinal products for injection. conditions for industrial production. Characteristics of solvents for injection drugs: aqueous, non-aqueous, mixed. ampoule glass. Production of ampoules, syringe-tubes

Injectable dosage forms. drugs for parenteral use. Injectable drugs. Infusions. Concentrates for the preparation of injection drugs and infusions. Powders for the preparation of injection drugs and infusions. Implants. Napkins. Basic requirements for injectable drugs: sterility, purity (absence of mechanical impurities), bacterial endotoxins-pyrogens, non-toxicity; Additional requirements: isotonicity, isohydricity, isoionicity and isosviscosity.

pyrogens. Characteristic. Effect on the body. Sources of pyrogenic substances in sterile and aseptically prepared dosage forms. Methods for determining pyrogenic substances.

Solvents for injection solutions: aqueous, non-aqueous and mixed. Characteristic. requirements for them. Obtaining water for injection in industrial conditions. Equipment. Apyrogenic single-stage, multi-stage and thermocompression water distillers. Obtaining water for injection by reverse osmosis. Storage of water for injection. Non-aqueous solvents and co-solvents: fatty oils, ethyl oleate, benzyl benzoate, ethyl alcohol, glycerin, propylene glycol, macrogols, amides, etc.

Collection and storage of water for injection. Quality control of water for injection.

Pharmaceutical substances and excipients for injectable drugs. Requirements. Decontamination, depyrogenation and sterilization.

Glass and polymer containers for sterile drugs. Requirements. glass classes. Quality control of glass containers. Test for hydrolytic and thermal stability, fixability of closures and tightness.

Syringe tubes. Production of ampoules. Preparation of ampoules for filling, opening, annealing. Vacuum and syringe methods for washing ampoules.

2.12 Study of the quality of ampoule glass. Ampoule washing

characteristics of the ampoules. Ampoule types. Compound, technical requirements, glass classes. Study of hydrolytic and thermal stability. Ampoule production. Glass core preparation: calibration, washing. Making ampoules on semi-automatic machines, annealing. Preparation of ampoules for filling. Opening of ampoules. Vacuum and syringe washing of ampoules. Drying and sterilization.

2.13. Production of ampouled solutions. Filling, sealing and sterilization. Labeling. Assessment of the quality of solutions in ampoules. Integrated mechanization and automation of ampoule production

Ways of filling ampoules with solutions: vacuum and syringe. Sealing ampoules. Semiautomatic devices for sealing ampoules. Sealing of ampoules with gas protection.

Sterilization of injection solutions. Pharmacopoeial methods of sterilization. Thermal methods of sterilization. Chemical methods of sterilization. Sterilization by filtration. Radiation sterilization method.

Sterilization equipment. Rules for working with devices under pressure. Preparation and implementation of sterilization in steam sterilizers. Air sterilizers. Sterilization modes depending on the properties of objects and their quantities. Sterilization reliability control. Safety precautions for various sterilization methods. Labeling of ampouled solutions.

Complex mechanization and automation of ampoule production.

Evaluation of the quality of injection solutions: transparency, color, volume, sterility, toxicity, bacterial endotoxins-pyrogens, test for mechanical inclusions.

Stabilization of injection solutions of salts of weak bases and strong acids; salts of strong bases and weak acids; easily oxidized substances.


2.14. Features of the private technology of solutions for injections in ampoules. infusion solutions. Production of solutions for injections in ampoules

Features of the production of injection solutions of glucose, novocaine, caffeine-sodium benzoate, apomorphine hydrochloride, calcium chloride, magnesium sulfate, calcium gluconate, ascorbic acid, etc. Oil solutions of camphor, hormones and their analogues.

infusion solutions. Types of infusion solutions: plasma-substituting, water-salt balance regulators for parenteral use, oxygen carriers and polyfunctional. Requirements of isotonic, isohydric, isoionic and isoviscous. Technology of saline, plasma-substituting and detoxification solutions. Solutions of Ringer-Lock, sodium bicarbonate, acesol, disol, chlosol, reopoliglyukin, polyglukin, hemodez, gelatinol.

Features of the technology of injection solutions of thermolabile medicinal substances.

Ways of stabilization of injection solutions. Assortment of stabilizers: acids, alkalis, antioxidants, anti-catalysts, etc. Gas protection. preservatives. Sterile suspensions of industrial production. Suspensions of insulin, corticosteroids, etc. Preparation of emulsions for parenteral use. Ultrasonic installations. Powders for sterile solutions. Technology features. Lyophilization. Packaging of powders in vials and ampoules. Prospects for the development of sterile dosage forms. Ways to improve shelf life.

2.15. Assessment of the influence of technological factors on the quality of injection solutions

Physical, chemical, biological processes occurring in drugs for injection. LS stability. Factors affecting the stability of drugs. Stabilization methods: physical and chemical. The basic principle of stabilization. The shelf life of the finished medicinal product.

2.16. Drawing up regulatory documentation for the production of injectable dosage forms

Technological schemes for the production of injection dosage forms. Description of the technological process for the production of injection dosage forms. Drawing up a material balance taking into account losses at individual stages and operations of production. Technical Code of Practice TKP 030-2 Good Manufacturing Practice. Guiding document of Belbiopharm RD 0408.2-96 “Pharmaceutical and microbiological industry products. Technological regulations of production. Development order".

2.17. Dosage forms for the eyes. Eye films. Sterile suspensions, emulsions, powders and tablets

Eye drops. Eye lotions. Powders for the preparation of eye drops and lotions. Eye soft drugs. Eye inserts. Characteristic. Requirements for stability, absence of foreign mechanical impurities, pH value, comfort, etc.

Industrial production of eye drops. Stages and operations of the technological process.

Stabilization. Preservation of eye drops. characteristics of preservatives. Use of buffer solvents. Prolongation of the action of eye drops with methylcellulose, polyvinyl alcohol, polyacrylamide, etc.

Isotonication. Calculation of isotonicity for eye drops. Sterilization. Quality control. Packaging, its effect on the stability and sterility of eye drops. Nomenclature.

Eye ointments. Requirements for ophthalmic ointments and bases for ophthalmic ointments. Sterility, stability of eye ointments. Technological scheme for the production of eye ointments in aseptic conditions. Standardization. Particle size, homogeneity, rheology, viscosity, pH, etc. Nomenclature. Packaging, storage.

Eye films. Characteristic. Film formers. Technological scheme for the production of eye films. Standardization of ophthalmic medicinal films. Nomenclature. Packaging, storage.

Powders for the preparation of eye drops and lotions. Characteristic. Quality assessment: content uniformity, mass uniformity.

2.18. Plasters. Classification. Production of plasters and mustard plasters

Plasters. Definition. Characteristics of patches. Classification. A range of excipients. Equipment for the production of plaster masses, spreading and drying of plasters (reactor, USPL-1 unit, chamber-loop dryer, etc.). The nomenclature of plasters: simple lead, epilin, corn, adhesive plaster, bactericidal, pepper. Liquid plasters: cleol, collodion, etc. Aerosol plasters. Production of mustard plasters. Package. Storage.

2.19. medical solutions. Solvents. Alcoholometry. Intensification of the dissolution process. Methods for cleaning solutions (settling, filtering, centrifugation). Standardization. Private Technology

medical solutions. Characteristic. Requirements. Classification of solutions depending on the nature of the solvent, concentration and method of preparation (by chemical interaction or dissolution): aqueous solutions, alcohol, oily, glycerin liquids, syrups, aromatic waters. Intensification of the dissolution process. Temperature and hydrodynamic conditions.

General characteristics of hydrodynamic processes. Fundamentals of hydraulics. The concept of real and ideal fluids. Hydrostatics. Hydrodynamics.

Laminar and turbulent motion of fluids. hydrodynamic boundary layer. Film flow of liquids. The flow of liquids through fixed granular layers and porous partitions.

Hydrodynamics of fluidized (boiling) granular layers. The use of fluidization in pharmaceutical production. fluidization characteristics. Basic properties of the fluidized bed.

Technological schemes for the production of solutions for internal and external use. General and private rules for the production of aqueous and non-aqueous solutions.

dissolution stages. Factors affecting the dissolution process: grinding, temperature change, mixing.

Solubility indicators of substances in various solvents and the designation of solubility in the SP RB.

mechanical mixing. Mixer designs, their characteristics. Pneumatic mixing with compressed gas, air, live steam. Bubblers. Circulating mixing.

Gravitational mixing. pulsating mixing. Rotary pulsation devices.

Theoretical foundations and use of ultrasound for dispersion. Electrostrictive and magnetostrictive ultrasound generators.

Separation of liquid and solid phases by settling. siphon devices. Filtration. Types of filters and schemes of filter installations. Centrifugation. Fundamentals of operation and types of centrifuges.

Separation of heterogeneous systems. Separation under the influence of gravity. Sedimentation and settling. Settling speed. Factors affecting the settling rate. The device of settling tanks of periodic and semi-continuous action.

Separation under the action of a pressure difference. Filtration. Filtering methods. Filtration equation. Types of filters: Nutsch - and Druk filters, filter presses, cartridge, drum, disk. Filters for cleaning gases from mechanical impurities. Characteristics of filter materials.

Separation in the field of centrifugal forces. Centrifugation. Separation factor. Centrifuges filtering and settling, periodic and continuous action. Supercentrifuges. Separators.

Evaluation of the quality of solutions for external and internal use. Nomenclature. Storage. Dilution of ethyl alcohol. Alcoholic tables.

2.20. Preparation of medical solutions

Preparation of solutions in various ways at pharmaceutical enterprises. Dissolution as a diffusion-kinetic process.

Modern nomenclature of solutions and prospects for its expansion. Standardization and storage of medical solutions. Production of medical solutions: basic aluminum acetate salt, basic lead acetate, alcohol and aqueous solutions of iodine, iodinol, iodonate, alcohol solution of methylene blue, brilliant green, etc.

2.21. Dilution and strengthening solutions

Methods for expressing the concentration of solutions. Density of solutions. Determination of density using a hydrometer and pycnometer: the use of formulas for diluting and strengthening solutions of salts, acids, alkalis. Methods for determining the concentration of alcohol and features of dilution or strengthening of alcohol solutions. Rules for the use of alcoholometric tables.

2.22. Features of industrial production of emulsions and suspensions, ointments and pastes. Equipment. Standardization. Private Technology

Characteristics of emulsions and suspensions as dosage forms. Factors determining their sustainability. Stabilizers. Technological scheme of industrial production of emulsions and suspensions. Dispersion of initial components. The use of ultrasound. Modern range of emulsions and suspensions. Quality control. Characteristics of ointments, their classification. Ointment bases. Requirements for the basics, prospects for application in industrial conditions. Features of the production of ointments in the enlarged production. Pastes: zinc, salicylic-zinc, boron-zinc-naftalan, etc.

2.23. Release of medicinal substances from suspension ointments

Quality control of ointments according to the Global Fund of the Republic of Belarus. Structural and mechanical properties of ointments (rheology). Determination of the bioavailability of medicinal substances from ointments in experiments in vivo.

2.24. Production of suppositories and medical pencils

Characteristics of industrial suppositories. Characteristics of suppository bases. Technological equipment for the production and packaging of suppositories. Characteristics of other rectal forms: ointments, capsules, aerosols, tampons, rektiol. Prospects for the development of the production of rectal dosage forms: expanding the range of excipients, mechanization and automation of production and packaging. Medical pencils. Characteristic. Types of medical pencils. Methods for obtaining pencils: pouring, pressing, dipping. Private technology of pencils: lapis, menthol, hemostatic, etc.

2.25. Aerosol production

Characteristics of the inhalation route of drug administration. LS for inhalation. Liquid drugs for inhalation: drugs that are converted into a vapor state, liquid drugs for spraying, metered drugs for inhalation, under pressure. Tests.

Powders for inhalation. Tests. HP under pressure. Aerosols. Classification.

Excipients used in the production of aerosols. Propellents, solvents, solubilizers, surfactants, film formers, etc.

Technological scheme for the production of aerosols. Aerosol cans, valve-spray systems, methods of filling aerosol cans. Nomenclature: inhalipt, cameton, levovinizole, etc. Assessment of the quality of aerosol packaging. Safety in the production, transportation and storage of aerosol packages. Ecological problems.

2.26. Production of aromatic waters and syrups

syrups. Characteristic. Classification. Syrups flavoring and medicinal. Nomenclature. The value of syrups in drug therapy. The use of new excipients sorbitol, fructose, synthetic sweeteners for the production of syrups with high bioavailability. Technological schemes for the production of syrups at pharmaceutical enterprises. Standardization of syrups. Nomenclature. Aloe syrup with iron, marshmallow, rose hips, etc. Packing. Storage.

Fragrant waters. Characteristic. Classification. Technological scheme for the production of aromatic waters - solutions and distilled. Apparatus for obtaining distilled aromatic waters. Aromatic water solutions: dill, mint. Distilled fragrant waters: spirit water of coriander, bitter almond water and its concentrate. Evaluation of the quality of aromatic waters. Storage.

2.27. medical capsules. Excipients. Technological process of production. Quality control. Production of medical capsules. Microencapsulation of drugs

medical capsules. Characteristic. Types of capsules: hard with caps, soft, with a whole shell for internal, rectal and vaginal administration. Enteric-soluble and modified-release capsules, cachets. Technological scheme for the production of gelatin capsules. Preparation of gelatinous mass, molding of capsules by immersion, pressing and drip. Equipment. Filling capsules. Coating of capsules. Standardization: determination of the average weight, dosing uniformity, disintegration, speed and completeness of the release (dissolution) of active substances from capsules. Nomenclature. Capsules of antioxycaps, antigrippin, oil solutions of vitamins A, E, etc.

Package. Storage.

Microcapsules and microgranules. Microencapsulation of pharmaceutical substances. Methods of microencapsulation: physical, physico-chemical, chemical. Characterization of excipients for microencapsulation. Dosage forms from microcapsules (tablets, capsules, ointments, suspensions, suppositories, spansules). Quality control.

2.28. The main regularities of extraction of capillary-porous raw materials with a cellular structure

General characteristics of mass transfer processes. Classification. Place and role of mass transfer processes in pharmaceutical technology.

Extraction of plant, animal, microbiological raw materials and tissue culture in the solid-liquid system, as one of the types of mass transfer processes.

Technological characteristics of the phases. The content of active, extractive substances and moisture in the raw materials; good quality of raw materials and extract, speed and magnitude of swelling of raw materials, absorption of extractant by raw materials, density, bulk density and bulk weight of raw materials, porosity and porosity, grinding of raw materials, surface of raw particles, washout coefficient, internal diffusion coefficient.

Extractants. Requirements for extractants: dissolving power, selectivity, polarity, viscosity, surface tension, medium reaction. Classification and modern assortment of extractants: water, ethyl alcohol, chloroform, ether, acetone, etc. Use of liquefied gases.

Patterns of extraction of capillary-porous raw materials with a cellular structure. Extraction stages: penetration of the extractant into the raw material, dissolution and desorption, internal molecular diffusion, external molecular and convective diffusion. Diffusion equations (first and second Fick equations and convective diffusion). Coefficients of internal, molecular and convective diffusion. diffusion losses. Diffusion Loss Calculations. Factors affecting the reduction of diffusion losses (absorption of the extractant by the raw material, division of the extractant and raw materials into parts).

Extraction methods: static and dynamic, periodic and continuous, equilibrium and non-equilibrium. Maceration, remaceration, percolation, repercolation, fast repercolation, continuous extraction, circulation.

Extraction equipment: maceration tanks, communicating and non-communicating batteries of extractors (percolators). Continuous extractors. Rotary pulsation devices.

Ways to intensify extraction: changing hydrodynamic conditions, grinding and deformation of raw materials in the extractant, exposure to ultrasound, electromagnetic field, electric pulse discharges, surfactants, etc.

Extraction in a liquid-liquid system. Characterization of solvents. Distribution coefficient.

The main methods of extraction separation: single and multiple extraction. Continuous countercurrent extraction.

Extractors. Classification. The device and principle of operation of spray, rotary-disk, pulsating, centrifugal and mixing-settling extractors.

2.29. Galenic preparations. Characteristic. History of development. Classification

Brief description of vegetable raw materials, sources of vegetable raw materials. Structural features of a plant cell. Characteristics of biologically active substances of medicinal plant materials. Stages of development of production of phytopreparations. Classification of phytopreparations. Total (native), or herbal preparations. Total purified (new-galenic) preparations. Preparations of individual substances isolated from plants. complex preparations. Technical and economic features of the production of phytopreparations. GF RB, good manufacturing practice (GMP) in the production of phytopreparations.

2.30. Tinctures. Characteristics of tinctures. Production of tinctures. Quality control. Recovery and rectification of alcohol

Tinctures. Classification. Technological scheme for the production of tinctures. Ways to obtain an extract: maceration and its modifications, 4-fold maceration. Turbo extraction. Percolation. Dissolution of extracts.

Private technology of tinctures: valerian, hawthorn, St. John's wort, belladonna, ginseng, lily of the valley, motherwort, eucalyptus and others. Complex tinctures. Package. Storage.

Recovery of alcohol from spent raw materials by water displacement and steam distillation. Equipment. Rectification.

2.31. Liquid extracts 1:1 and 1:2. production methods. Standardization. Preparation of liquid extracts and concentrate extracts

extracts. Classification according to consistency and used extractant.

liquid extracts. Nomenclature. Technological scheme for the production of liquid extracts. Extraction methods. Percolation. Repercolation methods with completed and incomplete cycles. Cleaning of hoods from ballast substances. Standardization. Nomenclature of liquid extracts (hawthorn, rhodiola, thyme, eleutherococcus, magnolia, passionflower, etc.). Package. Storage.

2.32. Thermal processes. The use of water vapor as a heat carrier. Heat exchangers. Evaporation. Evaporation under vacuum. Side effects of evaporation and how to overcome them

Heating agents and methods of heating. Evaporation. Evaporation methods: under vacuum, atmospheric pressure and high pressure. The device of evaporators: evaporators, receivers, vacuum pumps, refrigerators, receivers. Characteristics of single-shell and multi-shell evaporators: ball, tubular, film. Evaporation with thermal compression of secondary steam.

Side effects during evaporation: encrustation, temperature depression, hydrostatic effect, splash entrainment, foaming and ways to eliminate them.

2.33. Drying. Statics and kinetics of drying. Characteristics of dryers. Freeze drying and spray drying

Drying. Forms of connection of moisture with the material. Statics and kinetics of drying. Drying methods: contact and convective drying. Properties of air as a drying agent: temperature, absolute and relative humidity, moisture content and heat content. Contact dryers: vacuum drying cabinets, vacuum roller dryers. Air dryers: chamber, drum, fluidized bed. Sublimation and spray dryers.

2.34. Thick and dry extracts. Technological scheme of production. Methods for obtaining the primary extract. Ballast removal

Thick and dry extracts. Technological scheme for the production of thick and dry extracts. Methods for obtaining extracts (bismaceration, percolation, repercolation, countercurrent extraction, circulation extraction). Purification of water and alcohol extracts from ballast substances. Evaporation. Drying of extracts.

Standardization. Nomenclature of thick extracts (belladonna, licorice root, valerian, etc.). Nomenclature of dry extracts (belladonna, chilibukha, licorice root, marshmallow root, etc.). Package. Storage.

2.35. Private technology of thick and dry extracts. Production of liquid and dry concentrate extracts

Liquid (1:2) and dry extracts-concentrates for the preparation of aqueous extracts. Technological schemes of production. Standardization. The nomenclature of liquid extracts-concentrates 1:2 (valerian) and dry extracts-concentrates (Adonis, Marshmallow, Thermopsis).

Package. Storage.

2.36. Oil extracts. Production of oil extracts. LS from fresh vegetable raw materials. Preparations of biogenic stimulants

Oil extracts. Ways to get. Bleached oil, St. John's wort, wild rose, sea buckthorn.

LS from fresh vegetable raw materials.

Non-condensed and condensed juices, tinctures and extracts. Production features. Obtaining juices and extraction preparations. Standardization. Nomenclature. Juice of plantain, jaundice, Kalanchoe, etc. Tinctures from fresh raw materials.

Biogenic stimulants, their chemical structure, properties and production conditions. Means from vegetable and animal raw materials, obtaining and standardization. Aloe extract. Storage.

2.37. Novogaleny preparations. Methods for obtaining and cleaning the primary extract. Standardization. Private Technology

Novogaleny funds. A brief historical note on the creation of the most purified herbal preparations. Technological scheme for the production of novogalenovye preparations. Methods for obtaining the primary extract. Extractants. Methods for maximum purification of extracts from ballast and related substances: fractional precipitation, solvent change, liquid extraction, chromatography, etc. Private technology of novogalenic preparations. Adonizide.

Classification and technology of preparations of individual substances from medicinal plant materials. Digitoxin, Celanide, Digoxin, Ergometrine Oleate.

2.38. Organic preparations. Features of animal raw materials. Classification and methods for obtaining organ preparations for internal and injection use. Standardization. Private Technology

Medicines from animal raw materials. Characteristics and brief historical background of the creation of organ preparations. Classifications of organic preparations for medical use, the nature of active substances and methods of production. Features of animal raw materials. Technological scheme for the production of organic preparations from dried and defatted animal organs by extraction for internal and injection use.

Hormones from the thyroid gland (thyroidin), pituitary gland (ACTH), pancreas (insulin).

Enzyme preparations.

Standardization. Package. Storage.

2.39. Drawing up regulatory documentation for the production of extraction preparations

General characteristics and principles of drawing up normative and technological documentation for the production of extraction preparations.

2.40. Long-acting and directional drugs. Therapeutic systems: matrix, membrane, osmotic, targeted drug delivery systems

Long-acting and directional drugs.

Classification of drugs according to the time of action and the nature of the distribution of active substances in the body. Drugs of short-term periodic action and, as a rule, systemic distribution (drugs of the first generation). Drugs of long-term prolonged action and systemic distribution (drugs of the second generation). Long-term and directional drugs (third-generation drugs).

Methods of prolongation: decrease in the rate of excretion from the body, slowing down biotransformation, inhibition and duration of absorption. Immobilization of drugs on inorganic and organic carriers. Immobilization methods: physical (adsorption, inclusion in a gel, microencapsulation), physicochemical (formation of inclusion compounds, solid dispersions) and chemical (covalent binding of a drug substance with a polymer carrier, cross-linking of drug substance molecules with a polymer using bifunctional reagents, etc.) .

Therapeutic systems: matrix (biodegradable and non-biodegradable), membrane, osmotic, systems of targeted delivery of active substances. Transdermal therapeutic systems (TTS).

Directional drugs. Ringsdorf model. Model components: polymer carrier, solubilizer, drug substance, vector (targeting device).

Liposomes. Characteristic. Single-layer and multi-layer liposomes. Auxiliary substances for the production of liposomes. natural phospholipids. Methods for obtaining liposomes. Incorporation of drugs into liposomes. Directed transport of liposomes.

Erythrocytes as drug carriers. Methods of introducing drugs into erythrocytes.

Directed transport of drugs using a magnetic field. Ferrites. Ferrofluids. Magnetically controlled liposomes, microcapsules, erythrocytes.

2.41. Production of enzyme, hormonal and other preparations by microbiological synthesis. Basic processes and devices of biotechnology

Processes and devices of biotechnology.

Production of antibiotics, enzymes, hormones, monoclonal antibodies, vaccines, anti-cancer and other agents by microbiological synthesis.

General principles production of drugs by biotechnology. Strains of bacteria, plant and animal cells. Sterilization of nutrient media. The rate of death of microorganisms. Influence of temperature on the rate of the process. Periodic and continuous sterilization of culture media. Preparation of the nutrient medium. Mass transfer and oxygen consumption. Gas bubbling. The rate of absorption and consumption of oxygen. Influence of properties of culture liquids on mass transfer. Stirring during fermentation. fermentation process. Fermenters. Design and material of the fermenter. Sterilization of air and equipment. Theoretical Foundations of Aerosol Deposition. Characteristics of filter materials. Foaming and defoaming.

Technological scheme for the production of enzymes by biotechnology. Terrilitin, orase, solizim, streptolyase, asparaginase, penicillinase.

Manufacture of human insulin.

INFORMATIONAL AND METHODOLOGICAL PART
LITERATURE

Main:

1. A course of lectures on industrial technology of drugs: textbook.-method. allowance / Vitebsk State Medical University; auth.-stat. . - Vitebsk: VSMU, 2001. - 368 p.

2. Guidelines for the implementation of laboratory work on the industrial technology of drugs / [Vitebsk State Medical University, Department of Pharmaceutical Technology with the course of FPC and PC; comp.: ]. - Vitebsk, 2003. - 214 p.

3. industrial technology PM: textbook-method. allowance / Vitebsk State Medical University; auth.-stat. . - Vitebsk: VSMU, 20p.

4. Guidelines for implementation laboratory work on pharmaceutical technology of pharmaceutical production of drugs for students of the 4th year of the correspondence department / [Vitebsk State Medical University, Department of Pharmaceutical Technology with the course of FPC and PC; comp.: etc.]. - Vitebsk, 2007. - 295 p.

5. A practical guide to the implementation of laboratory work on the pharmaceutical technology of industrial production of drugs for students of the 5th year of the correspondence department: textbook.-method. allowance: / Vitebsk State Medical University; auth.-stat. . - Vitebsk: VSMU, 2008. - 181 p.

6. A practical guide to the pharmaceutical technology of pharmaceutical production of drugs for 3rd year full-time students: study method. allowance: / Vitebsk State Medical University; auth.-stat. [and etc.]. - Vitebsk: VSMU, 2008. - 432 p.

7. A practical guide to the pharmaceutical technology of pharmaceutical manufacturing of drugs for 3rd year full-time students: study method. allowance. / Vitebsk State Medical University; auth.-stat. [and etc.]. - Vitebsk: VSMU, 2008. - 432 p.

Additional:

8. Absorption and bioavailability of medicinal substances from tablets: educational and methodological development for students of pharmaceutical institutes and faculties / ed. . - M., 19s.

9. Mashkovsky, M. D. LS: In 2 volumes. 14th ed., revised, corrected. and additional / - M.: LLC "New Wave Publishing House": Publisher, T.s., T.s.

10. Good manufacturing practice drugs / Ed. , Angleless. - Kiev.- Morion, 1999.-896s.

11. Periodicals: MRM, RJH, Bulletin of Pharmacy, Recipe, Pharmacy, Chemical Pharmaceutical and other foreign journals.

12. Planovsky, and apparatuses for chemical and petrochemical
technologies: / , // Textbook for universities. Moscow: Chemistry, 1987, - 495 p.

Regulations:

13. "Instruction on the organization of pharmaceutical production of liquid drugs" (Reg. No.).

14. State Pharmacopoeia of the Republic of Belarus. Volume 1. - Minsk, 2006. - 656 p.

15. State Pharmacopoeia of the Republic of Belarus. Volume 2. - Minsk, 2008. - 471 p.

16. USP-24 Pharmacopoeia, British Pharmacopoeia.

17. RD RB 0408.02-96 Pharmaceutical and microbiological products. Technological regulations of production. Development order.

18. TKP 030-2 Technical code of established practice. Good Manufacturing Practice - Minsk, edition of the Ministry of Health of the Republic of Belarus, 2006 - 53 p.

19. Orders, instructions, guidelines MH RB.

20. State register of drugs. State register of medical equipment and products medical purpose/ Ministry of Health Rep. Belarus; Edited by. - Minsk: Minsktipproekt, 200s.

An indicative list of laboratory classes on the pharmaceutical technology of pharmacy manufacturing of drugs

1. Introduction to pharmaceutical technology. State regulation of the manufacture of drugs. Classification of drugs.

2. Basic provisions of biopharmacy.

3. Dosing in pharmaceutical technology. Dosing by weight, volume and drops.

4. Preparation of simple and complex powders from medicinal substances prescribed in equal and sharply different quantities, with difficult to grind and lightweight substances. Powder quality assessment.

5. Preparation of powders with substances of list A and B. Triturations.

6. Preparation of powders with odorous, coloring substances and extracts.

7. Solutions. Special cases of preparation of solutions.

8. Preparation of concentrated solutions for burette installation.

9. Technology of potions. The use of burette units for the preparation of liquid dosage forms.

10. Dilution of standard pharmacopoeial liquids. Solving problems for the dilution of standard pharmacopoeial liquids.

11. Preparation of non-aqueous solutions. Assessment of their quality. Solving problems on the cultivation of alcohol.

12. IUD solutions. Features of preparation depending on the structure of their molecules. Preparation of solutions of pepsin, gelatin, starch. Assessment of their quality.

13. Colloidal solutions. Features of their technology depending on the composition of micelles. Preparation of solutions of protargol, collargol and ichthyol.

14. Preparation of suspensions from hydrophilic substances. Assessment of their quality.

15. Suspensions of hydrophobic substances. Assessment of their quality.

16. Emulsions. Quality control. colloidal solutions. Suspensions.

17. Drops for internal and external use (except for the eyes). Assessment of their quality.

18. Preparation of aqueous extracts from VP containing alkaloids, cardiac glycosides, essential oils.

19. Preparation of aqueous extracts from VP containing saponins, tannins, anthraglycosides, phenol glycosides.

20. Preparation of aqueous extracts from VP containing mucus and from extracts - concentrates.

21. Liniment technology. Assessment of their quality.

22. Technology of homogeneous, emulsion and suspension ointments. Quality control.

23. Combined ointments. Pastes. Quality control.

24. Technology of suppositories. Assessment of their quality.

25. Water extracts. Liniments. Ointments. Suppositories.

26. Pill technology. Assessment of their quality.

27. Technology of solutions for injections. Stabilization of injection solutions. Evaluation of the quality of injection solutions.

28. Preparation of isotonic and infusion solutions. Assessment of their quality.

29. Preparation of injection solutions from thermolabile substances, suspensions and emulsions for injection, solutions with antibiotics, dosage forms for newborns and children under 1 year old. Assessment of their quality.

30. Drugs for the eyes. Preparation of eye drops, lotions. Assessment of their quality.

31. Technology of eye ointments and ointments with antibiotics.

32. Difficult cases and cases of incompatible combinations in complex powders, liniments, ointments, suppositories and pills.

33. Incompatibilities in liquid dosage forms.

An indicative list of laboratory classes on pharmaceutical technology for the industrial production of drugs

1. General principles for organizing the manufacture of drugs in pharmaceutical plants and factories. GMP rules. General concepts of machines and devices. Occupational health and safety.

2. Production of powders and collections.

3. Tablets. Study of physicochemical and technological properties of powders and granulates.

4. Production of tablets without granulation. Trituration tablets.

5. Production of tablets using granulation.

6. Evaluation of the quality of tablets. Release of drugs from tablets.

7. Bioavailability of medicinal substances from tablets.

8. Drawing up regulatory documentation for the production of tablets.

9. Injectable dosage forms. Ampoule glass quality research.

10. Manufacture of solutions for injections in ampoules.

11. Evaluation of the influence of technological factors on the quality of injection solutions.

12. Production of injectable dosage forms. Drafting of regulatory documentation.

13. Production of plasters. Mustard plasters.

14. Technology of drugs for industrial production.

15. Strengthening and dilution of solutions.

16. Dilution and strengthening of solutions.

17. Preparation of emulsions, suspensions, liniments.

18. Production of ointments and pastes.

19. Release of medicinal substances from suspension ointments.

20. Manufacture of suppositories and medical pencils.

21. Production of medical capsules.

22. Production of fragrant waters.

23. Preparation of syrups.

24. Theoretical foundations of extraction.

25. Production of tinctures.

26. Preparation of liquid extracts and concentrate extracts.

27. Preparation of thick extracts.

28. Production of dry extracts.

29. Production of oil extracts.

30. Preparation of new-galenic preparations.

31. Production of extraction drugs. Preparation of regulatory documentation for the production of extraction preparations.

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