Storage of medicines from exposure to light
4.1.1. Among the medicines that require protection from light include: antibiotics, herbal preparations (tinctures, extracts, concentrates from plant materials), herbal medicinal raw materials, organ preparations, vitamins and vitamin preparations; corticosteroids, essential oils, fatty oils, dragee preparations, salts of hydroiodic and hydrobromic acids, halogenated compounds, nitro and nitroso compounds, nitrates, nitrites, amino and amido compounds, phenolic compounds, phenothiazine derivatives.
4.1.2. Medicinal products that require protection from light should be stored in containers made of light-protective materials (orange glass glass containers, metal containers, packaging made of aluminum foil or polymeric materials painted black, brown or orange), in a dark room or cabinets painted painted inside with black paint with tight-fitting doors, or in tight-fitting boxes with tight-fitting lids.
4.1.3. To store medicinal substances that are especially sensitive to light (silver nitrate, prozerin, etc.), glass containers are pasted over with black opaque paper.
4.2. Features of storage of medicines requiring protection from moisture.
4.2.1. Among the drugs that require protection from moisture include: hygroscopic substances and preparations (for example, potassium acetate, dry extracts, herbal medicinal raw materials, hydrolyzable substances, salts of nitric, nitrous, hydrohalic and phosphoric acids, salts of alkaloids, sodium organometallic compounds, glucosides, antibiotics, enzymes, dry organ preparations), medicinal substances characterized by FS as "very easily soluble in water", as well as medicinal substances, the moisture content of which should not exceed the limit established by the Global Fund and other NTDs, and medicinal substances oxidized by atmospheric oxygen .
4.2.2. Medicines that require protection from exposure to atmospheric water vapor should be stored in a cool place, in a tightly closed container made of materials impervious to water vapor (glass, metal, aluminum foil, thick-walled plastic containers).
4.2.3. Medicinal products with pronounced hygroscopic properties should be stored in a dry room in a glass container with a sealed closure, filled with paraffin on top. When closing containers with such medicinal substances, it is necessary to carefully wipe the throat and cork.
4.2.4. Medicinal products of this group, obtained in packaging from a polymer film and intended for supplying a subordinate pharmacy network, should be stored in their original packaging or transferred in glass or metal containers.
4.2.5. Among the drugs of this group, special attention should be paid to the organization of storage of drugs such as burnt gypsum and mustard in powder, which, when absorbing moisture, turn from a fine amorphous powder into fine grains, lose their qualities and become unsuitable for medical use. To avoid damage:
Burnt gypsum should be stored in a well-closed container (for example, in tightly knocked down wooden boxes or barrels, preferably lined with plastic wrap on the inside);
Mustard powder should be stored in hermetically sealed cans, varnished inside;
Mustard plasters are stored in packs packed in parchment paper or plastic wrap, which are placed in tightly sealed containers (for example, cardboard boxes pasted over with a polymer film from the inside).
4.3. Features of storage of medicines requiring protection from volatilization and drying
4.3.1. Drugs requiring volatilization protection include:
- actually volatile substances ;
Medicines containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts);
Solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, hydrogen chloride over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.);
Medicinal plant materials containing essential oils;
Medicines containing water of crystallization (crystal hydrates);
Medicinal substances that decompose with the formation of volatile products (iodoform, hydrogen peroxide, chloramine B, sodium bicarbonate);
Medicinal substances with the lower limit of moisture content established by regulatory and technical documentation (magnesium sulfate, sodium aminosalicylate, sodium sulfate, etc.).
4.3.2. Medicines that require protection from volatilization and drying should be stored in a cool place, in hermetically sealed containers made of materials impervious to volatile substances (glass, metal, aluminum foil). The use of polymer containers for packaging and capping is allowed in accordance with the Global Fund and other NTD.
4.4. Crystalline hydrates, depending on the relative humidity of the air, can exhibit the properties of both hygroscopic and weathering substances. Therefore, they should be stored in a hermetically sealed glass, metal or thick-walled plastic container at a relative humidity of 50-65% in a cool place +5. Features of storage of medicines requiring protection from high temperatures
4.5.1. Medicines that require protection from exposure to elevated temperatures include:
A group of medicinal substances requiring protection from volatilization and drying out (section 4.3 of this Instruction);
fusible substances;
Immunobiological preparations;
antibiotics;
Organic preparations;
Hormonal preparations;
Vitamins and vitamin preparations;
Preparations containing glycosides;
Medical fats and oils;
Fat-based ointments and other substances.
4.5.2. Medicines that require protection from exposure to elevated temperatures should be stored at room (18-20°C) cool (or cold) - (12-15°C) temperature. In some cases, a lower storage temperature is required (for example, for ATP - (3-5 ° C)), which should be indicated on the label or in the instructions for use of the drug.
4.5.3. Immunobiological preparations should be stored in industrial packaging separately by name, at the temperature indicated; but for each name on the label or in the instructions for use.
4.5.4. Immunobiological preparations of the same name are stored in batches, taking into account their expiration date.
4.5.5. It is necessary to strictly comply with the requirements for the timely replacement of sera and vaccines in an irreducible supply with freshly prepared ones.
4.5.6. Immunobiological preparations should be visually inspected during storage at least once a month.
4.5.7. Antibiotics should be stored in commercial containers at room temperature unless otherwise indicated on the labels.
4.5.8. Organic preparations should be stored in a dark, cool and dry place at a temperature of 0 - +15°C, unless otherwise indicated on the labels or in the instructions for use.
4.5.9. Burov's liquid needs to be stored in a cool place. When cloudy, the solution is filtered and checked for compliance with all the requirements of the Global Fund. Solution opalescence is allowed.
QUESTION: Please clarify the requirements for the storage of photosensitive drugs when placing them on the windows of pharmacies and pharmacy points. The Center for Certification and Quality Control of Medicinal Products of the Ryazan Region believes that drugs, on the packages of which it is indicated "to store in a place protected from light", cannot be placed on display cases even when they are placed in secondary packaging.
Question: Please clarify the requirements for the storage of photosensitive drugs when placing them on the windows of pharmacies and pharmacy points. The Center for Certification and Quality Control of Medicinal Products of the Ryazan Region believes that drugs, on the packages of which it is indicated "to store in a place protected from light", cannot be placed on display cases even when they are placed in secondary packaging. According to the Certification Center, only empty secondary packaging can be displayed on the showcase, and drugs must be removed from the secondary packaging and stored in a closed cabinet. However, in the official response to Novartis Consumer Health Switzerland from the Institute for Standardization of Medicines in Moscow dated December 15, 2003 (ref. N 1650), the following is said: "packaging the drug in such primary packaging as dark glass bottles, an aluminum tube, disposable sachets made of a combined polyethylene/aluminum foil/polyethylene/paper material, an opaque plastic bottle made of low-density polyethylene, an opaque plastic tube with their subsequent insertion into a secondary consumer packaging (box or cardboard pack) allows you to ensure the storage of the drug "in a place protected from light under natural and artificial lighting in a pharmacy.
Answer: In accordance with clause 5.4. "Industry Standard. Rules for the Dispensing (Sale) of Medicinal Products in Pharmacy Organizations. Basic Provisions. OST 91500.05.0007-2003", approved by Order of the Ministry of Health of the Russian Federation of March 4, 2003 N 80 (as amended on August 23, 2004), medicines should be stored separately, taking into account their physical and physico-chemical properties, exposure to various environmental factors in accordance with established requirements.
The procedure for storing medicines in pharmacies is determined by the "Instructions for organizing storage in pharmacies of various groups of medicines and medical devices", approved by Order of the Ministry of Health of the Russian Federation of November 13, 1996 N 377.
Requirements for the storage of various groups of medicines and medical devices are set out in section 4 of this Instruction.
In accordance with paragraph 4.1.2. of this section, medicinal products that require protection from light should be stored in containers made of light-protective materials (orange glass glass containers, metal containers, packaging made of aluminum foil or polymeric materials painted black, brown or orange), in a dark room or cabinets. painted inside with black paint with tight-fitting doors or in tight-fitting boxes with tight-fitting lids.
At the same time, from the peculiarities of the structure of this section of the Instructions, it can be concluded that the requirements for the storage of medicines in paragraphs 4.1.-4.8. Instructions do not apply to finished dosage forms, since such requirements are highlighted in a separate paragraph of Instruction 4.9. "Peculiarities of storage of finished medicinal products".
According to the requirements of this paragraph, the storage of finished medicinal products must meet the requirements of the State Pharmacopoeia and all the general requirements of the Instructions for the storage of medicinal products, taking into account the properties of the ingredients included in their composition (clause 4.9.1.), while the storage of tablets and dragees must be carried out in a dry and, if necessary, in a place protected from light (clause 4.9.3.).
Thus, formally, such drugs should be stored in a "protected from light place." It should be noted that there is no clear definition of the concept of "protected from the light place". In our opinion, the expert opinion of the Institute for Standardization, to which you refer, actually defines this concept for SDF as "storage in natural and artificial premises in a pharmacy." Based on this conclusion, it can be assumed that the storage conditions "in a place protected from light" for ODF packed in primary and secondary packages, when they are laid out on display cases located inside the pharmacy and not exposed to direct sunlight (in this case, it is difficult to say on the natural lighting of the pharmacy), are observed.
Nevertheless, the regional Center for Certification and Quality Control of Medicinal Products has the right, in case of detection of a change in the pharmacological properties of drugs under the influence of light, to file a claim against the pharmacy in connection with the storage of medicinal products in improper conditions.
Director of a law firm
"Unico-94"
M.I.MILUSHIN
20.01.2005
If your skin develops a rash or unpleasant redness after a day in the sun, your medication may be to blame. Experts say some drugs make the skin more sensitive to the sun, which can cause cellular damage and an unsightly appearance.
“These skin reactions are caused by the sun's UVA and UVB wavelengths, which cause photobiological reactions to drugs, which are mostly free radicals. Free radicals and oxidative stress contribute to skin cell damage, causing redness and rashes in exposed areas of the skin, says Dr. Kelly Papantoniou, cosmetic dermatologist at Mount Sinai Health Center. "Studies have shown that certain medications can cause photosensitivity, and you should take good care of your skin when you're out in the sun and taking these medications."
Diuretics. Drugs that control high blood pressure and help reduce water retention—hydrochlorothiazide, bumetanide, and furosemide—sensitize the skin to sun exposure through photochemical activity. "A rash, like subacute lupus, can appear on exposed skin," says Papantoniou. - Sunscreen is very important in this case - it can prevent photodermatitis, also known as sun poisoning. Spend more time indoors if your skin is especially sensitive."
Antibiotics. Doxycycline and tetracycline are examples of antibiotics commonly used in the treatment of acne, which can also lead to phototoxicity when the skin is exposed to the sun. To avoid a potentially unpleasant reaction, apply sunscreen and avoid prolonged exposure to the sun.
Terbinafine. This popular antifungal medication, branded as Lamisil, is commonly prescribed to treat nail fungus. It can also make the skin extremely sensitive to the sun. Protect yourself with sunscreen.
Statins. Lovastatin and simvastatin, the two most commonly prescribed statins used to lower blood cholesterol, can make skin more sensitive to UVA and UVB.
Non-steroidal anti-inflammatory drugs. NSAIDs - naproxen, ibuprofen and ketoprofen - produce harmful free radicals when the skin is exposed to direct sunlight.
Hypoglycemic agents. Glipizide, glyburide, and sulfonylurea drugs are used to control blood sugar levels in people with diabetes. These medications also make the skin more sensitive to UV rays.
Antipsychotic drugs. Aaminazine and other phenothiazines cause photosensitivity through an oxidation process. Wear sunscreen to prevent skin damage.
Systemic retinoids. Isotretinoin and acitretin- systemic retinoids used to treat skin conditions, including acne and psoriasis. You must use sunscreen and take the necessary precautions.
Anti-aging creams. Extremely popular anti-aging creams that contain retinol and tretinoin can increase the skin's sensitivity to sunlight. For this reason, if you are using any of these products, stop taking them about a week before prolonged sun exposure, such as a trip to the beach. If you need them, be sure to use a broad-spectrum sunscreen containing titanium oxide or zinc oxide to protect your skin from UV radiation.
Alpha hydroxy acids. Although these drugs are not as strong, they can also sensitize the skin. In this case, apply SPF30 sunscreen every morning and repeat every two hours.
Question number 3. Features of storage of medicines related to list A and pesticides.List A drugs and pesticides must be stored with extreme caution and in strict accordance with the requirements of the Instructions for Handling Particularly Poisonous, Poisonous and Narcotic Drugs.
Strong medicines are stored in separate lockable rooms or in separate lockable cabinets.
Rooms and cabinets at the end of work must be locked.
Drugs capable of enhancing the effect of narcotic substances must be stored separately from other potent drugs in separate cabinets under lock and key in the room for storing potent drugs.
These drugs include: cyclodol (narcotan), all derivatives of barbituric acid (barbital, barbital sodium, phenobarbital, amytal sodium, hexobarbital, hexenal, thiopental sodium, quietal, etc.), adalin (carbromal), bromisoval (bromural) , tetridine, amizil, meprotan (meprobamate, andaxin), seduxen (diazepam, valium), tazepam (oxazepam), radedorm (eunoctine, nitrazepam), tryptizol, trioxazine, elenium (librium), diphenhydramine, levdopa, sedalgin, pentalgin, chloral hydrate.
The keys to the cabinets in which the listed drugs are stored must be kept by the person appointed by the order for the warehouse (depot, institution).
Question number 4. Features of storage hygroscopic and easily hydrolyzed, moisture sensitive and weathering drugs.
Hygroscopic and easily hydrolyzed medicinal products must be stored at a temperature of 12 to 20°C and a relative air humidity of not more than 60%, unless other storage conditions are indicated on the labels or in the relevant regulatory and technical documentation. To reduce indoor air humidity, place trays with calcined technical calcium chloride and other dehumidifiers.
Moisture-sensitive and weathering medicines should be contained in a moisture-proof (glass, metal, plastic), hermetically sealed container.
For hermetic sealing of containers use:
Ground glass stoppers;
Screw-on (rollable) covers made of metal and rigid polymers with an elastic gasket made of rubber;
Polyethylene plugs with three or more sealing rings, the outer diameter of which exceeds the inner diameter of the contacting part of the vessel by 1-1.5 mm;
Cork and rubber stoppers lined with parchment, polyethylene or rubber foil.
Stoppers, lids (with the exception of rolled ones) and the upper part of the necks of the vessels must be tied with parchment or film on the outside and filled with a moisture- and gas-tight composition (a mixture of paraffin with polyethylene, various resins, etc.). Stoppers (lids) can also be enclosed in moisture- and gas-tight cuffs that tightly fit them and the upper part of the neck of the vessel, made of heat- and frost-resistant plastic. In this case, the composition should adhere tightly to the material of the container, not be brittle and not crack.
Vessels with the most hygroscopic drugs are placed in additional packaging - a sealed hard case or a plastic bag containing silica gel or other desiccant.
Weathered medicinal products should be stored at a temperature of 12 to 20 ° C and a relative humidity of 70-80%, unless other storage conditions are specified in the relevant regulatory and technical documentation. Weathered preparations must be placed at a distance of at least 2 m from heat-emitting devices and devices and protected from direct sunlight.
During periodic inspections of moisture-sensitive and weathering drugs, special attention is paid to the humidity of the air in the premises, the integrity of the container and the tightness of its closure, the presence of changes in the appearance and weight of drugs.
If stored improperly, hygroscopic substances often melt due to the absorption of moisture, their mass increases. The mass of weathered substances decreases as a result of the loss of crystallization water during storage, which leads to a sharp increase in the content of the active drug substance in them and thereby creates the possibility of an overdose.
Weathered medicinal products should be subjected to additional control during storage for the content of water of crystallization in accordance with the requirements of regulatory and technical documentation.
Question No. 5. Features of storage of light-sensitive, heat-sensitive drugs and drugs that change under the influence of air gases.
Photosensitive drugs should be stored in dark, dry rooms at a temperature of 12-20 ° C and a relative humidity of not more than 60%. It is allowed to store small amounts of photosensitive drugs in ordinary (without darkening) rooms in cabinets made of opaque material with tightly closing doors or on racks carefully hung with opaque fabric.
Particularly photosensitive medicinal products should be stored in containers made of orange glass or opaque material. It is allowed, in the absence of such containers, as an exception, to contain these drugs in containers made of colorless glass, carefully wrapped in black, non-actinic paper.
The container in which photosensitive preparations are located must be hermetically sealed and impervious to atmospheric oxygen and moisture, since photochemical reactions are significantly accelerated in their presence.
During periodic inspections of photosensitive medicinal products, it is necessary to pay special attention to their color, light-shielding properties of the container, the integrity of the container, the opacity of the wrapper and the tightness of the closure.
Medicines that change under the influence of air gases should be stored in a gas- and moisture-tight, hermetically sealed container filled to the top at a temperature of 12-20 ° C and a relative air humidity of not more than 60%.
It is not allowed to take hold of the cork or the lid of the container when carrying and installing moisture-sensitive medicines on the racks, as this can break the tightness of the closure.
A container of large capacity should be taken with the left hand by the lower part of the throat, and with the right hand - by the bottom, a container of small capacity - by the cylindrical part of the vessel.
Among the heat-sensitive drugs, there are drugs that must be stored at air temperature:
10 to 15°C (in a cool place);
From 1 (2, 3, 4) to 10°C (in the refrigerator);
From 0°C and below (in the freezer).
To accommodate heat-sensitive drugs, depending on the established temperature regime of storage, cool rooms, various refrigeration units and refrigerators equipped with thermographs and hygrographs are used.
Heat-sensitive preparations must be placed away from heat-emitting devices and protected from direct sunlight.
During the storage of heat-sensitive medicinal products, special attention should be paid to the compliance of the temperature at which each specific drug is stored with the requirements indicated on the label and in the current regulatory and technical documentation.
Frost-sensitive medicinal products should be stored at an air temperature above the temperature at which they freeze or change their properties.
When examining drugs that have undergone freezing and thawing, it is necessary to carefully check the integrity of the container in which they are contained. Particular attention should be paid to glass containers with a large capacity.
If necessary, medicines should be placed in another container.
It is forbidden to dispense and use medicinal products that have significantly changed their physicochemical and pharmacological properties as a result of freezing and thawing.
Environmentally sensitive chemicals should be stored in accordance with the above requirements.
Imported heat-sensitive preparations labeled with "Cool" should be stored at an air temperature of 0 to 5°C. If the labels indicate ("Deep chill"), the drugs must be stored at an air temperature of -20 ° C.
Low-melting preparations and chemical reagents should be stored at an air temperature lower than their melting point. These preparations must be placed away from heat-emitting devices and devices and protected from direct sunlight.
Low-hardening preparations and chemical reagents should be stored at an air temperature above their solidification temperature. If during the inspection the preparations that have undergone freezing are detected, it is urgent to thaw them. After thawing, the preparations, if necessary, should be placed in another container.
Low-boiling preparations and chemical reagents must be stored in metal cylinders, sealed glass ampoules, as well as in other hermetically sealed metal, glass or thick-walled plastic containers at an air temperature lower than their boiling point. These preparations should be placed away from heat-emitting devices and devices and protected from direct sunlight.
Question number 6. Features of storage of medicines for injection.
Dosage forms for injections (water and oil solutions, suspensions, emulsions) in ampoules and vials should be stored separately from other drugs in a place protected from direct sunlight at an air temperature of 12 to 20 ° C. The optimum storage temperature for these drugs is as as a rule, 12-15 ° C.
When examining drugs for injection, it is necessary to pay special attention to the transparency and color of solutions, the absence of mechanical impurities in them, the integrity of vials and ampoules and the tightness of their capping (sealing).
The transparency of solutions should be checked by inspection in the light of a reflector lamp.
The absence of mechanical impurities in solutions must be controlled, guided by a special instruction given in the Guidelines for the operation of medical warehouses and depots.
It is forbidden to release and use for its intended purpose the following drugs for injection:
Not matching the description (color, transparency, consistency, etc.) to the requirements of regulatory and technical documentation;
Located in vials and ampoules, the integrity or tightness of the closure (sealing) of which is broken (cracks in the glass, seepage of the drug through the cork of the vial, etc.);
Found in vials and ampoules without labels (labels), with unclear labels that do not indicate data.
Liquid and thick extracts are stored in well-closed vessels in a place protected from light at an air temperature of 12-15 ° C.
Dry extracts are stored in hermetically sealed vessels in a dry, dark place at a temperature of 12-20 ° C and a relative humidity of not more than 60%.
Hygroscopic dry extracts are packaged in wide-mouth jars with a capacity of 30, 50 and 100 g.
It is forbidden to release and use thick extracts covered with a dense crust or mold, and dry extracts that have lost their flowability or become sticky.
The precipitates formed during storage in liquid extracts are filtered off, after which the extracts are subjected to a check for compliance with the requirements of the current regulatory and technical documentation. In the case of positive results of the analysis, liquid extracts are considered suitable for use.
Tinctures are stored in well-corked bottles and flasks in a place protected from light. Lily of the valley tincture is contained in an orange glass container. Some tinctures (motherwort tincture, etc.) are stored in a cool place.
The precipitates formed during the storage of tinctures are filtered out, after which the tinctures are checked for compliance with the requirements of regulatory and technical documentation. If the result of the analysis is positive, the tinctures are considered suitable for use.
Methods for determining the concentration (strength) of ethyl alcohol in tinctures and other water-alcohol solutions are given in the State Pharmacopoeia.
Essential oils are contained in small, well-sealed orange glass bottles or in cans (jars) made of tinplate, filled to the brim if possible. Bottles and cans with essential oils are placed in a tightly closed cabinet and stored in a dark place at an air temperature of 12-15 ° C.
Mineral waters are stored in a dry, protected from direct sunlight place at an air temperature of 5 to 12 ° C.
10. Particularly photosensitive drugs that require wrapping the container with black opaque paper during storage include all of the following, except:
silver nitrate
prozerin
glucose
1. pepsin 3. collargol,
2. basic bismuth nitrate 4. furatsilin.
1. crichin 4. riboflavin
2. indigo carmine 5. potassium permanganate
3. copper sulfate 6. methylene blue
13. When preparing aqueous extracts from medicinal plant materials in pharmacy conditions, the calculation of the amount of extractant is carried out using:
1. volume expansion ratio
2. substitution coefficient
3.Water absorption coefficient
14. Infusion of marshmallow roots is prepared at a temperature:
1. room
15. Flammable substances requiring special storage conditions include all of the following except:
1. turpentine 4. medical ether
2. sulfur 5. alcohol solutions
3. chloroethyl 6. x-ray films
16. Flammable substances include all, except:
1. dressing material
2. sulfur 5. vegetable oils
3. glycerin 6. herbal medicinal
4.Chloroethyl Raw Material
17. Purified water is stored in a pharmacy:
3. 12 hours
18. Disadvantages of tablet dosage forms:
localization of the action of the drug in a specific part of the gastrointestinal tract
possibility of precise dosing
low degree of bioavailability
possibility of protection from exposure to light, moisture
complexity of application in pediatrics
binding
loosening
antioxidant stabilizers
fillers
isotonic substances
absorption delay
decrease in selection rate
flowability improvements
pressing improvements
prevent delamination
1. disintegration
2. average weight
3. dissolution
4. mechanical strength
5. melting point
22. Time of disintegration of tablets without shells in purified water, not more than (min.):
15 3. 20 5. 45
30 4. 60
coating
production of multilayer tablets
receiving matrix tablets
introduction of lubricants
getting a spansul
children's dosage form, which is soft gelatin capsules with an "extended neck".
hard gelatin capsule for internal use, containing a mixture of microcapsules (micropellets) with a shell and different dissolution times of medicinal substances.
multilayer tablet
frame tablet
soft gelatin capsule
simple chemical modification
physical state
excipients, their nature and quantity
type of dosage form
pharmaceutical technology
trituration
matrix
lontab
duplex
multilayer
microcapsules (micropellets) pressed on tablet machines with a shell of different thickness, the release of medicinal substances from which is carried out throughout the entire gastrointestinal tract.
tablets with an insoluble skeleton, gradually releasing medicinal substances.
tablets obtained by molding moistened masses.
multilayer tablets
dragee
solid dosage form for internal use, obtained by repeated layering of medicinal and excipients on sugar granules.
dosage form in the form of grains (grains) of a round, cylindrical or irregular shape, intended for internal use.
solid dosage form for internal or external use, consisting of one or a mixture of several bulk medicinal substances, which, as a result of grinding and mixing, appear homogeneous when viewed from the naked eye.
solid dosage form obtained by pressing drugs or a mixture of drugs and excipients, intended for internal, external, sublingual, implantation or parenteral use.
micropellets placed in hard gelatin capsules
with conventional coated casing
matrix
retard
duplex
spansules
the number of pressed shells
due to osmotic pressure
due to the gradual dissolution of the coated shells
due to the gradual dissolution of medicinal substances included in the matrix
amount of loosening agent
tablets obtained by molding moistened powdered drug excipients
tablets obtained by multiple layering in the obductor
tablets, which are an insoluble matrix with an incorporated drug substance
micro-compressed tablets
spansules
rotating basket
rocking basket
friabillator
rotating blade
device "Rezomat"
rotating basket
rocking basket
friabillator
rotating blade
device "Rezomat"
1. ethyl alcohol
2. glycerine
3. sulfacyl sodium
4. sodium benzoate
5. barbital
35. Drugs containing functional groups enter into the hydrolysis reaction
1. amino group a) correct answers 1,2,3,4
2. imide b) correct answers 1,2,3,5
3. amide c) correct answers 1, 3, 5
4. hydrazide d) correct answers 2, 3, 4.5
5. ester e) correct answers 2, 3, 4
36. One molar solution (1 mol/l) contains
1. 1 g-mol of substance in 1000 ml of solution
2. 1 g-mol of substance in 1000 ml of solvent
3. 1 g-mol of substance in 100 ml of solution
4. 1 g-eq. substances in 1000 ml of solution
5. 1 g of substance in 100 ml of solution
37. A titer for an analyte is the amount of g of a substance
1. in 1 ml of solution
2. in 1000 ml of solution
3. in 1000 ml of solvent
4. in 100 ml of solution
5. corresponding to 1 ml of titrant
38. The titer for the analyte according to SP XII is calculated by the formula:
1. T = ExM/1000
2. T \u003d EhKv x M.m x M / Kt
3. T=EhM/100
5. T \u003d M.m.xM / 1000
39. Do not have the right to write prescriptions for drugs
2. pharmacist
3. midwife
4. paramedic
5. dentist
40. Pharmaceutical examination of the prescription is carried out by
2. pharmacist
3. midwife
4. paramedic
5. dentist
41. The patient is not issued a signature instead of a prescription if drugs are prescribed
1. poisonous and potent, subject to PKU
2. antibiotics
3. narcotic
4. ethyl alcohol
42. The main tasks of the pharmaceutical examination of the prescription, except for:
1. establishing compliance with the form of the prescription form, the availability of basic and additional details of the prescription
2. determination of the eligibility of the person who wrote the prescription
3. setting the expiration date of the prescription
4. determination of the cost of the medicine (prescription taxation)
5. determination of compliance of the prescription with the established procedure for dispensing the medicinal product
43. The preparation of concentrated solutions and semi-finished products in a pharmacy is engaged in
1. packer
2. pharmacist
3. pharmacist
4. pharmacy manager
5. deputy head of pharmacy
44. Features of the preparation of aqueous extracts from medicinal plant materials containing alkaloids:
1. acidification of the extractant,
2. alkalization of the extractant
3. use as extractant water for injection
45. The main laws governing the provision of medical and pharmaceutical care in the Russian Federation are:
Law on the Circulation of Medicines
Constitution of the Russian Federation
Law "On technical regulation"
Law "On Protection of Consumer Rights"
1. municipal
2. self-supporting
3. structural unit of a medical organization
4. department of the health authority
5. department of the pharmacy service management body
47. The control and permitting system for ensuring the quality of medicines at the federal level is represented by:
1. Ministry of Health and Social Development of the Russian Federation
2. Pharmacopeia Committee
3. Advisory Committee
4. Centers for quality control of drugs
5. Department for the quality of medicines and medical equipment.
48. Positions of pharmaceutical workers involved in the manufacture of medicines in a pharmacy:
1. packer
2. consultant
3. pharmacist
4. accountant
5. nurse-washer
49. Medicines are subject to registration in the "register of poisonous, other medicines and ethyl alcohol"
1. narcotic
2. ready
3. extemporaneous
4. with a limited shelf life
5. potent
50. To account for the shelf life of medicines in a pharmacy warehouse, the following is carried out:
1. registration card
2. sampling sheet
3. rack card
4. inventory card
5. forwarding card
51. Medicinal products manufactured in pharmacies are subject to the following types of selective control
1. Questionnaire
2. writing
3. physical
4. organoleptic
5. holiday control
52 . Licensing of pharmaceutical activities of pharmacy enterprises means:
determination of the compliance of the conditions and place of activity with the established requirements for the provision of drug care and services
a method of state control over the compliance by pharmacies with the requirements of the legislation for their organizational and legal status and pharmaceutical activities
study of documents, payment of the state fee for registration and payment for its execution.
53. Irrational combinations of drugs for the treatment of coronary artery disease:
1. β-blockers + dihydropyridines
2. dihydropyridines + nitrates
3. Β - blockers + nitrates
4. verapamil + β - blockers
54. Side effects typical for β-blockers:
1. arterial hypotension
2. muscle weakness
3. asthenia
4. neuroleptic
55. To stop an attack of angina pectoris, the following are used:
1. nitrong
2. nitroglycerin
3. verapamil
4. diltiazem
56. Nitroglycerin preparations are taken:
1. while eating
2. 30 minutes before meals
3. after eating
57 . Anti-ulcer drugs are:
1. antacids
2. antifungals
3. antiemetics
4. gastroprotectors
58. H2 blockers - histamine receptors:
1. adrenaline
2. atropine
3. famotidine
4. nizatidine
5. pirenzepine
6. cimetidine
59. In case of intestinal spasm, the following is prescribed:
1. m - anticholinergics
2. azlocillin
3. biseptol
4. laxatives
60. In acute pancreatitis appoint:
1. epinephrine hydrochloride
2. drugs that reduce the secretion and acidity of gastric juice
3. tavegil
4. antispasmodics
61. Means that normalize digestion:
1. enzymatic agents
2. fluoroquinolones
3. gentamicin
4. vitamins
62. Of the bacteriophages used for the treatment and prevention of intestinal infections:
1. dysenteric polyvalent
2. typhoid
3. salmonella
4. all of the above
63. For the treatment of arterial hypertension are used:
1. diacarb
2. angiotensin receptor blockers
3. antimicrobial agents
4. antifungals
64. Correct statements:
1. labetolol blocks α and β-adrenergic receptors
2. dichlothiazide - neuroleptic
3. captopril - potassium channel activator
4. losartan blocks α-adrenergic receptors
65. The following drugs reduce blood pressure by reducing the volume of blood plasma and changing the water-electrolyte balance:
1. losartan
2. dichlothiazide
3. halothane
4. sodium nitroprusside
CONTROL WORK №2
The first block of tasks
Extractive medicines from plant raw materials of industrial production: tinctures. Ways to improve technology. Quality control. Storage. Nomenclature.
Preparations from fresh and dried medicinal plant materials. Juices. Infusions and decoctions. Teas.
Extractive medicinal products from plant materials
The most purified phytopreparations. Preparations of individual substances from medicinal plant raw materials. Methods for obtaining, purifying and isolating biologically active substances. Standardization. Storage. Nomenclature.
Preparations from animal raw materials. Definition. Classification. Nomenclature.
GMP requirements for the organization of production of sterile and aseptically manufactured drugs.
Dosage forms requiring aseptic manufacturing conditions.
Modern methods of sterilization. Methods for evaluating the effectiveness of sterilization.
Solvents for injection solutions. Water for injections. Methods for obtaining it. Analysis of water for injection. Tests for non-pyrogenicity.
Modern aspects of the manufacture of solutions for injections. Technological scheme for obtaining injection solutions.
Stabilization of injection solutions.
Filtration of solutions. The principle of membrane filtration technology.
Evaluation of the quality of injection solutions.
Manufacture of medicines for newborns and children up to 1 year. Quality control. Storage.
Manufacture of drugs containing antibiotics. Quality control. Storage.
Ophthalmic drugs. Stabilization. Technology. Quality control. Storage.
Dosage forms with elastic or viscous-plastic properties. Ointments. Definition of dosage form. Requirements. Classification of ointments according to various criteria. Auxiliary substances in the technology of ointments.
Technology of ointments in a pharmacy and in industrial conditions. Packaging, storage.
Modern requirements for the standardization of ointments.
Rectal and vaginal routes of drug administration in modern pharmacotherapy.
Suppositories as a dosage form. Requirements. Classification.
Suppository technology in pharmacies and industrial enterprises. Standardization of suppositories. Storage.
Therapeutic and cosmetic drugs. Definition. Classification.
Auxiliary and biologically active substances in the technology of medical and decorative cosmetics.
pharmaceutical incompatibilities. Physical incompatibility and ways to eliminate it.
pharmaceutical incompatibilities. Chemical incompatibility and ways to eliminate it.
Homeopathic medicines. Homeopathy as a method of treatment.
Technology of homeopathic medicines from plant and animal raw materials.
Veterinary dosage forms. Corrective agents for veterinary dosage forms.
Technology of veterinary dosage forms. Quality assessment and storage.
Ecological problems of pharmacy. Drugs as a source of toxic effects on the body.
Pharmaceutical industry as a source of anthropogenic substances released into the environment. Environmental protection. Wastewater treatment and atmospheric emissions. Environmental protection in the production of antimicrobial and anticancer drugs.
pharmaceutical marketing. Marketing and its role in the economy of pharmaceutical enterprises.
Pharmaceutical market as a complex of goods market and services market. Features of the pharmaceutical market.
Demand and supply in the drug market. Features of marketing activities depending on the type of demand and type of market.
Promotion of goods in the pharmaceutical market. The main means of promotion: advertising, propaganda, personal selling, sales promotion.
Price and pricing policy in the marketing system. Formation of a pricing strategy, types and methods of setting prices.
Pharmaceutical economics. State regulation of the economy. The mechanism of privatization and nationalization. Antimonopoly legislation and regulation of the economy.
Finance and loans. Types of economic means of pharmacy organizations by functional purpose, sources of their financing.
Accounting and reporting of pharmacy organizations that are on the balance sheet of higher organizations. Documentation and promotion of inventory results.
Russian tax system. Tax law. Tax code. Tax control and responsibility of the taxpayer for a tax offense.
Basic federal taxes. Basic regional and local taxes. Tax control over the expenses of individuals.
Pharmaceutical informatics. Information technology in the practice of pharmacy organizations. Professional information about medicines. Computer technologies of information service.
Rules for the pharmaceutical examination of prescriptions, norms for dispensing drugs. Preparations of subject-quantitative accounting.
Features of the control of medicines in the conditions of pharmacy enterprises. The main types of control (mandatory and selective).
Storage and transportation of medicines. Factors affecting the conditions and terms of storage of medicines.
Analysis of herbal medicines. Normative documentation for medicinal plant raw materials.
The role and place of herbal medicines in the general list of medicines. Comparative analysis of phytopreparations and parapharmaceutical products of plant origin.
Requirements for microbiological purity of finished medicinal products, substances, auxiliary materials.
Peptic ulcer of the stomach and duodenum. Mechanism of action, indications and contraindications for use, features of prescription, side effects of drugs
Irritable bowel syndrome and nonspecific ulcerative colitis. Mechanism of action, indications and contraindications for use, features of the appointment, side effects of drugs:
Acute and chronic hepatitis. Mechanism of action, indications and contraindications for use, features of prescription, side effects of drugs
Cirrhosis of the liver. Mechanism of action, indications and contraindications for use, features of prescription, side effects of drugs.
Cholecystitis. Mechanism of action, indications and contraindications for use, features of prescription, side effects of drugs
Cholelithiasis. Mechanism of action, indications and contraindications for use, features of prescription, side effects of drugs
Acute and chronic pancreatitis. The mechanism of action, indications and contraindications for use, features of the appointment, side effects of pathogenetic and symptomatic therapies. Acute pancreatitis.
Modern principles of treatment and prevention of infectious diseases. Bacterial dysentery. Mechanism of action, indications for use, features of prescription, side effects of etiotropic therapy of bacillary dysentery
The role and place of detoxification agents and correctors of water-salt balance in the treatment of infectious diseases of the gastrointestinal tract.
Means that normalize digestion. Mechanism of action, indications for use, features of the appointment, side effects
The value of bacteriophages (polyvalent dysenteric, typhoid, salmonella, intesti-bacteriophage) for the treatment and prevention of intestinal infections.
