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Vol 68, No 5 (2019)

Articles

PROCEDURE FOR REGISTRATION OF DRUGS AND COSMETICS IN THE RUSSIAN FEDERATION AND FOREIGN COUNTRIES

Gegechkori V.I., Kobakhidze T.I., Parkhimovich P.O., Gorpinchenko N.V., Perederyaev O.I.

Abstract

Based on the analysis of legal issues and documentation in the field of statutory regulation of the circulation of medicines and cosmetics, the authors provide an overview of the procedure for registration of medicines and cosmetics in the Russian Federation, the European Union, and the USA. The procedure for registration of Russian and imported medicines, as well as cosmetics in the Russian Federation and foreign countries is provided at the federal level and has a number of substantial differences, the purpose of which is to obtain information on the efficacy and safety of a product.
Farmaciya (Pharmacy). 2019;68(5):5-10
pages 5-10 views

REQUIREMENTS FOR EXCIPIENTS AND PACKAGE AS DRUG MANUFACTURING QUALITY ASSURANCE

Durnovtseva A.E., Foteeva A.V., Bombella T.V., Rostova N.B.

Abstract

The main task of Russian drug manufacturers is to bring safe and effective drugs to the market. There are parameters that affect the quality of drugs; in particular these are the used active ingredients and excipients and applied packaging/corking system. The regulatory system in the Russian Federation has not contributed to the monitoring of the quality indicators of excipients and primary packaging materials for a long time. Harmonization of the national registration procedure and transition to the international requirements of the Eurasian Economic Community (ErrAsEC) have now resulted in a great change in the approach to assessing the quality indicators for expedients and the packaging/corking system from the point of view of the regulatory system. These positive changes contribute to the circulation of the most effective and safe proper-quality drugs on the market of the Russian Federation.
Farmaciya (Pharmacy). 2019;68(5):11-17
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DRUGS IN THE TREATMENT OF TELOGEN HAIR LOSS

Korsunskaya I.M., Melnichenko O.O.

Abstract

Telogen hair loss is a common type of alopecia. It is characterized by a sudden onset and can occur in both women and men at any age. Factors that can provoke both acute and chronic telogen hair loss, as well as drugs used in its therapy are considered. Exogenous (drugs and various chemicals) and endogenous (infectious diseases) intoxications play a substantial role in the development of this disease. Drug therapy for telogen hair shedding is based on the correction of nutrient, vitamin, and mineral deficiencies. The vitamin and mineral complexes prescribed should contain protein, essential fatty acids, zinc, selenium, copper, vitamin C, biotin, vitamins B, L-cysteine, if necessary, iron, copper, and folic acid. The patients with telogen hair loss may have a favorable prognosis when the causal factors are eliminated.
Farmaciya (Pharmacy). 2019;68(5):18-21
pages 18-21 views

STANDARDIZATION OF THE COMPOSITION OF GROWTH SUBSTRATES FOR OBTAINING AN ANTIFUNGAL ANTIBIOTIC

Yakovleva E.P., Kolodyaznaya V.A., Topkova O.V.

Abstract

Introduction. Natural raw materials with their unstable chemical composition are used as a source of carbohydrates in the biotechnology industry. Synthetic sugars, aryl-substituted xylose derivatives possessing antimicrobial activity do not have this disadvantage. Objective: to investigate synthetic sugars as an additional source of carbohydrates in the composition of a growth medium, as well as a means of protecting the cultivation process of a producer from possible contamination. Material and methods. The investigation object was an antibiotic imbricin producer by the actinomycete Streptomyces imbricatus strain 0112/90, as well as synthetic sugars. Results. It was shown that synthetic sugars could not serve as an additional source of carbohydrate nutrition, but have an antimicrobial effect. Conclusion. The synthetic saccharide (3,4-dinitrophenyl-ß-D-xyloxylopyranoside) at a 0.1% concentration can be recommended for addition to the composition of a growth medium as a means of protection against possible contamination at the fermentation stage.
Farmaciya (Pharmacy). 2019;68(5):22-26
pages 22-26 views

INVESTIGATIONS ON THE DEVELOPMENT OF A DRAFT PHARMACOPOEIA ARTICLE ON YELLOW IRIS (IRIS PSEUDACORUS) RHIZOMES: CHARACTERISTICS OF IDENTITY

Tikhomirova E.A., Sorokina A.A.

Abstract

Introduction. Yellow iris (Iris pseudacorus L.) is widespread in the Russian Federation. The plant has a complex multicomponent composition of biologically active substances. However, the use of yellow iris rhizomes is very limited in Russian officinal medicine. The wider use of yellow iris rhizomes as a pharmaceutical plant substance and the design of innovative drugs require regulatory documentation that meets the current requirements for medicinal plant raw materials. Objective: to conduct in-depth morphological and anatomical studies of yellow iris rhizomes for the subsequent development of the draft pharmacopoeia article (PA) «Yellow iris rhizomes» Material and methods. The dried yellow iris rhizomes stored in the Shatura District, Moscow Region, in the summer of 2015 were investigated. The appearance and anatomical structure of the rhizomes were analyzed using the methods laid down in the State Pharmacopoeia of the Russian Federation, 14th edition (SP 14). Results. The investigators provide a refined and extended description of the appearance of yellow iris rhizomes of different processing forms (the rhizomes can be left whole, grounded, or powdered). Microscopic analysis made it possible to clarify their diagnostic signs characterizing whole raw materials and to visualize them. Conclusion. The findings of the in-depth morphological and anatomical studies of yellow iris rhizomes, which revealed their diagnostic signs, can be used in the development of a draft PA for raw materials.
Farmaciya (Pharmacy). 2019;68(5):27-30
pages 27-30 views

BIOPHARMACEUTICAL STUDIES OF A COMBINATION GEL CONTAINING CO2-EXTRACT AND ESSENTIAL OIL OF CHINESE MAGNOLIA VINE (SCHIZANDRA CHINENSIS) SEEDS

Stepanova E.F., Morozov Y.A., Khadzhieva Z.D.

Abstract

Introduction. Chinese magnolia vine (Schizandra chinensis) is the most valuable type of medicinal plant materials, which can be used to design novel effective stimulants and adaptogens. Objective: to conduct in vitro biopharmaceutical studies on selecting the optimal composition of a combination gel containing supercritical carbon dioxide extract and essential oil of Chinese magnolia vine seeds. Material and methods. The investigation objects were Chinese magnolia vine seed essential oil extracted by steam distillation, followed by liquid-liquid extraction and supercritical carbon dioxide extraction from the oil cake remaining after distillation. The optimal composition of the gel was selected using dialysis through the biological membrane. The colloidal and thermal stability of the best composition, as well as its structural and mechanical properties were studied. Results. The highest degree of 72% release at hour 10 of the experiment was observed for the model composition with 2% essential oil; a further increase in its concentration is impractical. This composition has thermal and colloidal stabilities: delamination of the system and/or separation of oil phase droplets were not observed. The gel is able to alter its structure under mechanical action and to restore the previous structure after its cessation; it has thixotropic properties. Conclusion. The authors have proposed the optimal composition of the transdermal combination gel containing CO2 extract from oil cake and essential oil of Chinese magnolia vine seeds.
Farmaciya (Pharmacy). 2019;68(5):31-36
pages 31-36 views

HISTORICAL ASPECTS OF THE DEVELOPMENT AND USE OF MEDICAL CHESTS IN THE RUSSIAN ARMY AND NAVY

Miroshnichenko Y.V., Kononov V.N., Perfilyev A.B., Rodionov E.O., Kostenko N.L.

Abstract

The provision of the Russian Army and Navy with medical chests which were a specially selected and systematized range of medical products, packaged in a specific container was initiated in the Petrine era. It is established that numerous wars and armed conflicts, as well as the development of medicine became a powerful boost to improve the equipping of military medical units and military hospitals. It is shown that the scientists and specialists of the Military Medical Academy, the Scientific Research Sanitary Institute of the Red Army, and the Main Military Medical Administration made a weighty contribution to the development of medical chests and substantiated their configuration and content, which contributed to the better medical support of the Armed Forces.
Farmaciya (Pharmacy). 2019;68(5):37-43
pages 37-43 views

TURBIDIMETRIC METHOD IN DETERMINING THE BIOLOGICAL ACTIVITY OF AMINOGLYCOSIDE ANTIBIOTICS

Semenova E.N., Kuleshova S.I., Luttseva A.I., Sakanyan E.I.

Abstract

Introduction. Antibiotics are the most widely used group of drugs. Therefore, the standardization and subsequent quality control of drugs in the antibiotic group are of particular relevance. Objective: to develop a turbidimetric method to quantify neomycin sulfate in the medicines used in the Russian Federation. Material and methods. Solutions of neomycin sulfate concentration in the range of 1.5 to 3.66 IU/ml were assessed using the experimental nutrient medium inoculated with Staphylococcus aureus ATCC 6538P in an amount of 2% after 4.5-hour incubation. Results. The turbidimetric procedure for determining the biological activity of the aminoglycoside antibiotic neomycin sulfate was validated according to the following parameters: linearity, precision, accuracy, stability, and specificity. Conclusion. The results of validation tests of the procedure for the quantification of neomycin sulfate provide evidence that the turbidimetric method can determine the biological activity of aminoglycoside antibiotics in research and analytical laboratories and at enterprises. The developed procedure can significantly reduce the time of analysis.
Farmaciya (Pharmacy). 2019;68(5):44-50
pages 44-50 views

BIOLOGICAL ACTIVITY OF SOME DERIVATIVES OF N-ARYLBENZAMIDINES AND THEIR HYDROCHLORIDES

Kuvaeva E.V., Kolesnik D.A., Kirillova E.N., Fedorova E.V., Yakovlev I.P.

Abstract

Introduction. Organic molecules belonging to the class of amidines have a broad spectrum of biological activity: antimicrobial, anticoagulant, anti-inflammatory, analgesic, etc. But these compounds are poorly soluble in water and in most organic solvents, which is a substantial disadvantage in designing new pharmaceuticals based on them. The introduction of the substituents into the molecules of these compounds, which fail to alter the biological activity and toxicity, but change the solubility, or the obtaining of salts with a higher solubility, is one of the ways to solve this problem. Objective: to investigate the biological activity of synthesized N-arylbenzamidines and their hydrochlorides. Material and methods. N-arylbenzamidines were obtained by baking arylamines with benzonitrile in the presence of aluminum chloride. N-arylbenzamidine hydrochlorides were synthesized by passing dry hydrogen chloride through a suspension of N-arylbenzamidines. Acute toxicity was determined by the Miller-Teichner method. Anti-inflammatory activity was studied using the formalin-induced rat paw edema method. For experimental evaluation of analgesic activity, an acetic acid-induced writhing model was used in male mice. Antimicrobial activity was investigated by the serial dilution method. Results. Series of N-arylbenzamidines and their hydrochlorides were synthesized. The structure of the compounds obtained was proved using modern methods of analysis. The synthesized compounds were studied in terms of acute toxicity and biological (antimicrobial, analgesic and anti-inflammatory) activity. Conclusion. The acute toxicity of the obtained N-arylbenzamidines and their salts depends on the electronic nature of the substituent in the aryl moiety. Increasing the electron-acceptor nature of the substituent reduces the toxicity of synthesized compounds. N-arylbenzamidines, unlike their hydrochlorides, have pronounced antimicrobial, anti-inflammatory, and analgesic activities. These properties are at the level of widely used antimicrobial drugs, such as fluoroquinolones and chlorhexidine. The presence of an electron-acceptor substituent in the aryl moiety of amidines leads to an increase in antimicrobial activity.
Farmaciya (Pharmacy). 2019;68(5):51-56
pages 51-56 views

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