Vol 6, No 3 (2018)

Articles

MODERN REQUIREMENTS TO INDUSTRIAL PRODUCTION AND PHARMACEUTICAL MANUFACTURE OF INFUSION MEDICINAL PREPARATIONS IN THE RUSSIAN FEDERATION: SIMILARITIES AND DIFFERENCES

Gachenko R.A., Goryachev A.B.

Abstract

The quantitative reduction of the manufacturing pharmaceutical organizations significantly lowers public accessibility to medicinal preparations manufactured by pharmacies. The aim of this research has is the analysis of the normative legal standards regulating the industrial production and the pharmaceutical manufacture of infusion medicinal preparations in the territory of the Russian Federation. Materials and methods: The research has been carried out by the analysis of the current legislative and normative acts by means of documentary observation and content analysis. Results and discussion. Hereby the review has been done of the main acts along with normativelegal documentation regulating the industrial production and the pharmaceutical  manufacture of infusion medicines such as federal laws, regulations of the Government of the Russian Federation, the State Pharmacopeia (Editions XI and XIII), orders of the Ministry of Health of the Russian Federation, etc. It has been established that in the Russian Federation there has been developed and currently functioning the system of mandatory requirements to industrial production and quality control of infusion medicinal preparations produced by manufacturing enterprises. At the same time, despite the restrictions on the pharmaceutical manufacture of the aseptic medicines registered in the Russian Federation, the pharmaceutical organizations implement manufacture of the medicines which are not produced industrially. That makes it possible to provide an individual dosage of ingredients and take into account patients’ individual characteristics. The normative legal regulation system for the pharmaceutical manufacture significantly differs from the similar system for the industrial production. The scientific discussion on the implementation of the international Rules of Good Manufacturing Practices (GMP) into pharmaceutical activities has not arrived at a unanimous organizational and technological opinion because of essentially different purposes, a diverse range of the undertaken tasks and dissimilar economic opportunities of pharmaceutical organizations and manufacturing enterprises. Conclusion: The currently existing normative legal regulation system for the industrial production and the pharmaceutical manufacture of infusion medicines in the Russian Federation is aimed at providing the national health services’ needs of necessary remedies for infusion therapy. At the same time, the pharmaceutical manufacture does not oppose the industrial production, but quite the contrary, expands public accessibility to such preparations for treatment in emergency or urgent cases and also during routine treatment of patients.
Pharmacy & Pharmacology. 2018;6(3):214-228
pages 214-228 views

DEVELOPMENT OF METHODS OF PRE-COLUMNAR DERIVATIZATION OF GLUTATHIONES RECOVERED BY 4-METHOXY-2-NITROPHENYLISOTHIOTOCIONATE FOR DETERMINATION BY METHOD OF HIGH-EFFECTIVE LIQUID CHROMATOGRAPHY

Alexeeva K.A., Pisarev D.I., Novikov O.O., Malyutina A.Y.

Abstract

Nowadays the pharmacological role of glutathione in the therapy of carcinogenesis, neurodegenerative and ocular diseases, heart diseases, the immune system and aging of the organism is being actively investigated. Therefore, for the development of pharmaceutical medical forms on its basis, it is necessary to create an optimal analytical base. The aim of this study is to develop a methodology for the analysis of glutathione recovered by pre-columnar derivatization of 4-methoxy-2-nitrophenyl isothiocyanate. Materials and methods. Since glutathione does not have the necessary spectral characteristics for its direct analysis, a methodology for the determination of glutathione with the use of pre-columnar derivatization of 4-methoxy-2-nitrophenyl-isothiocyanate by reversed-phase high-performance chromatography (RP HPLC) has been developed on that basis. Detection of the resulting derivative has been carried out by absorption in UV light using a diode array detector. Results and discussion. In the course of the experiment described, chromatograms of a glulathione derivative with 4-methoxy-2-nitrophenyl isothiocyanate were obtained. This technique was also evaluated for the possibility of quantitative determination of glutathione. The sensitivity of the methods was 0.01% or 3.1*10-1 mol. The linear relationship between the analytical signal (peak area) and concentration was observed within the range of 0.01–0.08% and the correlation coefficient of 0.995. Conclusion. In the course of the studies, a methodology for the determination of glutathione has been developed with the use of pre-columnarderivatization of 4-methoxy-2-nitrophenyl-isothiocyanate by RP HPLC. In this case, the derivative is formed with the retention time of 22.3 minutes and the absorption maximum of 398 nm. This method also allows estimating the quantitative content of the object under study.
Pharmacy & Pharmacology. 2018;6(3):229-240
pages 229-240 views

CHEMICAL STUDY OF FLAVONS AND FLAVONOLS COMPOSITION IN PROPOLIS

Lupina E.V., Pisarev D.I., Novikov O.O., Malyutina A.Y., Vasilev G.V., Vasileva Y.G.

Abstract

The aim of the study. This article is dedicated to the comparative assessment of flavones and flavonols composition in various samples of propolis for providing the possibility of its standardization. Materials and methods. To carry out the research, 6 experimental samples of propolis were taken from different regions of Russia. Using those samples, we prepared the extracts with 80% ethanol according to traditional scheme of making tinctures in the ratio of 1:10. After that our extracts were filtered and used directly in the assessment. Chromatographic separation of spirit extracts of propolis was carried out on a liquid chromatograph of “Agilent Technologies 1200 Infinity”, USA. The detection was carried out on the basis of the diode array detector “Agilent 1200”. Results and discussion. Using the reversed-phase HPLC in gradient elution regime we managed to identify flavonols and flavones. It was found out that the composition of propolis has a stable composition of flavones and flavonols including quercetin, isoramnetin, 3,4’-dimethoxycempferol, ramnetin, penduletin, kaempferol, ramnocitrin, galangin, kaempherid, chrysin and methoxyhalangin. Among the identified components, the highest content is in flavonols, methoxyl derivatives ramnocitrin (22,0%), and kaempherid (12,0%); in flavones it is chrysin(16,0%). The specific gravity of each component within the specified group was calculated by the internal normalization method. It was established that about 84% of all flavonols are in kaempferol and its methoxyl derivatives. The composition of flavones and flavonols can vary depending on the sample. Hereby, kempferol was identified in all the studied samples, whereas some of the identified components were absent from separate propolis samples. Propolis standardization by method of high-performance liquid chromatography in respect of the content of flavonoids in terms of kaempferol as a stable, commercially most available component of propolis was suggested. With the use of absolute calibration, the quantitative content of kaempferol in propolis samples wasdetermined in the range of 0.0141-0.0159%. Conclusion. The results of the carried out experiments made it possible to recommend the quality assessment of propolis according to the content of kaempferol in the experimental samples.
Pharmacy & Pharmacology. 2018;6(3):241-254
pages 241-254 views

STUDY OF PSYCHOMODULATING PROPERTIES OF ASTRAGALUS VULPINUS WILLD EXTRACT AGAINST THE BACKGROUND OF INFORMATIONAL OVERLOAD

Samotrueva M.A., Sergalieva M.U.

Abstract

One of the main tasks of modern pharmacology is the development of new methods for correcting various stress-induced states. An essential role in solving this problem can be played by herbal medicinal products. A special interest is represented by Astragalus vulpinus Willd - a plant of a large Astragalus genus of the legume family (Fabaceae),growing in the Astrakhan Region. The aim of the study is to investigate the effect of the Astragalus vulpinus Willd extract on the psychoemotional state of animals against the background of informational overload (IО). Materials and methods. The experiment was performed on nonlinear male rats. All the manipulations with the animals were carried out according to the rules and principles of work with laboratory animals. The animals were divided into groups: Group 1 - control rats; Group 2 – the animals exposed to IО for 20 days; Group 3 – the animals treated with intragastric liquid extract of Astragalus vulpinus Willd in the dose of 50 mg / kg /a day for 14 days and exposed to IО;Group 4 – the animals treated with the comparative drug of Phenibut in the dose of 25 mg / kg for 14 days against the background of informational overload. The IO model was a multi-alternative labyrinth in which food-producing skills were formed. The psychoemotional state of rats was studied in the “Suok-test” (ST), which is a complex of several classical behavioral models. Results and discussion. The study of laboratory animals’ behavior in the “Suok-test” against the background of informational overload showed the formation of the state of increased anxiety, which was manifested by a decrease in the motor and research activity of white rats. It was established that the Astragalus vulpinus Willd extract has an anxiolytic and antidepressant effect, eliminating manifestations of an anxiety-depressive state developing against the background of informational overload. Conclusion. Estimating the influence of the Astragalus vulpinus Willd extract in comparison with the activity of Phenibutum, it can be concluded that the investigated drugs eliminate the changes in the psychoemotional state of the anxiety-depressive character, demonstrating a practically comparable anxiolytic and antidepressant effect.
Pharmacy & Pharmacology. 2018;6(3):255-268
pages 255-268 views

A COMPARATIVE ANALYSIS OF THE ASSORTMENT OF DIFFERENT MEDICATION GROUPS USED IN THE CENTRAL REGIONAL HOSPITAL OF THE MUNICIPAL REGION AND THE REGIONAL HOSPITAL OF THE FEDERAL STATE-OPERATED HEALTHCARE AGENCY “MEDICAL AND SANITARY CENTER-23” (FKUZ MSCH-23) OF THE FEDERAL PENITENTIARY SERVICE (FSIN) OF RUSSIA

Bochkarev B.G., Kalinin I.V., Kabakova T.I.

Abstract

Providing quality pharmaceutical care is a key task of healthcare; any medical organization must respond efficiently to a change in both external and internal factors that affect the medical support of patients. The aim of this study was to analyze the structure of medication consumption in comparable hospitals in the penitentiary and civilian healthcare systems. Materials and methods. The study was conducted on the basis of content analysis, documentary observation, ABC analysis, and comparison of performance indicators of medical organizations. Results and discussion. This study analyzed the assortment of commodity stocks of medications in the regional clinical hospital that is a part of the structure of FSIN and a typical central regional hospital (CRH). Using ABC analysis it was established that the Group A (the most costly) medications in the penitentiary medical organization consisted exclusively of anti-viraldrugs used for treating HIV-infected patients, which is 54.91% of the stock that are represented by 18 international non-proprietary medication names. In turn, Group A of the medication assortment of the State Budgetary Healthcare Organization of the Republic of Adygea (GBUZ RA) “Krasnogvardeiskaia CRH” consists of three pharmacological groups – plasma substitutes, cardiovascular medications, and antibiotics. On the basis of the obtained data, the study identified different groups of medications and studied their assortment based on international non-proprietary namesand medication forms that received preference either in the branch of Clinical Hospital-2 (KB-2) FKUZ MSCh-23 FSIN of Russia or GBUZ RA “Krasnogvardeiskaia CRH” (38 ATC groups in all). The first group consists of medications from the following 12 ATC groups (31.6%), the assortment of which can be found exclusively in the branch of “KB-2” FKUZ MSCh-23 of the Federal Penitentiary Service of Russia: antiretroviral, muscle relaxants, anticonvulsants, adaptogens, antidepressants) or significantly exceeds similar stocks in GBUZ RA “Krasnogvardeiskaia CRH”: anti-asthmatic agents (3 times), anti-fungal drugs (3 times), hormones except for insulin (2.2 times), respiratory regulators (2 times), non-steroidal anti-inflammatory drugs (1.7 times), medications regulating the gastrointestinal function (1.5 times), and antibacterial agents (1.4 times). The second group consists of medications of the following 9 ATC groups (23.7%) that are stocked only by GBUZ RA “Krasnogvardeiskaia CRH”: antifermental drugs, radiocontrast agents, chondroprotective and antiparasitic medications, and -- within a wider diapason of non-proprietary drugs and forms of manufacture – diuretics (5 times), antitubercular (3 times), antiviral with the exception of anti-HIV (2 times), spasmolytics (2 times), and hypertension drugs (1.5 times). It was determined that the main medical activity of medical organizations subordinate to FSIN of Russia, is aimed at treatment and prevention of complications of the most socially dangerous diseases – HIV/AIDS and tuberculosis – as well as therapy of the associated diseases. It was shown that pharmacists do not use methods of pharmacological-economic analysis in their work, and the medication needs of medical organizations are only 20% satisfied. Conclusion. The identified shortcomings attest to the need to develop and implement a more effective system for the formation of stockpiles in the pharmacies of the penitentiarymedical organization.
Pharmacy & Pharmacology. 2018;6(3):269-287
pages 269-287 views

MODELING PROCESS OF PALLIATIVE PHARMACEUTICAL CARE AS A COMPONENT OF PHARMACEUTICAL SAFETY AT THE LOCAL LEVEL

Tueva I.A., Geller L.N., Myimrina A.L., Escheva L.A., Vidyasova I.V.

Abstract

The importance of the pharmaceutical safety of the palliative care system, good timing of its delivery, accessibility and quality have been actively discussed in the professional environment only for the latest 4–5 years. Despite the urgency of the direction in question, the necessary number of pharmacies licensed for trafficking in narcotic drugs,psychotropic substances and their precursors has not yet been determined. The aim of the article is the optimization process of palliative pharmaceutical care system aimed at timely and prompt provision of patients with opioi analgesics in the right assortment and the required volume in Novokuznetsk of the Kemerovo region. Materials and methods.To carry out the research, the following materials and methods have been used: the content analysis of outpatient cards of 17 polyclinics in five districts of Novokuznetsk (750 cards), photo-timing data of pharmaceutical workers on prescription of drugs, psychotropic substances and their precursors (39,964 prescriptions), sociological survey(questionnaires) of 101 district therapists, social workers and patients (their legal representatives) for the period of 2014-2017, cluster modeling of the palliative care process. Results and discussion. The retrospective content analysis of 750 outpatient cards, photo-timing data for 39,964 prescriptions for narcotic drugs, psychotropic substances and their precursors for the period of 2014–2017 have shown an increase in the load per pharmacist. The introduction of a cluster model of interaction between medical and pharmaceutical staff at the outpatient stage of palliative care minimizesthe time spent on performing auxiliary procedures. Conclusion. In the conditions of an industrial center for 100 thousand inhabitants, at least one pharmacy organization dealing with the release of narcotic drug and psychotropic substances and their precursors is necessary for the proper and stable provision of patients in need of palliative care. Such a specialized pharmacy should be located in the territory with a good transport interchange, and its specialists are obliged to regularly raise the professional qualifications in the sphere of palliative care provision. One of the effectiveways to improve the quality and timeliness of the choice of anesthesia tactics, the necessary adjustment is the cluster organization of palliative care, based on the close professional relationship of medical and pharmaceutical personnel, ensuring the proper pharmaceutical safety of patients.
Pharmacy & Pharmacology. 2018;6(3):288-308
pages 288-308 views

TO THE JUBILEE OF PROFESSOR STEPANOVA ELEONORA FEDOROVNA

Kompantsev D.V., Kishchenko V.M., Veselova D.V., Koryanova K.N.

Abstract

The article is devoted to the anniversary of Professor Eleonora Fedorovna Stepanova – a bright representative of the Russian intelligentsia: a talented lecturer, an inventor, an author of numerous books, an internationally recognized scholar!
Pharmacy & Pharmacology. 2018;6(3):309-314
pages 309-314 views

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