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Vol 70, No 5 (2021)

Articles

Elaboration of regulatory approaches to managing the risk of the use of biomedical cell products in the Russian Federation

Taube A.A., Alyautdin R.N., Merkulov V.A., Melnikova E.V., Goryachev D.V.

Abstract

Introduction. In recent years, the Russian Federation has created a regulatory framework for putting biomedical cell products (BMCP) into civil circulation. The BMCP market in our country is just beginning to develop, while this market in the EU and the USA is actively providing new opportunities for healthcare and patients. Due to the complexity of the composition, to the individual use, and high cost of these medicines, developers and regulatory authorities face new questions about the management of risks associated with the use of BMCP. Objective: to analyze risk-oriented approaches by foreign regulatory authorities having their practical experience in examining and regulating the circulation of BMCP analogues on the market in order to elaborate national approaches to managing the risk of BMCP usage. Material and methods. The investigation was based on the normative documents regulating the circulation of BMCP analogues in the USA and the EU and the guidelines prepared by regulatory authorities. Logical methods of system analysis and modeling were used in the investigation. Results. The investigators studied the currently developed requirements for risk management at all stages of the BMCP life cycle, starting from the early development stage. The information about the introduced approaches to BMCP risk management is given. The analysis of various regulatory approaches to assessing the risks during BMCP circulation made it possible to propose areas for improving the regulation of BMCP circulation. It showed the necessity of creating separate guidelines for developers of BMCP at all stages of their life cycle, by taking into account the specific risks for each type of BMCP. Conclusion. It is necessary to create and maintain a patient and product traceability system with the necessary detail to ensure quality and establish causal relationships between drugs and incoming signals, as well as between a drug and a patient at all stages of the BMCP life cycle from production to destruction.
Farmaciya (Pharmacy). 2021;70(5):5-14
pages 5-14 views

Polyprenols as an original class of natural compounds having a wide spectrum of pharmacological activity

Antipina A.A., Popov V.S., Balabaniyan V.Y.

Abstract

The paper presents a review, generalization and systematization of literature data on the main plant sources of polyprenols, the methods of their preparation and standardization, biosynthesis, metabolism, a biological role, pharmacodynamic effects, mechanisms of action, and areas of therapeutic use of polyprenols. Polyprenols are an original class of natural compounds, namely: a group of long-chain isoprenoid alcohols, in which 2,3-dihydro derivatives, dolichols, are natural bioregulators. Dolichols are formed in the liver and are directly involved in the synthesis of cell membrane glycoproteins, being oligosaccharide donors in the process of N-glycosylation of proteins, which determines one of the mechanisms of their pharmacological action: the process of cell regeneration and renewal is accelerated. When entering the human body, natural polyprenols normalize natural cell needs for endogenous dolichol phosphate, promoting the intensification of glycoprotein biosynthesis. The most obvious mechanism of action of polyprenols, dolichols in particular, is the suppression of oxidative stress: due to their chemical structure, dolichols has been found to act as fat-soluble antioxidants. In addition, polyprenols are noted to be able to increase the fluidity and permeability of biological membranes, which favors the stimulation of metabolic processes and the increase of cell viability. The properties of polyprenols predetermine their wide spectrum of pharmacological action. The main sources of polyprenols are coniferous plants (various types of fir (Picea), silver fir (Abies), and pine (Pinus)), as well as maidenhair tree (Ginkgo biloba L.). At the same time, a long-chain polyprenol mixture isolated from the leaves of maidenhair tree is dominated by polyprenols that are similar in the number of isoprene units to that of mammalian dolichols. Polyprenols have a significant, not fully evaluated therapeutic potential, which is the initiating factor in the in-depth study of their pharmacological properties.
Farmaciya (Pharmacy). 2021;70(5):15-21
pages 15-21 views

Investigations for the development of a procedure for the quantitative analysis of redhaw hawthorn (Crataegus sanguinea) shoots

Volkova N.A., Kurkin V.A., Pravdivtseva O.E., Kurkina A.V., Varina N.R., Sharova O.V.

Abstract

Introduction. The flowers and berries of redhaw hawthorn (Crataegus sanguinea Pall., the rose family (Rosaceae)) are used in medical practice as cardiotonic agents. Its shoots contain flavonoids and therefore they are a promising type of medicinal plant raw materials and can be used as a source for obtaining herbal medicines. Objective: to develop a procedure for the assay of the amount of flavonoids, calculated with reference to vitexin 2"-O-rhamnoside, in the redhaw hawthorn shoots. Material and methods. The shoots of redhaw hawthorn of various species were collected in the Samara University Botanical Garden during the plant flowering stage. The collected raw materials were air dried without direct sunlight. The relationship between various extraction parameters and the yield of active substances from raw materials was studied. Results. The optimal parameters for the procedure of assaying the redhaw hawthorn shoots were extraction for 60 minutes in a boiling water bath where 70% ethanol was used as an extractant in a raw material-to-extractant ratio of 1:100. The expediency of quantitative determination of the amount of flavonoids, calculated with reference to vitexin 2II-O-rhamnoside at a wavelength of 392 nm was justified. The amount of flavonoids was studied in the shoots of redhaw hawthorn and other species of the Crataegus genus. The total content of flavonoids in the redhaw hawthorn shoots, which was calculated with reference to vitexin 2II-O-rhamnoside, was in the range of 2.04-3.79%. Conclusion. A procedure has been developed to assay the amount of flavonoids, calculated with reference to vitexin 2II-O-rhamnoside, in the redhaw hawthorn shoots, when analyzing the wavelength of 392 nm. The shoots of redhaw hawthorn are a promising source of new medicines.
Farmaciya (Pharmacy). 2021;70(5):22-27
pages 22-27 views

Analysis of consumer behavior in the population with myocardial infarction on the market of medical and pharmaceutical goods and services

Petrov A.G., Abramov N.V., Kashtalap V.V., Glembotskaya G.T.

Abstract

Introduction. The study of consumer behavior when choosing the necessary product is aimed at identifying and analyzing the factors that influence the purchasing decision. The findings allow medical and pharmacy practitioners to meet the needs of patients, including those with myocardial infarction (MI), for the necessary medicines in the process of pharmaceutical care. The denoted category of consumers in the country's healthcare system is particularly important in both medical and social contexts. Objective: to analyze needs and preferences in the consumers of medical and pharmaceutical goods and services in the system of pharmaceutical assistance to the population with MI. Material and methods. Data from a questionnaire-based survey of 416 patients with MI were used as primary documentation in the study. Respondents were selected from a random non-repeated sample. The concepts of the questionnaire blocks for studying the needs and preferences in the consumers of medical and pharmaceutical goods and services were considered as a studied phenomenon, which make it possible to identify the patterns of consumer behavior of the population with MI and can serve as a basis for optimizing medical and pharmaceutical care. The material was processed using the Statistica 10.0 program. Results. The needs and preferences of the population with MI, who are consumers of medical and pharmaceutical services, were studied. The sociodemographic characteristics of the members of reference groups were compiled. Data on their health status, medical and pharmaceutical culture were collected. The awareness about preferences in medical and pharmaceutical services, patients' adherence to medical recommendations, and preferences of medical and pharmaceutical services was explored. Conclusion. The performed studies confirm the need for a detailed assessment of customer satisfaction in the treatment of MI. On its basis, it is possible to more effectively form loyal or regular customers, which requires pharmacies to constantly meet consumer preferences and to ensure an improvement in the quality of medical and pharmaceutical care to the population.
Farmaciya (Pharmacy). 2021;70(5):28-34
pages 28-34 views

History of pharmacy. The 1992/1993 drug famine: the summands of the collapse

Zatravkin S.N., Vishlenkova E.A.

Abstract

Objective: to conceptualize the phenomenon of the 1992-1993 drug famine in Russia. Information basis. On the basis of publications in the pharmaceutical periodicals, the reference books of the Russian Statistics Agency, the interviews with the participants about events, on the basis of the texts of state reports on the health status of the population and the analytical reports of pharmaceutical companies, the authors of the article identify the quantitative and qualitative measures of hunger. Research approaches and methods. The gathered collection of historical sources is analyzed using the methods of behavioral economics, historical sociology, and neoinstitutionalism. This combination could identify transaction costs in the implementation of government decisions, determine the pattern of drug supply and import, and track an increase in prices and production volumes. The obtained quantitative data show a regression in meeting the country's need for medicines. Results. The authors of the paper argue that not every drug shortage can be called hunger. A drug famine manifested in a total shortage of medicines in retail sales and in healthcare facilities. Like a food famine, the drug famine took a heavy toll on human lives, and therefore its depth is quite measurable in numbers. Zatravkin and Vishlenkova prove that the reasons for the acute shortage of certain drugs and the total absence of other medicines in 1992-1993 were the specific characteristics of the socialist pharmaceutical industry and the destruction of the Soviet-type economy, the financial deficit of the state budget, the crisis of credit confidence by foreign partners, and government mistakes in regulating the pharmaceutical market.
Farmaciya (Pharmacy). 2021;70(5):35-42
pages 35-42 views

Determination of the wound-healing activity of a gel cream containing a synthetic selenoxanthene derivative

Zayats D.V., Buyuklinskaya O.V., Erimbetov K.T., Khoreva O.V., Felenko N.S.

Abstract

Actuality: In this timethere are many different topical medicines inducing wound healing. Many drug forms or their active substances are produced abroad. Active substance selenopyrane with antioxidant, immunomodulatory and other actions was synthesized by research center “Park of activemolecules” (Obninsk). Topical action of substance has not been researched. Research purpose: study of wound healing activity of gel-cream, containing 1% selenopyraneon a model of a full-thickness planar wound in rats. Material and methods: wound healing activity of gel-cream, containing 1% selenopyrane has researched on model of a fullthickness planar wound in rats. Animals were divided into 3 groups: I - intact group; II - group of rats, were treated by gel-cream with selenopyrane; III - group of rats, were treated by dexpanthenol cream (comparison drug). Histological preparations of skin from wound area were made after the end of research (day 14). Results: On the 3rd day of experiment relative wound area in animal treated by selenopyrane was 2.1 % less than in intact rats but differences were not statistically significant. On the 5th day of experiment there was statistically significant difference of relative wound area in II group of animals in comparison with I (intact) group: 45.8% and 64.6% accordingly. Thus, gel-cream containing 1% selenopyran accelerated the onset of the wound process second phase- proliferation phase. Histological research showed that gel-cream containing of 1% selenopyran stimulates the epithelization of the wound defect of the skin with epidermis layers differentiation.
Farmaciya (Pharmacy). 2021;70(5):43-47
pages 43-47 views

Differences in the psychological characteristics of higher and secondary pharmacy education students

Bogdanov V.V., Nozdrachev K.G., Shoshin A.S., Kuklin E.Y., Chavyr V.S.

Abstract

Introduction. For a long time, the boundary between higher and secondary pharmacy education specialists has been increasingly blurred. The requirements for the positions and functions of higher and secondary education pharmacists are largely similar. However, there are differences in the level of education, acquired competencies, social and cultural environment, motivation, worldview, etc., the study of which can be the basis for optimizing personnel policy in both the training of pharmacy personnel and for managing the latter in pharmaceutical organizations Objective: to study differences in the psychological characteristics of students going into higher and secondary professional pharmacy education. Material and methods. The data from four questionnaires, such as Motivation questionnaire, the Shmishek-Leonhard characterological questionnaire, the Cattell questionnaire, and dynamic properties questionnaire (proposed by Rusalov) were taken to study 42 students in specialty 33.05.01 Pharmacy (higher education pharmacists) and 107 students in specialty 33.02.01 Pharmacy (secondary education pharmacists). The results of statistical data processing of questionnaire scores were studied using the Mann-Whitney U test in the IBM SPSS Statistics program. Results. The similarities and statistically significant differences were identified by 11 criteria for the psychological characteristics of higher and secondary pharmacy education students. Conclusion. The higher pharmacy education students are more oriented to theory, a systematic logical description of the world, more self-restrained, rational, and psychologically rigid, and also with their high intellectual activity, they have an average physical activity level. The secondary pharmacy education students are more oriented to relationships between people, are more emotionally and psychologically mobile, they are oriented to the norms of behavior of the group of people around them, to the activities according to the plan, they are pedantic in work, are more eager for physical activity, and have a high speed in manual labor.
Farmaciya (Pharmacy). 2021;70(5):48-55
pages 48-55 views

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