Vol 7, No 3 (2019)

Articles

STUDY OF NEPETAE CATARIAE HERBA FRUITS AS PROMISING MEDICINAL PLANT RAW MATERIAL

Devyatov A.G., Lapshin G.S., Babaeva E.Y., Motina E.A., Zvezdina E.V., Vandishev V.V.

Abstract

Nepetae catariae herba is used in the Russian Federation as spice. The chemical compounds of herb have been studied. This plant has been introduced into the culture. There are its domestic varieties. The fruits of the plant accumulate up to 25% of fatty oil and contain specific laballenic acid, which has a wide range of antimicrobial and fungicidal actions. The yield of fruit crops is 5-6 c/ha.The aim is to study some criteria for the standardization of the quality of Nepetae catariae herb as a new medicinal plant raw material.Materials and methods. The studied fruits are from the biological collection of Federal State Budgetary Institution of All - Russia Research Institute of Medicinal and Aromatic Plants. Binocular magnifier brand MBS-10 and Axioplan 2 imaging microscope by Carl Zeiss were used. The sample preparation was carried out according to the State Pharmacopoeia of the Russian Federation (XIV edition). Anatomical diagnostic features were studied in powder and cross section with staining reagents for the presence of some biologically active substances. Qualitative reactions were carried out with water and alcohol-water extracts from the fruits. The content of the lipid complex according to pharmacopoeia monograph 2.5.0035.15 has been determined.Results. A description of the external and diagnostic anatomical features is given. The main groups of biologically active substances and the content of the lipid complex in a possible new material - the fruits of Nepeta cataria - have been identified.Conclusion. The description of the external features of the fruit has been specified. For the first time, crushed fruits have been characterized. It has been established that the morphology of endocarp cells and seed embryo cells are best preserved in a mellow fruit. Physico-optical properties of cellular structures and the ability for basic microchemical reactions are preserved in all zones of pericarp and seeds. Qualitative reactions showed the presence of the following components in the fruits: saponins, flavonoids and a lipid complex. A dispersion composition has been studied. The yield of the lipid complex and its appearance have been determined. Fruits can be used as promising fat-oil raw materials. The results of the study can be used in drafting Pharmacovigilance Reference Document considering a promising type of medicinal plant raw material on the basis of Nepetae catariae herba fruits.
Pharmacy & Pharmacology. 2019;7(3):120-128
pages 120-128 views

STUDY OF BAICALIN HYDROLYSIS KINETICS IN THE PROCESS OF ITS EXTRACTION FROM SCUTELLARIA BAICALENSIS GEORGI ROOTS

Boyko N.N., Pisarev D.I., Zhilyakova E.T., Maljutina A.Y., Novikov O.O., Bocharnikova M.A.

Abstract

The aim of this study was to investigate the kinetics of baicalin hydrolysis in the process of its extraction from Scutellaria baicalensis Georgi roots.Materials and methods. For the studies, Scutellaria baicalensis Georgi roots with a particle range of 0.1-0.5 mm were used. The method of extraction was a simple maceration during a specified period of time, the ratio of plant raw material : extractant was 1:10 w/v at the temperature of 24±1°C. Baicalin and baicalein contents were analyzed by reverse phase high performance liquid chromatography (RP HPLC) at the analytical wavelength of 275 nm. The extractant was a water solution of ethanol 26, 43, 59, 72, 81, 97±1% v/v. The time of the extraction was from 1 to 24 hours.Results. The experimental points of dependency of baicalin concentration in the extract on the time of extraction for ethanol solutions with a concentration of 43 and 72% v/v are closely approximated by a linear equation in coordinates lnC=f(t). The value of determination coefficient is more than R²˃0,99. Half lifetime for baicalin has been calculated: for ethanol with the concentration of 43% v/v it is 4.3±0.7 hours, and for ethanol with the concentration of 72% v/v it is 42.3±1.8 hours.Conclusion. Baicalin hydrolysis kinetics in the process of its extraction from Scutellaria baicalensis Georgi roots with 43 and 72% v/v ethanol concentration. has been studied. It has been established that the process of baicalin hydrolysis is well described by the first order kinetic equation. The constants of baicalin hydrolysis during its extraction from Scutelaria baicalensis roots with ethanol having different concentrations have been calculated. Recommendations on technology optimization for baicalin or baicalein extraction from Scutellaria baicalensis Georgi roots have been given.
Pharmacy & Pharmacology. 2019;7(3):129-137
pages 129-137 views

OPTIMIZATION OF THE METHOD FOR OBTAINING NANOCAPSULES, DEVELOPMENT OF THE METHODS OF DETERMINING THE DEGREE OF CINNARIZINE INCLUSION IN A PROLONGED DOSAGE FORM BASED ON POLY-D, L-LACTID-CO-GLICOLIDE, AND ITS VALIDATION

Sorokoumova M.V., Blagorazumnaya N.V., Kompantsev V.A., Shcherbakova L.I., Zyablitseva N.S., Medvetskaya Y.G., Vasina T.M., Miroshnichenko K.A.

Abstract

Common pathologies of the cardiovascular system are cerebrovascular disorders, for which cinnarizine is prescribed. An innovative, prolonged nanocapsule dosage form based on poly-D, L-lactide-co-glycolide (PLGA) has been developed.The aim of the research was improvement of the technology and development of the methods for determining the level of cinnarizine inclusion in nanocapsules. The research problem consisted of a great number of drug encapsulation peculiarities, as well as various physicochemical properties of the substances that cannot be taken into account in the existing methods of determination.Materials and methods. In the study, the following substances were used: cinnarizine, PLGA (50:50), polyvinyl alcohol (PVA). The remaining reagents and solvents fitted into the category of chemically pure. For development of the methods for quantitative determination of cinnarizine and its validation, a spectrophotometric method of analysis was used. Model mixtures used as objects of the study, had been prepared. Validation assessment of the methods was carried out upon such indicators as specificity, linearity, detection limit, repeatability, reproducibility.Results. Methods for spectrophotometric determination of the degree of cinnarizine inclusion has been developed. It has been established that encapsulation reaches 63.74%. Validation testing methods has been carried out. The results of such tests as specificity, linearity, detection limit, repeatability, reproducibility correspond to the safe range of values regulated by Product specification file. Due to the impossibility of determining the degree of cinnarizine inclusion on the basis of standard methods of preparation, the technology of producing nanocapsules has been adjusted.Conclusion. The technology has been optimized and new techniques have been developed. Taking into account the characteristics of production and the physicochemical properties of the components, they make a reliable analysis of the degree of cinnarizine inclusion in nanocapsules possible. The relative error of the developed methods of determination does not exceed ± 2.67%. Based on the results of the validation assessment, this methods is valid for all indicators.
Pharmacy & Pharmacology. 2019;7(3):138-147
pages 138-147 views

EFFECTS OF VARIOUS AVERSIVE ENVIRONMENTS ON OXYGEN CONSUMPTION OF MUSCLE AND BLOOD IN MICE UNDER CONDITIONS OF THE “FORCED SWIMMING” TEST

Voronkov A.V., Gerashchenko A.D., Pozdnyakov D.I., Khusainov D.V.

Abstract

The aim of the study is to assess the effect of various aversive environments on the oxygen consumption in muscles and blood in mice Under conditions of the “forced swimming” test.Materials and methods. The study was performed on outbred male mice. Exhausting physical activity was modeled in the “forced swimming” test in various aversive environments. The oxygen consumption by the muscle tissue, as well as the oxygen capacity of the blood, were estimated using the respirometry method (AKPM1-01L (“Alfa Bassens”, Russia)).Results. In the course of the study it was found out that in the group of the animals swimming in hot water (at the temperature of 41°C) as an aversive environment, there was no significant change in the oxygen consumption by mitochondria of striated muscle and by red blood cells in comparison with the intact group of the animals. At the same time, in the group of the mice, where cold water (at the temperature of 15°C) as an aversive environment was used, a statistically significant (by the end of the experiment) decrease in the swimming time was observed in relation to the intact group of the animals. It was accompanied by a decrease in the oxygen consumption by muscle mitochondria, with a constant level of the blood oxygenation. Under conditions of exhausting physical exertion, in the group of the animals that received Metaprot®, an increase in working capacity was noted in both hot and cold water. After peak days of working capacity, a slight decrease in physical activity was observed in both experimental groups. At the same time, it should be noted that oxygenation of blood and muscle tissue against the background of exhausting physical exertion in the group that received Metaprot®, did not differ from the group of intact animals in various aversive environments.Conclusion. Thus, based on the obtained data, it can be assumed that under conditions of “forced swimming” with loading, the most profound changes in the structure and functions of the striated muscles are observed in animals in cold (15°С) water That is reflected in a decrease in the physical strain and in reducing the oxygen consumption by muscle tissue. The use of the drug Metaprot® promoted correcting the changes in the physical performance of the animals, which was reflected in its increase by 144.8% (p <0.05), compared with the initial swimming time of this group, without the oxygen consumption by erythrocytes and mitochondria of striated muscles.
Pharmacy & Pharmacology. 2019;7(3):148-157
pages 148-157 views

MODERN MODEL FORMATION OF DRUG PROVISION OF PATIENTS WITH COMMUNITY-ACQUIRED PNEUMONIA IN KABARDINO-BALKARIA

Umirova A.A., Adzhienko V.L., Kabakova T.I., Korzhavykh E.A., Gatsan V.V.

Abstract

The increase in the incidence of community-acquired pneumonia (CAP) is a major problem of national and regional importance. Its pharmacotherapy is based on the active use of antibacterial drugs. That requires a special attention of both, a doctor and a patient, the search for all new and advanced medicines (drugs).The aim of the study is to justify and develop a regional model of drug provision of pharmacotherapy in community-acquired pneumonia.Materials and methods. The use of the resource approach and the methodology of pharmaceutical care (PhC) for the formation of a modern model of drug supply have been tested. Logical, retrospective, sociological, pharmacoeconomic, marketing, statistical and other analytical methods have been used. The materials were official statistics, literature data and the results of the research carried out by the authors themselves.Results. The state and tendencies of development of organizational, personnel, financial (population) and drug resources as the external factors affecting PhC to patients with CAP in the Kabardino-Balkarian Republic (KBR) have been identified. The following internal factors of PhC have been defined: medical prescriptions, consumer demands and the cost of pharmacotherapy. A model of drug provision for patients with CAP in the region has been formed. It is aimed at increasing the effectiveness of treatment, taking into account the stage of treatment and the price factor.Conclusion. Under the conditions of a particular region, the use of the resource approach and the PhC methodology allows to more accurately identify the problems and risks of both drug provision and pharmacotherapy of the patients’ population under study, and form a model adequate to reality, develop recommendations for all participants of PhC - a doctor, a patient and a pharmaceutist (a pharmacist).
Pharmacy & Pharmacology. 2019;7(3):158-169
pages 158-169 views

QUALITY MANAGEMENT SYSTEM OF A PHARMACEUTICAL ORGANIZATION: CRITERIA AND IMPLEMENTATION

Klimenkova A.A., Geller L.N., Skripko A.A., Gravchenko L.A., Fedorenko N.V.

Abstract

The aim of the study is a theoretical justification and development of a mechanism for the implementation of quality management systems (QMS) in the activities of retail trade in pharmaceutical products.Materials and methods. The study is based on the analysis of scientific literature data and Analytical Normative Documents regulating various aspects of QMS functioning in pharmaceutical organizations. Methods of documentary content analysis of international and national ISO standards, Series 9000, were used as the basis for the development and implementation of QMS organizations despite the type of their activities.Results. In the course of the study, the organization of the production process has been studied and the main production (business-) operations of seven structural subdivisions of “Apteka-Alex” LLC in Angarsk have been analyzed. The basic principles of QMS functioning are set forth and the author’s methodology for its development for retail trade in pharmaceutical products has been presented, taking into account the specifics of the organizational structure and production activities of pharmacy organizations. The mechanisms and successive stages of the QMS implementation have been specified and given grounds for. In accordance with the requirements of GOST R ISO 9000:2015, the definitions and classification of the main production operations (business processes) of the studied pharmacies have been made up. In addition, the list of mandatory (core) and basic standard operating procedures (SOPs), detailing the main production (business-) processes, has been made up, and an algorithm for developing and testing SOPs has been outlined.Conclusion. The results of the study allowed us to justify and propose a step-by-step methods of QMS implementation into the work of pharmaceutical organizations in the retail sector. The first results of the approbation and use of the developed methodology show that it contributes to the rational construction and functioning of the QMS, in accordance with the requirements of the existing standards, as well as the optimization of administrative management of all production (business-) processes.
Pharmacy & Pharmacology. 2019;7(3):170-179
pages 170-179 views

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