Full Journal №1 (2017)

UDC 615.07:633.15
Karpiuk U. V., Kotova E. E., Kotov A. G., Kyslychenko V. S.
Bogomolets National Medical University, Kyiv
National University of Pharmacy, Kharkiv
Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, Kharkiv
Matters of the introduction into the State Pharmacopoeia of Ukraine of national monograph «Corn silk»

The expediency of standardizing of domestic medicinal
plant material corn silk was shown. A comparative analysis of  approaches to the standardization of the quality of corn silk listed in the State Pharmacopoeia of the USSR XI edition (the SPh XI), the State Pharmacopoeia of the Republic of Belarus (SPh RB), in the French Pharmacopoeia (Ph. Fr.) and British Homeopathic Pharmacopeia (BHP). The quality of 8 samples of raw materials was studied for compliance the requirements of the SPh XI, GF RB, Ph. Fr. and BHP. For the identification of raw materials by TLC method the techniques, harmonized with the requirements of the European Pharmacopoeia (EP), were developed. The techniques are used for identification of phytosterols and flavonoids with available reference substance in corn silk. The method of quantity determination of phenolic compounds (flavonoids) in corn silk was proposed. The method is based on standardized EP/SPhU techniques. The project of national monograph «Corn silk» was developed.

Keywords: corn silk, standardization, identification, quantification, monograph project, the State Pharmacopoeia of Ukraine.


UDC 615.11:615.322
Kotov A. G.,Vovk O. G., Kotova E. E.,
Kolychev I. O., Kotov S. A.
State Enterprise «Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines»
To the question of the macroscopic identification of herbal drug Bidens tripartita

Macroscopic diagnostic features of bur-marigold grass (Bidens tripartita) in comparison with the characteristics of other closely related species has been studied. It has revealed that very often a impurity of pharmaceutical species is B. frondosa and sometimes B. cernua. For the purpose of a reliable comparison of external signs of these types the search of the herbarium of the specified types with the help of leading organizations of Ukraine were made as well as search for them in nature. It was found that in addition to macroscopic signs of stems, leaves, and flowers, especially the morphological structure of the achenes is a reliable key to the identification and diagnostic of B. tripartita and other not pharmacopoeia species of bur-marigold. As a result of the critical analysis of macroscopic samples of B. tripartita and other species of this genus the draft sections «Identification. Macroscopia» and «Impurities» of the
national monograph «Bur-marigold grassN» for its introduction in the State Pharmacopoeia of Ukraine were developed. The proposed macroscopic characteristics of bur-marigold species of the Ukraine flora are important for the diagnostic of B. tripartita, especially during its preparation and implementation in the pharmaceutical market of Ukraine.

Keywords: bur-marigold, herbal drugs, identification, diagnostics, achene, awn.


UDC 615.225.2:615.453.6
Sidenko L. M., Kazarinov M. O., Chub L. M.

State Enterprise «State Scientific Centre for Drugs and Medical Product», Kharkіv

Determination production parameters critical tablets fosinopril sodium 10 mg
Investigations of critical aspects of the production process of technological tablets fosinopril sodium 10 mg. The criteria for acceptance of the critical characteristics of the raw materials and process parameters for each stage of the manufacture of tablets by wet granulation. It is shown that the criticality characteristics fosinopril, which may affect the quality of the medicament are: quantitative content of substances in a substance, water solubility, particle size, bulk density, flowability, concomitant impurities. Study of physico-chemical and technological characteristics of the components of the drug showed that the development of technology tablet form are also critical homogeneity of the distribution of fosinopril in a mixture of excipients, the mass fraction composition for tableting. To develop optimal and critical process parameters by wet granulation, identifying the critical points the ratio of fillers and the boot order has been established; suggested way to make the process of the preparation of fosinopril by trituration by pre-mixing with lactose 200; to choose the optimal amount of adhesive component of the tablet weight, the concentration of the solution of the humidifier; the influence of the values technological of process parameters to change the tablet pharmaco-technological and biopharmaceutical properties of the drug tablets. The set values technological of the critical parameters of the technological process of production of tablets fosinopril 10 mg and the conditions of the permit is stable and is guaranteed to receive semi-finished and finished products, which meet the quality parameters established by the applicable regulations.
Keywords: fosinopril sodium tablets, criteria for acceptance, parameters critical, technological process.


UDC 616-097;616.594.171.2;534-143
Rybаlkіn М. V., Strelnikov L. S., Strilets О. P.
National University of Pharmacy
Determining the optimal extent and concentration of cell susspension fungi Candida albicans and Candida tropicalis ultrasonic disintegration
In recent years, recorded a significant development of this infection to disease around the world, due to irrational use of medicines, weakening immunity, deteriorating environment and increased pathogenicity of most pathogens. At the National University of Pharmacy plans to develop a combination vaccine for the prevention and treatment of this infection from fungi cell antigens Candida albicans and Candida tropicalis. Aim of the study was to determine the optimal concentration and volume of cell suspension fungi C. albicans and C. tropicalis. To determine the optimal concentration of cells used fungi for the disintegration of the following concentrations: 8×106-8×107, 8×108-8×10and 8×1010-8×1011 in 1 mL. To determine the optimal volume of cell suspension fungi C. albicans and C. tropicalis investigated following volume of 10 mL, 20 mL and 30 mL. Using a smaller volume of 10 mL technologically impossible to fulfill. After ultrasonic disintegration in each case carried rotation speed centrifugation at 1000 rev/min for 5 minutes and determined the content of proteins and polysaccharides in compliance with the State Pharmacopoeia of Ukraine. Results of the study of antigen solutions obtained show that the action of ultrasound on cells of fungi C. albicans and C. tropicalis with a concentration in 1 mL 8×106-8×10released the least amount of these substances. But the action of ultrasound on cells of fungi and 8×108-8×10and 8×1010-8×1011 concentration in 1 mL of polysaccharides and protein content was greater. Fungi cell suspensions C. albicans and C. tropicalis volume of
20 mL and 30 mL is unpromising as in these cases, the ultrasonic disintegration was received significantly less of these substances than using a cell suspension volume of 10 mL fungi. As a result of the research was reasonably optimal concentration of cell suspension fungi C. albicans and C. tropicalis, which is 8×108-8×10in 1 mL and was determined optimum volume — 10 mL.
Keywords: candidiasis, proteins, polysaccharides, antigen, technology, concentration, ultrasound.


UDC 615.454
Maslova N. F., Nikitina N. S, Litvinova O. V., Nosalska T. M., Somova Ya. V., Georgievsky V. P.
State Enterprise «State Scientific Center of Drugs and Medical Products», Kharkіv
Efficacy and safety of drug Quercetin in model of chronic renal failure
It has presented research data connecting with efficacy drug Quercetin in model of chronic renal failure and his safety in the study of acute, sub-acute and chronic toxicity in various animal species. The analysis results have shown that drug Quercetin in doses of 350, 500 and 700 mg/kg significantly increases the diuresis in animals with chronic renal failure and simultaneously reduces the urina specific density, it contributes elimination of blood catabolism products. Drug Quercetin in doses of 350, 500 and 700 mg/kg restores glomerular filtration and tubular reabsorption in rats with chronic renal failure. The optimal dose of drug Quercetin is 500 mg/kg, which significantly exceeds the effect of reference drug Chophytol and reference drug Canephron N. In acute experiments on three animal species it has established that the maximum administered dose of the drug Quercetin (mice — 5.0 g/kg, rats — 5.0 g/kg, rabbits — 2.0 g/kg) did not cause death of the animals, it did not provide toxic effect on animal body weight and serum biochemical parameters characterizing the functional state of the rat liver, it did not produce visible changes of animal internal organs. Quercetin, tablet, is the safe drug: in the sub-acute and chronic toxicity experiments it has established that the drug has no negative impact on vital organs and systems of animals and Quercetin has no teratogenic, embryotoxic, immunogenic and allergenic local irritating action.

Keywords: quercetin, diuresis, glomerular filtration, tubular reabsorption, safety, toxicity.


UDC 615.213'453.6.015
Belenichev I. F., Kucherenko L. I., Nimenko A. R., Kuzio N. V.
Zaporizhzhia State Medical University, Ukraine
SPA «Farmatron»
Comparative evaluation of carbamazepine and «Karbatril» tablets on higher functions of the central nervous system

Purpose of the study — comparative evaluation of the influence of carbamazepine and «Karbatril» on the higher functions of the central nervous system according to such indicators as reference and working memory, as well as motion and search activity. The study was carried out on 20 rats of the Wistar line at the age of 6 months weighing 220-290 g. The study on memory was conducted using LE760 radial maze, «Open Field» meth- od, SSC-DC378P color video camera, of Microsoft Excel 2016 with AtteStat 12 statistical processing package. During the study, carbamazepine in an average therapeutic dose were administered to experimental animals, that leads to significant decrease in cognitive functions of the central nervous system, deterioration of mnestic functions of CNS, led to high anxiety in animals. In this case, the similar administration of «Karbatril» does not cause similar changes in the central
nervous system, but also led to a decrease in these indicators in relation to the control group. As a result of conducted experiment, it should be concluded that «Karbatril» does not adversely affect the higher functions of the central nervous system, as opposed to carbamazepine.
Keywords: «Karbatril» tablets, the reference and working memory, motion and search activity.


UDC 615.252.349:615.453.6
Maslova N. F., Bomko T. V., Litvinova О. V.
State Enterprise «State Scientific Centre for Drugs and Medical Products», Kharkіv
Pharmacological action of metfonorm in model of type 2 diabetes in aged rats
Diabetes mellitus is one of the most common high-cost chronic diseases, which is a serious medical and social and economic health problem all over the world — both industrialized and developing countries. Metformin is one of widely used antidiabetic drugs. Since 2007, metformin is exclusive drug for the drug prevention of type 2 diabetes at the recommendation of American diabetes association (ADA). Metformin is particularly reasonable in the early stages of the disease because the drug does not stimulate insulin secretion and therefore treatment is not accompanied by the risk of hypoglycemic states. The aim of this work is comparative study of the specific pharmacological activity of the domestic drug «Metfonorm», tablets 0.5 g, comparably «Dianormet 500», tablets 0.5 g («Polfa», Poland), in model of type 2 diabetes in aged rats. It has established that domestic drug «Metfonorm», tab- lets 0.5 g, in dexamethasone diabetes in aged rats has a pronounced hypoglycemic effect, which manifests in reducing hyperglycemia in glucose loading. Long-term administration of domestic drug «Metfonorm», tablets 0.5 g, in dexamethasone diabetes in aged rats causes a reduction of baseline glucose level and a normalization of glycemic curves, which correspond to the nature of those of the young animals. Hypoglycemic activity of domestic drug «Metfonorm», tablets 0.5 g, is identical to the active of referential drug — «Dianormet 500», tablets 0.5 g («Polfa»).

Keywords: «Dianormet 500», «Metfonorm», type 2 diabetes, dexamethasone diabetes, glycemic curve.


UDC 615.12:339.187.2
Piven O.P., Sofronova I.V., Tkachenko I.V.
National University of Pharmacy
Customer loyalty to the company: the basic concepts and methods of evaluation
The definition of customer loyalty to the pharmaceutical company has been proposed. Segments according to degree of loyalty by the example of the retail pharmaceutical enterprises (pharmacies) have been presented. The analysis of approaches to the definition of loyalty to the company has been carried out. Investigated, in accordance with the key components of loyalty there are behavioral loyalty, attitude (intentions) loyalty, and comprehensive loyalty. It was established that for assessing customer loyalty to the company methods that take into account certain aspects of loyalty (behavioral, attitude, intention) depending on the selected priority and techniques that reflect several components are used. Determined that the complex methods are most reasonable. The analysis of the application of customer loyalty evaluation methods has been carried out. It was established that the method of Net Promoter Score and Marketing scaling method can be used for evaluation of loyalty to the company and to the brand. RFM-analysis, method «Servqual», «Servloyal», «Ipsos Loyalty C3», Secure Customer Index are primarily used for assessing customer loyalty to the company. Methods «Division of needs», «Share of benefits and share of rejection», Brand Keys Customer Loyalty Engagement Index, a method based on the traditional approach, «Conversion Model» and RAPID model are used primarily for evaluation of customer loyalty to the brand. Net Promoter Score (NPS) and method of marketing scaling are most popular among methods of evaluation of customer loyalty to the company that reflect separate components of loyalty. Method «Servqual» prevails among the comprehensive methods of evaluation clients’ loyalty to the company.

Keywords: loyalty, loyalty components, types of customer loyalty, methods of loyalty evaluation, pharmaceutical enterprise, brand.