Vol 69, No 7 (2020)

The paper considers the approaches applied to determine impurities having potential genotoxicity in the pharmaceutical substances. This type of impurities is able to disrupt the structure of DNA, regardless of their concentration entering the body, as well as to tend to accumulate in tissues and organs. In view of the fact that the cases of detecting genotoxic impurities in pharmaceutical substances have become frequent, the literature sources describing the determination of the impurities in various matrices have been studied. The results of the investigation could divide the genotoxic impurities into two groups, based on their origin. The most commonly used methods for their identification have been defined for each group. Trends in the determination of genotoxic impurities as an aspect of quality control have been formulated.

Introduction. Medicinal plant raw materials of representatives of the genus Juglans of walnuts have antimicrobial and general tonic effects due to the fact that it contains naphthoquinone derivatives (juglone, hydrojuglone) and other phenolic compounds. Despite a wide spectrum of pharmacological activities, walnut (Juglans regia L.) is not pharmacopoeial in the Russian Federation. For inclusion of walnut leaves into the State Pharmacopoeia of the Russian Federation, it is necessary to conduct a set of pharmacognostic studies, including the development of regulatory documents that confirm the quality of medicinal plant materials. Objective: to develop a procedure for the quantitative determination of total flavonoid contents in walnut leaves. Material and methods. The investigation used the walnut leaves stored in the Samara State Medical University Botanical Garden in 2018-2019, as well as differential spectrophotometry. Results. A study of spectral characteristics showed that the total content of flavonoids in the walnut leaves could be determined with reference to rutin at an analytical wavelength of 412 nm. A procedure for quantification of the amount of flavonoids in the investigated plant raw materials was developed and validated. The error of a single determination with a confidence level of 95% is ±3.49%. Conclusion. The developed procedure was used to analyze a number of samples of walnut leaves growing in the Samara State Medical University Botanical Garden. The total flavonoid contents calculated with reference to rutin ranged from 3.58 to 3.72%. The developed procedure can be used in further investigations of this type of medicinal plant material.

Introduction. The original Russian pharmaceutical substance Piron belongs to the group of nonsteroidal anti-inflammatory drugs. Its dosage form (50-mg tablets) has been designed for the treatment of musculoskeletal system diseases. Objective: to optimize the composition of 50-mg film-coated Piron tablets in order to increase the release of the pharmaceutical substance from the tablets into the dissolution medium. Material and methods. The composition of the tablets was optimized by incorporating the disintegrants of various chemical compositions. The release of the active ingredient was assessed in accordance with the requirements of the 14th Edition of the State Pharmacopoeia of the Russian Federation. The dissolution test was carried out on an RC-3 paddle mixer. Quantitative determination was performed using an HPLC system based on a Shimadzu modular chromatograph (Japan). Results. A number of compositions for direct compression were designed and tested, where disintegrants (crospovidone, croscarmellose sodium, and pregelatinized starch) and silicon dioxide (Aerosil) were additionally incorporated in various combinations. The degree of transition of the active substance into the solution was quantified by HPLC and a relationship was determined between the release of Piron into the dissolution medium and the proportion of various disintegrants in the composition of tablets. The optimal composition of the solid dosage form was established and a pilot batch of tablet cores was obtained using a ZP-9 rotary tablet press. The quantity of the active ingredient passing from the tablets of this composition into the solution was found to be 98%. Conclusion. The investigators have designed the optimized composition of 50-mg film-coated Piron tablets with the increased release of the active ingredient, which contains a combination of two disintegrants: croscarmellose sodium and pregelatinized starch. The chosen excipients considerably improve the release of the substance from the dosage form as compared to the baseline values.

Introduction. The importance of pharmacies has not been diminishing for about 400 years. In modern conditions, retail and wholesale pharmaceutical organizations provide medicinal assistance to the population and health care facilities. The transition of pharmaceutical organizations to market relations has made changes in the structure of pharmaceutical service at all levels, various organizational and legal entities of pharmaceutical (pharmacy) organizations have appeared, and their management system and principles of placement have changed. Objective: to investigate the organizational aspects of pharmacy dislocations (in case of one Kazan district). Material and methods. The investigation object was the pharmacies of the Novo-Savinovsky District of Kazan. The study methods were sociological (questionnaire survey of pharmacy managers and visitors) and cartographic analyses. Results. The investigators analyzed the responses from two groups of respondents (pharmacy managers and visitors) concerning the most important issues in planning the dislocation of pharmacies in the region: the average radius of pharmacy service; the average time taken to move from pharmacy to pharmacy; the average number of visitors per pharmacy per day, and a number of other issues. Conclusion. The study showed the need to develop standards for the dislocation of pharmacies. Investigation of the organizational aspects of the dislocation of pharmacies in case of one of the most numerous and dynamically developing Kazan districts made it possible to propose standards for the placement of pharmacies, by taking into account the optimal size of the population served by a pharmacy, the number of pharmacy visitors during 1 day and the time required to move from pharmacy to pharmacy.