Modern Approaches to the Development of Standard Samples of Drugs

This review addresses the history of the creation of standard samples (SS) around the world and in Russia, along with studies of the current condition of the state system for standardization of medicinal products (MP) based on the use of SS. Standardization in the area of drugs is directed to guaranteeing the quality of the items standardized, which includes products (raw materials, other materials, ready MP, etc.), services, and processes. The continuing development of manufacturing technologies and the discovery of novel MP increases the need for standard samples, as drug quality control involves the use of complex, highly effective, specific, and precise physicochemical and biological analysis methods. © 2020, Springer Science+Business Media, LLC, part of Springer Nature

Determination of Therapeutic Substance Sibutramine Using Physicochemical Methods in the Composition of Multicomponent Biologically Active Food Supplements

The problem of the illegal addition of the drug sibutramine to biologically active food supplements (BAFS) and their dissemination into the territories of the Russian Federation are discussed. The aim of the present work was to develop methods for preliminary and confirmatory detection of sibutramine in BAFS. TLC was used for screening and instrumented methods such as HPLC-MS and GC-MS were used for confirmation, with the objective of controlling the import and circulation of the illegal food additive sibutramine to BAFS. Methanol and components of the BAFS had no effect on sibutramine detection, confirming the specificity of the method. Application of these methods detected sibutramine in four of eight BAFS samples. © 2021, Springer Science+Business Media, LLC, part of Springer Nature

Production of biomedical cell products: Requirements for the quality of donor material and excipients of animal origin (review)

Donor biological materials and excipients of animal origin are important components in the production of biomedical cell products (BMCPs). Their quality ensures the stability, safety, effectiveness and purity of the final product. This review discusses quality requirements for biological excipients intended for the production of biomedical cell products, in terms of the necessary information that should be included in the BMCP registration dossier during state registration and is subject to expert assessment during quality control. Considering that there is currently no production of biomedical cell products in the Russian Federation, the authors considered international approaches to ensuring the safety of donor material and excipients for the manufacturing of human cell- and tissue-based products (BMCP analogues). This journal is © The Royal Society of Chemistry

Статистический анализ использования антидепрессантов группы СИОЗС флуоксетина и флувоксамина при оказании стационарной помощи больным депрессивными расстройствами

Depression is a state of multifocal etiology, including genetic, biochemical, hormonal, psychological and social components and manifested in the suppression of mental disorders. More than 300 million people from all age groups suffer from it. It was revealed that women are more prone to depression than men. Depression makes a significant “contribution” to the global burden of disease - it is believed that by 2020 it will be the second cause of disability in the world after coronary heart disease.Депрессия - состояние мультифокальной этиологии, включающее генетическое, биохимические, гормональные, психологические и социальные компоненты и проявляющееся в подавлении психических расстройств. От нее страдает более 300 миллионов человек из всех возрастных групп. Выявлено, что женщины в большей мере подвержены депрессии, чем мужчины. Депрессия вносит значительный «вклад» в глобальное бремя болезней - считается, что к 2020 году она станет второй после ишемической болезни сердца причиной инвалидности в мире

An improved extraction protocol for therapeutic dabigatran monitoring using HPLC-MS/MS

A new sample extraction protocol was developed for pharmacokinetic studies of dabigatran with high-performance liquid chromatography separation - electrospray ionization time-of-flight mass spectrometry analysis. After protein precipitation with acetonitrile, free dabigatran and its metabolites are separated into water phase by water-dichloromethane liquid-liquid extraction to purify the sample from proteins and endogenous lipophilic compounds. Chromatographic separation was achieved on an Agilent Zorbax SB-CN column (150 × 4.6 mm, 5 µm)) using 0.1% aqueous solution of formic acid and acetonitrile (80:20) as the mobile phase. Agilent Zorbax SB-CN column was selected to improve sample resolution and to avoided early elution of dabigatran previously seen when using a C18 column. The extended calibration curve was constructed from 5 to 1000 ng/L while precision and accuracy were assessed at four levels across the linear dynamic ranges. Within-run precision was <5.6% and the between-run precision was <3.9%. The method accuracy ranged from 89.8% to 104.4%. The developed method was successfully applied to 30 patient samples to evaluate antithrombotic efficacy and anticoagulant activity of dabigatran following knee endoprosthesis surgery. © 2019 Elsevier B.V

Standardization of bee venom as a raw material for the production of medicines for immunotherapy, including allergen and allergoid from bee venom [Стандартизация пчелиного яда как сырья для производства лекарственных средств для иммунотерапии, в том числе аллергена и аллергоида из пчелиного яда]

Introduction. Pharmaceutical industry widely uses beekeeping products to obtain medicines. Among beekeeping products for medical use, bee venom represents number three on its importance. Pharmaceuticals based on bee venom are used externally, or as injections, or for oral administration. In the production of medicines containing bee venom, it is important to take into account the dose and possible individual response of the human body. The chemical composition of raw bee venom is very complex. Currently, there is no modern normative documentation for standardization of bee venom as a raw material for pharmaceutical preparations. Hence, quality control and standardization of the substance of bee venom intended for the production of medicines represent the urgent need. Aim of research is to study the physicochemical characteristics of raw bee venom of various batches in order to evaluate and standardize its quality. Material and methods. We have studied 5 batches of raw bee venom from the same manufacturer. The analysis was carried out on the basis of GOST 30426-97 Methods of purification and standardization of purified bee venom were developed in this study. Those included gel chromatography and PAAG electrophoresis. Results. According to the results of studies of raw bee venom, 4 batches of 5 did not correspond the requirements of the GOST 30426-97 in terms of mass fraction of water-insoluble impurities (6.01 %); mass fraction of water (9.17 %); hemolysis time (300 s), mass fraction of melittin and apamin (35 %; 0.6 %), respectively. Methods for the purification and standardization of preparations from raw bee venom were suggested. Conclusion. In our study, we have proven the low level of the standardization of raw poison. The lack of approved normative documents leads to the fact that different pharmaceutical companies use different methods for evaluating the quality of raw materials and methods for their purification, which, in turn, affects the quality of final pharmaceutical products. Therefore the part of General Pharmacopoeia «Raw Bee Poison» (related to standardization of raw materials from which pharmaceuticals are being obtained) should be developed. © 2021 Meditsina Publishers. All rights reserved