Currently, the development of pharmaceutical science and industry, the introduction and development of evidence-based medicine dictate the need for a voluminous and at the same time careful attitude to the standardization of newly proposed original dosage forms. But any modern instrument variants require the use of a SS – standard capable of confirming the stability and expediency of the developed methodology. Therefore, this article focuses not only on technology and the choice of the optimal composition, but also on analytical support. In this paper, we have studied the possibility of obtaining a rectal dosage form of lornoxicam based on microemulsion by selecting the optimal composition that provides the necessary release of the active substance, as well as solving the issue of standardization of the dosage form using a standard sample.

In the group of fat-soluble vitamins, vitamin D is one of the most relevant objects, that is why the problem of its technology optimization is under consideration. In general, there is a number of ways to obtain this substance, although it is not produced in Russia yet.The aim of the study was to select optimal process conditions to increase the efficiency of protein transformation with the isolation of a fat fraction containing fat-soluble vitamin D.Materials and methods. Various types of fish and the vitamins contained in them are described as the main research models. Variants of technological solutions have been considered: the possibility of using extraction to obtain the vitamin D substance has been tested. Classical maceration and intensifying maceration have been used; the circulating extraction method and the alkaline hydrolysis method have been applied. The yield of the target product has been determined by HPLC.Results. Methods for obtaining the substance of fat-soluble vitamin D from fish raw materials have been considered in detail. The optimal technological characteristics of the vitamin release by alkaline hydrolysis with a 12.5% decrease in the concentration of the hydrolyzing alkaline component – potassium hydroxide – has been established; that concentration ensured the maximum yield of the fat fraction containing vitamin D.Conclusion. The use of the resulting substance makes it possible to develop domestic standard samples applicable both in the pharmaceutical field and in the field of technical regulation.

This article discusses the issues of creating a standard sample (CO) with the use of a substance obtained from natural raw materials as a starting component, using the principles of lean manufacturing and affecting the problem of the production of domestic raw materials. The paper also discusses issues related to the standardization of the finished product, starting from the stage of choosing the material of the CO and ending with control at the stage of forming the material stock of products in a warehouse. As the main model of the study, a material with retinol palmitate isolated from natural raw materials is used. We have used technological techniques for the production of the product under development with the use of step-by-step, starting from the stage of CO preparation, stability control according to the indicator "Uniformity", which in turn is one of the main quality characteristics. Classical manufacturing techniques of pharmaceutical products were used, quantitative and qualitative determination methods, high-performance liquid chromatography (HPLC) at a wavelength of 326 nm and IR spectroscopy in the radiation range of the spectrum from 4000 to 400 cm-1 were used to control the quality of the initial component. A variant of the technological scheme for the production of vitamin A CO has been considered, this technology has been tested, and the received applicant has been standardized according to the main compliance indicators. The developed SO allows, when conducting chemical research, to ensure metrological comparability and convergence of the analysis results between tests conducted not only by different chemical experts, but also between different laboratories and at different times, it is possible only with the use of measuring instruments of a standard sample (SO) with the appropriate certified characteristic for calibration. The use of CO in conformity assessment is one of the first conditions in the work of the laboratory for the recognition of its test results as reliable.

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Предпосылки проведения исследования: Выбор темы настоящей статьи обусловлен общей значимостью витаминов, их серьёзной биологической ролью для организма человека и животных. В настоящее время производству витаминов, особенно их жирорастворимой группе свойственны определенные сложности, связанные с технологическими решениями на производстве и вопросами стандартизации. Заполняемый пробел в существующем знании и цель исследования: Современный уровень состояния анализа органических соединений категорично предполагает использование современных и перспективных физико-химических методов с высокой точностью и чувствительностью анализа. А это в свою очередь требует создания стандартов – чистых веществ в качестве эталона. Однако сегодня отечественных стандартных образцов практически нет: доминируют стандартные образцы зарубежных фармакопей, и это несомненно пробел в нормативном регулировании, в то время как витамин А особенно значим в настоящее время в связи с эпидсостоянием в мире и для медицины, и для фармации и продолжает использоваться в пищевых производствах и косметологии. Цель исследования – определение основных направлений технологии витамина А, изучение стабильности его стандартного образца в условиях естественного хранения и методом «ускоренного старения» и «стресс-исследований».Материалы и методы исследования: В эксперименте были использованы три серии ретинола пальмитата. Стабильность изучали с помощью естественного хранения 12 месяцев при температуре 25°С, влажности до 45%, защищенном от света месте. Первичная упаковка соответствовала требованиям нормативного документа. В случае «ускоренного старения» температура хранения материала СО – 40±2°С, при влажности 75±5°С. Стресс-исследования проводили при температуре -18°С. Периодичность контроля в обоих вариантах – 12 месяцев. Эксперимент выполнялся при постоянном контроле параметров микроклимата лаборатории. Анализ образцов проводили методом ВЭЖХ.Результаты и их применение: В результате в настоящей статье теоретически обоснована принципиальная возможность получения стандартного образца витамина А из природного сырьевого материала. Экспериментально установлен срок годности образца в естественных условиях – 1 год и при «ускоренном старении» – 2 года. Выполненные исследования способны обеспечить валидацию производства витамина А и единство измерений, связанных с производством витаминов в различных областях отечественной промышленности и сельском хозяйстве.