Farmaciya (Pharmacy)

Introduction. In scientific medicine, buds and fruits of Sophora japonica L. are used to obtain medicines as medicinal plant raw materials. The State Pharmacopoeia of the Russian Federation of the XV edition includes a pharmacopoeia article on raw materials «Sophora Japonica fruits» FS.2.5.0130. The section «Quantitative determination» provides for the quantitative determination of the amount of phenolic compounds by spectrophotometry in terms of genistein (4',5,7-trihydroxyisoflavone). The «Identification» section includes the identification of the authenticity of this raw material by TLC using a standard solution of soforicoside (4'-O-β-D-glucopyranoside of genistein). In this regard, it is advisable to provide a scientific justification for the standardization of this raw material in terms of the content of flavonoids in both sections.

The aim of this work is to study the flavonoid composition of Japanese sophora fruits cultivated in the Krasnodar region.

Material and methods. The research material was the air-dry fruits of Japanese sophora, cultivated in the Krasnodar Territory. Flavonoids were isolated using column chromatography on silica gel and polyamide. The chemical structure of the isolated phenolic compounds was studied using UV, ¹H-NMR, ¹³C-NMR spectroscopy, mass spectrometry, as well as the results of chemical transformations.

Results. The research material was the air-dry fruits of Japanese sophora, cultivated in the Krasnodar. As a result of the studies conducted from the fruits of Sophora japonica L., along with flavonoids known for this plant, genistein (4',5,7-trihydroxyisoflavone), sophoricoside (4'-O-β-D-glucopyranoside of genistein), genistin (7-O-β-O-glucopyranoside of genistein) and kaempferol-3-O-sophoroside [3-O-(2"-β-D-glucopyranosyl)-β-D-glucopyranoside 3,5,7,4'-tetrahydroxyflavone] were first isolated 4'-O-α-L-rhamnopyranoside of genistein) and 4'-O-rutinoside of genistein [genistein-4'-O-(6"-α-L-rhamnopyranosyl)-β-D-glucopyranoside], which are new natural compounds.

Conclusion. As a result of the studies, 6 flavonoids were isolated from the fruits of Sophora japonica L., including 4'-O-α-L-rhamnopyranoside of genistein) and 4'-O-rutinoside of genistein [genistein-4'-O-(6"-α-L-rhamnopyranosyl)-β-D-glucopyranoside], which are new natural compounds. Taking into account the fact that soforicoside is the dominant and diagnostically significant isoflavone, we consider it advisable to use this flavonoid as a standard sample in the “Quantitative determination” section.

Introduction. Salvia oficinallis L. is a medicinal plant of the Lamiaceae family containing essential oils, flavonoids and tannins. S. oficinallis L. and S. sclarea L. are used in medicine because of their anti-inflammatory, antimicrobial properties.

The aim of the work was to conduct comparative qualitative and quantitative analyses of phenolic compounds in the leaves and stems of some species of the genus Salvia L.

Material and methods. The object of the study is the leaves and stems of some representatives of the genus Salvia L.: Salvia officinalis L., Salvia nemorosa L., Salvia dumetorum Andrz. ex Besser, Salvia verticillata L., Salvia nutans L. Qualitative determination of flavonoids was carried out by thin-layer chromatography. Quantitative determination of the amount of flavonoids in aqueous-alcoholic extracts from raw materials of some species of the genus Salvia was carried out by differential device in terms of the standard sample of cynaroside.

Results and discussion. The diagnostic feature of shas been confirmed. medicinal by the presence of water-alcohol extracts from leaves and stems of apigenin and luteolin on chromatographic profiles. The content of rutin in the leaves and stems of medicinal plants is not undermined by TLC analysis, however, it was reliably detected on chromatographic profiles of S. dumetorum in its leaves and stems.

Conclusion. The interspecific features of the spectra in the differential absorption curves make it possible to carry out chemical taxation of medicinal products, which increases the importance of spectrophotometry as a method of detecting authenticity for this type of medicinal plant raw materials

Introduction. The development of novel drug formulations remains a key challenge in modern pharmaceutical science. One promising direction is the design of soluble tablets that ensure rapid dissolution in water, high bioavailability of active ingredients, and ease of use. The development of effervescent tablets containing a solid dispersion of tamsulosin hydrochloride could significantly enhance the therapeutic efficacy of the drug by increasing its dissolution rate and improving the absorption of the active substance. This study aims to develop an optimal composition and manufacturing technology for effervescent tablets with a solid dispersion of tamsulosin hydrochloride, intended for the preparation of oral solutions (per os).

Objective. The development of an optimal composition and efficient manufacturing technology for soluble tablets containing a solid dispersion of tamsulosin hydrochloride, intended for the preparation of peroral aqueous solutions. This includes the selection of the solid dispersion composition, development of the technological process, evaluation of the pharmaceutical characteristics of the obtained tablets, investigation of solubility and active substance release, as well as optimization of the stability of the resulting dosage form.

Material and methods. The composition includes the pharmaceutical substance tamsulosin hydrochloride, a polymer base – polyvinylpyrrolidone – 10000±2000 (pure grade), gas-forming agents: anhydrous sodium carbonate (pure grade), malic acid (analytical grade), tartaric acid (pure grade), citric acid (pure grade), a preservative component – sodium benzoate (pure grade), as well as solvents – 96% ethyl alcohol (pure grade), a structure-forming agent – mannitol, and purified water. The granulate production process was carried out by wet granulation in a fluidized bed using a Tofflon-HO Fluid Bed Dryer Mini DGC (China). Tableting was performed on a manual hydraulic testing press model “PRG” manufactured by VNIIR (Russia). A study was conducted on the relationship between compression pressure and such tablet quality indicators as disintegration time, friability, and crushing strength. The technological characteristics of the granulated mass and the finished effervescent tablets, including the establishment of expiration dates and determination of optimal storage conditions, were evaluated in accordance with the requirements of the State Pharmacopoeia of the Russian Federation XV edition.

Results. A composition of effervescent tablets containing a solid dispersion of tamsulosin hydrochloride as the active substance has been developed. The soluble tablets ensure the formation of a true solution of tamsulosin with a concentration of 0.0004% in 100 ml of water at a temperature of 20°C within less than 5 minutes. Validation of the method for the quantitative determination of tamsulosin hydrochloride content in the effervescent tablets has been conducted. Quality standards for physicochemical methods of testing the tablet composition have been established. Tests, including accelerated aging and storage under normal conditions, confirmed the stability of the developed effervescent tablet composition.

Conclusion. A technological composition of a fast-dissolving effervescent dosage form of tamsulosin hydrochloride based on a solid dispersion has been developed. The formulation is presented as soluble tablets ensuring rapid release of the active substance with enhanced bioavailability.

Relevance. The article explores the potential applications of artificial intelligence technologies in managing the export activities of pharmaceutical companies. It examines the key directions of the digital transformation of the industry, including the use of machine learning algorithms, natural language processing, intelligent analytics, and predictive monitoring within the Pharma 4.0 framework.

The aim of this study was to examine the using artificial intelligence to improve the management of pharmaceutical exports and to develop an objective system for assessing the export readiness of pharmaceutical companies.

Material and methods. Special attention is given to the formation of integrated intelligent ecosystems that establish interconnections between the levels of Technological Readiness (TRL), Manufacturing Readiness (MRL), and Export Readiness (ERL) of enterprises. The development of the ERL concept has become one of the essential steps toward creating a universal system for measuring the maturity of export-oriented pharmaceutical companies. However, the practical implementation of this methodology requires tools capable of continuously collecting, processing, and interpreting data from various sources – from manufacturing and regulatory to financial and logistics. At this stage, artificial intelligence becomes a central element, transforming ERL assessment from a static audit into a dynamic monitoring process.

Results. The introduction of AI-driven systems enables the transition from descriptive management models to predictive and prescriptive strategies, based on data analysis from corporate information systems and external regulatory databases.

Conclusion. The article presents practical examples of AI applications for regulatory analytics automation, prediction of manufacturing deviations, optimization of pharmaceutical logistics, and assessment of reputational risks using open-source data. Particular emphasis is placed on data interoperability and standardization, which form the foundation for harmonizing national and international readiness assessment systems. The study demonstrates that artificial intelligence is becoming an integral component of the pharmaceutical export management system, enhancing the transparency, resilience, and global competitiveness of the Russian pharmaceutical industry.

Introduction. Diabetes mellitus (DM) is a chronic non-infectious disease widespread in the Russian Federation, which has a significant impact on the health of the population and the budget of the health care system. For drug therapy of patients with DM, federal and regional programs of preferential drug provision are being implemented, however, a significant part of federal beneficiaries purchase drugs at the expense of personal funds.

The purpose of the study is to study the features of the sale of antidiabetic drugs in the retail sector of the pharmaceutical market of the Volga Federal District.

Material and methods. The objects of the study are the nomenclature of antidiabetic drugs sold in 16,554 pharmacy organizations of the Volga Federal District for the period from 2021 to 2024. The source of information is the AlphaRM database. Methods: pharmacoepidemiological, comparative, systemic, retrospective analyses, content analysis, grouping methods, descriptive statistics.

Results. Pharmacoepidemiological analysis of retail sales of sugar-lowering drugs (SLP) in pharmacy organizations of the Volga Federal District in 2021-2024 was carried out.

Conclusion. Features of population consumption of FMF were identified with a focus on retail sales of combination drugs.