卷 74, 编号 1 (2025)

Introduction. Fermentation is a biochemical process that changes the qualitative and quantitative composition of biologically active substances (BAS) and, accordingly, may change the pharmacological activity and toxicity of medicinal plants. Fermentation usually carried out for fresh medicinal plant raw materials (MPRM). However, to date, there is no information on the relationship between enzyme activity (in particular, polyphenol oxidase) and the BAS content. In this work, calendula flowers standardized for flavonoids were used as a model object.

Purpose of the study. To assess the effect of calendula flower fermentation on the flavonoid content and polyphenol oxidase activity.

Material and methods. The object of the study was calendula flowers (Calendulae flos, Calendula officinalis L., Asteraceae). The following fermentation options were studied: hot fermentation at 40 and 60°С; fermentation under natural conditions; cold fermentation, as well as thermal and ultrasonic pre-treatment. Immediately after the completion of fermentation, heat and ultrasound treatment, the polyphenol oxidase activity was determined in the processed fresh MPRM using the method of A.N. Boyarkin.

After 6 hours of fermentation of fresh MPRM at 40 and 60°С; after 1 day of fermentation under natural conditions; after cold fermentation and ultrasound treatment, heat treatment was carried out to stop the polyphenol oxidase activity. The flavonoid content was determined spectrophotometrically by the reaction with aluminum chloride.

Results. Hot fermentation of fresh calendula flowers at 40°С for 2–3 hours leads to a significant increase in the flavonoid content; hot fermentation at 60°С reduces the its content. The flavonoid content and polyphenol oxidase activity at 40°С are higher than at 60°С. A reliable relationship was revealed between the flavonoid content and polyphenol oxidase activity. Cold fermentation reduces the flavonoid content and polyphenol oxidase activity. Natural fermentation for 3 days increases the flavonoid content.

Ultrasonic treatment significantly increases the flavonoid content. Heat treatment does not significantly increase the its content. Thermal inactivation of the enzyme after hot, cold and natural fermentation and ultrasonic treatment reduces the flavonoid content.

Conclusion. Among all the studied methods of pre-treatment of fresh calendula flowers (hot, cold and natural fermentation, heat and ultrasonic treatment with and without thermal inactivation), the most significant increase in flavonoid content was achieved with ultrasonic treatment.

Introduction. In the family Myrtaceae (Myrtaceae L.) there are more than 100 genera and more than 3000 representatives. Insufficiency of data on diagnostics of raw materials of common myrtle and closely related species is an actual problem of modern pharmacognosy.

The aim of the present study is a comparative qualitative and quantitative analysis of essential oil components of leaves of common myrtle, closely related to Myrtle species – Eucalyptus twiggy of family Myrtaceae, as well as industrial samples of essential oils of Myrtle and Eucalyptus by gas chromatography-mass spectrometry.

Material and methods. Leaves of common myrtle harvested in the Republic of Crimea (Russia) and Relizane province (Algeria) were used as objects of research. Also as objects of comparison were used leaves of eucalyptus twiggy, harvested in Abkhazia, and industrial samples of common myrtle and eucalyptus twiggy essential oils. Samples of essential oil were obtained from leaves of myrtle and eucalyptus. Essential oil samples were obtained from myrtle and eucalyptus leaves and the qualitative and quantitative composition of their components was determined by gas chromatography-mass spectrometry.

Results and discussion. Essential oils samples of Myrtaceae representatives leaves are characterised by a high content of mono- and bicyclic monoterpenes, but they differ significantly in dominant components depending on the place of growth. In a sample of essential oil from the leaves of Crimean Myrtle, 1,8-cineol (eucalyptol) dominates, and in a sample from the leaves of Algerian Myrtle, α-pinene dominates.

In the study, it was found that some identified components of the common myrtle essential oil, such as myrtenyl acetate, humulene, linalyl acetate, β-myrcene and their derivatives, were absent in the eucalyptus twiggy essential oil, which may serve as a diagnostic sign for Myrtus species. On the contrary, the presence of globulol and its derivatives in the component composition of essential oil was found only in samples of Eucalyptus viminalis L. species and are not determined in the common myrtle essential oil. Industrial samples of essential oils are characterised by the absence of such important components of Myrtle essential oil as α-pinene, globulol, myrtenyl acetate, geraniol, linalool, terpinen-4-ol, humulene and its derivatives.

Conclusion. Species specificity of the common myrtle can be confirmed by gas chromatography-mass spectrometry on diagnostically significant components of the common myrtle essential oil, which are absent in the essential oil of the species closely related to myrtle – еucalyptus twig, which can be used in the preparation of the draft pharmacopoeial article on a new type of medicinal plant raw material – ‘Common myrtle leaves’.

Introduction. The guidelines do not suggest one true path to risk management. Pharmaceutical enterprises develop their own local regulations to ensure compliance with the regulations of the Russian Federation and the EAEU. There are very few studies on how domestic pharmaceutical enterprises solve the problem of introducing a quality risk management system into the enterprise’s quality management system. In this regard, work to study the functioning of the risk management system at Russian pharmaceutical enterprises seems extremely relevant.

Objective. Analysis of the activities of the risk management system for the quality of domestic pharmaceutical enterprises to identify systemic errors in its functioning and the subsequent development of methodological approaches to its improvement within the framework of compliance with current good manufacturing practices.

Materials and methods. Questionnaire method, descriptive statistics.

Results. According to the survey results, the majority of enterprises in the pharmaceutical industry (70.8%) have a system for monitoring and reviewing risks, which indicates a serious approach to risk management. However, almost a third of enterprises (29.2%) do not have such a system, which may indicate possible risks in quality management, as well as the need to implement such systems to ensure more effective control and reduce risks to drug quality. Some domestic enterprises (29.2% of responses) lack systems for monitoring and reviewing risks, which may indicate insufficient control over risks and lack of timely adaptation of the risk management system to changing conditions. The opinion of 52.3% of respondents that the risk management system at their enterprise is formal in nature indicates that the risk assessment system is currently not working effectively enough. The identified problems of the pharmaceutical industry in the field of risk assessment to ensure product quality are formulated: insufficient awareness of employees about some aspects of GMP rules, problems with the distribution of roles and responsibilities when carrying out routine procedures, insufficient theoretical training, inconsistency in the application of standards and procedures, low level of formality in risk assessment procedures, gaps in the understanding and application of risk assessment methods, lack of a systematic approach to monitoring and reviewing risks.

Conclusion. Based on the identified problems, the following proposals were developed to improve the quality risk management system at enterprises in the pharmaceutical industry.

Introduction. A current problem is the increase in the incidence of cardiovascular diseases (CVD) due to the growing prevalence of CVD risk factors, the intense pace of life, and the increasing proportion of the elderly population. Studies conducted in Russia, Western Europe, and the United States have shown that, despite the widespread introduction of fairly effective means of treating chronic heart failure in medical practice, the mortality rate of patients within a year in this population remains high.

Based on the above, the author M.A. Agzamova isolated a triterpene compound, Cycloseversioside F, from the plant Astragalus pterocephalus, which has a potential cardiotonic effect.

Objective: was to study the cardiotonic activity of the triterpene compound Cycloseversioside F from the plant Astragalus pterocephalus.

Material and methods. The study of cardiotonic activity was carried out on a model of chronic heart failure caused by the introduction of mesaton, followed by dynamic physical exercise. The reference drug with a metabolite effect, «Meldonium» capsules 500 mg, was chosen as a reference drug.

Results. The results of the study showed that the test preparation has reliable cardiotonic activity, which is manifested in the normalization of the heart weight coefficient, in the normalization of biochemical parameters of blood serum (lactodehydrogenase, creatine kinase MB and sodium). At the same time, a comparative study of the cardiotonic activity of the test preparation with the reference cardiac metabolite showed that the test preparation is not inferior to the reference drug in cardiotonic activity, and in some cases even surpasses it.

The most effective dose was also found – 1000 mg/kg, and the obtained data on such effective doses as ED30 400 mg/kg, ED50 445 mg/kg and ED100 1000 mg/kg, can serve as a basis for calculating starting and subsequent doses for clinical studies.

Conclusion. The studied triterpene series compound cyclosiversioside F from the plant Astragalus pterocephalus has reliable cardiotonic activity, which is not inferior to the reference drug, and in some cases superior.