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Scientific relevance. The State Pharmacopoeia of the Russian Federation, edition XIV, requires the identification of aniseed and fennel fruits by the same thin-layer chromatography (TLC) procedure using Sudan III and menthol. These markers are neither specific nor related to the therapeutic effects of these herbal drug products. The visual interpretation of chromatograms is complicated because of the low intensity of adsorption zones. Moreover, the corresponding compendial monographs do not characterise the adsorption zones specific to each of the plants. The most abundant component in aniseed and fennel essential oils, trans-anethole, would make a better reference standard from a methodological point of view.Aim. This study aimed to optimise the TLC procedure for essential oil determination in herbal drugs and herbal medicinal products of aniseed and fennel fruits and subsequently recommend it for inclusion in the relevant compendial monographs.Materials and methods. The study examined samples from several batches of herbal drugs, including aniseed and common fennel fruits, sourced from Russian manufacturers. The reference standards comprised commercial reagents, including trans-anethole, anise oil, and linalool, as well as fresh essential oils that had been steam distilled from the test samples in a Clevenger apparatus. The study was conducted by TLC. Sample preparation involved using Merck aluminium TLC plates, an IKA KS-501 digital orbital shaker, and a CAMAG Linomat 5 semi-automatic sample application system. The authors heated the plates in either a Binder ED53 drying oven or a CAMAG TLC plate heater. For visualisation, the authors selected a CAMAG TLC VISUALIZER 2 UV imaging and documentation system.Results. The informational and experimental research showed the feasibility of using trans-anethole as an identification reference standard for common anise and fennel fruits. The authors selected the optimal solvent for extracting active substances from the test products (hexane) and a detection reagent for improving visual evaluation of the chromatograms (1% sulfovanillin). The authors established characteristic adsorption zones for differentiating between aniseed and fennel fruits.Conclusions. The optimised procedure identifies the main components in the essential oils of aniseed and fennel fruits with a specific reference standard. This procedure may be recommended for inclusion in draft monographs for the corresponding herbal medicinal products.

Ascorbic acid (vitamin C) is involved in many vital biochemical processes in the human body. Rose hips are a natural source of ascorbic acid. Rose hips are used in decoctions and many vitamin herbal teas. Russian compendial methods for the quantitative determination of ascorbic acid have certain limitations precluding its objective measurement in herbal drugs, herbal drug preparations, and herbal medicinal products.The aim of the study was to develop an analytical procedure for the quantitative determination of ascorbic acid in herbal drugs, herbal medicinal preparations, and herbal medicinal products using high performance liquid chromatography (HPLC).Materials and methods. The study involved two herbal medicinal products, Rose Hips (rose hips) and Vitamin Herbal Tea 2 (rose hips and rowan fruits), and reference standards for ascorbic acid, rutoside, quercetin, gallic acid, caffeic acid, chlorogenic acid, luteolin-7-glucoside, citric acid, DL-malic acid, thiamine, and pyridoxine hydrochloride. The authors used a 1260 Infinity II chromatograph with a diode array detector by Agilent and an Inertsil ODS-3 chromatographic column (250 mm × 4.6 mm, 5 µm) by GL Sciences. The HPLC system was operated in gradient elution mode, and the detector was set at 244 nm.Results. Ascorbic acid content in herbal drugs, herbal medicinal preparations, and herbal medicinal products can be determined by HPLC. Adequate sample preparation and chromatography conditions allow for inhibiting ascorbic acid oxidation in aqueous solutions for a period sufficient to complete testing (not less than 8 h).Conclusions. The authors developed a highly sensitive and selective HPLC procedure for the quantitative determination of ascorbic acid intended for the standardisation of herbal drugs, herbal medicinal preparations, and herbal medicinal products. The procedure is worthy of inclusion in the Rose Hips and Vitamin Herbal Tea 2 monographs of the State Pharmacopoeia of the Russian Federation. Switching to HPLC should not require lowering the limit for ascorbic acid (not less than 0.2%) established in the Rose Hips and Vitamin Herbal Tea 2 monographs for the titration method. The ascorbic acid content was below this limit in the vast majority of study samples. However, this discrepancy may be explained by the presence of dog rose (Rosa canina) species low in vitamin C, which should normally be used only as choleretics.

When used to quantify alkaloids in thermopsis dry extract, acidimetric titration has several limitations, including insufficient specificity of the method and arbitrary selection of a titration endpoint. Different parts of the Thermopsis lanceolata plant produce alkaloids in different proportions: the herb is rich in thermopsine, whereas the seeds are rich in cytisine. Since thermopsine and cytisine have different pharmacological effects, it is important to identify and quantify individual alkaloids in thermopsis dry extract.The aim of the study was to develop and validate an analytical procedure for identifying and quantifying total alkaloids in thermopsis dry extract by high-performance thin-layer chromatography (HPTLC) with densitometric detection.Materials and methods. The study included samples from two pilot-scale batches of thermopsis dry extract and reference standards for cytisine and thermopsine. The authors used Merck HPTLС Silica Gel 60 F254 20×10 cm plates for chromato-graphic separation and analysed the results with a CAMAG® TLC Scanner 4 densitometer and the winCATS software.Results. The authors identified thermopsis dry extract using HPTLC separation followed by spectrodensitometry. The alkaloid-specific solution applied to chromatography plates helped to identify the three most abundant and four minor alkaloids of thermopsis. The most abundant alkaloids were thermopsine, cytisine, and an unidentified alkaloid with a retention factor of approximately 0.2. These three alkaloids accounted for almost 80% of the total alkaloid content of the dry extract. The authors quantified cytisine, thermopsine, and total alkaloids expressed as thermopsine.Conclusions. The authors developed and validated an analytical procedure for identifying and quantifying total alkaloids in thermopsis dry extract. This procedure offers the possibility of reducing the analysis time from 4–5 hours to 2–2.5 hours.

Currently, there is an increase in preand post-approval testing of medicinal products containing diosmin and hence a need to unify approaches to standardisation of this group of pharmaceuticals. Moreover, the State Pharmacopoeia of the Russian Federation lacks a monograph for these products.The aim of the study was to determine an approach to standardisation of medicinal products containing diosmin.Materials and methods: the study analysed scientific publications, as well as monographs of leading foreign pharmacopoeias. Experimental work was carried out using samples of diosmin-containing pharmaceuticals in the form of 500 and 1000 mg film-coated tablets produced by Russian and foreign manufacturers. The study involved high performance liquid chromatography with UV detection using an Agilent 1260 Infinity II liquid chromatography system with a diode array detector. The following reference standards were used: a diosmin RS, USP grade; a hesperidin CRS, Ph. Eur. Grade; and a diosmin CRS for testing chromatography system suitability for identification of impurities A, B, C, D, E, and F, Ph. Eur. grade.Results: the authors reviewed quality requirements for pharmaceutical products containing diosmin and analysed experimental data obtained during preand post-approval testing of Russian and foreign medicines. The comparison of regulatory documents for registered diosmin-containing medicinal products showed a difference in approaches to assessing the contents of related substances and active pharmaceutical ingredients. Having analysed the literature, experimental data and regulatory requirements for standardisation of diosmin-containing pharmaceuticals, the authors recommended an approach to standardisation. According to the approach, concomitant flavonoids (hesperidin, isorchoifolin, linarin, and diosmetin) contributing to the pharmacological activity of a medicinal product are specified as part of Assay, and process-related by-products (impurities A and D) are specified and evaluated as part of Related substances tests.Conclusion: the authors propose to evaluate the contents of concomitant flavonoids (hesperidin, isorchoifolin, linarin, diosmetin) under Assay and to specify impurities A and D, as well as single unidentified impurities and total amount of impurities under Related substances.

The ongoing pandemic of the new coronavirus infection allows us to discover new information concerning the clinical course of the disease. Despite the rarer registration and mild course of COVID-19 in children, we get new data on more severe manifestations in the form of damage to various organs including cardiovascular system. SARS-CoV-2 can lead to myocarditis development, arrhythmia, heart failure, etc.According to an infectious diseases hospital in Omsk, heart changes were recorded in 5.8% of hospitalized children with COVID-19. The article presents a clinical case of the new coronavirus infection in a child of 15 years old who was on treatment in the infection diseases hospital of Budgetary Healthcare Institution of Omsk Oblast City Children's Clinical Hospital №3 of Omsk. The diagnosis was confirmed by examining nasopharyngeal smears for evidence of RNA SARS-CoV-2 by PCR. The course of infection in this patient is characterized by myocarditis development following medium severity disease without comorbid pathology.