The inclusion of requirements for independent determination of arsenic, cadmium, mercury, and lead, and the current sample preparation techniques into the State Pharmacopoeia of the Russian Federation (Ph. Rus.) requires the revision of the existing limits for elemental toxicants in herbal substances and herbal medicinal products produced from them.The aim of the study was to analyse the data on elemental toxicant content obtained during quality control of herbal substances (herbs, medicinal herb mixtures, extracts, and tinctures) using current test methods and sample preparation techniques, and to compare the obtained results with the Russian and foreign scientific and specialist literature.Materials and methods: the internal data on the content of critical heavy metals and arsenic in different dosage forms of herbal medicinal products, which were obtained by inductively coupled plasma mass spectrometry after sample preparation by decomposition in closed vessels, were compared with literature data. Results: it was demonstrated that the content of lead, cadmium, and mercury in all the test samples did not exceed the Ph. Rus. limits and was consistent with the analysed literature. The arsenic content in some herbal medicinal products was higher than the established Ph. Rus. limits, but complied with the less stringent Ph. Eur. and USP requirements for herbal substances. The authors investigated the link between the content of elemental toxicants and the place of collection and the part of the plant being tested. It was shown that different types of medicinal plants had a tendency to accumulate particular elements. The authors determined the content of the elements to be controlled in extracts and tinctures. The differences in the Russian and foreign requirements for the content of elemental toxicants may be attributed to the method of obtaining experimental data that form the basis for the setting of limits.Conclusions: the results of the study confirm the validity of the existing limits for elemental toxicants in herbal medicinal products. The authors demonstrated the need to revise the existing limits for arsenic in herbal medicinal products.
Описана процедура валидации методики анализа содержания нормируемых элементных токсикантов в лекарственном растительном сырье на масс-спектрометре с индуктивно-связанной плазмой при использовании микроволновой кислотной минерализации. Предлагаемая методика пробоподготовки обеспечивает максимальный переход тяжелых металлов в раствор при неполном разложении органической матрицы с помощью концентрированной азотной кислоты. Для оценки применимости методики были выбраны образцы разных морфологических частей растений: корневища аира, трава череды, плоды можжевельника. На основании полученных экспериментальных данных была проведена оценка линейности, предела количественного определения, правильности, сходимости и внутрилабораторной прецизионности валидируемой методики. На основе определенных коэффициентов извлечения мышьяка, свинца, ртути и кадмия были рассчитаны стандартные отклонения, коэффициенты вариации, доверительные интервалы, систематические погрешности, F-критерии Фишера и t-критерии Стьюдента. Показано, что полученные статистические характеристики удовлетворяют критериям приемлемости валидационных параметров, представленным в отечественной и зарубежной нормативной документации.
Mint is a medicinal herbal drug; and its leaves are also widely used in the food and cosmetic industries. Medical literature states that mint is naturally resistant to toxic elements and capable of accumulating them in significant amounts.The aim of the study was to compare heavy metals, arsenic, and aluminum contents in mint leaves and products.Materials and methods: the study covered peppermint leaves, tinctures, and oils, as well as teas and dietary supplements made of different varieties of mint. Elemental analysis was performed according to the procedure of inductively coupled plasma mass spectrometry (ICP-MS) developed by the authors.Results: the authors studied the compliance of the experimentally established contents of heavy metals, arsenic, and aluminum in peppermint leaves and products to the requirements of Russian and foreign regulatory documentation. Nonparametric Spearman correlation coefficients were calculated to characterise the interaction between chemical elements.Conclusions: arsenic contents in mint leaves may exceed the limit given in the State Pharmacopoeia of the Russian Federation, 14th ed. It is supposed that the increased contents are not a result of the anthropogenic factor, but a specific characteristic of this plant. The study demonstrated synergistic absorption of aluminum, iron, and vanadium, as well as copper and zinc by mint. It was established that manganese had an antagonistic effect on the absorption of nickel, lead, and cobalt by mint.
The group of progestogen hormones includes progesterone (corpus luteum hormone) and a number of synthetic preparations with a structure close to that of progesterone (norethisterone, lynestrenol, levonorgestrel, desogestrel, etc.).The process of state control of the commercial progestogen hormonal preparations and the corresponding normative documentation are not free of significant drawbacks (in particular, some documents operative in the Russian Federation do not regulate the contents of related steroids). For this reason, the problems pertaining to the increase in the level of standardization and control of the quality of progestogen hormonal preparations require permanent attention and thorough consideration.A lot of information concerning the analysis of progestogen hormones is contained in the monograph of G6rrg [1]. However, there are some new data accumulated since that publication.The main methods used for the analysis of progesterone and related drugs were reviewed in [2].An analysis of the published data shows that the authenticity of ethisterone [3][4][5], norethisterone [4,5], and hydroxyprogesterone capronate [5] is established using a color reaction with sulfuric acid; levonorgestrel is identified by its reaction with m-dinitrobenzene in alkaline medium [5]; ethis-I State Research Institute of Drug Standardization and Control, Ministry of Health and Medical Industry, Moscow, Russia.
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