Abstract
Abstract. Identification of hellebore (Veratrum Lobelianum Bernh.) herbal substance, as well as hellebore-based herbal preparation and herbal medicinal product by the same group of biologically active substances using the same test method is in line with the so-called “consistent standardisation” principle.The aim of the study was to develop a harmonised approach to identification of steroidal alkaloids in hellebore products (hellebore water, hellebore tincture) and hellebore herbal substance (hellebore rhizomes with roots).Materials and methods: samples of hellebore water, hellebore tincture, and hellebore rhizomes with roots were analysed by high-performance thin-layer chromatography (HPTLC) using an HPTLC plate.Results: the authors developed a harmonised identification procedure for products made from hellebore rhizomes with roots (herbal substance, herbal preparation, and herbal medicinal product) based on HPTLC detection of steroidal alkaloids. The results of the study will be used to prepare amendments to the Identification part of monograph FS.2.5.0104.18 “Hellebore rhizomes with roots”. The developed test procedure is proposed for inclusion into draft monographs “Hellebore rhizomes with roots, tincture” and “Hellebore rhizomes with roots, tincture, solution for external use”.Conclusions: the developed test procedure can be used as an identification test for a range of products from the hellebore herbal substance to hellebore-based herbal medicinal products, which is based on the detection of the same group of biologically active substances.
Highlights
herbal medicinal product by the same group of biologically active substances using the same test method is in line with the socalled “consistent standardisation
a harmonised approach to identification of steroidal alkaloids in hellebore products
hellebore rhizomes with roots were analysed by highperformance thin-layer chromatography
Summary
3 Судебно-химическое определение вератрина в трупном материале. ТСХ-методика, приведенная в разделе «Под линность» ФС.2.5.0104.18 «Чемерицы Лобеля корневища с корнями», имеет ряд недостатков:. - отсутствует стадия очистки получаемого спиртового извлечения с помощью реэкстракции или другим подходящим способом;. - локализацию зон адсорбции на хроматограмме проводят просматриванием в УФ-свете, что не является специфичным для данного класса биологически активных веществ. Стероидные алкалоиды являются умеренно полярными соединениями, поэтому для их выделения следует использовать неполярные органические растворители: хлороформ или эфир с добавлением щелочи [1]. В связи с этим в ТСХ-методику определения подлинности лекарственного растительного сырья, фармацевтической субстанции и лекарственного препарата на основе чемерицы Лобеля нами было предложено добавить стадию предварительной очистки, осуществляемой экстракцией стероидных алкалоидов эфиром, содержащим аммиака раствор 25%
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