According to the authors’ analysis of regulatory documents for homoeopathic medicines of Virginian witch hazel (Hamamelis virginiana L.), there is a need to transform quality assessment approaches and to unify analytical procedures for identification and assay tests.The aim of the study was to determine approaches to identification and assay of homoeopathic mother tinctures of Virginian witch hazel leaves and bark and medicinal products based on the tinctures.Materials and methods: in order to select quality evaluation procedures, the authors analysed scientific literature, Russian and foreign pharmacopoeias and regulatory documentation regarding homoeopathic medicines of Witch hazel. The authors performed practical evaluation of the selected procedures based on thin-layer chromatography, spectrophotometry, qualitative reactions, and titrimetry, using samples of homoeopathic mother tinctures of Witch hazel leaves and bark, as well as corresponding homoeopathic medicinal products in various dosage forms.Results: the authors proposed identification and assay procedures for the studied active pharmaceutical ingredients (APIs) and homoeopathic medicinal products and prepared the drafts of pharmacopoeial monographs Hamamelis virginiana e foliis (Hamamelis, Folium) homoeopathic mother tincture and Hamamelis virginiana (Hamamelis) homoeopathic mother tincture. The unified procedures were included in the draft monographs for homoeopathic medicinal products Hamamelis, homoeopathic drops; Hamamelis D1, homoeopathic ointment; Hamamelis, folium D1, homoeopathic ointment; Hamamelis virginiana e foliis D1, rectal homoeopathic suppositories.Conclusions: the developed procedures are compatible with the principle of holistic, end-to-end standardisation, as they make it possible to carry out identification tests and assays using the same class of biologically active compounds throughout the whole range of homoeopathic medicines from APIs to finished products. The authors proposed the methodology for assessing homoeopathic medicinal products’ quality, taking into account the degree of dilution of the homoeopathic tinctures used.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.