Регуляторные исследования и экспертиза лекарственных средств (Jul 2022)
Relevant Aspects of Standardisation of Plant Raw Materials and Herbal Medicinal Products Containing Phenolic Compounds
Abstract
Currently experts are actively working on Russian specifications for herbal drugs, herbal drug preparations, and herbal medicinal products, and specifically on analytical procedures to evaluate the quality of these medicines. The aim of this study was to provide a scientific basis for improving the procedures of qualitative and quantitative analysis of herbal drugs, herbal drug preparations and herbal medicinal products containing phenolic compounds. It was shown that the chemical nature, physicochemical and spectral characteristics of biologically active compounds should be considered a basis for the development of new methodological approaches to standardisation of plant raw materials and herbal medicines. The study used an example of herbal drugs and herbal medicinal products containing flavonoids, phenylpropanoids, and anthracene derivatives to justify the feasibility of standardisation using TLC, HPLC, spectrophotometry, as well as indicative reference standards as criteria of identity and quality. The study substantiated the necessity of a state system for development and registration of reference standards for pharmacopoeial analyses.
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