Methodology of specific enzyme biotest-systems in vitro application in herbal medicines complex laboratory quality control system

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Abstract

Relevance. Improving methods for quality control of medicines, including those of plant origin, is one of the urgent tasks of modern pharmaceutical science and practice. The growing interest in herbal medicine stimulates not only the expansion of the diversity of raw materials and the development of new drugs, but also the constant improvement of approaches and methods for controlling their quality.

The purpose of the study is to develop a methodology for the use of specific in vitro enzyme biotest systems (IBTS) in complex laboratory quality control of herbal medicines for additional assessment of their biological activity, which determines therapeutic effectiveness, in addition to physical, physicochemical, and chemical indicators.

Material and methods. We used in silico (PASS), in vitro (specific enzyme biotest systems) and in vivo (experimental models) methods.

Results. A method has been developed for the use of specific in vitro enzyme biotest systems (IBTS) in complex laboratory quality control of medicines, as well as methods of physical, physico-chemical, and chemical analysis to assess their biological properties, which determine the therapeutic effectiveness of medicines.

Conclusions. Specific enzyme biotest systems make it possible to identify the specific biological activity of research objects and confirm the feasibility of their use in an in vitro quality control system for herbal medicines at different stages of their life cycle, as demonstrated by the example of extracts from native and biotechnological raw materials, as well as experimental dosage forms, developed at FGBNU VILAR, and comparison drugs.

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About the authors

I. A. Lupanova

All-Russian Research Institute of Medicinal and Aromatic Plants

Author for correspondence.
Email: lupanova@vilarnii.ru
ORCID iD: 0000-0001-8183-2877

Ph.D. (Biol.), Head of Pre-clinical Studies Center

Russian Federation, Moscow

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2. Рис. 1. Схема поэтапного контроля качества растительных лекарственных средств с применением специфических ферментных биотест-систем in vitro

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3. Рис. 2. Схема исследований in vivo с использованием лабораторных животных

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