vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-106Research ArticleСТАНДАРТИЗАЦИЯ И КОНТРОЛЬ КАЧЕСТВА ЛЕКАРСТВЕННЫХ СРЕДСТВSTANDARDIZATION AND QUALITY CONTROL OF MEDICINESВзаимодействие биологически активных веществ лекарственных растительных препаратов с другими фармакотерапевтическими лекарственными средствамиInteractions of bioactive substances in herbal medicinal products with other pharmacotherapeuticsШихЕ. В.ShikhE. V.noemail@neicon.ruБулаевВ. М.BulaevV. M.noemail@neicon.ruДемидоваО. А.DemidovaO. A.noemail@neicon.ruСоковаЕ. А.SokovaE. A.noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201613022018044852Copyright © Ших Е.В., Булаев В.М., Демидова О.А., Сокова Е.А., 20182018Ших Е.В., Булаев В.М., Демидова О.А., Сокова Е.А.Shikh E.V., Bulaev V.M., Demidova O.A., Sokova E.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/106

Проведен анализ данных научной литературы о результатах клинических исследований, свидетельствующих о том, что биологически активные вещества некоторых лекарственных растительных препаратов изменяют эффективность и безопасность лекарственных препаратов различных фармакологических групп при их совместном применении. Рассмотрены виды взаимодействия между биологически активными веществами лекарственных растительных препаратов и лекарственных препаратов синтетического происхождения. Показано, что лекарственные растительные препараты оказывают воздействие на фармакодинамику лекарственных препаратов синтетического происхождения при их совместном применении. Это может приводить как к повышению эффективности и безопасности лечения, так и к развитию нежелательных реакций. Показана необходимость унификации разделов в инструкциях по применению лекарственных растительных препаратов, разрешенных в России для медицинского применения, отражающие их безопасность.

We have conducted an analysis of literature data on results of clinical trials suggesting that bioactive substances in some herbal medicinal preparations influence the efficacy and safety of medicines comprising various pharmacological classes if used concomitantly. Types of interactions between bioactive substances as a part of herbal medicines and chemically synthesized drugs have been discussed. It has been shown that in the case of concomitant use herbal medicinal products influence the pharmacodynamics of chemically synthesized drugs. This can either result in better safety and efficacy, or in adverse reactions. It is proved to be necessary to unify safety sections of patient information leaflets for herbal medicinal products approved in Russia for human use.

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The authors declare that there are no conflicts of interest present.