中药安全性评价的发展、现状及其对策

Progress of Safety Evaluation of Traditional Chinese Medicines and Its Strategy in Further Studies

由于中药不良反应事件时而不断的被报道,所以中药安全性已为国内外所关注。本文对近年来我国在中药安全性方面研究取得的成绩和进展进行了概述,其中包括国家立项资助中药毒理学的课题明显增多、GLP实施以及中药注射剂安全性的评价、有毒中药的系统研究等;针对目前在中药毒理学研究中存在的问题,例如毒性的分级、控毒方法、毒性的早期发现以及基于有毒中药的中药新药研发等方面进行了讨论,并提出了相应解决的建议和对策以期克服上述中药安全性的问题。

Objective：Traditional Chinese medicine （TCM） safety has drawn more concerns from domestic and abroad because of its adverse reactions that were occasionally reported.In this article,recent achievements and research progress in TCM safety evaluation were reviewed,which included more research grants on TCM toxicology,GLP practice,TCM injections safety evaluation,systematic study of ‘ toxic TCMs’,and so on.Finally,TCM safety problems that currently exist,such as classification of ‘toxic TCMs’,methodology on the control of TCM toxicity,early discovery of its toxicity,research and development of a new drug from ‘toxic TCMs’,and so on,were discussed,and then,a study strategy of TCM toxicology was proposed to be aimed at overcoming the problems.