有毒中药安全性评价研究进展

现代有毒中药的概念是使用不当时,损伤人体的组织、器官,扰乱或破坏正常生理功能,产生病理变化甚至可能危及生命的中药。《中国药典》2010年版共收载毒性中药83种,其中大毒10种,有毒42种,小毒31种。目前我国在有毒中药的药效组分学研究、毒代动力学研究、代谢组学研究等方面都取得了一定进展,但也存在纳入中药安全性评价研究的种类少、研究方法较局限、管理尚不规范等问题。借鉴国外安全性评价方法、制定严格规范的质量标准等都是保障有毒中药合理应用的有效方法。

Research progress in safety evaluation of toxic traditional Chinese medicine

The toxic traditional Chinese medicine（TCM） is the drugs that may damage the body＇s tissues and organs,disrupt or destroy the normal physiological function,lead to pathologic changes,and even threaten life when the drugs are improperly used.Totally 83 kinds of toxic TCM,including 10 kinds of extremely toxic,42 kinds of toxic,and 31 kinds of slightly toxic TCM as described in the Chinese Pharmacopoeia（2010）.Currently,progresses have been made in the studies on bioactive components, toxicokinetics,and metabonomies of the toxic TCM in our country.But some problems still exist,such as relatively small species members of TCM were entered in the safety evaluation research,limited study methods, and the non-standard management.The effective ways to promote rational use of toxic TCM include some measures such as learning the safety evaluation methods in other counties and formulating the strict quality standards.