中药品种众多成分复杂，易受贮藏条件、炮制工艺、包装材料等条件的影响，发生质量变异现象，导致疗效降低甚至产生有毒成分。明确中药有效期可以保障中药质量及临床用药的安全性和有效性，为中药国际化的发展奠定基础。通过对有毒中药稳定性和有效期的研究进展进行综述，将有毒中药根据“毒-效”关系分为“毒-效”成分相同、“毒-效”成分不同、“毒-效”成分的相互转化3类，并对有毒中药稳定性和有效期研究方法进行介绍，为后续中药有效期的制定提供参考。

Many kinds of traditional Chinese medicines have complex ingredients, which are easily affected by storage conditions, processing processes, packaging materials and other conditions, and quality variation occurs, resulting in reduced efficacy and even the production of toxic components. Clarifying validity period of traditional Chinese medicines can ensure quality of traditional Chinese medicines, as well as the safety and effectiveness of clinical drugs, and lay foundation for development of internationalization of traditional Chinese medicines. In this paper, the research progress on the stability and validity of toxic Chinese medicines were reviewed, according to the “toxic-effect” relationship, toxic Chinese medicines were divided into three categories: the same “toxic-effect” component, different “toxic-effect” component, the mutual transformation of “toxic-effect” component, and the stability and validity research methods of toxic Chinese medicines were introduced to provide reasonable reference for the subsequent formulation of the validity period of traditional Chinese medicines.

R285.62

国家中医药管理局青年岐黄学者支持项目