传统中药毒性分级理论的科学内涵与《中国药典》(一部)标注修订建议

Theory of toxic classification of traditional Chinese medicine and recommendations for revision of China Pharmacopeia(volume 1)

中药毒性分级理论是我国传统医药对人类认识药物毒性和科学应用的特有发明和贡献,中药毒性分级问题已经成为关系人民群众的用药安全、我国民族医药产业健康持续发展和中医药国际化的重大科学问题。该文对传统中药毒性分级理论的形成历史和嬗变过程进行了分析总结,并基于新形势下中药产业化、现代化、国际化的发展需求,对中医药行业亟待解决的中药毒性分级本质、科学内涵及风险控制等问题进行了分析,并对《中国药典》(一部)收载中药材毒性分级标注提出修订建议。一方面,从科学研究的角度,针对现有小鼠/大鼠急性毒性分级不适合中药毒性特点,发展新的生物毒性测试技术方法(如Microtox,ADME/Tox等),制定有毒中药分级研究技术指导原则,建立既能体现中医药优势和特色,又与国际接轨的中药毒性分级的评价方法体系与技术方案标准操作规程(SOP);另一方面,从药品监督管理角度,鉴于传统中药"毒性"与现代医学"毒性"并不等同,有必要进一步完善和拟定有毒中药风险分级管理名单,建议取消《中国药典》(一部)正文[性味与归经]项下对"有大毒"、"有毒"、"有小毒"的表述,有利于国际接轨和提高中药产业的国际国内竞争力。为了传统中医药理论继承和体现中医药特色,在正文[注意]项下,保留根据历代本草记载标注"有大毒"、"有毒"、"有小毒"的表述,同时在该项下根据现代研究成果加注中药毒性的具体表现、量效关系、毒性机制、毒性物质等描述,共同作为临床用药的警示性参考,有利于人民群众的用药安全和中药的现代化、国际化。

Toxic classification of traditional Chinese medicine,as a contribution of traditional Chinese medicine（TCM） to the recognition of medicinal toxicity and rational use of medicinal materials by Chinese people,is now a great issue related to safe medication,sustainable development and internationalization of Chinese medicine.In this article,the origination and development of toxic classification theory was summarized and analyzed.Because toxic classification is an urgent issue related to TCM industrialization,modernization and internationalization,this article made a systematic analysis on the nature and connotation of toxic classification as well as risk control for TCM industry due to the medicinal toxicity.Based on the toxic studies,this article made some recommendations on toxic classification of Chinese medicinal materials for the revision of China Pharmacopeia（volume 1）.From the aspect of scientific research,a new technical guideline for research on toxic classification of Chinese medicine should be formulated based on new biological toxicity test technology such as Microtox and ADME/Tox,because the present classification of acute toxicity of mice/rats can not met the modern development of Chinese medicine any more.The evaluation system and technical SOP of TCM toxic classification should also be established,and they should well balance TCM features,superiority and international requirements.From the aspect of medicine management,list of toxic medicines and their risk classification should be further improved by competent government according to scientific research.In China Pharmacopeia（volume 1）,such descriptions of strong toxicity,toxicity or mild toxicity should be abandoned when describing medicine nature and flavor.This revision might help promote TCM sustainable development and internationalization,and enhance the competitive capacity of Chinese medicine in both domestic and international market.However,description of strong toxicity,toxicity or mild toxicity might be used when making cautions for the medicine,stating that the description is based on Chinese classic works.In this way,TCM traditional theory might be inherited and features of Chinese medicine maintained and reflected.Besides,modern findings should be added to the cautions,including dose-response relationship,toxic mechanism,and toxic elements.The traditional toxic descriptions and modern findings,as a whole,can make the caution clear and scientific,and then promote safe medication and TCM modernization and internationalization.