Zhao Junning, Ye Zuguang
Institute of Pharmacology and Toxicology, Key Laboratory of Biological Evaluation of Traditional Chinese Medicine Quality of the Administration of Traditional Chinese Medicine, Sichuan Provincial Key Laboratory of the Quality and Innovation Research of Chinese Materia Medica, Sichuan Provincial Engineering Technology Research Center of System Development of Famous-region Drug, Sichuan Academy of Chinese Medicine Sciences, Chengdu 610041, China.
Zhongguo Zhong Yao Za Zhi. 2012 Aug;37(15):2193-8.
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 I), 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.
中药毒性分类作为中医药对中华民族认识药物毒性及合理用药的贡献,现已成为关乎中药安全用药、可持续发展及国际化的重大问题。本文对毒性分类理论的起源与发展进行了总结分析。由于毒性分类是关乎中药产业化、现代化及国际化的紧迫问题,本文对毒性分类的本质内涵以及中药产业因药物毒性所面临的风险控制进行了系统分析。基于毒性研究,本文对《中国药典》(一部)中药材毒性分类的修订提出了一些建议。从科研角度看,应基于诸如Microtox和ADME/Tox等新的生物毒性测试技术制定新的中药毒性分类研究技术指南,因为现行的小鼠/大鼠急性毒性分类已无法适应中药的现代发展。还应建立中药毒性分类的评价体系和技术标准操作规程,使其兼顾中药特色、优势及国际要求。从药品管理角度看,政府主管部门应依据科研进一步完善毒性药品清单及其风险分类。在《中国药典》(一部)中,描述药物性味时应摒弃“大毒”“有毒”“小毒”等表述。此次修订或许有助于推动中药可持续发展及国际化,提升中药在国内外市场的竞争力。不过,在对药物进行警示时可使用“大毒”“有毒”“小毒”表述,并注明该表述依据中医典籍。如此,既能传承中医传统理论,又能保持和体现中药特色。此外,警示内容中应增添现代研究成果,包括剂量-反应关系、毒理机制及有毒元素等。传统毒性描述与现代研究成果相结合,可使警示清晰科学,进而促进安全用药以及中药现代化和国际化。