Faculty of Pharmacy, The University of Sydney, Sydney, NSW 2006, Australia.
J Ethnopharmacol. 2013 Mar 7;146(1):40-61. doi: 10.1016/j.jep.2012.12.027. Epub 2012 Dec 31.
While there is an increasing number of toxicity report cases and toxicological studies on Chinese herbal medicines, the guidelines for toxicity evaluation and scheduling of Chinese herbal medicines are lacking.
The aim of this study was to review the current literature on potentially toxic Chinese herbal medicines, and to develop a scheduling platform which will inform an evidence-based regulatory framework for these medicines in the community.
The Australian and Chinese regulations were used as a starting point to compile a list of potentially toxic herbs. Systematic literature searches of botanical and pharmaceutical Latin name, English and Chinese names and suspected toxic chemicals were conducted on Medline, PubMed and Chinese CNKI databases.
Seventy-four Chinese herbal medicines were identified and five of them were selected for detailed study. Preclinical and clinical data were summarised at six levels. Based on the evaluation criteria, which included risk-benefit analysis, severity of toxic effects and clinical and preclinical data, four regulatory classes were proposed: Prohibited for medicinal usage, which are those with high toxicity and can lead to injury or death, e.g., aristolochia; Restricted for medicinal usage, e.g., aconite, asarum, and ephedra; Required warning label, e.g., coltsfoot; and Over-the-counter herbs for those herbs with a safe toxicity profile.
Chinese herbal medicines should be scheduled based on a set of evaluation criteria, to ensure their safe use and to satisfy the need for access to the herbs. The current Chinese and Australian regulation of Chinese herbal medicines should be updated to restrict the access of some potentially toxic herbs to Chinese medicine practitioners who are qualified through registration.
尽管越来越多的关于中草药毒性报告案例和毒理学研究，但缺乏对中草药毒性评估和分类的指导原则。
本研究旨在回顾当前有关潜在有毒中草药的文献，并开发一个调度平台，为这些中草药在社区中的循证监管框架提供信息。
以澳大利亚和中国的法规为起点，编制了一份潜在有毒草药清单。对 Medline、PubMed 和中国 CNKI 数据库中的植物学和药物拉丁语名、英文和中文名称以及可疑有毒化学物质进行了系统的文献检索。
确定了 74 种中草药，其中 5 种被选为详细研究对象。在六个级别上总结了临床前和临床数据。根据评价标准，包括风险效益分析、毒性作用的严重程度以及临床和临床前数据，提出了四类监管类别：禁止药用，即那些毒性高且可能导致伤害或死亡的草药，例如马兜铃；限制药用，例如乌头、细辛和麻黄；需要警告标签，例如款冬花；非处方药，即那些毒性安全的草药。
应根据一套评估标准对中草药进行分类，以确保其安全使用，并满足对草药的获取需求。应更新当前中澳对中草药的监管规定，限制某些潜在有毒草药的使用，只允许通过注册的合格中医执业医师使用。
