中药毒性与安全性评价研究进展

Research Progress on Safety Evaluation and Toxicity of Traditional Chinese Medicine

随着中草药及其制剂在国内和国际上的应用愈发广泛,其安全问题亦逐渐凸显,受到关注。中药普遍被认为安全无毒,但中药毒性是客观存在的。目前对中药毒性的研究尚处于探索阶段,基础研究亦需要积累,中药又具有自身的独特性,因此深化对中药及其相关产品的安全性评价及其方法研究势在必行。该文章依次从概念与定义、关键基础问题、研究方法、对策建议等方面,综合国内外文献与相关研究的观点与结果,依次阐明中药毒性与不良反应的相关概念,分析中药毒性研究的层次关系,描述性研究（毒性反应特点与物质基础）、解释性研究（毒性机制与动力学特征）及应用管理性研究（炮制解毒、配伍解毒、风险效益评估与临床管理）,列举有代表性的实验（常规毒性实验、特殊毒性实验）和保健食品与新食品原料的安全性评价方法,并提出了逐步解决中药安全性问题的建议和展望（质量标准、科学制备与应用、药物警戒等）,全面而准确地描绘出中药安全性评价之图景,引出近年来在思路和方法上的创新,带给研究者以整体性和前瞻性的参考。

As Chinese herbal medicines and its preparations have become widely used at home and abroad,their safety problems have also been highlighted and concerned. Traditional Chinese medicine（ TCM） is widely believed to be safe and non-toxic,but the toxicity of TCM is present indeed. At present,the research on the toxicity of TCM is still in the exploration stage,and the basic research still needs to be accumulated; in addition,TCM has its unique characteristics,so it is imperative to deepen its toxicity research and safety evaluation and related products. By integrating the views and results of literature and related research at home and abroad,this paper would successively elucidate related concepts of TCM toxicity and adverse reactions,analyze the hierarchical relationships in TCM toxicity research： descriptive study（ toxic reaction characteristics and material basis）,interpretive study（ toxicity mechanism and pharmacokinetics characteristics）,application and management study（ detoxification by processing,detoxification by compatibility,risk benefit assessment and clinical management）,list the representative examples of toxicological test methods and results（ conventional toxicity test,specific toxicity test） as well as the safety evaluation of health food and raw materials,and propose the suggestions and prospects of how to gradually solve the safety problem of TCM（ quality standard,scientific preparation and application,and pharmacovigilance,et al）,in turn from the aspect of literature background,key problems,classical methods and countermeasures. A picture of TCM safety evaluation would be comprehensively and accurately described,and the innovation in ideas and methods would be introduced to bring a comprehensive and prospective reference for researchers.