试析中药新药药效与非临床毒性研究的相关性  

Relationship between pre-clinical toxicity and efficacy of traditional Chinese medicine

作　　者：游云[1] 李建荣[1] 黄芳华[2] 韩玲[2] YOU Yun LI Jian-rong HUANG Fang-hua HAN Ling(Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China Drug Control Center, China Food and Dug Administration, Beijing 100038, China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国中药杂志》2017年第20期4045-4048,共4页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81274006)

摘　　要：该文根据中医药的临床证候与西医疾病的相互关系,对部分中药新药药效与非临床毒性研究的相关性进行了分类。如果中药药效靶点与现代医学一致,或者是以毒为能的中药制剂,中药复方的毒性表现往往可见到药效的放大与延伸;中药药效靶点与现代医学有交叉但又不完全一致,或者二者之间无交叉的情况下,中药复方的毒性往往不能从药理作用预测。随着中药活性部位提取分离技术的提高,中药新辅料的应用,某些中药复方制剂毒性可能来自于与药效无关的反应。分析结果提示研究人员应关注中药毒理学试验方案的设计及研究过程的质控等问题,综合多学科分析评价中药的药效及毒性特点。Based on the different category of syndromes between traditional Chinese medicine （TCM） and Western medicine, the relationship between the efficacy and non-clinical toxicity of the TCM was analyzed. If TCM preparations have the same pharmacological targets to treat disease with modern medicine or the Chinese herbal preparations treat the diseases with its toxicity, their toxicity often exhibits the amplification and extension of activity ; on the other hand, if TCM preparations have overlapped pharmacological targets but not completely the same with modern medicine, or if they have totally different pharmacological targets, the toxicity of TCM could not be inferred by pharmacological activity. With the great progress in extraction and separation technique for active parts of TCM as well as the application of some novel technique and excipients, some toxicity may be from the reactions unrelated with the pharmacological ac- tivity. In conclusion, better design and quality control could be obtained by understanding the relationship between pharmacological and toxicological study for the investigation of new traditional medicine.

关 键 词：中药 药效 毒性 相关性 

分 类 号：R285.1[医药卫生—中药学]