摘要
由于含毒性中药复方制剂的临床不良反应时有报道,所以中药复方的毒性评价备受关注。本文对毒性中药复方临床安全性方面的再评价工作进行了探讨,其中包括如何从中医药的角度认识毒性中药,建立符合毒性中药复方的安全再评价标准,将基因组学、蛋白组学及代谢组学等新技术引入中药安全性再评价中等。针对中药复方在安全性评价中存在的问题进行了讨论,并提出了相应的建议,以期为构建出符合中药特点的安全性再评价方法学体系提供参考。
Clinical adverse reactions of toxic traditional Chinese medicine( TCM) were occasionally reported,so the toxicity evaluation of TCM has drawn more concerns. In this article,the safety re-evaluation of clinical TCM compounds were discussed,including how to recognize toxic TCM from the perspective of TCM,the establishment of safety re-evaluation criteria in line with toxic TCM compounds,and the application of genomics,proteomics and metabolomics technology in safety re-evaluation of TCM. Problems in safety evaluation of TCM compounds were discussed,and the corresponding recommendations were put forward in order to build safety re-evaluation methodology system in line with the characteristics of TCM.
作者
严妍
吴娟
焦月华
姜波
房城
刘树民
YAN Yan WU Juan JIAO Yue-hua JIANG Bo FANG Cheng LIU Shu-min(Center of Drug Safety Evaluation, Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第15期1762-1766,共5页
Chinese Journal of New Drugs
基金
黑龙江省应用技术研究与开发计划项目(引导项目)(PC13S14)
黑龙江省中医药科研项目(ZHY16-090)
黑龙江省教育厅科学技术研究项目(12521510)
黑龙江中医药大学科研基金项目(201513)
关键词
毒性中药
中药复方
中医药理论
安全性再评价
toxic traditional Chinese medicine(TCM)
TCM compound
TCM theory
safety re-evaluation