Wang Ting, Zhou Gang
Centre for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China.
Zhongguo Zhong Yao Za Zhi. 2012 Sep;37(17):2653-5.
This article emphasized the problems about toxic herbs in the process of research and development of new traditional Chinese medicine (TCM). It describe and explain what the researchers should pay attention to, such as processing, the usage and dosage, quality control of the toxic herbs, and chronic in toxicity trial, course of treatment, choice and detection of safe target in clinical trial about preparation of the new TCM. The goal is to lead the researchers to attach the importance of toxic herbs in the new TCM.
本文强调了中药新药研发过程中有毒中药的相关问题。它描述并解释了研究人员应注意的事项,如炮制、用法用量、有毒中药的质量控制,以及新中药制剂的慢性毒性试验、疗程、临床试验中安全指标的选择与检测等。目的是引导研究人员重视中药新药中的有毒中药。