Gao Yue, Ma Zengchun, Zhang Boli
Beijing Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing 100850, China.
Zhongguo Zhong Yao Za Zhi. 2012 Jan;37(1):1-4.
The research of new herbal drugs involves in new herbal drugs development and renew the old drugs. It is necessary to research new herbal drugs based on the theory of traditional Chinese medicine (TCM). The current development of famous TCM focuses on the manufacture process, quality control standards, material basis and clinical research. But system management of security evaluation is deficient, the relevant system for the safety assessment TCM has not been established. The causes of security problems, security risks, target organ of toxicity, weak link of safety evaluation, and ideas of safety evaluation are discussed in this paper. The toxicology research of chinese herbal drugs is necessary based on standard of good laboratory practices (GLP), the characteristic of Chinese herbal drugs is necessary to be fully integrated into safety evaluation. The safety of new drug research is necessary to be integrated throughout the entire process. Famous Chinese medicine safety research must be paid more attention in the future.
新中药的研究涉及新中药开发和老药更新。基于中医理论开展新中药研究很有必要。当前名老中药的发展集中在生产工艺、质量控制标准、物质基础和临床研究方面。但安全性评价的系统管理存在不足,尚未建立中药安全性评价的相关体系。本文探讨了安全性问题的成因、安全风险、毒性靶器官、安全性评价的薄弱环节以及安全性评价思路。基于良好实验室规范(GLP)标准开展中药毒理学研究很有必要,要将中药的特性充分融入安全性评价中。新药研究的安全性必须贯穿于整个过程。未来必须更加重视名老中药的安全性研究。