摘要
“安全、有效、质量可控”是药物研发和评价的基本准则,保证药品安全更是前提和基础。中药作为药品的一种类型在安全性质量控制方面与其他药品具有共性要求,但也因其在中医药理论指导下使用且来源于植物、动物、矿物等原因,使其在降低不良反应、有害成分质量控制等方面存在自身特点。通过总结影响中药质量安全的因素及相关质量控制措施,提出重视人用经验对于中药安全性质量控制的重要作用,加强中药安全性风险识别、管理和控制等建议,以期为中药研发提供参考。
“Safety, effectiveness and quality controllability” is the basic criterion for drug development and evaluation, and ensuring drug safety is the premise and foundation. As a type of medicine, traditional Chinese medicine(TCM) has common requirements with other medicines in terms of safety and quality control. However, because it is used under the guidance of TCM theory and is derived from plants,animals, and minerals, it has its own characteristics in other aspects, such as adverse reaction and quality control of harmful ingredients.By summarizing the factors affecting the quality and safety of TCM and relevant quality control measures, some suggestions, such as paying attention to the important role of human experience in the safety and quality control of TCM, and strengthening the identification,management and control of the safety risks of TCM were put forward in this paper, in order to provide reference for research and development of TCM.
作者
郑天骄
韩炜
ZHENG Tian-jiao;HAN Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中草药》
CAS
CSCD
北大核心
2023年第1期8-14,共7页
Chinese Traditional and Herbal Drugs
关键词
中药安全性质量控制
内源性毒性成分
外源性污染物
炮制
人用经验
风险防控
safety and quality control of traditional Chinese medicine
endogenous toxic components
exogenous pollutants
processing
human experience
risk prevention and control
作者简介
郑天骄,助理研究员,审评员,主要从事药品技术审评工作。E-mail:zhengtj@cde.org.cn;通信作者:韩炜,博士,主任药师,高级审评员,主要从事药品技术审评工作。E-mail:hanw@cde.org.cn。
