符合中药特点的安全性相关质量研究及质量控制.pdf

·8 · 中草药 2023 年1 月 第54 卷 第1 期 Chinese Traditional and Herbal Drugs 2023 January Vol. 54 No. 1 符合中药特点的安全性相关质量研究及质量控制 郑天骄，韩 炜* 国家药品监督管理局 药品审评中心，北京 100022 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。 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 中图分类号：R285.53 文献标志码：A 文章编号：0253 - 2670(2023)01 - 0008 - 07 DOI: 10.7501/j.issn.0253-2670.2023.01.002 Safety-related quality research and quality control according to characteristics of traditional Chinese medicine ZHENG Tian-jiao, HAN Wei Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China Abstract: “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. Key words: safety and quality control of traditional Chinese medicine; endogenous toxic components; exogenous pollutants; processing; human experien