中国食品药品监管Issue(12)：142-149,8.DOI:10.3969/j.issn.1673-5390.2025.12.015
国家药品抽检探索性研究发现问题处置案例分析与思考
Analysis and Reflection on Case Studies of Problem Handling in National Sampling Exploratory Research
DENG Gao-yang 1ZHANG Qing-fen 2ZOU Jie 2ZOU Yu-ting3
作者信息
- 1. Department of Pharmacy,Nanfang Hospital Zengcheng Campus,Southern Medical University
- 2. Evaluation&Inspection Center of GDMPA
- 3. Guangdong Medical Products Administration
- 折叠
摘要
Abstract
Objective:Through exploratory research conducted within the national drug sampling program,this study aims to identify typical cases,elucidate the mechanisms by which process time deviations affect quality during the manufacturing of traditional Chinese medicine(TCM)preparations,propose systematic risk control and regulatory optimization measures,and provide practical references for improving quality management throughout the entire drug life cycle.Methods:A suspected regulatory violation involving Compound Houttuynia cordata Tablets in Guangdong Province was selected as a case study.Process defects were identified through unannounced inspections,revealing an excessive interval(21.5h)between washing and extraction.Statutory testing and exploratory research were conducted in parallel,combined with enzymatic hydrolysis kinetic analysis to establish a time-quality correlation model and trace by which uncontrolled preprocessing time led to abnormal conversion of baicalin.Results:When the interval between washing and extraction extended 10h,the peak area ratio of wogonoside to baicalin increased significantly,resulting in changes in the material basis of the product.However,the current Good Manufacturing Practice(GMP)regulations lack explicit requirements for TCM preparations.Conclusion:Exploratory research serves as a technical bridge between quality regulation and process optimization;however,further improvements are needed in method validation and policy support.It is recommended to revise the GMP appendix for TCM preparations for process time control,promote the transformation of exploratory approaches,such as peak area ratio method,into statutory standards,and strengthen the main responsibility of enterprises for post-marketing research.关键词
国家药品抽检/探索性研究/质量管控/工艺偏差/GMP修订Key words
national drug sampling/exploratory research/quality control/process deviation/GMP revision分类
医药卫生引用本文复制引用
DENG Gao-yang,ZHANG Qing-fen,ZOU Jie,ZOU Yu-ting..国家药品抽检探索性研究发现问题处置案例分析与思考[J].中国食品药品监管,2025,(12):142-149,8.
