中国食品药品监管Issue(12)：114-125,12.DOI:10.3969/j.issn.1673-5390.2025.12.012
中药补充检验方法存在问题分析与解决方案思考
Challenges and Optimization Strategies for Supplementary Testing Methods of Traditional Chinese Medicine
摘要
Abstract
Supplementary testing methods are a critical component of the national drug standard system.Through statutory authorization,they fill technical gaps left by routine standards in combating drug adulteration,contamination,and counterfeiting,and are characterized by both mandatory applicability and timeliness.This study systematically examines the legal status of supplementary testing methods for traditional Chinese medicine(TCM),the core issues they aim to resolve,key technical considerations in their development,and the review and approval process.It identifies several current challenges,including the rationality of limit setting,the specificity of key control indicators,and issues within the review and approval procedures.Accordingly,this paper proposes establishing general supplementary testing methods for TCM,further improving the review and approval process,and optimizing the risk early-warning mechanism.These measures aim to better leverage the role of supplementary testing methods in combating illegal adulteration and counterfeiting.关键词
中药补充检验方法/方法分类/制定要点/限度制定/指标成分/通用性检测方法Key words
supplementary testing methods for traditional Chinese medicine/method classification/key technical considerations/limit setting/indicator components/general analytical methods分类
医药卫生引用本文复制引用
LIU Xiao-xiao,ZHENG Wen-yan,LI Lu-lu,JIN Hong-yu,WEI Feng,WU Qun-yue..中药补充检验方法存在问题分析与解决方案思考[J].中国食品药品监管,2025,(12):114-125,12.基金项目
药品监管科学全国重点实验室课题(2024SKLDRS0201) （2024SKLDRS0201）
广东省药品监督管理局科技创新项目(2025YDZ04) （2025YDZ04）
广东省科学技术厅科技计划项目(2023A1111120025) （2023A1111120025）
