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探索中药材质量优化:GAP、HACCP和ISO体系的综合运用

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中医药在世界范围内的应用增加,但我国中医药产品进入国际市场仍面临东西方文化差异、中药质量标准不完善、全球针对植物药的政策壁垒、中药材质量不达标等问题。2022年《中药材生产质量管理规范》引入危害分析与关键控制点理念,对中药材生产中的危害因素进行控制;同时,国际标准化组织中医药技术委员会ISO/TC249成立后,建立中医药国际标准,中医药企业开展GAP和ISO双认证,从源头上控制中医药的质量,是我国中医药扩大国际市场份额的根本途径。本文通过GAP、HACCP和ISO体系在中药材质量控制应用现状的对比研究,提出我国的中药材生产规范要充分借鉴国际上其他质量管理体系的优点,在降低生产风险和成本的同时,使GAP更具有操作性。
Optimization of Quality of TCM Medicinal Materials:Comprehensive Application of GAP,HACCP and ISO Systems
The global use of TCM has been steadily increasing,yet Chinese TCM products still face significant challenges in entering international markets,including cultural differences between East and West,inadequate quality standards for TCM,regulatory barriers against herbal medicines,and the substandard quality of medicinal materials.The 2022 edition of Chinese Herbal Medicine Production Quality Management Code introduced the concept of Hazard Analysis and Critical Control Points(HACCP)to control the harmful factors in the production of Chinese herbal medicine;at the same time,the international standard of TCM was established after the establishment of ISO/TC249 to control the quality of TCM from the source by carrying out GAP and ISO double certification,which is the fundamental way for Chinese TCM to expand its international market share.This study conducted a comparative analysis of the application status of three key systems—GAP(Good Agricultural Practices),HACCP and ISO(International Organization for Standardization)—in the quality control of TCM.Based on this analysis,this article proposed that China's TCM production standards should draw upon the strengths of these international quality management systems to reduce production risks and costs while enhancing the practicality and implementation of GAP guidelines.

TCMGAP systemHACCP systemISO systemquality control

俸世洪、叶霄、赵文吉

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成都天仙子农业科技发展有限公司,四川成都 610504

四川省农业科学院经济作物研究所,四川成都 610306

四川省草原科学研究院青藏高原高寒草地生态修复工程技术研究中心,四川成都 611743

中药材 GAP体系 HACCP体系 ISO体系 质量控制

2025

中国中医药信息杂志
中国中医科学院中医药信息研究所

中国中医药信息杂志

影响因子:0.889
ISSN:1005-5304
年,卷(期):2025.32(1)