基于中药质量特征和HACCP体系的中药可追溯系统的应用  

Application of traditional Chinese medicine(TCM)traceability system based on TCM quality characteristics and HACCP system

作　　者：金安琪 池秀莲[1] 李明福[2] 江宗岳 阙灵 周修腾[1] 杨光[1] JIN An-qi;CHI Xiu-lian;LI Ming-fu;JIANG Zong-yue;QUE Ling;ZHOU Xiu-teng;YANG Guang(NationalResource Center for Chinese Materia Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;China Academy of Inspection and Quarantine,Beijing 100176,China;Beijing Chinese Medicine Science DevelopmentFoundation Qihuang,Beijing 100089,China;School of Economics andResource Management,Beijing Normal University,Beijing 100875,China)

机构地区：[1]中国中医科学院中药资源中心,北京100700 [2]中国检验检疫科学研究院,北京100176 [3]北京岐黄中医药文化发展基金会,北京100089 [4]北京师范大学经济与资源管理研究院,北京100875

出　　处：《中国中药杂志》2020年第21期5304-5308,共5页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2017YFF0210300,2017YFF0210301)。

摘　　要：为稳定中药市场的定价秩序、重构中药质量信号的传递通路,建立一套完善的中药质量可追溯管理体系至关重要。该研究通过梳理国内外食品、药品监管过程中的成熟经验,在分析"药食同源"理论即中药质量特征的基础上,提出中药产品的质量控制可借鉴食品安全质量控制的危害分析临界控制点(HACCP)体系。研究指出HACCP体系可为中药的追溯管理过程提供技术指导,并对提升中药产品质量和中医药的安全风险控制提供思路。HACCP体系在中药质量监管中的应用可以帮助中医药建立起与国际对话的平台,有助于实现中药产业的现代化、国际化发展目标。It is crucial to establish a complete set of traditional Chinese medicine(TCM)quality traceability management process system,in order to stabilize the pricing order of TCM market and reconstruct the transmission path of TCM quality signals.In this study,we reviewed the mature experience of food and drug supervision at home and abroad,analyzed the quality characteristics of TCM,and put forward that the quality control of TCM products can learn from the hazard analysis and critical control point(HACCP)system in food safety quality control.This study points out that the HACCP system provides not only technical guidance for the traceability management of TCM,but also ideas for improving the quality of TCM products and the safety risk control of TCM.The application of the HACCP system in TCM quality control can help establish an international dialogue platform for TCM and help realize the modernization and internationalization of TCM industry.

关 键 词：危害分析临界控制点 中药可追溯体系 中药质量管理 中药质量风险控制点 

分 类 号：R288[医药卫生—中药学] O213.1[医药卫生—中医学]