中药质量系统评价研究进展I 中药质量可追溯技术研究.pdf

文档介绍：中药质量系统评价研究进展 I:中药质量可追溯技术研究
李西文 1,2, 陈士林 2, 王一涛1
(,中药质量研究国家重点实验室(澳门大学),澳门 999078 2. 中
国中医科学院,中药研究所,北京 100700)
摘要:我国中药生产长期处于粗放式经营状态,一旦发生药品质量事件无法真正快速准确的找到问题源头,难以
采取及时有效的纠正措施,影响了消费者的权益。中药质量追溯技术是通过信息记录、查询和召回问题产品,实
现“从栽培到销售”的全过程药品安全管理的重要手段,而我国中药质量可追溯技术尚处于探索和试点阶段。本
文通过综述现有可追溯技术发展现状,基于中药的商品和药品双重属性,提出了 DNA 二维条形码为主体的中药
质量可追溯技术,并对存在的问题进行了讨论。
关键词:中药质量;追溯;二维码;DNA
Systematic Studies on Quality of Chinese Medicine (I):
Traceability in Quality of Chinese Medicine
LI Xiwen 1, CHEN Shilin 2, WANG Yitao 1
(1. State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical
Sciences, University of Macau, Macao, China; 2. Institute of Chinese Materia Medica, China Academy
of Chinese Medical Sciences, Beijing 100700, China)
Abstract:Traceability for quality assurance is ponent of the Chinese medicine production
process from cultivation to sale by recoding information, inquiring files and recalling production.
Currently technology of traceability in Chinese medicine remains in fancy and has not been applied on
marketing. This paper reviews the development of traceability technology and provides a method for
quality assurance of Chinese medicine using traceability based on 2-dimensional DNA barcodes. Some
limited factors for application of traceability technology in Chinese medicine are evaluated.
Keywords