2017-2021年全国中药饮片抽检质量状况分析

Overall Review on the Quality of Chinese Medicinal Materials and Decoction Pieces in China during 2017-2021

近5年,得益于国家药品抽检工作的精心部署和顺利进行,中药饮片合格率逐年稳步提升。对2017-2021年全国中药饮片抽检数据进行整理、归纳和统计分析,概括了近5年全国中药饮片抽检的总体情况,总结了抽检过程中发现的主要质量问题,并剖析了其产生的原因,提出了相关的质量监管策略与建议,以期为规范中药材及饮片生产加工、提升其质量控制水平、修订完善中药材及饮片质量标准、建立健全饮片质量源头监管机制等提供参考。

The quality pass rate of Chinese medicinal materials and decoction pieces has been increasing over the last five years,because of the cautious deployment and efficient execution of different national pharmaceutical sampling and inspection tasks.We reviewed and statistically analyzed the national sampling data and then summarized the overall quality situation of Chinese medicinal materials and decoction pieces inspected from 2017 to 2021.Furthermore,we analyzed the causes of the main quality problems and proposed pertinent measures and suggestions for the quality control.This review provides support for updating the quality standards,standardizing the production and processing,and establishing a reliable source-based quality control system for Chinese medicinal materials and decoction pieces.