2021年国家药品抽检饮片专项品种有关问题及建议

Problems and Suggestions on Chinese Medicinal Decoction Pieces in the National Drug Sampling and Inspection in 2021

2021年国家药品抽检中药饮片共计9个品种,合计1957批,整体合格率为98.36%。基于这9种饮片的质量分析报告,对标准检验进行数据汇总及分析,结合探索性研究结果,剖析中药饮片现有品种质量情况和标准现状,对中药饮片标准修订、检验和监管提出合理化建议,为提升中药饮片质量、消除质量安全风险、保障人民群众用药安全有效提供坚实的基础。

In 2021,a total of 1957 samples of 9 varieties of Chinese medicinal decoction pieces were inspected by the National Medical Products Administration,with an overall pass rate of 98.36%.We summarized the data of the quality reports and analyzed the quality situation and the current status of standards.Finally,we proposed suggestions for the revision,inspection,and management of the standards.This study lays a solid foundation for improving the quality,eliminating quality and safety risks,and ensuring the safety and effectiveness of Chinese medicinal decoction pieces in the future.