2022年国家药品抽检中药饮片专项质量分析、标准修订和监管建议

Quality Analysis,Standard Revision,and Regulatory Recommendations for Chinese Medicinal Decoction Pieces in the National Drug Sampling Inspection in 2022

国家药品监督管理部门组织全国开展中药饮片专项抽检,目的在于促进野生中药材资源的保护和种植的规范性,防控和化解中药饮片质量风险、强化中药饮片安全管理、保障中药饮片临床安全有效。2022年,国家药品抽检饮片专项包含艾叶、川牛膝、大黄、紫草、茜草、菊花、桃仁、金银花、片姜黄9个品种,抽样合计1679批,其中合格1623批,整体合格率为96.66%。借助这9个品种抽检数据的统计分析,结合探索性研究,对各品种法定标准和主要质量问题等进行总结与分析,提出未来标准修订和监管的建议,为全面推进中药饮片质量提升奠定基础。

The national medical products administrative department organized focused sampling inspections of Chinese medicinal decoction pieces.It aims to enhance protection and standardization in planting and cultivating wild Chinese herbal medicines,forestall,control,and defuse the quality risks of Chinese medicinal decoction pieces,strengthen safety management efforts of Chinese medicinal decoction pieces,and safeguard the safety and efficacy of their clinical applications.In 2022,9 varieties of decoction pieces including Artemisiae Argyi Folium,Cyathulae Radix,and Rhei Radix et Rhizoma were sampling inspected,totaling 1679 batches,of which 1623 were qualified,and the overall qualification rate reached 96.66%.This paper summarized and analyzed the legal standards and main quality problems of each variety by the statistical analysis of 9 varieties of sampling data,combined with exploratory research.It proposed recommendations for standard revisions and regulation,laying the foundation for comprehensively promoting the quality of Chinese medicinal decoction pieces.