从2020年国家药品抽检专项有关问题谈中药材及中药饮片监管

国家药品评价性抽检项目采用“分散抽样-标准检验-探索性研究-综合评价”的模式对上市后的药品进行全面的质量评价,从而促进药品质量的提升,保障人民用药安全,引导医药产业健康有序发展。中药饮片抽检是国家药品评价性抽检的重要组成部分。以2020年国家药品抽检8个中药饮片品种的质量报告为基础,对标准检验及探索性研究结果进行数据汇总及分析,剖析中药饮片质量情况、标准现状、中药材及中药饮片全产业链中存在的相关问题。相关建议可为加强科学监管、提升中药质量提供参考。

Discussion on the Supervision of Chinese Medicinal Materials and Chinese Medicinal Decoction Pieces: Based on National Drug Sampling and Testing in 2020

In national drug evaluative tests, experts adopt the "scattered sampling-standard test-exploratory research-comprehensive evaluation" mode to comprehensively assess the quality of post-marketing drugs, in an attempt to promote the improvement of drug quality, ensure drug use safety, and guide the healthy and orderly development of the pharmaceutical industry. The evaluative tests also involve Chinese medicinal decoction pieces. Based on the quality report of 8 Chinese medicinal decoction pieces tested in the national drug sampling and testing in 2020, this paper summarized the results of standard test and exploratory research, and analyzed the quality of Chinese medicinal decoction pieces, the status quo of standards, and the problems in the whole industry chain of Chinese medicinal materials and Chinese medicinal decoction pieces. Finally, we put forward some suggestions to strengthen the scientific supervision and improve the quality of Chinese medicine.