基于2021年国家药品抽检中成药质量状况分析的监管策略研究

Research on the Supervision Strategy Based on the Analysis of the Quality Status of Chinese Patent Medicines in the National Drug Sampling and Testing in 2021

目的通过分析目前中成药抽检质量现状及存在的质量风险,提出强化中成药质量监管、防控安全风险的建议。方法回顾全国药品抽检中成药历年质量状况,介绍中成药抽检品种监管理念及模式,针对2021年全国药品抽检中成药的整体质量情况进行总体分析,重点对发现的主要质量问题及风险进行挖掘和分析。结果中成药抽检合格率呈现逐年向好趋势,但通过探索性研究,发现中成药质量在工艺处方、内控标准、原药材、辅料、有害物质残留、非法添加等方面仍然存在一定的潜在质量风险。结论国家药品抽检在强化中药质量安全监管等方面发挥着重要作用。针对中药不同产业链特点,应采取不同的监管策略,构建更为科学合理的中成药监管模式,提升中成药质量控制水平及行业标准。

OBJECTIVE To put forward suggestions on strengthening the quality supervision of Chinese patent drugs and preventing and controlling safety risks by analyzing the current quality situation and quality risks of sampling inspection of Chinese patent drugs.METHODS Reviewed the quality status of Chinese patent drugs for national drug sampling and testing over the past years,introduced the supervision concept and mode of Chinese patent drugs,conducted an overall analysis of the overall quality of Chinese patent drugs for national drug sampling and testing in 2021,focused on the mining and analysis of the main quality problems and risks identified.RESULTS Although the qualified rate of sampling inspection of Chinese patent medicines had shown a positive trend year by year,through exploratory research,it was found that there were still some potential quality risks in the quality of Chinese patent medicines in terms of process prescriptions,internal control standards,raw medicinal materials,excipients,harmful substance residues,illegal addition,etc.CONCLUSION Drug quality sampling and testing plays an important role in strengthening the quality and safety supervision of traditional Chinese medicine.According to the characteristics of different industrial chains of traditional Chinese medicine,different regulatory strategies should adopt,build a more scientific and reasonable regulatory model for Chinese patent medicine,and improve the quality control level and industry standards of Chinese patent medicine.