2023-我国口服中成药抽检结果的大数据分析与思考.docxVIP

? ? 2014 我国口服中成药抽检结果的大数据分析与思考 ? ? 王田田 宋婉婷 蔡绮薇 Summary 目的：基于国家药品抽检结果数据，分析评价我国中成药产品质量状况，为相关监管部门和药品生产企业提供参考。方法：收集2014—2018年间，国家药品监督管理局和各省局公布的药品抽检通告，对5 433条不合格批次数据进行归类统计，重点分析口服固体和口服液体中成药制剂的质量问题。结果：中成药片剂、胶囊剂的不合格批次数较多，分别占口服剂型不合格批次总数的47.60%和26.47%，其次是丸剂与颗粒剂。检查项是口服中成药最常见的不合格项，不合格内容以装（重）量差异、水分和微生物限度为主。结论：近5年间我国中成药质量状况总体乐观，周期性药品抽检结果回顾有利于发现药品质量问题趋势，为药品质量监督水平和药品全产业链质量控制水平的提高提供有益参考。 Key 药品抽检;大数据;中成药;口服固体制剂;口服液体制剂 Abstract Objective：Based on the national drug sampling results data， to analyze and evaluate the quality of Chinese patent medicine products in my country， and provide references for relevant regulatory authorities and drug manufacturers. Methods：The drug sampling notices issued by the national and provincial drug administrations from 2014 to 2018 were collected. Classification and statistics of 5 433 unqualified batch data were conducted. And we focused on the quality problems of oral solid and oral liquid Chinese patent medicine preparations. Results：There were many unqualified batches of Chinese patent medicine tablets and capsules， accounting for 47.60% and 26.47% of the total number of unqualified batches of oral dosage forms， followed by pills and granules. The inspection items were the most common unqualified items of oral Chinese patent medicines， and the unqualified contents were mainly the difference in loading （weight）， moisture and microbial limits. Conclusion：In the past five years， the quality of Chinese patent medicines in my country is generally optimistic. The review of the results of periodic drug inspections is conducive to discovering the trend of drug quality problems and provides a useful reference for the improvement of the level of drug quality supervision and the level of quality control of the entire drug industry chain. Keywords Drug sampling and testing; Big data; Chinese patent medicines; Oral solid preparations; Oral liquid preparations 中圖分类号：R95;F203 ：A doi：10.3969/j.issn.1673-7202.2020.22.028 药品监督抽检是监控药品质量安全可靠的保障手段之一。从1952年开始，我国开始药品检验