中国现代中药2024，Vol.26Issue(4)：603-608,6.DOI:10.13313/j.issn.1673-4890.20240102001
从国家药品抽检角度分析已上市中成药需要关注的相关问题
Analysis of the Related Issues of Listed Traditional Chinese Patent Medicines and Simple Preparations from the Perspective of National Drug Sampling Inspection
摘要
Abstract
Drug sampling inspection is an important technical support tool for drug supervision and law enforcement.By analyzing the sampling results,quality risks of post-market drugs can be effectively identified,and the quality of drugs in a certain category or region can also be evaluated.Based on the quality problems and potential safety risks of traditional Chinese patent medicines and simple preparations varieties found in the national drug sampling inspection over the years,this paper aims to analyze the relevant issues that need attention of the listed traditional Chinese patent medicines and simple preparations with the raw materials,production processes,excipients,packaging materials and other links related to the quality of traditional Chinese patent medicines and simple preparations as the starting point,so as to provide a reference for the quality improvement and supervision of traditional Chinese patent medicines and simple preparations.关键词
国家药品抽检/中成药/评价/监管Key words
national drug sampling inspection/Chinese patent medicines/evaluation/regulatory分类
医药卫生引用本文复制引用
汪祺,于健东,王翀,金红宇,魏锋,马双成..从国家药品抽检角度分析已上市中成药需要关注的相关问题[J].中国现代中药,2024,26(4):603-608,6.基金项目
国家重点研发计划项目(2023YFC3504103) （2023YFC3504103）
