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
投稿时间:2024-01-02     点此下载全文
引用本文: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
DOI:10.13313/j.issn.1673-4890.20240102001
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作者中文名作者英文名单位中文名单位英文名E-Mail
汪祺 WANG Qi 中国食品药品检定研究院,北京 100050 National Institutes for Food and Drug Control, Beijing 100050, China  
于健东 YU Jian-dong 中国食品药品检定研究院,北京 100050 National Institutes for Food and Drug Control, Beijing 100050, China  
王翀 WANG Chong 中国食品药品检定研究院,北京 100050 National Institutes for Food and Drug Control, Beijing 100050, China  
金红宇 JIN Hong-yu 中国食品药品检定研究院,北京 100050 National Institutes for Food and Drug Control, Beijing 100050, China  
魏锋* WEI Feng 中国食品药品检定研究院,北京 100050 National Institutes for Food and Drug Control, Beijing 100050, China  
马双成* MA Shuang-cheng 中国食品药品检定研究院,北京 100050 National Institutes for Food and Drug Control, Beijing 100050, China  
基金项目:国家重点研发计划项目(2023YFC3504103)
中文摘要:药品抽检是药品监督和执法的重要技术支撑手段,通过分析抽检结果可有效发现上市后药品的质量风险,同时也可评价某类或一定区域内药品的质量。立足于历年国家药品抽检中发现的中成药品种质量问题和潜在安全风险,以与中成药质量相关的原料、生产工艺、辅料及包装材料等环节为切入点,分析已上市中成药需要关注的问题,以期为中成药质量的提升和监管工作的开展提供参考。
中文关键词:国家药品抽检  中成药  评价  监管
 
Analysis of the Related Issues of Listed Traditional Chinese Patent Medicines and Simple Preparations from the Perspective of National Drug Sampling Inspection
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.
keywords:national drug sampling inspection  Chinese patent medicines  evaluation  regulatory
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