基于2008—2021年国家药品抽检的18种中成药质量分析  

Quality Analysis of 18 Chinese Patent Medicines Based on 2008—2021 National Drug Sampling and Inspection

作　　者：刘静[1] 刘燕[1] 郑笑为[1] 汪祺[1] 聂黎行[1] 何轶[1] 胡晓茹[1] 何风艳[1] 王亚丹[1] 鲁静[1] 戴忠[1] 马双成[1] LIU Jing;LIU Yan;ZHENG Xiao-wei;WANG Qi;NIE Li-xing;HE Yi;HU Xiao-ru;HE Feng-yan;WANG Ya-dan;LU Jing;DAI Zhong;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国现代中药》2022年第11期2066-2072,共7页Modern Chinese Medicine

基　　金：“重大新药创制”国家科技重大专项(2018ZX09735-006)。

摘　　要：国家药品抽检是我国对上市后药品监管的重要手段,在药品质量评价与药品监督管理等方面发挥了重要作用。2008—2021年,中国食品药品检定研究院中药民族药检定所负责完成了18种中成药的国家药品抽检工作,品种涉及丸剂、注射剂、散剂、片剂和胶囊剂多种临床常用剂型,抽检总计2149批次。对各品种质量分析报告进行总结,结果显示各品种标准检验合格率高,但探索性研究发现一些质量问题,并对此进行梳理与归纳。同时,还对上述国家药品评价抽检工作成果、创新质量评价模式探索等关注点进行总结。在此基础上提出了一些对中成药国家药品抽检工作的思考与建议,以期为中成药质量的进一步提升提供参考。Sampling inspection,as an important means of post-marketing drug supervision in China,plays a crucial part in the quality evaluation and management of drugs.From 2008 to 2021,National Institutes for Food and Drug Control sampled 2149 batches of 18 Chinese patent medicines in the dosage forms of pills,injections,powder,tablets,and or capsules.According to the quality reports,the overall qualified rate was high,but there were some problems.Meanwhile,several highlights including the sampling inspection achievements and innovative quality evaluation mode were also summarized.Additionally,some thoughts and suggestions on national drug sampling inspection were put forward.This study is expected to provide a reference for further quality improvement of Chinese patent medicine.

关 键 词：国家药品抽检 中成药 质量安全 

分 类 号：R286[医药卫生—中药学]