2013—2021年药品抽检中药质量分析及抽检模式探讨  

Quality Analysis of Chinese Medicine Based on Drug Sampling Inspection from 2013 to 2021 and Discussion on Sampling Inspection Mode

作　　者：王莹[1] 刘丽娜[1] 许玮仪[1] 左甜甜 王赵[1] 李静[1] 金红宇[1] 马双成[1] WANG Ying;LIU Li-na;XU Wei-yi;ZUO Tian-tian;WANG Zhao;LI Jing;JIN Hong-yu;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国现代中药》2022年第2期210-216,共7页Modern Chinese Medicine

基　　金：国家中医药管理局项目(GZYYGJ2019042);福建中医药大学研究项目(XJJGY1908)

摘　　要：国家评价性抽检工作是药品质量监管的重要手段,为标准完善及药品监管提供了有力支持。对2013—2021年中国食品药品检定研究院中药民族药检定所天然药物室完成的国家评价性抽检工作进行总结,近9年完成抽检样品3300批,其中饮片2639批、配方颗粒226批、成方制剂435批,通过部分项目标准测定总合格率为82.3%,总体市场状况良好。结合抽检工作的探索性研究初步认为,完善标准检测项目、科学建立限度值及加强质控体系建设对中药监管有重要意义。同时,对抽检模式进行探讨,认为应加强对风险产品质量的跟踪、推进相关科研项目及加强部门协作,最大限度发挥药品抽检的作用。Drug sampling inspection is an important way of drug quality supervision,which supports standard improvement and drug supervision.The present study summarized the sampling inspection of Chinese medicine completed by the National Institutes for Food and Drug Control from 2013 to 2021.A total of 3300 batches of samples have been sampled in the period of nine years,including 2639 decoction pieces,226 formula granules,and 435 Chinese patent medicines.The total qualified rate of samples reaches 82.3% according to the determination of standards,which is indicative of a good market condition of Chinese medicine.Based on the exploratory research on the sampling inspection,it is preliminarily considered that improving the inspection items,scientifically establishing the limit value,and strengthening the construction of quality control system is of great significance to the supervision of Chinese medicine.Moreover,in terms of sampling inspection mode,it is considered that the tracking of risk product quality,the research on standard improvement projects,and the cooperation between departments should be strengthened to give full play to the role of drug sampling inspection.

关 键 词：抽检 中药 质量情况 存在问题 监管建议 

分 类 号：R286[医药卫生—中药学]