10种庆阳产中药饮片微生物污染状况调研  

Investigation on Microbial Contamination of 10 Traditional Chinese Medicine Pieces Produced in Qingyang

作　　者：张煜琳 李哲 周芸 吴伟 王建声 田幸平 曹磊 贾佳琳 杜彦辉 ZHANG Yu-lin;LI Zhe;ZHOU Yun;WU Wei;WANG Jian-sheng;TIAN Xing-ping;CAO Lei;JIA Jia-lin;DU Yan-hui(Qingyang Pharmaceutical Inspection and Testing Center,Qingyang 745000,China;Qingyang Food Inspection and Testing Center,Qingyang 745000,China;Jinchang Drug Testing Center,Jinchang 737100,China;Audit and Inspection Center of Gansu Provincial Drug Administration,Lanzhou 730030,China)

机构地区：[1]庆阳市药品检验检测中心,甘肃庆阳745000 [2]庆阳市食品检验检测中心,甘肃庆阳745000 [3]金昌市药品检验检测中心,甘肃金昌737100 [4]甘肃省药品监督管理局审核查验中心,甘肃兰州730030

出　　处：《化工管理》2023年第11期40-44,共5页Chemical Engineering Management

基　　金：庆阳市科技计划项目(编号:QY-STK-2022A-068)。

摘　　要：为掌握庆阳市生产的中药饮片微生物污染情况,文章按照《中国药典》2020年版四部1108中药饮片微生物限度检查法进行检验检测和调研,发现5家生产企业生产的10种饮片中有50批次产品的微生物负载率较高;同一品种不同厂家的染菌量大体相同;微生物污染与饮片炮制方式无明显关联。文章提出逐步完善药典中的限度标准,提高生产企业对微生物控制的质量意识,从而促进企业健康良好发展,保障患者的用药安全。In order to understand the microbial contamination of traditional Chinese medicine slices produced in Qingyang City,the article conducted testing and investigation in accordance with the 1108 microbial limit test method for traditional Chinese medicine slices produced in the fourth part of the Chinese Pharmacopoeia(2020).It was found that 50 batches of products produced by 5 manufacturers had a high microbial loading rate.The amount of bacteria infected by different manufacturers of the same variety is generally the same.There was no signif icant correlation between microbial contamination and the processing method of prepared slices.The article proposes to gradually improve the limit standards in the pharmacopoeia and enhance the quality awareness of production enterprises on microbial control,so as to promote the healthy and sound development of enterprises and ensure the safety of medication for patients.

关 键 词：中药饮片 微生物污染 饮片质量 

分 类 号：R282[医药卫生—中药学]