蒙药冠心七味片微生物限度检查结果分析  

Analysis of microbial limit test of Guanxin qiwei tablets

作　　者：高瑞霞 GAO Rui-xia(Inner Mongolia Institute for Drug Control,Inner Mongolia 010020)

机构地区：[1]内蒙古自治区药品检验研究院,内蒙古呼和浩特010020

出　　处：《中国民族医药杂志》2020年第6期32-34,共3页Journal of Medicine and Pharmacy of Chinese Minorities

摘　　要：通过比较不同厂家冠心七味片的微生物限度检查结果,探讨引起微生物数量差异的特点及规律,为提高蒙成药产品质量提供参考。按照《中国药典》2015年版四部通则非无菌产品微生物限度检查对冠心七味片进行方法适用性试验,并测定其需氧菌数、霉菌和酵母菌数并进行控制菌的检查。不同厂家冠心七味片检测出的需氧菌数有很大差异。应加强对生产单位的监督管理,规范生产,完善蒙成药微生物限度标准。To investigate the occurrence characteristics and regularities of bacterial count differences through the comparison of the microbial limit test results of Guanxin qiwei tablets from different enterprises,and to provide a reference for the quality control of traditional Mongolian medicine.The verification test was carried out in accordance with the microbial limit testing method recorded in the microbiological examination of non-sterile products in the appendices volume IV of Chinese Pharmacopeia(edition 2015),and the count of aerobic bacteria,mould and yeast in these tablets was determined.Meanwhile,the microbiotic contro1 for these tablets was evaluated.There were significant differences in aerobic bacterial counts between Guanxin qiwei tablets from different enterprises. Inspection and management of pharmaceutical enterprises should be reinforced, the production should be standardized, and the microbe limitation standard should be improved for tradition Mongolian medicine.

关 键 词：微生物限度检查 冠心七味片 蒙成药 方法适用性 

分 类 号：R291.2[医药卫生—民族医学]