开胸顺气丸微生物限度检查方法建立及检查结果分析  

Establishment of Microbial Limit Test Method for KaiXiong ShunQi Pills and Analysis of Test Results

作　　者：常宁宁 黄春娥 CHANG Ning-ning;HUANG Chun-e(Xiamen Institute for Food and Drug Quality Control,Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院

出　　处：《海峡药学》2019年第11期98-99,共2页Strait Pharmaceutical Journal

摘　　要：目的建立并验证开胸顺气丸的微生物限度检查方法。方法按照2015年版《中国药典》非无菌微生物限度检查法进行需氧菌总数、霉菌及酵母菌数、大肠埃希菌、耐胆盐革兰阴性菌和沙门氏菌检查方法验证,并对44个厂家共378批样品进行微生物限度检查。结果需氧菌总数采用1∶100稀释法,其余项目均采用直接法进行检查,378批样品的微生物限度检查合格率为99.7%。结论开胸顺气丸卫生状况良好。该方法可用于开胸顺气丸的微生物限度检查。OBJECTIVE Establish and verify the microbial limit test method for the KaiXiong ShunQi pills.METHODS According to the 2015 edition of the Chinese Pharmacopoeia,non-sterile microbial limit test were carried out to verify the total number of aerobic bacteria,mold and yeast,Escherichia coli,bile-salt Gram-negative bacteria and Salmonella.Microbial limit tests were performed on 378 batches of samples from 44 manufacturers.RESULTS The total number of aerobic bacteria was 1∶100 dilution m ethod,and the other items were examined by direct method.The microbial limit inspection rate of 378 batches was 99.7%.CONCLUSION The KaiXiong ShunQi pill is in good condition.This method can be used to check the microbial limit of Kaixuan Shunqi pill.

关 键 词：开胸顺气丸 微生物限度 方法验证 

分 类 号：R927[医药卫生—药学]