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.
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)
出处
《海峡药学》
2019年第11期98-99,共2页
Strait Pharmaceutical Journal
关键词
开胸顺气丸
微生物限度
方法验证
KaiXiong ShunQi pill
Microbial limit
Method validation
