摘要
目的:建立水合氯醛糖浆微生物限度检查方法。方法:采用2010年版《中国药典》(二部)微生物限度检查法对水合氯醛糖浆进行微生物限度检查方法验证。结果:采用常规法进行水合氯醛糖浆细菌、霉菌及酵母菌计数方法验证时,金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、黑曲霉的回收率<70%,改用培养基稀释法后菌回收率均>70%,符合要求;控制菌(大肠埃希菌)采用常规法可检出。结论:水合氯醛糖浆微生物限度检查可采用培养基稀释法检查细菌及霉菌,常规法检查控制菌。
OBJECTIVE：To establish the microbial limit test for Chloral hydrate syrup.METHODS：According to the method of Chinese Pharmacopoeia（2010 edition,Ⅱ）,microbial limit test of Chloral hydrate syrup was studied.RESULTS：When bacteria,mycete and saccharomycetes of Chloral hydrate syrup were counted by using routine method,recoveries of Staphylococcus aureus,Bacillus subtilis,Candida albicans and Asperqillus niger were less than 70%;those of above bacteria were more than 70% and in line with the regulations when using culture medium dilution method.The control bacterias（Escherichia coli）could be detected by routine test method.CONCLUSIONS：In microbial limit test of Chloral hydrate syrup,the amount of bacteria and molds can be determined by culture medium dilution method,and control bacteria can be determined by routine method.
出处
《中国药房》
CAS
CSCD
2014年第21期1998-2000,共3页
China Pharmacy
关键词
水合氯醛糖浆
微生物限度检查
回收率
培养基稀释法
Chloral hydrate syrup
Microbial limit test
Recovery rate
Culture medium dilution method
