雷贝拉唑钠肠溶片微生物限度检查方法的建立

Establishment of Microbial Limit Test for Rabeprazole Enteric-coated Tablets

目的:建立雷贝拉唑钠肠溶片(RBT)的微生物限度检查方法。方法:采用常规法和培养基稀释法(0.5mL/皿)分别检查RBT对5种菌株(大肠埃希菌、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,并对控制菌进行验证试验。结果:常规法中金黄色葡萄球菌、枯草芽孢杆菌回收率小于70%,其余菌回收率大于70%;培养基稀释法中各菌回收率均大于70%。验证试验表明可采用常规法检查控制菌。结论:RBT的微生物限度检查可采用培养基稀释法进行细菌计数,采用常规法进行霉菌及酵母菌计数和控制菌检查。

OBJECTIVE：To establish the method of microbial limit test for Rabeprazole enteric-coated tablets（RBT）.METHODS：The recovery rates of 5 tested strains treated by RBT were detected by routine method and culture medium dilution method（0.5 mL/medium）,such as Escherichia coli,Staphylococcus aureus,Bacillus subtilis,Candida albicans and Aspergillus niger.And microbial limit test method for control bacteria was validated.RESULTS：In routine test,recovery rates of S.aureus and B.subtilis treated by RBT were lower than 70% while that of other strains were higher than 70%.In culture medium dilution method,recovery rates of tested strains were all higher than 70%.Validation test showed that routine method was suitable for microbial limit test of control bacteria.CONCLUSIONS：The bacteria count can be conducted by culture medium dilution method.Routine method can be used for saccharomycetes count and the test of control bacteria.