【摘要】 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。更多还原

【Abstract】 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.更多还原