复方炉甘石樟脑搽剂微生物限度检查方法的建立及验证

Establishment and Validation of Microbial Limit Test Method for Compound Calamine Camphor Liniment

目的建立复方炉甘石樟脑搽剂微生物限度的检查方法,并对方法进行验证。方法按照2015版《中国药典》四部微生物限度的检查方法,采用平皿法、培养基稀释法及薄膜过滤法进行试验,同时验证控制菌(金黄色葡萄球菌、铜绿假假单胞菌)的检查方法。结果根据回收率试验得出,需氧菌总数检查中,平皿法中金黄色葡萄球菌未达到0.5~2的范围,而培养基稀释法(1∶50)及薄膜过滤法的阳性菌回收率均在0.5~2;霉菌和酵母菌总数检查中,平皿法、培养基稀释法(1∶50)及薄膜过滤法的阳性菌回收率均在0.5~2;控制菌检查中,常规法可检出铜绿假单胞菌而未检出金黄色葡萄球菌,而薄膜过滤法可检出金黄色葡萄球菌及铜绿假单胞菌。结论需氧菌总数检查采用培养基稀释法(1∶50);霉菌和酵母菌总数检查采用常规法;控制菌检查中,金黄色葡萄球菌采用薄膜过滤法,铜绿假单胞菌采用常规法。

OBJECTIVE To establish and verify Microbial Limit Test Method for Compound Calamine Camphor Liniment.METHODS According to Chinese Pharmacopoeia 2015,Experiments were carried out by plate method,medium dilution method and membrane filtration method.At the same time the control bacteria(Staphylococcus aureus,Pseudomonas aeruginosa) inspection methods were verified too.RESULTS On the aerobic bacteria count,Staphylococcus aureus was not up to 0.5~2 in the plate method,but the positive rates of culture medium dilution(1∶50) and membrane filtration were 0.5 to 2 according to the test of recovery rate.On the inspection ofmold and yeast count,the recovery rates of positive bacteria were all 0.5-2 by plate method,medium dilution method(1∶50) and membrane filtration method.On the control bacteria test,the conventional method can detect Pseudomonas aeruginosa but not Staphylococcus aureus,while the membrane filtration method can both detect Staphylococcus aureus and Pseudomonas aeruginosa.CONCLUSION The total number of aerobic bacteria was examined by medium dilution(1∶50),yet the total number ofmolds and yeasts was examined by routine method.On the examination of control bacteria,Staphylococcus aureus was filtrated by membrane and Pseudomonas aeruginosa by conventional method.