国产克霉唑乳膏微生物限度检查方法研究及卫生状况评价

Establishment of the Method for Microbial Limit Test and Evaluation of Hygiene Condition of Domestic Clotrimazole Cream

目的:建立有普遍适用性的克霉唑乳膏微生物限度检查方法,并采用该方法对国产克霉唑乳膏进行微生物限度检查,评价其卫生状况。方法:采用培养基稀释法、薄膜过滤法、常规法对样品进行大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、黑曲霉的回收率检测以筛选各菌的检查方法,并应用于19个厂家276批样品的检查。结果:细菌计数测定采用培养基稀释法(每皿0.5mL),霉菌和酵母菌计数测定采用薄膜过滤法(冲洗量每膜300mL),金黄色葡萄球菌检查采用培养基稀释法(培养基用量为300mL),铜绿假单胞菌检查采用常规法;5株菌中白色念珠菌对克霉唑最为敏感,可作为质控菌株;276批样品的合格率为99.3%。结论:所建立方法适用性好;国产克霉唑乳膏卫生状况良好。

OBJECTIVE： To establish a common suitable method for microbial limit test of Clotrimazole cream, and to evaluate the hygiene condition of domestic Clotrimazole cream with the results of microbial limit test of national-wide products. METHODS： Culture medium dilution, membrane-filter procedure, routine method were used to detect recovery of Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Candida albicans and Aspergillus niger. The validation method was screened and used for the determination of 276 batches of samples from 19 manufacturers. RESULTS： Culture medium dilution was used for bacterial count （0.5 mL in each medium）, membrane-filter procedure （300 mL in each washing liquid） was used for mold and saccharomyceres count and culture medium dilution was used for Staphylococcus aureus （300 mL in each culture medium）. Routine method was used for Pseudomonas aeruginosa count. Candida albicans was the most sensitive strain which can be used as positive control. The acceptability of result of microbial limit test of 276 samples was 99.3%. CONCLUSION： The method is applicable. The hygiene condition of domestic Clotrimazole cream is satisfactory.