克霉唑乳膏微生物限度检查方法学研究

Methodological Study of Microbial Limit Determination for Clotrimazole Cream

目的对克霉唑乳膏微生物限度检查方法进行研究。方法采用常规的直接接种法、培养基稀释法和薄膜过滤冲洗法进行对比研究,同时确定克霉唑乳膏基质的最适分散剂。结果恒温45℃、pH=7.0的无菌氯化钠-蛋白胨缓冲液为较适宜的分散剂,细菌、霉菌和酵母菌检查可经分散剂分散后采用薄膜过滤冲洗法,最少冲洗量为每筒不少于800 mL;控制菌金黄色葡萄球菌和铜绿假单胞菌可采用培养基稀释法进行检查。结论克霉唑乳膏细菌、霉菌检查可采用薄膜过滤冲洗法消除抑菌成分,控制菌检查可采用培养基稀释法有效消除克霉唑乳膏中的抑菌成分。

Objective To investigate the antimicrobial effect of Clotrimazole Cream and to establish a microbial limit test method for Clotrimazole Cream.Methods The methods of direct inoculation,culture medium-diluting and membrane filtration irrigation were adopted for the comparative study.At the same time,the optimal dispersant for the base material of Clotrimazole Cream was determined.Results The buffer solution of sterile sodium chloride-peptone with the constant temperature 45 ℃and pH=7.0 was the more suitable dispersant.The bacterial,fungal and yeast detection could be performed by the membrane filtration irrigation method after dispersing by dispersant.The minimal irrigation amount was no less than 800 mL per canister.The control bacteria Staphylococcus aureus and pseudomonas aeruginosa could be detected by the culture medium-diluting method.Conclusion In bacterial,fungal and control bacterial detection for Clotrimazole Cream,the bacteriostasis components can be eliminated by the membrane filtration irrigation method and the culture medium-diluting method respectively.