地米樟酚乳膏微生物限度检查方法的验证

Validation of Microbial Limit Test for Dexamethasone Acetate Camphor and Phenol Cream

目的建立地米樟酚乳膏的微生物限度检查方法。方法使用常规法、培养基稀释法对地米樟酚乳膏进行验证,通过比较回收率来确定适宜的检验方法。结果采用培养基稀释法(0.2 mL/皿)进行细菌计数;采用培养基稀释法(0.1 mL/皿)进行霉菌、酵母菌计数;采用常规法进行控制菌(金黄色葡萄球菌、铜绿假单胞菌)检查。结论所建立的微生物限度检查方法用于地米樟酚乳膏微生物限度检查,可消除本品抑菌活性对试验的干扰。

Objective To establish a method for the microbial limit test of Dexamethasone Acetate Camphor and Phenol Cream. Methods The routine method and the medium dilution method were adopted to validate Dexamethasone Acetate Camphor and Phenol Cream. The suitable test was determined by comparing the recovery rates. Results The bacterial counting and fungi,yeast counting were conducted by the medium dilution method（0.2 mL/Petri-dish, 0. 1 mL/Petri-dish）.The control bacteria counting （staphylococcus, Pseudomonas aeruginosa） was performed by the routine method. Conclusion The established microbial limit test method can be used for Dexamethasone Acetate Camphor and Phenol Cream,which can eliminate the interference of the bacteriostatic activity on the test.