莫匹罗星软膏微生物限度检查的方法学验证

目的建立莫匹罗星软膏的微生物限度检查方法。方法依据《中国药典》2010年版规定,采用常规法、培养基稀释法、薄膜过滤法进行方法验证。结果莫匹罗星软膏具有明显的抑菌活性。其微生物限度检查的细菌计数宜采用薄膜过滤法,真菌及酵母菌计数采用常规法;控制菌检查中的金黄色葡萄球菌宜采用薄膜过滤法,铜绿假单胞菌采用常规法。结论确立了莫匹罗星软膏的微生物限度检查方法,可有效控制其质量。

Verification of methodology for the microbial limit test of Mupirocin Ointment

Objective To establish a microbial limit test method for Mupirocin Ointment. Methods According to Chinese Pharmacopoeia,common method,dilution method and membrane filtration method were used for the verification of methodology on Mupirocin Ointment. Results The results suggested that membrane filtration method can be used for count of bacteria and detection of staphylococcus aureus. Common method can be used for count of molds and yeasts,detection of pseudomonas aeruginosa. Conclusion The microbial limit test of Mupirocin Ointment was established,and the method was assured.