苯酚滴耳液微生物限度检查方法的建立与验证

目的建立苯酚滴耳液微生物限度检查方法,并进行验证。方法按中国药典2010年版,采用常规法、薄膜过滤法和中和法对苯酚滴耳液进行抑菌活性试验,计算每次试验的回收率。结果采用薄膜过滤法联合中和剂,且冲洗量为500 m L时,可使大肠埃希菌、枯草芽孢杆菌和金黄色葡萄球菌的回收率均>70%;采用常规法联合中和剂,可使白色念珠菌和黑曲霉的回收率均>70%。结论苯酚滴耳液具有抑菌活性,薄膜过滤法联合中和剂适用于苯酚滴耳液细菌计数检验;常规法联合中和剂适用于苯酚滴耳液霉菌和酵母菌计数检验以及控制菌检查。

Establishment and Validation of Microbial Limit Test of Phenol Ear Drops

OBJECTIVE To establish a method for microbial limit test of Phenol Ear Drops and to verify this method. METHODS The method for microbial limit examination in Chinese Pharmacopoeia (2010) was followed, involving conventional method and membrane filtration method. The validation had been tested by recovery. RESULTS Comparison of membrane filtration and neutralization, Escherichia coli, Staphylococcus aureus and Bacillus subtilis were higher than 70%. Comparison of conventional method and neutralization, Candida albicans and Aspergillus niger were higher than 70%. CONCLUSION The results suggested that comparison of membrane filtration and neutralization could be applied to bacteria counting, while comparison of conventional method and neutralization was used to moulds and yeasts counting as well as controlled bacterium.