苯酚滴耳液微生物限度检查方法的建立与验证

Establishment and Validation of Microbial Limit Test of Phenol Ear Drops

关键词:  苯酚滴耳液  微生物限度检查  常规法  薄膜过滤法  中和剂  验证

Key words:  Phenol Ear drops  microbial limit  conventional method  membrane filtration  neutralization  verification

摘要:

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 mL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。

Abstract:

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 Combination of membrane filtration and neutralization, recoveries of Escherichia coli, Staphylococcus aureus and Bacillus subtilis were >70%. Combination of conventional method and neutralization, recoveries of Candida albicans and Aspergillus niger were >70%. CONCLUSION Combination of membrane filtration and neutralization can be applied to bacteria counting, while combination of conventional method and neutralization is used to moulds and yeasts counting as well as controlled bacterium.