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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。
Objective To establish a microbial limit test method of phenol ear drops and to verify. Methods According to the Chinese Pharmacopoeia 2010 edition, the antibacterial activity of phenol ear solution was tested by conventional method, membrane filtration method and neutralization method, and the recovery rate of each experiment was calculated. Results The membrane filtration combined with neutralizer and the flushing volume of 500 m L could recover the recovery of Escherichia coli, Bacillus subtilis and Staphylococcus aureus to more than 70%. Using the conventional method combined with neutralizer, Candida albicans and Aspergillus niger can recover> 70%. CONCLUSION Phenolic ear drops have antibacterial activity. The combination of membrane filtration and neutralizing agent is suitable for bacterial count test of phenol ear drops. Conventional method combined with neutralizer is suitable for counting mold and yeast count of phenol ear drops, as well as for controlling bacteria.