薄膜过滤法和中和法联用在复方乳酸依沙吖啶软膏微生物限度检查中的应用研究  

Application of membrane filtration-neutralization method in microbial limit test of compound ethacridine lactate ointment

作　　者：牛振东 陈卓 刘文杰 井良义 NIU Zhendong;CHEN Zhuo;LIU Wenjie;JING Liangyi(Beijing Institute Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,北京102206

出　　处：《中国药品标准》2022年第4期440-445,共6页Drug Standards of China

摘　　要：目的:建立了复方乳酸依沙吖啶软膏的微生物限度检查方法。方法:根据《中国药典》2020年版四部通则1105和1106要求进行方法适用性验证试验。利用卵磷脂、聚山梨酯80的中和作用,采用薄膜过滤法和平皿法测定复方乳酸依沙吖啶软膏对金黄色葡萄球菌等5种试验菌种的回收率,并对金黄色葡萄球菌作为特定微生物的试验方法的适用性进行了验证。结果:需氧菌总数计数采用薄膜过滤法(冲洗量700 mL),霉菌和酵母菌总数计数采用平皿法,5种试验菌的回收试验结果均在0.5~2.0之间,控制菌检查法采用薄膜过滤法(冲洗量700 mL),控制菌方法可行。结论:本实验所建立的方法适用于复方乳酸依沙吖啶软膏微生物限度检查。Objective:To establish a microbial limit test method for compound ethacridine lactate ointment.Methods:The adaptability experiments were performed according to General chapters 1105 and 1106 of the Chinese Pharmacopoeia 2020 VolumeⅣ.The recovery rates of compound ethacridine lactate ointment against 5 kinds of test microorganisms including Staphylococcus aureus were measured by membrane filtration and petri dish methods and using the neutralization of lecithin and polysorbate 80,and suitability of the test method of Staphylococcus aureus as specified microorganisms was also performed.Results:The membrane filtration method(Rinse 700 mL)can be used for the total aerobic microbial count.The total combined yeasts and molds count was determined by plating method.The recoveries of the five strains were from 0.5-2.0.The specified microorganisms were tested by the membrane filtration method(Rinse 700 mL).Conclusion:The method established in this experiment can be used for the microbial limit examination of compound ethacridine lactate ointment.

关 键 词：复方乳酸依沙吖啶软膏 微生物限度检查 薄膜过滤法 中和法 

分 类 号：R921.2[医药卫生—药学]