复方氯霉素洗剂微生物限度方法适用性的探讨  

Discussion on the Applicability of Microbial Limit Method for Compound Chloramphenicol Lotion

作　　者：郭瑜蓉 GUO Yu-rong(Quanzhou Institute for Food and Drug Control,Quanzhou 36200,China)

机构地区：[1]泉州市食品药品检验所

出　　处：《海峡药学》2019年第11期100-102,共3页Strait Pharmaceutical Journal

摘　　要：目的建立皮肤医院外用制剂复方氯霉素洗剂的微生物限度检查方法。方法按照《中国药典》2015年版四部,采用平皿法、薄膜过滤法对复方氯霉素洗剂微生物限度方法适用性进行探讨。结果计数方法适用性试验:五个试验菌株回收率均在0.5~2范围内;控制菌检查方法适用性试验:检出所加试验菌相应的反映特性。结论按常规法制备1∶100供试液检查需氧菌总数;按薄膜过滤法检查霉菌和酵母菌总数、控制菌。OBJECTIVE To establish a method for microbial limit examination of compound chloramphenicol lotion used in skin hospital.METHODS According to“Chinese Pharmacopoeia”(2015,fourth edition)the applicability of microbial limit method for compound chloramphenicol lotion was discussed by the method of flat dish and membrane filtration.RESULTS The applicable examination of the counting method:the recovery rates of five exper imental bacteria were in the range of 0.5-2.The applicable examination of the control bacteria:detect the corresponding reaction characteristics of the experimental bacteria.CONCLUSION The total number of aerobic bacteria was 1∶100 for testing liquid by conventional method.Check the total number of mold and yeast and control bacteria by membrane filtration.

关 键 词：复方氯霉素洗剂 方法适用性试验 非无菌产品微生物限度检查法 

分 类 号：R927[医药卫生—药学]