复方氯霉素酊微生物限度检查方法适用性研究  

Study on Microbial Limit Test Method for Compound Chloramphenicol Tincture

作　　者：余鹏 吴磊明 刘丹 宫灿仪 YU Peng;WU Leiming;LIU Dan;GONG Canyi(Dermatosis Hosiptal,Southern Medical University,Guangzhou,Guangdong 510095,China)

机构地区：[1]南方医科大学皮肤病医院,广东广州510095

出　　处：《今日药学》2018年第8期523-525,共3页Pharmacy Today

摘　　要：目的建立医院制剂复方氯霉素酊的微生物限度检查方法。方法采用薄膜过滤法,进行3次独立平行试验,按照《中国药典》2015版4部的要求对计数方法和控制菌检查法进行验证。结果计数法验证:金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉等5个试验菌株的回收比值均在0.5~2范围内;控制菌检查:各阳性试验菌均被检出,阴性对照均无菌生长。结论本品的需氧菌总数、霉菌和酵母菌总数以及控制菌均可用薄膜过滤法进行检查。OBJECTIVE To establish a method for the determination of the microbial limit test of compound chloramphenicol tincture. METHODS According to Ch P 2015 Volume IV,three parallel tests were carried out by applying membrane-filtering procedure. RESULTS The recovery rates of five microorganisms including Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger were more than 50% and less than 200% by plate counting. Every positive test microorganism could be detected while negative control one could not grow in the examination of control microorganisms.CONCLUSION Membrane-filtering procedure can be used to check the total number of aerobic bacteria,mold and yeast and control bacteria of compound chloramphenicol tincture.

关 键 词：复方氯霉素酊 质量控制 薄膜过滤法 微生物限度检查法 

分 类 号：R917[医药卫生—药物分析学]