甲氧苄啶注射液无菌检查方法学研究  

Verification of Sterility Test for Trimethoprim Injection

作　　者：高锦[1] 程洋[1] 嵇扬[1] 付聪[2] 聂渝琼[1] 付晓菲[1] 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100071 [2]解放军第307医院

出　　处：《中国药事》2010年第10期968-971,共4页Chinese Pharmaceutical Affairs

基　　金：国家药典委员会"<中国药典>2010年版(二部)化学药品科研项目"(编号国药典化发[2008]25号)

摘　　要：目的建立甲氧苄啶注射液无菌检查方法。方法按《中国药典》2005年版无菌检查法验证实验的有关要求,取供试品10支.膜-1(批出厂检验量)按薄膜过滤法过滤,再用0.1%无菌蛋白胨水溶液分次冲洗,每膜不少于400mL,阳性对照菌为大肠埃希菌。结果经方法验证,供试品阴性组、阴性对照组均无菌生长,供试品7种阳性菌试验组各滤器中试验菌与阳性菌对照组比较均生长良好,说明供试品的检验量在该检验条件下已消除其抑菌作用或其抑菌作用可以忽略不计。结论本法简便、科学可靠,可作为甲氧苄啶注射液的常规无菌检查方法。Objective To establish a method of sterility test for Trimethoprim Injection.Methods The method based on the verification of sterility test of Chinese Pharmacopoeia（2005 edition） and the membrane-filter method was used.The quantity of sample was 10 bottles and each filter was washed with 0.1% peptone solution 400mL.The positive control bacteria was Escherichia coli.Results The result of verification test showed that the sample and negative control tubes had no growth of microorganism and the test and all of positive control tubes revealed growth of microorganism.It illustrated that the sample had no antimicrobial activity in this sample quantity and test condition.Conclusion The sterility test method is simple and scientific.The method can be used in sterility test control for Trimethoprim Injection.

关 键 词：甲氧苄啶注射液 无菌检查 薄膜过滤法 验证实验 

分 类 号：R927.33[医药卫生—药学]