大环内酯类抗生素口服制剂微生物限度检查方法的建立  

Establishment of method for microbial limit test of macrolide antibiotics

作　　者：刘鹏[1] 戴翚[1] 马仕洪[1] 杨美琴[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国抗生素杂志》2009年第6期352-354,358,共4页Chinese Journal of Antibiotics

摘　　要：目的建立大环内酯类抗生素微生物限度检查方法。方法采用薄膜过滤并在冲洗液中加入增溶剂的方法,去除大环内酯类抗生素的抗菌活性。结果本方法满足中国药典2005版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对大环内酯类抗生素最敏感,可作为大环内酯类抗生素微生物限度检查方法的质控菌株。结论该方法可作为大环内酯类抗生素的常规微生物限度检查方法。Objective To establish a method for microbial limit test of macrolide antibiotics. Method The filtration method was used to inhibit the residual antimicrobial activity when the solubilizer was added into the solution. Result The method can compatible with the validation test of Chinese Pharmacopoeia 2005 version. The Bacillus subtilis is the most sensitive strain among the five validation strains, which is recommend as positive control in experiments. Conclusion This method has been used in microbial limit test for macrolide antibiotics preparation control.

关 键 词：大环内酯类抗生素 薄膜过滤 增溶剂 质控菌株 

分 类 号：R978.1[医药卫生—药品]