β-内酰胺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 oral preparationβ-lactam 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：《药物分析杂志》2010年第4期673-676,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立β-内酰胺类抗生素微生物限度检查方法。方法:采用薄膜过滤并在培养基中加入β-内酰胺酶的方法,去除β-内酰胺类抗生素的抗菌活性。结果:本方法满足中国药典2005年版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对β-内酰胺类抗生素最敏感,可作为β-内酰胺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β-内酰胺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 oral preparationβ- lactam antibiotics. Method：The filtration method was used to inhibit the residual antimicrobial activity whenβ- lactamase was added into the culture media.Result：The method can pass the validation test of Chinese pharmacopoeia 2005 version.Bacillus subtilis is the most sensitive strain among the five validation strains,which is recommend as positive control in experiments.Conclusion：The method has been used in microbial limit test forβ- lactam antibiotics preparation control.

关 键 词：Β-内酰胺类抗生素 薄膜过滤 Β-内酰胺酶 质控菌株 

分 类 号：R917[医药卫生—药物分析学]