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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第4期673-676,共4页
Chinese Journal of Pharmaceutical Analysis