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

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.