加替沙星微生物限度检查方法的建立  

Establishment of method for microbial limit test of gatifloxacin

作　　者：刘鹏[1] 马仕洪[1] 戴翚[1] 特玉香[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》2007年第6期881-884,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:完善加替沙星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中和剂(0.1 mol·L^(-1)的硫酸锰溶液)的方法,去除加替沙星的抗菌活性。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加替沙星最敏感,可作为加替沙星微生物限度检查方法的质控菌株。结论:该方法可作为加替沙星口服制剂的常规微生物限度检查方法。Objective：To establish a method for microbial limit test of gatifloxacin. Method：The filtration method was first used to remove the drug, material and then 0. 1 mol · L^-1 of manganese sulfate solution as neutralizer was added into the nutrient agar medium to inhibit the residual antimicrobial activity. Result：The method passed the validation test of Chinese pharmacopoeia 2005 version. The Bacillus subtilis was the most sensitive strain being recominended among the five validation strains, which is recommend for positive control in experiments. Conclusion：The method has been used in microbial limit test control for gatifloxacin oral preparation.

关 键 词：加替沙星 薄膜过滤 中和剂 质控菌株 

分 类 号：R917[医药卫生—药物分析学]