动态显色法定量测定加替沙星原料药中细菌内毒素含量

摘要

Objective:To establish a method for the detection of bacterial endotoxins in gatifloxacin.Methods:Kinetic Chromogenic analysis was adopted to generate the standard curve and dilution rate of test sample.Bacterial endotoxin was added into test sample for in-terference test, and bacterial endotoxins in samples were determined.Results:The endotoxin test wasn′t interfered at concentrations be-low 0.312 mg・mL-1 .The recovery rate of bacterial endotoxin was 50%~200%.The concentration of endotoxin in the 3 batches of sam-ples met the requirements for bacterial endotoxins.Conlusion:The kinetic chromogenic analysis is suitable for bacterial endotoxin test of iodixanol injection.%目的：应用动态显色法定量测定加替沙星中的细菌内毒素含量。方法：建立动态显色法测定细菌内毒素标准曲线，通过外加内毒素测回收试验，对样品预处理方法进行了验证，证实供试液制备过程不会破坏样品本底的细菌内毒素；通过干扰试验确定样品浓度检测范围，并对样品的细菌内毒素进行定量测定。结果：样品在0.312 mg・mL-1以下浓度时，对试验无干扰作用，细菌内毒素回收率在50％～200％内，样品中的内毒素含量可定量测定。结论：动态显色法可用于定量检测加替沙星中的细菌内毒素。