动态浊度法定量检测氧氟沙星注射液中的内毒素

目的:对氧氟沙星注射液进行内毒素动态浊度法检查,建立定量检测氧氟沙星注射液中内毒素实验方法以代替热原检查法,提高内毒素的检出率。方法:采用《中国药典》2000年版附录检测内毒素的动态比浊法。结果:氧氟沙星注射液经2倍及以上倍数稀释后,对鲎试剂反应无干扰作用,内毒素回收率在50%～200%范围内。结论:本方法干扰因素小,检测结果准确,可作为日常检测使用。

Quantitative determination of endotoxin in ofloxacin injection by kinetic turbidimetry

Objective:To establish the kinetic turbidimetric technique for quality control of endotoxin content in ofloxacin injection,and to study a reasonable limit of endotoxin for ofloxacin injection and a rapid and accurate method for examining endotoxin instead of pyrogen test.Methods:The kinetic turbidimetric technique in Chinese pharmacopoeia,2000 edition was used.Results:Ofloxacin injection did not interfere with limulus test in dilution at twice or more cencentration,The endotoxin recovery was more than 50% to less than 200%.Conclusion:This mehod is slight in interference and accurate in detection result,and can be used as routine assay.