盐酸左氧氟沙星注射液中细菌内毒素的检测

Detection of bacterial endotoxins in the levofloxacin hydrochloride by limulus test

目的建立快速检测盐酸左氧氟沙星注射液中细菌内毒素的方法。方法以不同厂家的鲎试剂对3批盐酸左氧氟沙星注射液分别进行干扰试验。结果盐酸左氧氟沙星注射液稀释至0.25mg/mL时可消除对试验的干扰。3批盐酸左氧氟沙星注射液细菌内毒素检查结果均符合规定。结论盐酸左氧氟沙星注射液的热原检查可用细菌内毒素检查法替代家兔升温法。

OBJECTIVE To establish the method for assaying bacterial endotoxins in levofloxacin hydrochloride injection.METHODS The interference test of 3 batches of levofloxacin injection with 2 kinds of limulus test agent was studied. RESULTS The interference between the samples and limulus test agents was eliminable(below 0.25mg/mL).The detection results were up to standard.CONCLUSION The bacterial endotoxin in sample can be examined by limulus test instead of pyrogen test in rabbits.