乳酸左氧氟沙星注射液中细菌内毒素的检测

Bacterial endotoxin test for levofloxacin lactate injection

目的 :建立凝胶法进行注射用乳酸左氧氟沙星注射液中细菌内毒素检测的方法。方法 :用不同厂家的鲎试剂对不同批号的注射用乳酸左氧氟沙星注射液分别进行干扰实验 ,考察确立注射用乳酸左氧氟沙星注射液中细菌内毒素检测法。结果 :注射用乳酸左氧氟沙星注射液样品浓度在 1 .0g·L-1 以下时可消除干扰 ,结果准确可靠。结论 :注射用乳酸左氧氟沙星注射液可用内毒素检查取代热原检查法。

OBJECTIVE To investigate bacterial endotoxin test of levofloxacin lactate injection.METHODS By interfering test, to study the inhibitive action of levofloxacin lactate injection in bacterial endotoxin test.RESULTS The interference between the sample and relative TAL was eliminable when the sample is diluted below 1.0 g ·L -1 .CONCLUSIONS Levofloxacin lactate injection can be examined by bacterial endotoxin test instead of the pyrogen test.