硫酸奈替米星注射液细菌内毒素定量法(动态比浊法)的研究

Application of the kinetic turbidimetric limulus test to netilmicin sulfate injection

目的 应用动态比浊法鲎试验定量测定硫酸奈替米星注射液中的细菌内毒素含量。方法 对样品中定量添加标准内毒素进行干扰预试验 ,从回收率判断供试液对鲎试验有无干扰作用。结果 加入标准内毒素 5 .0 0、0 .50 0、0 .0 50 0Eu·ml- 1 ,将硫酸奈替米星制备成浓度为 50 0 0 μ·ml- 1 ,样品中定量添加标准内毒素 ,回收率均为 50 %～ 2 0 0 % ,认为供试液对试验无干扰作用 ,可用于样品检查。

Objective The kinetic turbidimetric Limulus test was used in the endotoxin assay of netilmicin sulfate injection.Methods The validation test was fulfiled ,when the amount of endotoxin spiked in netilmicin sulfate injection sample were recovered in 50%～200%.Results With standard endotoxin working curve is 5.00?0.500?0.0500Eu·ml -1 .The 5000u·ml -1 solution to netilmicin sulfate is effective to eliminate the interference in limulus test.Conclusion The kinetic turbidimetric limulus test provide a new way to the detection of endotoxin in netilmicin sulfate injection.