动态浊度法测定人凝血酶原复合物制品中细菌内毒素含量

Kinetic turbidmetric limulus test for quantative determination of bacterial endotoxin in human prothrombin complex

摘要: 目的建立动态浊度法定量测定人凝血酶原复合物制品中细菌内毒素含量的方法。方法通过对样品中定量添加标准内毒素的干扰试验，检测其回收率应在50%~200%范围。结果人凝血酶原复合物制品对鲎试验无干扰作用，动态浊度法定量检测结果与家兔实验结果基本一致。结论应用本方法定量测定人凝血酶原复合物制品中细菌内毒素含量是可行的。

Abstract: Objective To determine bacterial endotoxin quantitatively in human prothrombin complex by kinetic turbidimetric limulus test.Methods The validation was investigated, when the amount of endotoxin spiked in the sample were recovered within the range 50%-200%.Results Human prothrombin complex did not interfere in limulus test.Conclusion The result by kinetic turbidimetric limulus test was consistent with that of the rabbit pyrogen test. The kinetic turbidimetric limulus test is suitable for quantitative determination of endotoxin in human prothrombin complex.