Determination of bacterial endotoxin in human coagulation factor Ⅷ by kinetic turbidimetric limulus test
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摘要: 目的 应用动态浊度法定量测定人凝血因子Ⅷ制品中细菌内毒素含量。 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 将样品进行1→100稀释可以有效地消除其对鲎试验的干扰。 结论 应用动态浊度法定量测定人凝血因子Ⅷ制品中细菌内毒素含量是可行的,与热原检查法结果一致。Abstract: Objective To establish a method for determination of bacterial endotoxin in human coagulation factor Ⅷ by kinetic turbidimetric limulus test. Methods Based on interference experiment, the endotoxin was added in the samples, whose recovery should be within the range 50%~200%. Results The interference from limulus test was eliminated by diluting the Human coagulation factor Ⅷ (1→100 solution). Conclusions Turbidimetric-kinetic method was feasible, and had the same result with the rabbit-pyretogen test.
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