节点文献
动态浊度法鲎试验用于检测人凝血因子Ⅷ制品中细菌内毒素的研究
Determination of bacterial endotoxin in human coagulation factor Ⅷ by kinetic turbidimetric limulus test
【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.
【关键词】 人凝血因子Ⅷ;
细菌内毒素;
动态浊度法鲎试验;
干扰试验;
【Key words】 human coagulation factor Ⅷ; bacterial endotoxin; kinetic turbidimetric limulus test; interference test;
【Key words】 human coagulation factor Ⅷ; bacterial endotoxin; kinetic turbidimetric limulus test; interference test;
- 【文献出处】 药学实践杂志 ,Journal of Pharmaceutical Practice , 编辑部邮箱 ,2012年02期
- 【分类号】R927.2
- 【被引频次】2
- 【下载频次】90