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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

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【作者】 盛凤仙熊可强王惠之张幼捷高莉萍

【Author】 SHENG Feng-xian,XIONG Ke-qiang,WANG Hui-zhi,ZHANG You-jie,GAO Li-ping(Shanghai Xinxing Medicine Co.,Ltd.,Shanghai 200135,China)

【机构】 上海新兴医药股份有限公司

【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.

  • 【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
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