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
投稿时间:2011-12-22  修订日期:2012-03-06  点此下载全文
引用本文:盛凤仙,熊可强,王惠之,张幼捷,高莉萍.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[J].药学实践杂志,2012,30(2):107~108,114
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作者单位E-mail
盛凤仙 上海新兴医药股份有限公司, 上海 200135  
熊可强 上海新兴医药股份有限公司, 上海 200135  
王惠之 上海新兴医药股份有限公司, 上海 200135  
张幼捷 上海新兴医药股份有限公司, 上海 200135  
高莉萍 上海新兴医药股份有限公司, 上海 200135 liping-gao@163.com 
中文摘要: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。
中文关键词:人凝血因子Ⅷ  细菌内毒素  动态浊度法鲎试验  干扰试验
 
Determination of bacterial endotoxin in human coagulation factor Ⅷ by kinetic turbidimetric limulus test
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.
keywords:human coagulation factor Ⅷ  bacterial endotoxin  kinetic turbidimetric limulus test  interference test
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