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.
-
[1] Van DK, Van Der Bom JG, Lenting PJ, et al. Facter Ⅷ half-life and clinical phenotype of severe hemophilia A [J]. Haematologica, 2005,90(4):494. [2] 赵艳华, 马 平, 卜凤荣. 凝血因子分子生物学研究进展[J]. 生物技术通讯,1999,10(2):158. [3] 国家药典2010版.三部[S]. 2010:95. [4] 劳海燕,罗宇芬,林秋晓.动态比浊法用于检测生脉注射液中细菌内毒素的研究[J].广东药学学报,2002,18(1):21. -
点击查看大图
计量
- 文章访问数: 5270
- HTML全文浏览量: 319
- PDF下载量: 446
- 被引次数: 0
下载:
