重组人凝血因子Ⅷ细菌内毒素检测方法研究

Study on Bacterial Endotoxin Test Method of Recombinant Human Coagulation Factor Ⅷ

为建立重组人凝血因子Ⅷ细菌内毒素检查方法,按《中国药典》2015年版(二部)附录收载的细菌内毒素检查方法及指导原则开展试验。结果表明,鲎试剂动态浊度法在适当的稀释倍数下,重组人凝血因子Ⅷ细菌内毒素检测方法准确可靠,可以用于对重组人凝血因子Ⅷ原液、半成品、成品的检定,且不受人员、仪器和日期的影响。

In order to establish bacterial endotoxin test method of recombinant human coagulation factor Ⅷ, the test was carried out according to the bacterial endotoxin test method and the guiding principle in the appendix of Chinese Pharmacopoeia(2015 Edition)(two). The results showed that under the appropriate dilution multiple, the bacterial endotoxin test method of recombinant human coagulation factor Ⅷ was accurate and reliable, can be used for verification of recombinant human coagulation factor Ⅷ solution, semi-finished products and finished products, which is not affected by personnel, equipment and dates.