人凝血因子Ⅷ制品配方研究

Formulation research of human coagulation factorⅧ product

目的摸索一种适用于人凝血因子Ⅷ制品的配方。方法以人凝血因子Ⅷ质量为指标,进行成分筛选实验,对选定的成分再进行剂量选择,获得最终配方、制备成品。进行质量与安全性、稳定性考察,评估最终配方的效果。结果得到的配方效果令人满意,经稳定性（2-8℃、24个月;25℃、24个月;40℃、6个月）考察证明配方稳定有效。结论研发出一种适合人凝血因子Ⅷ制品的配方。

Objective To search for a formulation suitable for human coagulation factor Ⅷ （FⅧ） product .Methods By using the human FⅧ quality as the indicator ,the compositions screening experiment was conducted ,then the dosage selection was per‐formed on the selected compositions ,finally the formulation was obtained for prepaing the FⅧ product .The quality ,safety and sta‐bility were investigated .The effect of final formulation was evaluated .Results The effect of obtained formulation was satisfactory , which was proved to be stable and effective by the stability test （2-8 ℃ × 24 months ,25 ℃ × 24 months ,40 ℃ × 6 months） .Con‐clusion The formulation of FⅧ product suitable for human is developed .