目的 探究在研重组人凝血因子VIII（recombinant human coagulation factor Ⅷ，rhFⅧ）对凝血因子Ⅹa（coagulation factor Ⅹa，FⅩa）生成的促进效果，并与已上市同类产品进行比较；进一步开展rhFVIII对小鼠模型凝血功能影响的研究。方法 分别在固定FⅧ、FⅩ、FⅨa中任意2个因子、改变第3个因子浓度时，通过体外实验检测FⅩa活性，测定在研rhFⅧ和市售FⅧ产品的FXa生成速率并比较。A型血友病模型小鼠（HA小鼠）尾静脉单次静脉注射在研rhFⅧ或市售rhFⅧ产品后，检测小鼠凝血相关指标的变化。结果 体外实验中，与市售rhFⅧ产品ADVATE、血源性人FⅧ相比，在研rhFⅧ在不同条件下均具有相似或更高的FⅩa生成速率。注射在研rhFⅧ后HA小鼠活化部分凝血活酶时间缩短（50和100 IU/kg剂量下分别为29.43和20.78 s），具有剂量依赖性，同剂量下与市售rhFⅧ产品Xyntha一致。结论 在研rhFVIII与市售rhFⅧ和血源性人FⅧ相比，在体外具有相同的促FⅩa生成活性，且在HA小鼠模型中促凝血效果得到了验证，具备成药性的潜质。

Objective  To explore the promoting effect on coagulation factor Xa (FXa) production of recombinant human coagulation factor Ⅷ (rhFⅧ) in development, in comparison to similar products on the market, and to further study the effect on coagulation function of rhFⅧ in mouse model. Methods  Under fixed concentrations of any 2 factors and varying concentration of the rest factor among FⅧ, FⅩ, and FⅨa, the in vitro production rates of FXa promoted by rhFⅧ in development and commercial products of FⅧ were determined and compared by FⅩa activity test. After a single intravenous injection into tail vein of commercial or rhFⅧ in development, the coagulation-related indexes of hemophilia A model (HA) mice were measured. Results  In vitro, compared with commercial rhFⅧ ADVATE and blood-derived human FⅧ, rhFⅧ in development had similar or higher FXa production rate under different conditions. After injection of rhFⅧ in development, the activated partial thromboplastin time of HA mice was shortened in a dose-dependent manner (29.43 and 20.78 s at 50 and 100 IU/kg dosages, respectively), and was consistent with that of commercial rhFⅧ Xyntha at the same dosage. Conclusion  Compared with commercial rhFⅧ and blood-derived human FⅧ products, rhFⅧ in development has similar or better activity of promoting FXa generation in vitro, and the effect of promoting blood coagulation in mouse model has been verified, both suggesting the potential of druggability.