Purpose To select a protectant for the freeze-drying and the 100 X, dry-heat inaclivation process of human coagulation factor Ⅷ(F Ⅷ). Methods The intermediate product from the same batch was divided into several portions,25 ,50 and 100 g/L of glycine, mannitol,sucrose and maltose were added separately into each portion,and then the products were freeze-dried and dry-heat inactivated. The F Ⅷ activity,moisture residual and reconstituted time were determined. Results The products with mannitol as the protectant had the lowest residual moisture,the shortest reconstituted time,and the highest activity recovery after freeze-drying and dry-heat inactivation process. Meanwhile, there were no significant differences on moisture residual, reconstituted time and FⅧ activity between different concentrations of mannitol. Conclusion Mannitol is an ideal protectant for the freeze-drying and the dry-heat inactivation process of F Ⅷ.%目的 选择一种人凝血因子Ⅷ(FⅧ)冻干及100℃干热灭活过程的保护剂.方法 将同一批次的半成品分成多份,分别加入25,50,100 g/L的甘氨酸、甘露醇、蔗糖和麦芽糖,进行冻干和干热灭活,测定灭活后的FⅧ活性、水分残留以及复溶时间.结果 采用甘露醇作为保护剂,冻干和干热灭活后水分残留最低、复溶时间最短,而且活性回收率最高；不同浓度甘露醇作为保护剂对制品水分、复溶时间以及活性的影响不显著.结论 甘露醇是FⅧ冻干和干热灭活的理想保护剂.
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