人凝血因子Ⅷ制剂冻干工艺

优选了人凝血因子Ⅷ(FⅧ)制剂的冻干工艺。通过电阻法测定共晶点,再采用正交试验法,对预冻温度、主要干燥温度、主干燥时间、解析温度与真空压力等进行研究以优选冻干工艺,得到最佳的冻干工艺:-40℃预冻1.5 h;主要干燥温度从-40℃升温至-33℃,再从-33℃升温至0℃,总耗时36 h,真空压力为30 Pa;解析温度维持在35℃,真空压力为5 Pa,于终点测试压力无变化时结束。由于该工艺冻干出的人凝血因子Ⅷ制剂符合《中国药典》3部该项下的质量要求,经验证该冻干工艺能够应用于人凝血因子Ⅷ制剂的大规模生产。

Study on freeze-drying process of human coagulation factor Ⅷ

The freeze-drying process of human coagulation factor Ⅷ（FⅧ） was optimized. Eutectic point was determined and the key parameters of FⅧ vacuum freeze-drying process were studied by orthogonal experiment. The optimum freeze-drying process is as follows： pre freezing at-40 ℃ for 1. 5 h,main drying temperature from-40 to-33 ℃,then to 0 ℃,total time 36 h,and vacuum pressure 30 Pa.The temperature of desorption was maintained at 35 ℃,vacuum pressure was 5 Pa,and the experiment finished when the final test pressure was not changed. The FⅧ by this process met the requirement of the Chinese Pharmacopoeia.