CAJ | 학술논문

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。
우선료인응혈인자Ⅷ（FⅧ）제제적동간공예。통과전조법측정공정점，재채용정교시험법，대예동온도、주요간조온도、주간조시간、해석온도여진공압력등진행연구이우선동간공예，득도최가적동간공예：-40℃예동1?5 h；주요간조온도종-40℃승온지-33℃，재종-33℃승온지0℃，총모시36 h，진공압력위30 Pa；해석온도유지재35℃，진공압력위5 Pa，우종점측시압력무변화시결속。유우해공예동간출적인응혈인자Ⅷ제제부합《중국약전》3부해항하적질량요구，경험증해동간공예능구응용우인응혈인자Ⅷ제제적대규모생산。
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 FⅧby this process met the requirement of the Chinese Pharmacopoeia.