摘要
为建立最优的人凝血酶原复合物(PCC)冻干工艺,先通过实验确定共晶点,再采用正交实验法,对PCC真空冷冻干燥过程的预冻时间、主要干燥温度、主干燥时间、解吸温度和真空压力等关键参数进行研究。获得PCC最优的冻干工艺:-40℃预冻1h;主要干燥温度从-40℃升温至-28℃,再从-28℃升温至5℃,总耗时22 h,真空压力为25 Pa;解析温度维持在33℃,真空压力为5 Pa,终点测试压力无变化时结束。通过该工艺冻干出的PCC符合《中国药典》2010年版三部该项下的质量要求,经验证该冻干曲线能够应用于人凝血酶原复合物的大规模生产。
In order to establish the optimized freeze drying strategy of prothrombin complex concentrate（PCC）,eutectic point was determined through experiments,and then the key parameters of PCC vacuum freeze drying process were studied by the orthogonal experiment.The key parameterswas include prepare freezing time,main drying temperature,main drying time,temperature of desorption and vacuum pressure.The results showed that the PCC optimum freeze-drying process for：-40 ℃ freezing 1h;main drying temperature from-40 ℃ to-28 ℃,then heated to 5 ℃,time 16 h,vacuum pressure was 25 Pa,the temperature of desorption was maintained at 33 ℃,vacuum pressure was 5 Pa,end the experiment when the final test pressure was no change.The PCC by this process met the requirement of the Chinese Pharmacopoeia,the freeze drying process was applicable for the production after be validated.
出处
《南昌大学学报（工科版）》
CAS
2013年第2期134-138,共5页
Journal of Nanchang University(Engineering & Technology)
关键词
生物制品
正交实验
人凝血酶原复合物
冻干工艺
biological products
orthogonal experiment
prothrombin complex concentrate
freeze-drying process
