CAJ | 학술논문

目的：通过优化冷沉淀制备过程中的工艺条件，获得最佳的人凝血因子Ⅷ生产用冷沉淀的制备工艺。方法主要对溶解过程中的夹层循环水温度、搅拌转速和离心过程中的离心机转速、出液温度和进液速度等影响因素进行考察，以人凝血因子Ⅷ效价为衡量指标进行研究。结果通过该试验研究，获得的最佳制备工艺为：循环水温度大于25~30℃，搅拌转速100 r/min，离心机转速14000 r/min，出液温度0~2℃，每台进液速度为3 kg/min。结论通过该试验研究，获得了最佳的人凝血因子Ⅷ生产用冷沉淀的制备工艺，为提高人凝血因子Ⅷ的质量和产量奠定了基础。
목적：통과우화랭침정제비과정중적공예조건，획득최가적인응혈인자Ⅷ생산용랭침정적제비공예。방법주요대용해과정중적협층순배수온도、교반전속화리심과정중적리심궤전속、출액온도화진액속도등영향인소진행고찰，이인응혈인자Ⅷ효개위형량지표진행연구。결과통과해시험연구，획득적최가제비공예위：순배수온도대우25~30℃，교반전속100 r/min，리심궤전속14000 r/min，출액온도0~2℃，매태진액속도위3 kg/min。결론통과해시험연구，획득료최가적인응혈인자Ⅷ생산용랭침정적제비공예，위제고인응혈인자Ⅷ적질량화산량전정료기출。
Objective To obtain the best preparation technology of human coagulation factorⅧwith cryoprecipitate by optimizing the process conditions of preparing cryoprecipitate. Methods It was mainly investigated on mezzanine circulating wa-ter temperature,speed of agitator in the course of dissolution and the centrifuge speed ,the fluid temperature and liquid feed speed in the process of centrifugation ,and the human coagulation factorⅧwas taken as the measurement index for study. Re-sults The optimum preparation technology was obtained through the experiment:circulating water temperature was above 25℃and not more than 30℃,speed of agitator was 100 r/min,centrifuge speed was 14 000 r/min,the fluid temperature was 0-2℃, liquid feed speed of each centrifuge was 3 kg/min. Conclusion The optimum technology for preparing human coagulation factorⅧby cryoprecipitate obtained through this study provides basis for improving the quality and quantity of human coagulation factorⅧ.