聚乙二醇沉淀法和离子交换层析法纯化人凝血因子Ⅷ效果的比较

Comparison of purification effects on human coagulation factor Ⅷ by polyethylene glycol precipitation and ion exchange chromatography

目的 比较聚乙二醇（polyethylene glycol，PEG）沉淀法和离子交换层析法纯化人凝血因子Ⅷ（human coagulation factor Ⅷ，FⅧ）制品的效果。方法 分别采用PEG沉淀法和离子交换层析法纯化工艺制备各3批FⅧ，按照中国药典2015年版三部的要求检测各项质量指标，比较两种纯化工艺生产的FⅧ的回收率以及相关质量指标。结果 离子交换层析法和PEG沉淀法纯化的FⅧ的回收率分别为68.25%和29.90%，成品比活分别为61.8和3.8 IU/mg，成品磷酸三丁酯残留量分别为0.8和4.0μg/ml。结论 以离子交换层析法纯化FⅧ能有效提高制品质量，且更适合规模化生产。

Objective To compare purification effect on human coagulation factor Ⅷ（FⅧ） between polyethylene glycol （PEG） precipitation and ion exchange chromatography. Methods Three batches of FⅧ each were purified with PEG precipitation and ion exchange chromatography, respectively. Each quality index test was carried out according to Chinese Pharmacopoeia 2015 （volume Ⅲ）. The recoveries and relative quality indexes of FⅧ purified by 2 purification processes were compared. Results The recoveries of FⅧ purified by PEG precipitation and ion exchange chromatography were 29.90% and 68.25%, respectively. The specific activity and the tributyl phosphate residual amount of final FⅧ product were 3.8 IU/mg and 4.0μg/ml with PEG precipitation, and 61.8 IU/mg and 0.8 μg/ml with ion exchange chromatography. Conclusion FⅧ purification with ion exchange chromatography can improve FⅧ quality effectively, and is more suitable for large scale production.