中国输血杂志2023，Vol.36Issue(12)：1143-1147,5.DOI:10.13303/j.cjbt.issn.1004-549x.2023.12.015
高收率人凝血酶原复合物生产工艺优化
Optimization of large-scale production process for human prothrombin complex concentrates
赵良超 1李冠军 1马小伟 1赵东生 1王明华 1宋博1
作者信息
- 1. 华兰生物工程股份有限公司,河南 新乡 453003
- 折叠
摘要
Abstract
Objective To determine the optimal process conditions for efficiently extracting human prothrombin complex concentrates from human plasma.Methods Using human plasma as the materials and the yield of prothrombin complex con-centrates as the evaluation standard,the preparation process parameters were studied and optimized through design of expore-ment(DOE),orthogonal experiments,and single factor experiments.Results The optimal process conditions were as fol-lows:DEAE Sephadex A50 gel was selected,which balanced to pH 7.6,and then the amount of 1.7-2.5 g/L of plasma weight is added into the cryoprecipitate supernatant for adsorption for 40 minutes;Washing solution(0.15-0.175 mol/L so-dium chloride)with 3 times the volume of gel was washed 3 times,and eluent(0.5-2.0 mol/L sodium chloride)was washed 3 to 5 times;Add stabilizer(heparin 35 IU,sodium chloride 0.1 mol/L)for ultrafiltration dialysis.Conclusion By using the optimized process mentioned above,the yield(measured by human coagulation factor Ⅸ)can reach 620 000 to 630 000 IU/ton of plasma,which is suitable for large-scale production.关键词
人凝血酶原复合物/人血浆/冷沉淀上清液/纯化/血液制品Key words
prothrombin complex concentrates/human plasma/cryoprecipitate supernatant/purification/blood products分类
医药卫生引用本文复制引用
赵良超,李冠军,马小伟,赵东生,王明华,宋博..高收率人凝血酶原复合物生产工艺优化[J].中国输血杂志,2023,36(12):1143-1147,5.
