用凝胶色谱纯化人凝血酶原复合物的工艺  

Purification Process of Human Prothrombin Complex by Gel Chromatography

作　　者：侯春久[1] 张猛 李洪强 罗二华 HOU Chunjiu;ZHANG Meng;LI Hongqiang;LUO Erhua(Jiangxi College of Traditional Chinese Medicine,Fuzhou 344000;Boya Bio-Phamaceutical Group Co.,Ltd.,Fuzhou 344000;Key Lab.of Blood Products of Jiangxi Province,Fuzhou 344000;Engineering Research Center of Blood Products of Jiangxi Province,Fuzhou 344000)

机构地区：[1]江西中医药高等专科学校,江西抚州344000 [2]博雅生物制药集团股份有限公司,江西抚州344000 [3]江西省血液制品重点实验室,江西抚州344000 [4]江西省血液制品工程研究中心,江西抚州344000

出　　处：《中国医药工业杂志》2021年第8期1083-1086,共4页Chinese Journal of Pharmaceuticals

摘　　要：研究了用凝胶色谱纯化人凝血酶原复合物的工艺。采用正交设计优化A50凝胶吸附人凝血酶原复合物的工艺参数,比较不同盐浓度的洗涤液对人凝血因子Ⅸ效价收率和比活性的影响,分析A50凝胶的总离子交换容量及对人凝血因子Ⅸ的吸附能力,确定A50凝胶的使用寿命。结果显示,A50凝胶吸附人凝血酶原复合物的最佳工艺参数为吸附温度20℃、吸附时间60 min、吸附胶量为1.5%、吸附pH 7.0;洗涤液中氯化钠的最佳浓度为0.18 mol/L;A50凝胶可在有效期内重复使用40次。The purification process of human prothrombin complex by gel chromatography was studied.Orthogonal design was used to optimize the process parameters of adsorption of A50 gel for human prothrombin complex,and the effect of washing solution with different salt concentrations on the titer yield and specific activity of human coagulation factorⅨwas investigated.The total ion exchange capacity of the A50 gel and the adsorption capacity for human coagulation factorⅨwere analyzed,and the service life of the A50 gel was determined.The optimal process parameters for A50 gel to adsorb human prothrombin complex were shown as follows:adsorption temperature of 20℃,adsorption time of 60 min,adsorption gel volume of 1.5%,and adsorption pH of 7.0.The optimal concentration of sodium chloride in the washing solution was 0.18 mol/L,and the A50 gel could be reused 40 times within the validity period.

关 键 词：人凝血酶原复合物 人凝血因子Ⅸ A50凝胶 凝胶色谱 

分 类 号：R973.1[医药卫生—药品] R554[医药卫生—药学]