新型树脂扩张床吸附分离PCC的工艺及其放大研究

目的优化新型离子交换树脂CG-6从人血浆吸附分离凝血酶原复合物的工艺并作放大研究。方法采用两因素两水平正交试验,优化筛选大孔阴离子交换树脂CG-6从人血浆中吸附分离PCC的保护剂;比较2种规模扩张床流体力学性能,研究吸附柱放大规律;考察该工艺生产PCC的回收率并分析成分。结果优化保护剂0.12 mol/L甘露醇+100 IU/L肝素条件下,FⅨ一次性洗脱回收率为(90.7±7.8)%,回收率提高41%。扩张床吸附柱放大效应小。ф25 mm柱洗脱液中杂蛋白少,FⅡ、FⅦ、FⅨ、FⅩ回收率分别为(72.6±4.9)%、(72.9±10.6)%、(70.4±6.16)%、(77.8±11.8)%。结论工艺优化后制备的PCC比活及均衡度均优于传统工艺制得的产品。

Study on technical conditions of separating PCC by a new resin CG-6 in expanded bed and its scale up

Objective To optimize the technical conditions of separating PCC by a new ion-exchange resin CG-6 in expanded bed from human plasma,and to study the effects of scaling up.Methods Screening the best protective agent used in the process of separating PCC from human plasma by macroporous anion exchange resin CG-6,with orthogonal experiment.The rules of expanded bed adsorption column amplification were investigated.And the recovery of this PCC production process and the composition were analyzed.Results In the condition of 0.12 mol/L mannitol and 100 IU/L heparin,which was the best protective agent,the recovery of FⅨ by one elution step was(90.7±7.8)%,in which the recovery raised 41%.The scaling up effects on expanded bed adsorption column was small.The hybridprotein in ф25mm column was little,and the recovery of FⅡ、FⅦ、FⅨ、FⅩ was(72.6±4.9)%、(72.9±10.6)%、(70.4±6.16)%、(77.8±11.8)%,respectively.Conclusion The specific activity and proportion of four coagulation factors of the PCC prepared by expanded bed adrsorption in this study were better than that prepared by traditional methods.