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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。
OBJECTIVE: To optimize the process for the separation and purification of prothrombin complex from human plasma by a novel ion exchange resin CG-6. Methods Two-factor and two-level orthogonal test was used to optimize the screening of macroporous anion exchange resin CG-6 to adsorb and remove PCC from human plasma. The fluid mechanical properties of the two kinds of expanded beds were compared to study the amplification of adsorption column. PCC recovery and analysis of ingredients. Results The optimal recoveries were 0.12 mol / L mannitol + 100 IU / L heparin, the recovery of FIX was (90.7 ± 7.8)% and the recovery rate was 41%. Expanded bed adsorption column amplification effect is small. The recovery of FⅡ, FⅦ, FⅨ and F Ⅹ were (72.6 ± 4.9)%, (72.9 ± 10.6)%, (70.4 ± 6.16)% and (77.8 ± 11.8)%, respectively. Conclusion The specific activity and equilibrium of PCC prepared after the process optimization are better than that of the traditional process.