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目的 制备纯度较高 ,潜在血栓性小的凝血因子Ⅸ (FⅨ )复合物。方法 以人新鲜冰冻血浆为原料 ,采用SD病毒灭活工艺 ,经国产DEAE SepharoseFastFlow胶批式吸附和Ca3 (PO4) 2 吸附制备凝血因子Ⅸ复合物。结果 两步的活性收率分别为 ( 89.94± 1.31) % (n =7)、( 82 .2 7± 2 .18) % (n =6 ) ,制品的FⅨ∶C比活为 ( 16 .2 8± 2 .80 )IU/mg。FIX的量为 ( 12 6 .82±11.6 0 )IU/瓶 ( 2 0 0PE)。结论 本工艺实用性较高 ,可用于制备低成本 ,高质量的凝血因子Ⅸ复合物。
OBJECTIVE: To prepare a coagulation factor Ⅸ (FIX) complex with high purity and small potential thrombus. Methods Human fresh frozen plasma was used as raw material. The SD virus inactivated process was used to prepare coagulation factor Ⅸ complex by DEAE Sepharose Fast Flow plastic batch adsorption and Ca3 (PO4) 2 adsorption. The results showed that the FIX: C specific activities of the two products were (89.94 ± 1.31)% (82.7 ± 2.18)% (n = 7) and 8 ± 2 .80) IU / mg. The amount of FIX was (12 6 .82 ± 11.6 0) IU / flask (200 SPE). Conclusion The technology is highly practical and can be used to prepare low-cost, high-quality coagulation factor Ⅸ complex.