批式吸附法制备人凝血因子Ⅸ复合物(英文)

A batch procedure for preparation of factor Ⅸ complex concentrates

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 produce factor Ⅸ(FⅨ) complex concentrates with high purity and low potential thrombogenicity. METHOD Fresh frozen plasma was adsorbed successively by domestic DEAE Sepharose Fast Flow gel and Ca 3(PO 4) 2 , and then solvent detergent (S/D) treatment was used.RESULTS The activity recovery rates of the two adsorption processes were (89.94±1.31)%( n =7)and (82.27±2.18)% ( n =6). The specific activity of the product is (16.28±2.80)IU/mg. The content of the FⅨ was (126.82±11.60) IU/200PE. CONCLUSION This method is highly practicable, and it can be used in producing high quality Factor Ⅸ complex concentrates in low cost.