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目的 评价两种凝血因子Ⅸ复合物的潜在致血栓危险性。方法 采用鼠非停滞模型 ,动态监测可溶性纤维蛋白单体复合物、纤维蛋白降解产物、D 二聚体、组织纤溶酶原激活剂等指标的变化。结果 采用国产DEAE 琼脂糖快胶离子交换层析和Ca3(PO4 ) 2 吸附法相结合的层析工艺制备的凝血因子Ⅸ复合物引起的上述指标的变化均明显低于改良凝胶吸附法制备的凝血因子Ⅸ复合物。结论 用国产DEAE 琼脂糖快胶离子交换层析和Ca3(PO4 ) 2 吸附法相结合的层析工艺可明显减少凝血因子活化 ,降低制品的潜在致血栓性
Objective To evaluate the potential thrombotic risk of two coagulation factor Ⅸ complexes. Methods The rat non-stagnant model was used to dynamically monitor the changes of soluble fibrin monomer complex, fibrin degradation products, D-dimer and tissue plasminogen activator. Results The changes of the above indexes induced by the chromatographic process using the combination of DEAE agarose gel ion exchange chromatography and Ca3 (PO4) 2 adsorption method were significantly lower than those of the modified gel adsorption method Factor Ⅸ complex. Conclusion Chromatography with DEAE-Sepharose fast ion exchange chromatography and Ca3 (PO4) 2 adsorption can significantly reduce the activation of coagulation factors and reduce the potential thrombosis of the products