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一般因子Ⅷ浓制剂中均含少量纤维蛋白原(FG),给血友病患者长期使用可能导致病人FG负荷过重,过多的FG可干扰纤维蛋白聚合,使之不能全部转变为纤维蛋白,反而引起病人出血。另外由于制剂含有少量免疫球蛋白(Ig),大量输注、尤其是给小儿长期使用,还必须注意因Gm的不相容性而引起严重反应的危险。迄今尚无FG<10mg%、Ig<100mg/ml的因子Ⅷ商品问世。本文作者介绍了一改良的制备方法,此法可获得高纯度的因子Ⅷ浓制剂,并已扩大到9000L批量生产规模。
The general factor Ⅷ concentrated formulations contain a small amount of fibrinogen (FG), long-term use of hemophilia patients may lead to FG overloaded patients, too much FG can interfere with fibrin polymerization, so that all can not be converted to fibrin, Instead, it causes the patient to bleed. In addition due to the preparation containing a small amount of immunoglobulin (Ig), a large number of infusions, especially for long-term use in children, but also must pay attention to the risk of serious reactions due to the incompatibility of Gm. So far there is no FG <10mg%, Ig <100mg / ml factor VIII product available. The authors describe an improved method of preparation, this method can obtain high-purity factor VIII concentrates, and has been expanded to 9000L batch production scale.