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人凝血因子Ⅷ的溶血性和血管刺激性研究

Study on hemolysis and vascular irritation of human coagulation factor Ⅷ in rabbits
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摘要 目的 评估人凝血因子Ⅷ(human coagulation factorⅧ,hFⅧ)的溶血性和血管刺激性.方法 以家兔为实验动物,对hFⅧ进行体外溶血和体内血管刺激性实验.结果 在3h体外实验期间未观察到兔红细胞发生溶血和凝聚.当以40 IU/kg剂量的hFⅧ对家兔进行静脉注射时,未观察到家兔耳缘静脉的血管刺激性反应.结论 静脉注射推荐剂量的hFⅧ不会发生溶血和血管刺激反应. Objective To evaluate hemolysis and vascular irritation of human coagulation factor Ⅷ (hFⅧ).Methods Using rabbits as experimental animals, hemolysis and vascular irritation of hFⅧ were studied by in vitro and in vivo tests.Results Hemolysis and agglutination of rabbit erythrocytes were not observed during the in vitro test within 3 h.The vascular irritation reaction of ear vein was not observed with intravenous administration of hFⅧ at 40 IU/kg.Conclusion There is no hemolysis or vascular irritation with intravenous administration of hFⅧ at recommended dosage.
出处 《国际生物制品学杂志》 CAS 2015年第5期213-216,共4页 International Journal of Biologicals
基金 国家高技术研究发展计划(863计划)(2012AA021904)
关键词 因子Ⅷ 溶血 血管刺激性 Factor ⅧFactor ⅧFactor Ⅷ Hemolysis Vascular irritation
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参考文献5

  • 1Soni NS, Patel AR, Vohra RM, et al. Hemophiliac with hemolytic anemia resulting from factor ~ concentrate F J3. Acta I-Iaematol, 1977, 58(5) . 294-297.
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  • 3Seeler RA. Hemolysis due to anti-A and anti-B in factor preparations EJ3. Arch Intern Med, 1972, 130(1) : 101-103.
  • 4国家食品药品监督管理总局药品审评中心.GPTl—1治疗用生物制品非临床安全性技术审评一般原则[s/0L].2007(2010-05—06)[2015—06一05].http://wede.org,en/zdy五do?method=largePage~id=100.
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