目的 研究人凝血因子Ⅸ（human coagulation factor Ⅸ，FⅨ）制品的溶血性和血管刺激性。方法 根据国家药品审评中心发布的《药物刺激性、过敏性和溶血性研究技术指导原则》规定，针对FⅨ产品，采用体外试管法评价药物的溶血性；采用同体左右侧自身对照法，经耳缘静脉注射1.6 mL/kg的FⅨ或生理盐水7 d，开展家兔刺激性实验。结果 FⅨ在50国际单位（international unit，IU）/mL的浓度下未引起溶血和红细胞凝聚反应；家兔给药及停药恢复期间，一般情况观察未见明显异常，血管刺激评分均为0分；家兔停药恢复14 d，血管刺激评分均为0分；家兔末次给药后96 h及停药恢复期14 d结束，病理得分均值均为0分。结论 50 IU/mL浓度的FⅨ对家兔不产生溶血性和血管刺激性。

Objective To investigate the hemolysis and vascular irritation of human coagulation factor Ⅸ (FⅨ) products.Methods According to the provisions of the Technical Guidelines for Studies on Irritation, Sensitization, and Hemolysis of Drugs issued by the Center for Drug Evaluation of the National Medical Products Administration, for FⅨ products, the in vitro test tube method was used to evaluate the hemolytic potential of the drug, and the self-control method with left-right side of the same animal was adopted to conduct the rabbit irritation test by auricular vein injection of 1.6 mL/kg FⅨ or saline for 7 d.Results At a concentration of 50 international unit（IU）/mL, FⅨ did not induce hemolysis or erythrocyte agglutination. During the drug administration period and the recovery period after drug withdrawal in rabbits, no significant abnormalities were observed in general condition, and the vascular irritation scores were all 0. Fourteen days after drug withdrawal, the vascular irritation scores of rabbits remained 0. At 96 h after the last administration and at the end of the 14 d recovery period, the mean pathological scores of rabbits were both 0.Conclusion FⅨ at a concentration of 50 IU/mL does not exhibit hemolytic activity or vascular irritation in rabbits.