高浓度静注人免疫球蛋白的溶血性和血管刺激性研究  

Study on Hemolysis and Vascular Irritation of High Concentration Human Immunoglobulin for Intravenous Injection

作　　者：刘勇 余雨蓉 邓靖 张尧 李丹 肖春桥 李泽秀 陈云华 LIU Yong;YU Yurong;DENG Jing;ZHANG Yao;LI Dan;XIAO Chunqiao;LI Zexiu;CHEN Yunhua(GuiZhou TaiBang Biological Products Co.Ltd.,Guiyang,Guizhou 550025,China)

机构地区：[1]贵州泰邦生物制品有限公司,贵州贵阳550025

出　　处：《今日药学》2021年第5期384-387,共4页Pharmacy Today

基　　金：贵州省科技计划项目(黔科合成果[2020]4Y019);贵阳市国家创新型城市“百城百园”行动项目(筑科[2020]22-5)。

摘　　要：目的评价高浓度(10%)静注人免疫球蛋白(human immunoglobulin for intravenous injection, IVIG)的溶血性和血管刺激性。方法以家兔红细胞作为体外受试对象,分别加入0.5,0.4,0.3,0.2,0.1 mL的10%IVIG (100 mg·mL^(-1)),观察3 h内细胞溶血和红细胞凝聚情况,以此评价其溶血性。采用家兔耳缘静脉单次给药10%IVIG 10 mL·kg^(-1)·d^(-1)和连续7 d给药3 mL·kg^(-1)·d^(-1),观察给药部位血管刺激性症状并进行组织病理学检查,以此评价其血管刺激性。结果阳性对照管呈溶血状态,阴性对照管和各剂量10%IVIG试验管180 min内均未出现溶血或红细胞凝聚情况。单次给药10%IVIG对家兔耳缘静脉及周围组织无刺激作用;多次给药对耳缘静脉无刺激性作用,渗漏后对耳缘静脉周围组织有轻度刺激性作用,在恢复期结束后可恢复。结论静脉输注推荐剂量的10%IVIG对家兔未产生溶血性和血管刺激性反应。OBJECTIVE To evaluate the hemolysis and vascular irritation of high concentration human immunoglobulin for intravenous injection(10% IVIG). METHODS Rabbit red blood cell were used as experiment in vitro and were added with 10% IVIG(100 mg·mL^(-1)) at dosages of 0.5, 0.4, 0.3, 0.2 and 0.1 mL.And hemolysis and condensation were observed within 3 h to evaluate the hemolysis.Rabbits were given 10% IVIG by ear vein infusion 10 mL·kg^(-1)·d^(-1) for a single dose and 3 mL·kg^(-1)·d^(-1) for consecutive doses lasting 7 d.Vascular irritation symptoms in injection sites were observed.Meanwhile, histopathological examination was carried out. RESULTS Hemolysis or red blood cell aggregation reaction was found in positive control group, but no found in the negative group and the group of 10%IVIG at various dosages within 180 min.No irritation was observed in the rabbit ear veins and surrounding tissues by single dose.Multiple doses also had no irritation to rabbit ear veins, but mild irritating effect on the surrounding tissues was found after infiltrating.The irritating effect was recovered at the end of the recovery period. CONCLUSION 10% IVIG at the recommended dosage shows no hemolysis and vascular irritation to rabbits.

关 键 词：高浓度静注人免疫球蛋白 溶血性 血管刺激性 

分 类 号：R973[医药卫生—药品]