【摘要】 作者参照美国 Cutter Biological 的免疫球蛋白第三代产品 Gamimune-N~R 的工艺,以低温乙醇法从人血浆分离的组分Ⅱ沉淀糊为原材料,经过再加工制得最终酸碱度为 pH 4.0、蛋白浓度为5%,麦芽浓度为10%的冻干制剂。该制剂的 r 球蛋白纯度>98%;IgG 分子单体为100%,无聚合体和碎片;IgG 亚类均存在并与正常人血浆构成比相似;抗补体活性(ACA)和前激肽释放酶激活物活性(PKA)测定均符合有关质量标准。该制剂的冻干剂型较液体剂型对热的稳定性明显提高。安全性良好、疗效肯定。更多还原

【Abstract】 A native method of preparing intravenous IgG without any chemical modification andenzymatic treatment was introduced.This low pH IVIG was prepared from Fraction Ⅱ paste of the cold ethanol plasma fractionation method.The high purity IgG was improved by DEAE-Sephadex A-50 adsorption.The ethanol was removed by UF (NMWL=100,000) at pH 4.0.The final productwas formulated at pH4.0 as a 5% protein cincentration in water with 10% maltose,and freeze-dried.The product contained at least 98% IgG,of which almost 100% was monomer.All IgG subclasseswere present in proportion to the ratio of them in normal human plasma.Both ACA and PKA tests metthe requirements for IVIG.The heat treatment of this freeze-dried product in the final containershowed its reliable heat stability,no significant adverse reaction occurred during clinical trial on thereplacement therapy and the treatment of the idiopathic thrombocytopenic purpura.更多还原