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Method of preparing an intravenously administrable immune globulin preparation containing antibodies and preparations produced according to this method

机译:制备含有抗体的静脉内施用的免疫球蛋白制剂的方法以及根据该方法制备的制剂

摘要

A method of preparing an intravenously administrable immune globulin preparation containing antibodies, in which human blood plasma is fractionated and an immune-globulin-containing fraction is freed from undesired protein impurities by a single or repeated precipitation with polyethylene glycol, is characterized in that the immune-globulin-containing fraction is subjected in a first purification step prior to the polyethylene glycol precipitation to a treatment with an aqueous solution of a salt of an inorganic acid, and in that at least one of the following purification steps is carried out with polyethylene glycol in the presence of a soluble carbohydrate or a non-protein-precipitating polyol, whereupon the immune globulin freed from protein impurities is precipitated from the remaining solution by water-soluble polymers and is finished in a known manner to the pharmaceutical preparation.
机译:一种制备包含抗体的静脉内给药的免疫球蛋白制剂的方法,其特征在于,通过单次或重复地用聚乙二醇沉淀,将人血浆分级,并且将含有免疫球蛋白的级分除去不需要的蛋白质杂质。在聚乙二醇沉淀之前,将含-球蛋白的级分在第一纯化步骤中用无机酸的盐的水溶液进行处理,并且以下纯化步骤中的至少一个是用聚乙二醇进行的在可溶性碳水化合物或非蛋白质沉淀多元醇的存在下,不含蛋白质杂质的免疫球蛋白随后通过水溶性聚合物从剩余溶液中沉淀出来,并以药物制剂已知的方式完成。

著录项

  • 公开/公告号ES484292A1

    专利类型

  • 公开/公告日1980-05-16

    原文格式PDF

  • 申请/专利号ES19790484292

  • 发明设计人

    申请日1979-09-19

  • 分类号C07G7/026;A61K37/04;

  • 国家 ES

  • 入库时间 2022-08-22 18:07:43

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