Method of preparing an intravenously administrable immune globulin
preparation containing antibodies and preparations produced according
to this method
    1.
    发明授权
    Method of preparing an intravenously administrable immune globulin preparation containing antibodies and preparations produced according to this method 失效
    制备含有根据该方法制备的抗体和制剂的静脉内施用的免疫球蛋白制剂的方法

    公开(公告)号:US4276283A

    公开(公告)日:1981-06-30

    申请号:US74257

    申请日:1979-09-10

    CPC分类号: C07K16/065 Y10S530/83

    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.

    摘要翻译: 制备含有抗体的静脉内施用的免疫球蛋白制剂的方法,其中人血浆被分级,并且含有免疫球蛋白的级分通过用聚乙二醇单次或重复沉淀而不含有不需要的蛋白质杂质,其特征在于免疫 含有球蛋白的级分在聚乙二醇沉淀之前的第一纯化步骤中经过无机酸盐的水溶液处理,并且至少一个以下纯化步骤用聚乙二醇 在可溶性碳水化合物或非蛋白沉淀多元醇的存在下,免去蛋白质杂质的免疫球蛋白从剩余的溶液中被水溶性聚合物沉淀,并以已知的方式完成药物制剂。

    Method of producing a factor VIII (AHF) containing fraction
    3.
    发明授权
    Method of producing a factor VIII (AHF) containing fraction 失效
    制备含有因子VIII(AHF)的级分的方法

    公开(公告)号:US4814435A

    公开(公告)日:1989-03-21

    申请号:US108458

    申请日:1987-10-15

    摘要: There is disclosed a method of producing a Factor VIII (AHF) containing fraction having a specific activity of at least 2.5 units of Factor VIII/mg protein as well as a portion of immunoglobulin G (IgG) of 10 mg/1000 units of Factor VIII at the most. Its risk of transmission of viral or bacterial infections is to be avoided or largely reduced. The method consists in that undesired proteins are at first precipitated from a Factor VIII (AHF) containing plasma fraction in the presence of SPS. The purified Factor VIII containing solution is treated with suitable salts or salt mixtures in order to obtain a Factor VIII containing precipitate. This precipitate is dissolved, lyophilized and finally heat-treated.

    摘要翻译: 公开了一种生产含有至少2.5单位因子VIII / mg蛋白的比活性的因子VIII(AHF)的部分以及10mg / 1000单位因子VIII的免疫球蛋白G(IgG)的一部分的方法 至多,最多。 其传播病毒或细菌感染的风险是要避免或大大降低。 该方法包括在SPS存在下首先从含有血浆级分的因子VIII(AHF)沉淀不需要的蛋白质。 用合适的盐或盐混合物处理纯化的含Ⅷ因子的溶液,以获得含Ⅷ因子的沉淀物。 将该沉淀溶解,冻干,最后进行热处理。

    Method of producing a factor-VIII(AHF)-high-concentrate
    5.
    发明授权
    Method of producing a factor-VIII(AHF)-high-concentrate 失效
    生产因子VIII(AHF) - 高浓缩物的方法

    公开(公告)号:US4404131A

    公开(公告)日:1983-09-13

    申请号:US287912

    申请日:1981-07-29

    摘要: In a method of producing a factor-VIII(AHF)-high-concentrate having a specific activity of at least 2.5 units AHF and a fibrinogen content of less than 0.25 mg/mg protein from human or animal plasma, the plasma is subjected to a multi-step fractionation. The fraction purified by these fractionation measures and enriched in factor VIII (AHF) is subjected to a cryoalcohol precipitation and the resulting precipitate is processed into a stable form.

    摘要翻译: 在生产具有至少2.5单位AHF的比活性和来自人或动物血浆的纤维蛋白原含量小于0.25mg / mg蛋白质的因子VIII(AHF) - 高浓缩物的方法中,将等离子体进行 多步分馏。 通过这些分级测量纯化并富集因子VIII(AHF)的级分进行冷冻醇沉淀,并将所得沉淀物加工成稳定的形式。

    Method for producing a preparation containing factor VIII (AHF)
    8.
    发明授权
    Method for producing a preparation containing factor VIII (AHF) 失效
    制备含有因子VIII(AHF)的制剂的方法

    公开(公告)号:US4522751A

    公开(公告)日:1985-06-11

    申请号:US611638

    申请日:1984-05-18

    摘要: There is described a method for producing a preparation having a high content of Factor VIII (AHF), i.e. with a specific activity of at least 1.5 units of Factor VIII/mg protein, immunoglobulin G (IgG) of from 15 to 30 mg/1000 units of Factor VIII and fibrinogen of from 20 to 40 mg/100 units of Factor VIII. The method consists in that a Factor VIII containing plasma fraction is dissolved in a buffer, the solution is purified from undesired proteins by precipitation and is concentrated, the precipitation of undesired proteins being carried out in the presence of sulfated polysaccharide at a pH of from 6 to 7. After separation of the undesired proteins, a Factor VIII concentrate is precipitated, dissolved and processed into stable form. If desired, an antithrombin III-heparin complex or an antithrombin III-heparinoid complex is added to the solution.

    摘要翻译: 描述了一种制备具有高含量因子VIII(AHF)的制剂的方法,即具有至少1.5单位因子VIII / mg蛋白质的比活性,15至30mg / 1000的免疫球蛋白G(IgG) 因子VIII和纤维蛋白原单位为20至40mg / 100单位因子VIII。 该方法包括将含有因子VIII的血浆级分溶解在缓冲液中,通过沉淀将溶液从不想要的蛋白质中纯化并浓缩,不需要的蛋白质的沉淀在硫酸化多糖的存在下进行,pH为6 在分离不需要的蛋白质之后,将因子VIII浓缩物沉淀,溶解并加工成稳定的形式。 如果需要,向溶液中加入抗凝血酶III-肝素复合物或抗凝血酶III-类肝素复合物。

    Immunoglobulin-G-containing fraction
    9.
    发明授权
    Immunoglobulin-G-containing fraction 失效
    含有免疫球蛋白的G含量

    公开(公告)号:US5122373A

    公开(公告)日:1992-06-16

    申请号:US569535

    申请日:1990-08-20

    CPC分类号: C07K16/065 A61K38/00

    摘要: An immunoglobulin-G-containing fraction from human or animal plasma comprising monomeric IgG molecules as well as at least 70% gammaglobulins, destined for intravenous application.The fraction has a low anticomplementary activity and is substantially free of vasoactive and leucopenically active as well as bronchospastic substances.

    摘要翻译: 来自人或动物血浆的含有免疫球蛋白G的级分包含单体IgG分子以及至少70%的用于静脉内应用的丙种球蛋白。 所述级分具有低抗补体活性,并且基本上不含血管活性和有丝分裂活性物质以及支气管痉挛物质。