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    • 4. 发明授权
    • Method of producing immunoglobulin preparations for intravenous injection
    • 生产用于静脉注射的免疫抑制素制剂的方法
    • US5132406A
    • 1992-07-21
    • US348139
    • 1989-05-05
    • Yahiro UemuraKatuhiro UriyuKazuo TakechiYutaka HiraoTadakazu Suyama
    • Yahiro UemuraKatuhiro UriyuKazuo TakechiYutaka HiraoTadakazu Suyama
    • A61K39/395A61K38/00A61L2/00C07K16/00
    • C07K16/00A61L2/0023A61K38/00
    • A method of producing immunoglobulin preparations for intravenous injection which starts with an immunoblobulin-containing fraction and comprises the treatment steps of:(a) treating said fraction with 4-10 weight/volume percent of polyethylene glycol having a molecular weight of 1,000-10,000 under conditions of pH 4-6, ion strength 0.0001-0.1M and temperature 0.degree.-4.degree. C. and recovering the supernatant,(b) treating the supernatant obtained in step (a) with 10-15 weight/volume percent of polyethylene glycol having a molecular weight of 1,000-10,000 under conditions of pH 6-9, ion strength 0.0001-0.1M and temperature 0.degree.-4.degree. C. and recovering the resulting precipitate, and(c) heat-treating, in any desired step, said immunoglobulin in the presence of a stabilizer under conditions sufficient to inactivate contaminant viruses.The preparations obtained according to the invention retain immunoglobulins without substantial inactivation thereof, and are substantially free of such contaminants as anti-human blood group substance antibodies. With contaminant viruses inactivated as a result of the heat treatment, said preparations have good solubility and are sufficiently low in anticomplement activity.
    • 一种生产用于静脉注射的免疫球蛋白制剂的方法,其起始于含免疫球蛋白的级分,并且包括以下处理步骤:(a)用4-10重量/体积%的分子量为1,000-10,000的聚乙二醇处理所述级分, 条件pH 4-6,离子强度0.0001-0.1M,温度0℃-4℃,回收上清液,(b)用10-15重量/体积%聚乙二醇处理步骤(a)中得到的上清液 在pH 6-9,离子强度为0.0001-0.1M,温度为0〜-4℃的条件下分子量为1,000〜10,000,回收所得沉淀物,(c)在任何所需步骤中热处理, 所述免疫球蛋白在足以灭活污染性病毒的条件下在稳定剂存在下进行。 根据本发明获得的制剂保留免疫球蛋白而基本上不灭活,并且基本上不含抗人血型物质抗体等污染物。 随着由于热处理而灭活的污染物病毒,所述制剂具有良好的溶解性并且抗补体活性足够低。