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    Manufacturing process to control particle size
    5.
    发明授权
    Manufacturing process to control particle size 失效
    制造工艺控制粒度

    公开(公告)号：US06730286B2

    公开(公告)日：2004-05-04

    申请号：US09795272

    申请日：2001-02-28

    申请人： Ernst Schramm ,  Rama K. Narra ,  Bruce Kuczynski ,  Julius P. Zodda

    发明人： Ernst Schramm ,  Rama K. Narra ,  Bruce Kuczynski ,  Julius P. Zodda

    IPC分类号： A61K5100

    CPC分类号： A61K51/1217 ,  A61K51/1255

    摘要： A process for preparing a sterile injectable suspension of radiolabeled macroaggregated serum albumin suitable for use in scanning a mammalian patient consisting of: 1) purifying serum albumin with a saline solution; 2) buffering the purified serum albumin; 3) adding stannous halide in HCl solution to the buffered mixture to obtain a reaction mixture; 4) gradually heating and cooling the reaction mixture to form macroaggregate particles; 5) separating the macroaggregates from the reaction mixture; 6) suspending the macroaggregates in sterile water for injection; 7) adding purified serum albumin; 8) lyophilizing the suspension; and 9) reconstituting the radiolabeled lyophilizate with 99mTc. The invention also includes a process for preparing a stable, sterile lyophilizate of macroaggregate particles of human serum albumin consisting of steps 1-7.

    摘要翻译： 一种适用于扫描哺乳动物患者的放射性标记大分散血清白蛋白的无菌可注射悬浮液的方法，该方法包括：1）用盐水溶液纯化血清白蛋白; 2）缓冲纯化的血清白蛋白; 3）在HCl溶液中加入卤化亚锡 缓冲混合物以获得反应混合物; 4）逐渐加热和冷却反应混合物以形成大粒聚集体颗粒; 5）从反应混合物中分离出大聚集体; 6）将大聚集体悬浮在无菌注射用水中; 7）加入纯化血清 白蛋白; 8）冻干悬浮液; 和9）用99mTc重建放射性标记的冻干物质。 本发明还包括制备由步骤1-7组成的人血清白蛋白的大颗粒聚集体颗粒的稳定的无菌冻干物质的方法。