Manufacturing process to control particle size
    8.
    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

    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。

    Tamper evident syringe barrel
    9.
    发明授权
    Tamper evident syringe barrel 失效
    篡改明显的注射器筒

    公开(公告)号:US06726652B2

    公开(公告)日:2004-04-27

    申请号:US10265986

    申请日:2002-10-07

    IPC分类号: A61M500

    摘要: A prefilled syringe of cartridge barrel having a tamper evident closure. Tamper evidence is provided by: a frangible tip seal which is integral with the tapered tip of the barrel; a frangible tip cap covering the tip, the tip seal and a portion of the distal end of the barrel; and an overwrap covering the frangible tip cap and the distal end of the barrel sealed to the distal end of the barrel by a tamper evident seal. The tapered tip is optionally equipped with a luer collar to receive an external luer connector. Alternatively, the tapered tip can be provided with a bore therethrough which can be closed with an elastomeric plug and the external connector can be a tubing conduit.

    摘要翻译: 具有防拆封闭的暗盒筒的预充式注射器。 篡改证据由以下提供:与桶的锥形尖端成一体的易碎顶端密封; 覆盖所述尖端,所述尖端密封件和所述筒体的远端的一部分的易碎顶端帽; 以及通过显窃启密封件覆盖易碎的尖端盖和筒的远端的外包装,其密封到筒的远端。 锥形尖端可选地配备有鲁尔接头以接收外部鲁尔连接器。 或者,锥形尖端可以设置有穿过其中的孔,其可以用弹性塞子封闭,并且外部连接器可以是管道导管。