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    Process for preparing a human thrombin concentrate intended for therapeutic use
    2.
    发明授权
    Process for preparing a human thrombin concentrate intended for therapeutic use 失效
    制备用于治疗用途的人凝血酶浓缩物的方法

    公开(公告)号：US5304372A

    公开(公告)日：1994-04-19

    申请号：US913933

    申请日：1992-07-17

    申请人： Catherine Michalski ,  Dominique Dernis

    发明人： Catherine Michalski ,  Dominique Dernis

    IPC分类号： A61K38/48 ,  A61K38/00 ,  A61P7/04 ,  C12N9/74 ,  A61K35/14 ,  C07K3/00 ,  C07K13/00

    CPC分类号： C12N9/6429 ,  C12Y304/21005 ,  A61K38/00

    摘要： Process for preparing a human thrombin concentrate from the PPSB fraction of plasma that does not involve any addition of factors of animal origin to induce activation of the prothrombin to produce thrombin, and which includes a viral inactivation step using solvent-detergent and purification by cation exchange chromatography. The choice of a protective medium ensures the high specific activity of the final product. The thrombin concentrate obtained using this process is intended for therapeutic use, either alone, to serve as a local hemostatic agent, or in combination with a fibrinogen concentrate to form biological glue.

    摘要翻译： 从血浆PPSB级分制备人凝血酶浓缩物的方法，其不涉及动物来源的任何因素来诱导凝血酶原激活以产生凝血酶，并且其包括使用溶剂洗涤剂和通过阳离子交换纯化的病毒灭活步骤 色谱法。 保护介质的选择确保最终产品的高比活性。 使用该方法获得的凝血酶浓缩物单独用于治疗用途，用作局部止血剂，或与纤维蛋白原浓缩物组合以形成生物胶。

    DETERMINATION OF THE THROMBOGENIC POWER OF HUMAN IMMUNOGLOBULINS
    3.
    发明申请
    DETERMINATION OF THE THROMBOGENIC POWER OF HUMAN IMMUNOGLOBULINS 有权
    人类免疫球蛋白的致癌力测定

    公开(公告)号：US20140295471A1

    公开(公告)日：2014-10-02

    申请号：US14343642

    申请日：2011-11-18

    申请人： Catherine Michalski

    发明人： Catherine Michalski

    IPC分类号： G01N33/86

    CPC分类号： G01N33/86 ,  G01N33/6854 ,  G01N2333/96463

    摘要： A kit for the determination of the thrombogenic power of human immunoglobulins contained in a biologically acceptable product. Also a process making it possible to determine the thrombogenic power linked to the presence of activated Factor XI and/or activated Factor IX and/or activated Factor XII, and/or activated Factor VII and/or activated Factor X in a sample capable of being administered to humans.

    摘要翻译： 用于确定生物可接受产品中所含的人免疫球蛋白的血栓形成能力的试剂盒。 还有一种方法可以确定与能够存在活化因子XI和/或活化因子IX和/或活化因子XII和/或活化因子VII和/或活化因子X的样品相关的血栓形成功能 给予人。

    Preparation of a high-purity human factor IX concentrate and other plasmatic proteins and their therapeutic use
    5.
    发明授权
    Preparation of a high-purity human factor IX concentrate and other plasmatic proteins and their therapeutic use 失效
    制备高纯度人因子IX浓缩液及其他血浆蛋白及其治疗用途

    公开(公告)号：US5457181A

    公开(公告)日：1995-10-10

    申请号：US683109

    申请日：1991-04-11

    申请人： Catherine Michalski ,  Thierry Burnouf

    发明人： Catherine Michalski ,  Thierry Burnouf

    IPC分类号： G01N33/48 ,  A61K35/14 ,  A61K38/00 ,  A61K38/43 ,  B01D15/08 ,  C07K1/16 ,  C07K1/18 ,  C07K1/22 ,  C07K1/30 ,  C07K14/00 ,  C07K14/745 ,  C12N9/64 ,  G01N30/88

    CPC分类号： C12N9/647 ,  C07K14/745 ,  A61K38/00

    摘要： The present invention relates to a method for preparing a high purity Factor IX concentrate. The starting material for the process is the supernatant fraction of a cryoprecipitated human plasma. A pre-purification step is performed by DEAE-Sephadex chromatography. The resulting Factor IX fraction has a specific activity of at least 0.5 IU/mg protein. The purification method of the invention comprises two successive chromatography separations. First, ion-exchange chromatography on DEAE-sepharose is conducted so that the Factor IX is eluted when the ionic force of the buffer is increased to 0.34-0.38M sodium chloride. Then, affinity chromatography is conducted on heparin-sepharose. The elution buffer is a citrate buffer at a pH of 7.4 adjusted with 0.45M sodium chloride and supplemented with arginine as a stabilizer for Factor IX activity. Lysine is added as a stabilizer before freeze-drying of the purified Factor IX.

    摘要翻译： 本发明涉及制备高纯度因子IX浓缩物的方法。 该方法的起始原料是冷沉淀的人血浆的上清液部分。 通过DEAE-Sephadex色谱法进行预纯化步骤。 所得的因子IX级分具有至少0.5IU / mg蛋白质的比活性。 本发明的纯化方法包括两次连续的色谱分离。 首先，进行DEAE-琼脂糖凝胶上的离子交换层析，使得当缓冲液的离子力增加至0.34-0.38M氯化钠时，因子IX被洗脱。 然后，对肝素琼脂糖进行亲和层析。 洗脱缓冲液是用0.45M氯化钠调节pH 7.4的柠檬酸盐缓冲液，补充精氨酸作为因子IX活性的稳定剂。 加入赖氨酸作为稳定剂，然后冷冻干燥纯化的因子IX。