一因子(纤原蛋白)纯化工艺的专利(英文)0803.doc

PROCESSES FOR THE PREPARATION OF FIBRINOGEN ? Bibliographic data ? ? Description ? ? Claims ? ? Mosaics ? ? Original document ? ? INPADOC legal status ? ? ? Description of WO2004007533 ??? Desc/Clms Page number 1Processes for the preparation of fibrinogen The present invention relates to processes for the purification of fibrinogen, and to readily solubilised fibrinogen preparations. Fibrinogen is a blood plasma protein which is concerned in clot formation. It is converted into fibrin monomer by the action of the plasma protease thrombin. Fibrin monomers cluster together to form a weak clot and are then cross-linked by the action of activated factor XIII (i. e. factorXIIIa) to a form a stronger clot. Fibrinogen is used in therapy in combination with thrombin in the so-called fibrin sealants to achieve haemostasis, to seal wounds and for the controlled adhesion of tissue. Fibrinogen concentrates are also used for replacement therapy treatment of patients with fibrinogen deficiency(afibrinogenaemia) which may be inherited or acquired. For all clinical applications, it is important to have highly pure fibrinogen in order to minimise any undesirable side effects resulting from, for example, the presence of unwanted contaminating proteins. In particular, it is desirable for fibrinogen preparations for clinical use to be free of plasminogen and plasmin(Blomback B. , Blomback M. ,Purification of human and bovine fibrinogen, Arkiv for Kemi 1956; 10: 415-443, and Mosesson M. W. ,The preparation of human fibrinogen free of plasminogen, Biochim Biophys Acta 1962,57 : 204-213). Plasminogen is the inactive precursor of plasmin, a fibrinolytic enzyme which digests fibrin clots. Therefore the presence of plasminogen in a fibrinogen preparation intended for use in vivo is undesirable because any plasmin generated from the plasminogen at the site of clot formation may thendestabilise the clot. Plasminogen tends to c