Pharmaceutical preparation for the treatment of blood coagulation disorders

Beschrieben wird ein pharmazeutisches Präparat zur Behandlung von Blutgerinnungsstörungen, welches gereinigte ProthrombinaseFaktoren, insbesondere gereinigtes Prothrombin und gegebenenfalls gereinigten Faktor Xa, als aktive Komponente enthält. The following are claimed: (1) a pharmaceutical composition for treating blood clotting disorders, containing ≥ 2 clotting factors that are components of a pro-thrombinase or pro-pro-thrombinase and are free of phospholipids; (2) a composition containing purified prothrombin as the sole active ingredient; (3) a composition for treating clotting disorders, containing biologically active purified prothrombin; (4) a complex consisting of prothrombin, factor Xa and optionally factor V or Va; (5) a complex consisting of prothrombin and factor V or Va; (6) a complex consisting of factor X and factor V or Va; (7) a preparation containing the complex of (4), (5) or (6) and calcium ions; (8) a process for preparing a purified pharmaceutical prothrombin composition, comprising subjecting a prothrombin complex concentrate to chromatographic purification and converting the fraction containing prothrombin into a pharmaceutical preparation; (9) a prothrombin composition obtainable by the process of (8) which is free of thromboembolic side effects at a dose of ≥ 150 U prothrombin/kg, as expressed by a score of ≤ 3 in the Wessler thrombosis model, and which in freeze-dried form can be reconstituted to a clear solution with an activity of ≥ 10 U prothrombin/ml in a dissolution time of ≤ 1 minute, and (10) use of purified pro-thrombinase factors to produce a pharmaceutical preparation for establishing supra-normal prothrombin concentrations in the blood of a patient.