Thrombin preparations and process for their production
AssigneeCSL Behring GmbH
InventorsHubert Metzner, Heinrich Scheider
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Abstract
The production of a thrombin preparation which is obtained from prothrombin which is, after activation to thrombin without the addition of thromboplastin, purified by a hydrophobic interaction chromatography, it being possible subsequently also to inactivate or remove viruses, is described. Before or after the hydrophobic interaction chromatography it is also possible in addition to carry out a cation exchange chromatography. A thrombin preparation which contains as stabilizer a noncovalently binding inhibitor and to which further stabilizers can be added for stabilization in the liquid state is additionally described.
Claims6
A stable thrombin preparation comprising thrombin and benzamidine or p-aminobenzamidine as stabilizer, and further comprising calcium chloride sodium chloride as stabilizer, at least one buffer substance, and at least one of
- I-histidine,
- mannitol,
- sodium succinate,
- sodium lactate, or
- I-arginine
- wherein, after at least 12 months of storage at 20-25° C. in the liquid state, the thrombin activity of the preparation, measured by a coagulation test with a fibrinogen substrate, over 70-80% of its initial level prior to the storage.
Dependencies are inferred from the claim text.