| 摘要 |
<p>A lyophilised fibrinogen is produced which is subjected to a severe terminal viricidal heat treatment in order to inactivate viruses present, whilst retaining desirable biological properties. In particular the lyophilised fibrinogen has a solubility in water or other aqueous solution to 40 g/l in less than 20 minutes at 20 °C, and a clotting time of less than 10 seconds when exposed to at least 200 U/ml thrombin. The product may be heat treated at 80 °C for 72 hours up to 100 °C for 10 hours depending on formulation and water content. In the production process cyoprecipitate is washed with polyethylene glycol solution at 4 to 10 °C and pH 6.8 to 8 at low ionic strength, prior to two-stage freeze drying.</p> |
