| 摘要 |
A pharmaceutical active agent preparation (I), for the production of a thrombin-generating or thrombin-containing medicament, comprises: (a) prothrombin (coagulation factor II) obtained from plasma or by genetic engineering; (b) coagulation factors V, VIII, IX and X (all at least partially in activated form) and coagulation factor IXa, all obtained from plasma or by genetic engineering; and (c) prion-safe, coagulation-active phospholipids (optionally contained in liposomes). Independent claims are included for: (i) thrombin-generating or thrombin-containing medicaments prepared from (I); (ii) a medicament mixture which (before use) coagulates within 30-300 seconds on mixing a thrombin generating medicament as in (i) with a fibrinogen-containing medicament; (iii) the production of a thrombin-containing pharmaceutical active agent preparation, by treating a thrombin-generating active agent preparation with calcium ions then chromatographically purifying the obtained thrombin-containing product; (iv) the production of a pro-cofactor concentrate containing factors V and VIII by dissolving cryoprecipitate (obtained from plasma) and separating fibrinogen from the solution to give a solution containing factors V and VII, which can be treated with calcium chloride; and (v) the production of a factor XI-containing pro-cofactor concentrate, additionally containing factors II, VII, VIIA, IX and X, plus factor XIa at 0.030 mu g or more per mu g of prothrombin, by adsorbing cryoprecipitate supernatant (obtained from plasma) on an anion exchanger, washing, storing in the cold and eluting the required concentrate. ACTIVITY : Hemostatic; vulnerary. MECHANISM OF ACTION : Thrombin generation. |
