METHOD FOR PRODUCING CONCENTRATED HUMAN THROMBIN LIQUID FOR THERAPEUTIC APPLICATION

摘要

PURPOSE: To obtain a human thrombin concentrate useful as a topical styptic in an industrial scale by washing a serum PPSB fraction with sodium chloride to remove some kinds of inhibitors and subsequently purifying the treated fraction with cation exchange chromatography. CONSTITUTION: This method for producing a human thrombin concentrate comprises preliminarily washing a serum PPSB fraction (prothrombin complex concentrate) with a citrate salt buffer solution containing sodium chloride to remove fibrinogen and prothrombin activation inhibitors, recalcifying the treated product with calcium chloride, subjecting the calcified mixture as such to a virus-inactivation treatment using a solvent-surfactant (e.g. TnBP/TWeen), and subsequently purifying the treated product with strong cation exchange gel chromatography in the presence of sodium gluconate. Thus, the thrombin concentrate having a coagulation activity equivalent to at least 500NIH-U/ml and having a specific activity equivalent to at least 1,000NIH-U/mg protein is obtained.