PRODUCTION OF ANTITHROMBIN-III FOR MEDICAL USE

摘要

PROBLEM TO BE SOLVED: To obtain the subject safe and useful antithrombin(AT)-III by heating an aqueous solution containing AT-III in the presence of a specific stabilizing agent, thereby stably keeping the activity of AT-III and suppressing the denaturation of AT-III. SOLUTION: The objective antithrombin(AT)-III for medicinal use can be produced by heating an aqueous solution containing 10-500 unit/mL of AT-III originated from human and purified to an extent to enable the use as a medicine. The heat-treatment is carried out at pH 5-10 and 50-70 deg.C for 10min to 20hr in the presence of a stabilizing agent selected to keep the activity of the heat-treated AT-III to >=85% of the AT-III before the heat-treatment and to keep the ratio of the AT-III monomer to >=95%. The stabilizing agent selected to satisfy the above conditions is preferably an organic acid salt (e.g. sodium citrate), a sugar (e.g. sorbitol) or sodium chloride.