Their preparation and sustained-release preparation of physiologically active polypeptide

摘要

PROBLEM TO BE SOLVED: To obtain a sustained release preparation for improving handleability of physiologically active polypeptide powder in a pharmaceutical preparation process, facilitating the mass production of the sustained release preparation, raising inclusion ratio of a physiologically active polypeptide in the sustained release preparation and showing high retention concentration in blood having stability for a long period of time. SOLUTION: This method for producing a sustained release preparation comprises adding a water-miscible organic solvent and/or a volatile salt to an aqueous solution of a physiologically active polypeptide, lyophilizing the aqueous solution to give physiologically active polypeptide powder, dispersing the powder into an organic solvent solution of a degradable in an organism and removing the organic solvent. The physiologically polypeptide has =10 μm average particle diameter. The physiologically active polypeptide is a growth hormone and the growth hormone is a human growth hormone. The water miscible organic solvent is an alcohol and the alcohol is methanol or ethanol.