Processes for producing a sustained release preparation, and for producing a physiologically active polypeptide powder, sustained release preparation, physiologically active polypeptide powder, and, uses of physiologically active polypeptide powder, and a water-miscible organic solvent and / or a volatile salt

摘要

"PROCESSES TO PRODUCE SUSTAINABLE RELEASE PREPARATION, AND TO PRODUCE A PHYSIOLOGICALLY ACTIVE POLYPEPTIDE DUST, PHYSIOLOGICALLY ACTIVE AND FOLIOUSLY SOLID POLYPETIDE PREPARATION, / OR A VOLATILE SALT ". A process for producing a sustained release preparation comprising dispersing a physiologically active polypeptide within a biodegradable polymer organic solvent solution and removing the organic solvent, wherein the polypeptide is a powder obtained by lyophilizing an aqueous solution of the polypeptide. an aqueous solution having a water miscible organic solvent and / or a volatile sa wherein the ease of handling the physiologically active polypeptide powder in the process for producing the preparation is improved; wherein it is possible industrially to produce large-scale sustained release preparation; which provides a sustained release preparation having high and stable concentration of the active component in the blood in the long term, low initial physiologically active polypeptide release ratio and high polypeptide entrapment ratio within the sustained release preparation.