AGGREGATE COMPOSITION FOR SUSTAINED−RELEASE PREPARATION,PROCESS FOR PRODUCING THE SAME,AND SUSTAINED−RELEASE PREPARATION CONTAINING THE SAME

摘要

A composition for sustained−release protein or peptide medicines which contains a biologically active protein highly stably and from which a preparation can be easily produced; and a process for producing the composition. The aggregate composition for sustained−release preparations comprises a biologically active protein or peptide, an acidic mucopolysaccharide, and polyvalent metal ions and has been aggregated in a neutral region. The process comprises (1) preparing an acidic mucopolysaccharide solution, (2) adding to this solution a solution containing at least one member selected from the group consisting of biologically active proteins and peptides, (3) subsequently adding a solution of polyvalent metal ions at a neutral region, and (4) optionally adding serum protein to thereby yield an aggregate composition. The process may optionally further include adding a pharmaceutically acceptable additive to the aggregate composition and molding the mixture to obtain the target composition for sustained−release preparations.