SUSTAINED-RELEASE FINE GRANULAR PREPARATION OF HUMAN GROWTH HORMONE AND PROCESS FOR PRODUCING THE SAME

摘要

It is intended to provide a sustained release fine granular preparation of human growth hormone having both of biodegradability and sustained-release performance with the use of an organic solvent in a minimized amount, ensuri ng the release of human growth hormone over 3 days or longer, showing regulated initial burst release, being able to have human growth hormone at a content of 10% or more, allowing the quantitative adsorption/encapsulation of sustained - release fine granules of human growth hormone up to 20%, and having favorabl e dispersion and needle penetration properties, and a process for producing th e same. This preparation comprises a porous apatite derivative, human growth hormone and a water-soluble divalent metal compound.