AN IMPROVED BIODEGRADABLE MICROSPHERE COMPOSITION SUITABLE FOR THE CONTROLLED RELEASE OF HUMAN GROWTH HORMONE AND FORMULATION THEREOF

摘要

A biodegradable microsphere composition for the controlled release of human growth hormone is provided to maintain stability, increase C_1day value and inhibit initial burst release of human growth hormone by using cyclodextrins and multivalent metal cation, so that the human growth hormone is continuously released. A biodegradable microsphere composition for the controlled release of human growth hormone comprises human growth hormone, cyclodextrins, multivalent metal cation, and biodegradable polyester polymer as a polymer carrier, and is prepared by forming a first emulsion by dispersing human growth hormone, cyclodextrins and multivalent metal cation in a droplet of surfactant, and dispersing the first emulsion in a droplet of an emulsifier, wherein the multivalent metal cation is ZnCO3, ZnSO4, ZnCl2, Zn3(C6H5O7)2, Mg(OH)2, MgCO3, Mg(OAc)2, MgSO4, MgCl2, Mg3(C6H5O7)2 or CaCO3 and the biodegradable polyester polymer is poly-L-lactic acid, poly-glycolic acid, poly-D-lactic acid-co-glycolic acid, poly-L-lactic acid-co-glycolic acid, poly-D,L-lactic acid-co-glycolic acid, poly-carprolactone, poly-valerolactone, poly-hydroxy butyrate or poly-hydroxy valerate.