COMPOSITION FOR STABILIZED LIQUID FORMULATION OF HUMAN GROWTH HORMONE WHICH MINIMIZES DEAMIDATION, POLYMER FORMATION AND OXIDATIVE DISSOCIATION OF HUMAN GROWTH HORMONE(HGH)

摘要

PURPOSE: A composition for stabilized liquid formulation of human growth hormone is provided, which composition minimizes deamidation, polymer formation and oxidative dissociation of human growth hormone(hGH), so that the stability of the liquid formulation can be improved. CONSTITUTION: The composition for stabilized liquid formulation of human growth hormone comprises 1 to 10 mg/ml of human growth hormone(hGH), 5 to 100 mM of buffering agent, 0.001 to 20 mg/ml of polyethylene glycol(PEG) and 5 to 100 mg/ml of tonicity adjustment agent, wherein the human growth hormone is recombinant methionyl human growth hormone or recombinant natural human growth hormone; the buffering agent is sodium citrate; the tonicity adjustment agent comprises sodium chloride, mannitol and a mixture thereof; and the composition has pH 5.5 to 6.5.