PURPOSE: A high concentration liquid formulation of long-acting human growth hormone (hGH) conjugates with a larger molecular weight than a natural type and enhanced physiological activity lasting time provides high stability without viral infection by excluding factors harmful to human serum albumin and human body.CONSTITUTION: A high concentration liquid formulation of long-acting hGH contains a pharmacologically effective amount of a long-acting hGH conjugate and an albumin-free stabilizing agent. The hGH conjugate contains hGH which is a physiologically active peptide and immunoglobulin Fc. The stabilizing agent contains a buffer solution, a non-ionic surfactant, sugar alcohol, and sodium chloride as an isotonizing agent. The buffer solution is an acetate buffer solution. The concentration of the hGH is 20-100 mg/ml.COPYRIGHT KIPO 2013[Reference numerals] (AA) Latching hGH purity (%) by IE-HPLC analysis (BB) 0 week (CC) 1 week (DD) 2 weeks (EE) 3 weeks (FF) 4 weeks (GG) Retention period본 발명은 생리활성 펩타이드인 인간 성장 호르몬(Human Growth Hormone, hGH)과 면역글로불린 Fc 영역이 결합된 약리학적 유효량의 고농도 지속형 인간 성장 호르몬(hGH) 결합체, 및 알부민-비함유 안정화제를 포함하며, 상기 안정화제는 완충용액, 당알코올, 비이온 계면활성제 및 등장화제로서의 염화나트륨을 함유하는 지속형 인간 성장 호르몬 결합체 고농도 액상 제제 및 상기 제제의 제조방법에 관한 것이다.
