RIM, HWA PEOUNG,林和平,KIM, HYUN UK,金贤煜,金賢煜,IM, HO TAEK,林昊泽,林昊澤,KIM, SANG YUN,金尙允,LIM, HYUNG KYU,林亨奎,BAE, SUNG MIN,裵城敏,KWON, SE CHANG,权世昌,權世昌
申请号：
TW103133464
公开号：
TW201605468A
申请日:
2014.09.26
申请国别(地区):
TW
年份:
2016
代理人:
摘要：
The present invention relates to a formulation of a long-acting human growth hormone (hGH) conjugate, comprising a long-acting human growth hormone conjugate in which the human growth hormone as a physiologically active peptide is linked to an immunoglobulin Fc region, a buffer, a non-ionic surfactant and a sugar alcohol, specifically a lyophilized formulation and a liquid formulation of a long-acting human growth hormone conjugate, a method for preparing the lyophilized formulation, a method for reconstituting the lyophilized formulation and a kit comprising the lyophilized formulation and a solution for reconstitution.本發明係關於一種長效人類生長激素(hGH)接合物之製劑，其包含：長效人類生長激素接合物，其中，該人類生長激素作為生理活性胜肽係連結至免疫球蛋白Fc區域；緩衝液；非離子性界面活性劑及糖醇，具體而言為長效人類生長激素接合物之凍乾製劑及液態製劑；一種用於製備該凍乾製劑的方法；一種用於將該凍乾製劑再製的方法；以及一種套組，其包含該凍乾製劑及再製用溶液。
