KIM, HYUN UK,金贤煜,金賢煜,LIM, HYUNG KYU,林亨奎,JANG, MYUNG HYUN,张明贤,張明賢,KIM, SANG YUN,金尙允,BAE, SUNG MIN,裵城敏,KWON, SE CHANG,权世昌,權世昌
申请号：
TW102140249
公开号：
TWI602583B
申请日:
2013.11.06
申请国别(地区):
TW
年份:
2017
代理人:
摘要：
The present invention relates to an albumin-free liquid formulation comprising a long-lasting oxyntomodulin conjugate in which an oxyntomodulin peptide comprising a derivative, variant, precursor or fragment of oxyntomodulin is linked to an immunoglobulin Fc region, which can increase the duration of physiological activity of the long-lasting oxyntomodulin conjugate and maintain the in vivo stability thereof for an extended period of time, as compared to native oxyntomodulin, as well as a method for preparing the liquid formulation. The liquid formulation comprises a buffer, a sugar alcohol and a nonionic surfactant and does not contain a human serum albumin and factors that are potentially harmful to the human body, and thus is not susceptible to viral infection. In addition, the oxyntomodulin conjugate of the invention comprises oxyntomodulin linked to an immunoglobulin Fc region, and thus has a large molecular weight, prolonged physiological activity, and excellent storage stability, compared to native oxyntomodulin.本發明係有關不含白蛋白之液態製劑，其包含長效型調酸素接合物，其中包含調酸素之衍生物、變異體、前體或片段之調酸素胜肽係連接於免疫球蛋白Fc區，相較於天然調酸素，可增加該長效型調酸素接合物生理活性之持續時間及長時期維持其體內穩定性；以及製備該液態製劑之方法。該液態製劑包含緩衝劑、糖醇與非離子性界面活性劑，不含人血清白蛋白及潛在有害人體之因子，因此不易遭病毒感染。此外，本發明之調酸素接合物包含連接於免疫球蛋白Fc區之調酸素，因此，相較於天然調酸素，具有較大之分子量、延長之生理活性、及優異之貯存穩定性。
