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長效人類生長激素共軛物之液態配方
专利权人:
HANMI HOLDINGS CO.; LTD.
发明人:
HONG, SUNG HEE,洪性熙,LEE, BYUNG SUN,李炳善,IM, DAE SEONG,任大成,LEE, JAE MIN,李才敏,BAE, SUNG MIN,裴城敏,KWON, SE CHANG,权世昌,權世昌
申请号:
TW100125060
公开号:
TW201215404A
申请日:
2011.07.14
申请国别(地区):
TW
年份:
2012
代理人:
摘要:
Disclosed is a liquid formulation of long-acting human growth hormone (hGH) conjugate, free of albumin, which can guarantee the stability of the long-acting hGH conjugate when stored over a long period of time, wherein the long-acting human growth hormone conjugate includes a human growth hormone linked to an immunoglobulin Fc region, and has a prolonged in vivo stability compared to the native form. The liquid formulation of hGH conjugate including a pH 5.0~6.0 buffer, a sugar alcohol, a salt and a non-ionic surfactant is free of human serum albumin and other hazardous factors which are potentially contaminated with viruses, and can provide excellent storage stability customized for a long-acting hGH conjugate composed of an hGH polypeptide and an immunoglobulin Fc region which has higher molecular weight and in vivo durability, compared to the native.係揭示一種長效人類生長激素(hGH)共軛物之液態配方,不含白蛋白,其可確保經長時間儲存後,長效hGH共軛物之安定性,其中該長效人類生長激素共軛物包含連結至免疫球蛋白Fc區域之人類生長激素,且與天然形式相較,具有體內延長之安定性。包含pH 5.0至6.0之緩衝液、醣醇、鹽,以及非離子性界面活性劑之hGH共軛物之液態配方不含人類血清白蛋白與其他可能會被病毒污染之危害因子,具有適用於由hGH多胜肽與免疫球蛋白Fc區域組成之長效hGH共軛物(與天然形式相較,其具有較高分子量與體內耐久性)的絕佳儲存安定性。
来源网站:
中国工程科技知识中心
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http://www.ckcest.cn/home/

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