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치료용 면역글로불린 제제 제조에 사용되는 산성 완충액, 이를 이용한 치료용 면역글로불린 제제 제조방법 및 이 제조방법으로 제조된 치료용 면역글로불린 제제
专利权人:
JEON; SOOK YEONG
发明人:
JEON, SOOK YEONGKR,전숙영,NAHM, DONG HOKR,남동호
申请号:
KR1020150044142
公开号:
KR1020150115639A
申请日:
2015.03.30
申请国别(地区):
KR
年份:
2015
代理人:
摘要:
The present invention relates to an acidic buffer solution used for preparing a therapeutic immunoglobulin preparation, a method for preparing a therapeutic immunoglobulin preparation using the acidic buffer solution, and an immunoglobulin preparation prepared by the preparation method. Provided is an acidic buffer solution used for preparing a therapeutic immunoglobulin preparation, which is used as an acidic buffer for eluting immunoglobulin proteins from an immunoglobulin adsorption resin and composed of 5-50 mM of acidic sodium citrate solution. As the preparation method, provided is a method for preparing the therapeutic immunoglobulin preparation, comprising three steps of: an adsorption step of allowing immunoglobulin proteins to be adsorbed into an immunoglobulin adsorption resin by making a cell culture medium, which contains the blood plasma or immunoglobulin proteins of a mammal, come into contact with the immunoglobulin adsorption resin a washing step of removing, through washing, other materials other than the immunoglobulin proteins adsorbed into the immunoglobulin adsorption resin by allowing a washing solution to pass through the immunoglobulin adsorption resin after the adsorption step is completed and an elution step of preparing a final therapeutic immunoglobulin preparation by allowing an acidic buffer, comprising the 5-50 mM of sodium citrate solution, to pass through the immunoglobulin adsorption resin so as to elute the immunoglobulin proteins adsorbed into the immunoglobulin adsorption resin after the washing step is completed. In addition, provided is a therapeutic immunoglobulin preparation comprising immunoglobulin proteins and the 5-50 mM of sodium citrate solution.COPYRIGHT KIPO 2016본 발명은 치료용 면역글로불린 제제 제조에 사용되는 산성 완충액, 이를 이용한 치료용 면역글로불린 제제 제조방법 및 이 제조방법으로 제조된 면역글로불린 제제에 관한 것으로서, 본 발명은 면역글로불린 흡착 레진으로부터 면역글로불린 단백질을 용출하기 위한 산성 완충액으로 사용되는 산성의 5mM에서 50mM의 sodium citrate 용액으로 이루어진 것을 특징으로 하는 치료용 면역글로불린 제제 제조에 사용되는 산성 완충액을 제공하며, 제조방법으로는 ⅰ) 면역글로
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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