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SOLUTION PREPARATION CONTAINING STABILIZED ANTIBODY
专利权人:
发明人:
申请号:
HK16113344.8
公开号:
HK1224947A
申请日:
2013.04.18
申请国别(地区):
HK
年份:
2017
代理人:
摘要:
An objective of the present invention is to provide stable antibody-containing formulations which are suitable for subcutaneous administration and in which aggregation formation is suppressed during long-term storage. The present inventors discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid as a counter ion species in histidine buffer or tris(hydroxymethyl)aminomethane, specifically by using histidine-aspartate buffer or histidine-glutamate buffer, or tris(hydroxymethyl)aminomethane-aspartate or tris(hydroxymethyl)aminomethane-glutamate as a buffer. The present inventors also discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid, as a counter ion species to a basic amino acid such as arginine, specifically by using arginine-aspartate or arginine-glutamate.提供抑制長期保存時締合體生成之穩定、適於皮下投予之含抗體製劑。發現藉由使用酸性胺基酸之天門冬胺酸或麩胺酸作為組胺酸緩衝液或三羥甲基胺基甲烷的反離子,亦即使用組胺酸-天門冬胺酸鹽緩衝液或組胺酸-麩胺酸鹽緩衝液,或三羥甲基胺基甲烷-天門冬胺酸鹽或三羥甲基胺基甲烷-麩胺酸鹽作為緩衝液,具有顯著地穩定化效果。而且,使用酸性胺基酸之天門冬胺酸或麩胺酸作為精胺酸等鹼性胺基酸的反離子,亦即使用精胺酸-天門冬胺酸鹽或精胺酸-麩胺酸鹽時,發現具有顯著地穩定性效果。
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中国工程科技知识中心
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