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Teriparatide-containing liquid pharmaceutical composition with excellent stability
专利权人:
旭化成ファーマ株式会社
发明人:
宮部 康平,山口 貴宏,松縄 保宏,渡邉 成実
申请号:
JP2020053255
公开号:
JP6766286B2
申请日:
2020.03.24
申请国别(地区):
JP
年份:
2020
代理人:
摘要:
PROBLEM TO BE SOLVED: 1) The liquid pharmaceutical preparation in which the production of a deamidated product of teriparatide or a salt thereof is suppressed, and 2) the liquid pharmaceutical preparation in which the production of an aspartic acid residue isomerization product of teriparatide or a salt thereof is suppressed. 3) To provide the above-mentioned liquid pharmaceutical preparation which is stable for a long period of time, 4) The above-mentioned liquid pharmaceutical preparation in which the production of an oxidized form of teriparatide or a salt thereof is suppressed. SOLUTION: In order to suppress the formation of a deamidated form of teriparatide acetate during storage of a liquid pharmaceutical preparation for human subcutaneous administration containing teriparatide acetate, the formulation is selected from sodium chloride and sodium acetate. One or more kinds of salts are contained, and the pH of the preparation is set to 3.6 to 5.0. [Selection diagram] None
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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