专利名称 | Pharmaceutical compositions and manufacturing method thereof | ||
申请号 | JP2018545181 | 申请日 | |
公开(公告)号 | JP2019506440A | 公开(公告)日 | 2016-03-01 |
申请(专利权)人 | 发明人 | 戴榮歡; 張雷; 覃亮政; 陶安進; 袁建成 | |
专利来源 | 国家知识产权局 | 转化方式 | |
摘要 |
The present invention relates to the field of polypeptides, and particularly, provides a pharmaceutical composition and a manufacturing method thereof. The pharmaceutical composition comprises a Liraglutide, and the manufacturing method of the pharmaceutical composition comprises : mixing, in a solvent, the Liraglutide and an adjuvant, stirring the resultant mixture at 500-1100 rpm until homogeneous, and adjusting the pH value to 7.5-9.5. Various manufacturing process parameters can influence the stability of Liraglutide and may cause significant changes in oligomerization, single maximal impurity, and total impurity. The infrared spectra show an amide band I (at about 1645 nm -1 ), indicating the presence of an ?helix structure, with strong absorption and a basically consistent peak shape. The present invention controls, by examination of the secondary structure of a polypeptide, parameter screening of a pharmaceutical preparation process. |
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