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COMPOSITION PHARMACEUTIQUE ET SON PROCÉDÉ DE FABRICATION
专利权人:
Hybio Pharmaceutical Co.; Ltd
发明人:
DAI, Ronghuan,ZHANG, Lei,QIN, Liangzheng,TAO, Anjin,YUAN, Jiancheng
申请号:
EP16891976
公开号:
EP3424521A4
申请日:
2016.03.01
申请国别(地区):
EP
年份:
2019
代理人:
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.
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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