一种药物组合物及其制备方法技术

本发明专利技术涉及多肽领域，具体地提供了一种药物组合物及其制备方法。该药物组合物包括利拉鲁肽，其制备方法为：在溶剂中，取利拉鲁肽与辅料混合，以500～1100rpm搅拌至均匀，调节pH值至7.5～9.5。工艺参数对利拉鲁肽的稳定性有影响，寡聚体、最大单个杂质、总杂质有明显的变化趋势。从红外光谱色谱图可以看出，在酞胺I带(约1645nm

A pharmaceutical composition and its preparation method

The invention relates to the field of polypeptide, in particular to a pharmaceutical composition and a preparation method thereof. The pharmaceutical composition includes liraglutide, which is prepared by mixing liraglutide with excipients in a solvent, stirring to uniformity with 500-1100 rpm, and adjusting the pH value to 7.5-9.5. The stability of liraglutide was affected by the technological parameters. The oligomer, the largest single impurity and the total impurity had obvious change trend. From the infrared spectra, it can be seen that in the phthalamine I band (about 1645 nm).

【技术实现步骤摘要】
【国外来华专利技术】PCT国内申请，说明书已公开。

【技术保护点】
PCT国内申请，权利要求书已公开。

【技术特征摘要】
【国外来华专利技术】PCT国内申请，...

【专利技术属性】
技术研发人员：戴荣欢，张雷，覃亮政，陶安进，袁建成，
申请(专利权)人：深圳翰宇药业股份有限公司，
类型：发明
国别省市：广东,44