Method for improving stability of polypeptide bulk drug

• Main Authors: SUN HAO, ZHANG YUNJUAN, SU QING, XIANG QIQI, ZHANG JIN, WANG LINSHUNXIN, XIAO CHENGTAO, XU JIANFENG
• Format: Patent
• Language: Chinese; English
• Published: 16.01.2024
• Subjects: CHEMISTRY; METALLURGY; ORGANIC CHEMISTRY; PEPTIDES; PERFORMING OPERATIONS; PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL; SEPARATION; TRANSPORTING

The invention discloses a method for improving the stability of a polypeptide bulk drug, and relates to the technical field of polypeptide drug preparation, the method for improving the stability of the polypeptide bulk drug comprises the following steps: injecting affinity chromatography for primary purification, and collecting to obtain a primary main peak solution; injecting into the affinity chromatography again for secondary purification, and collecting to obtain a secondary main peak solution; obtaining a polypeptide raw material medicine solution after the organic solvent is removed; and freeze-drying the polypeptide bulk drug solution without the organic solvent to obtain a finished product of the polypeptide bulk drug. The finished product of the polypeptide bulk drug is packaged in an oxygen-free environment, so that the risk of oxidation reaction is reduced. According to the method, impurities are removed and the purity of the medicine is improved through two times of affinity chromatography purifi