A method for purifying atosiban acetate

Abstract

The present application relates to the technical field of polypeptide drug purification, and particularly relates to a purification method of atosiban acetate. The method comprises the following steps: dissolving atosiban acetate crude product in an acidic aqueous solution, filtering to obtain a crude product solution; adding oxidized glutathione and reduced glutathione to the crude product solution, performing oxidative renaturation treatment to obtain a treated solution; performing multi-mode chromatography on the treated solution, adopting a pH gradient and a salt gradient combination elution, detecting at a wavelength of 220 nm, and collecting main peak eluent; performing reverse phase chromatography on the main peak eluent, detecting at a wavelength of 220 nm, and collecting main peak eluent; and performing desalting and freeze-drying to obtain atosiban acetate pure product. Through the synergistic effect of oxidative renaturation treatment and multi-mode chromatography, the present application can simultaneously and efficiently remove disulfide bond mismatched isomers and related toxic impurities, the product has high yield and high purity, the process condition is mild, the operation is simple, and the method is suitable for industrial production.

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