Purifying method for terlipressin

Abstract

The invention relates to a purifying method for terlipressin. The method is characterized by comprising the following steps: step 1, dissolving a crude terlipressin product with water and adjusting a pH value to 3 to 4; step 2, flushing a C18 reversed-phase filled column by using an ion pair mobile phase A containing surfactant; step 3, loading a solution obtained in the step 1 into a C18 reversed-phase filling material; step 4, carrying out gradient procedures, wherein the initial-state mobile phase B of an elution gradient is 5% which is maintained for 5 min, then the proportion of the mobile phase B is increased to 30% within 60 min, and a part of target peak elution fraction is collected; and step 5, carrying out nanofiltration membrane desalination and then freeze drying so as to obtain pure terlipressin.

Description

technical field

[0001] The invention relates to a purification method of polypeptide drug-terlipressin, which is a purification method with long-acting vasopressin analogs. Background technique

[0002] Terlipressin, English name: Terlipressin, is a cyclic polypeptide with the following structural formula:

[0003]

[0004] The chemical formula is as follows:

[0005] .

[0006] Terlipressin is a synthetic triglycine-lysine-vasopressin, which is a synthetic vasopressin analogue. It is a prodrug, inactive in itself, and acts on aminopeptidase in vivo. After removing the three glycyl residues at its N-terminus, the active lysine vasopressin is slowly "released", so terlipressin is equivalent to a lysine vasopressin that can release lysine at a steady rate Vegetable storage. The main function of terlipressin is to contract visceral vascular smooth muscle and reduce visceral blood flow (such as reducing the blood flow of mesentery, spleen, uterus, etc.), thereby reducin...

Images