Purification method of Ziconotide

Abstract

The invention relates to a purification method of Ziconotide. The method is characterized by including the following steps that 1, the pH of a crude Ziconotide solution is regulated to 3-4 through trifluoroacetic acid; 2, the gradient is set according to the volume fraction, a reversed-phase filler column is washed for 10 min through a 50% mobile phase B, and then isocratic elution balancing is performed for 10 min through a 5% mobile phase B; 3, the solution in the step1 is loaded into the reversed-phase filler; 4, the gradient is set according to the volume fraction, the original state mobile phase B of the elution gradient is 5% and is maintained for 5 min, then the proportion of the mobile phase B is increased to 22% within 60 min, and elution fractions are collected; 5, the elution fractions are subjected to salt transfer, concentration and freeze-drying to obtain fine Ziconotide.

Description

technical field

[0001] The invention relates to a purification method of polypeptide drugs, in particular to a purification method of ziconotide. Background technique

[0002] Ziconotide is a synthetic ω-MVIIA conotoxin, which was first reported as a peptide component of hallucinogenic conotoxin. Its 25 amino acid sequences are: Cys-Lys-Gly-Lys-Gly-Ala-Lys-Cys-Ser-Arg-Leu-Met-Tyr-Asp-Cys-Cys-Thr-Gly-Ser-Cys-Arg- Ser-Gly-Lys-Cys-NH 2 (1-16), (8-20), (15-25)-tris(disulfide).

[0003] Ziconotide can produce significant analgesic effect on patients with severe chronic pain who are ineffective with opioid analgesics, and no patients were found to be resistant to Ziconotide in clinical studies. At present, Ziconotide has become the first new type of neurotherapeutic drug --- N-type calcium ion channel blocker (NCCB). As a non-opioid analgesic, ziconotide is distinguished from other analgesic drugs by its safety and efficacy in clinical application, thus heralding its important...

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