Method for purifying semaglutide

A semaglutide and solution technology, which is applied in the field of purification of polypeptide drugs, can solve the problems of difficult production, short service life, cumbersome steps, etc., and achieve the effects of reducing production cost, maintaining biological activity, and improving separation effect.

Inactive Publication Date: 2020-10-30
SHENZHEN READLINE BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] At present, there are some methods and patents for the purification of semaglutide, but the steps are cumbersome, the yield is low, the purification inv

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  • Method for purifying semaglutide
  • Method for purifying semaglutide
  • Method for purifying semaglutide

Examples

Experimental program
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Effect test

Embodiment 1

[0042] 1. Sample treatment: take 500 grams of crude semaglutide synthesized in solid phase and dissolve it in 5 L of acetic acid aqueous solution (10% concentration by mass) to obtain a crude product solution;

[0043] 2. Precisely filter the crude product solution with a ceramic membrane cross-flow filtration system, and collect the filtrate for later use;

[0044] 3. The first step of reverse phase purification

[0045] Chromatographic conditions: chromatographic column 450X250mm, reversed-phase C8 filler, mobile phase A: 80mMol phosphoric acid solution, adjust pH to 7.2 with triethylamine, mobile phase B: acetonitrile, gradient 40-60%, loading 150 grams, monitoring wavelength The concentration was 230nm, and a linear gradient elution was performed to collect the fraction solution of the first step of semaglutide purification. Use acetic acid to adjust the pH to 6.0, and recover acetonitrile under reduced pressure at 30-32°C to obtain the first-step purification solution fo...

Embodiment 2

[0051]1. Sample treatment: take 800 grams of solid-phase-synthesized crude semaglutide and dissolve it in 8 L of acetic acid aqueous solution (mass percentage concentration 10%) to obtain a crude product solution;

[0052] 2. Precisely filter the crude product solution with a ceramic membrane cross-flow filtration system, and collect the filtrate for later use;

[0053] 3. The first step of reverse phase purification

[0054] Chromatographic conditions: chromatographic column 450X250mm, reversed-phase C8 filler, mobile phase A: 80mMol phosphoric acid solution, adjust pH to 7.2 with triethylamine, mobile phase B: acetonitrile, gradient 40-60%, loading 200 grams, monitoring wavelength The concentration was 230nm, and a linear gradient elution was performed to collect the fraction solution of the first step of semaglutide purification. Use acetic acid to adjust the pH to 5.0, and recover acetonitrile under reduced pressure at 30-32°C to obtain the first-step purification solutio...

Embodiment 3

[0060] 1. Sample treatment: take 1000 grams of solid-phase synthesized crude semaglutide and dissolve it in 10 L of acetic acid aqueous solution (mass percentage concentration 10%) to obtain a crude product solution;

[0061] 2. Precisely filter the crude product solution with a ceramic membrane cross-flow filtration system, and collect the filtrate for later use;

[0062] 3. The first step of reverse phase purification

[0063] Chromatographic conditions: chromatographic column 450X250mm, reversed-phase C8 filler, mobile phase A: 80mMol phosphoric acid solution, adjust pH to 7.2 with triethylamine, mobile phase B: acetonitrile, gradient 40-60%, loading 250 grams, monitoring wavelength The concentration was 230nm, and a linear gradient elution was performed to collect the fraction solution of the first step of semaglutide purification. Use acetic acid to adjust the pH to 5.5, and recover acetonitrile under reduced pressure at 30-32°C to obtain the first-step purification solu...

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Abstract

The invention relates to the field of purification of polypeptide drugs, in particular to a purification preparation method for synthesizing semaglutide by a solid-phase fragment method. According tothe preparation method, column chromatography is combined with a membrane separation technology to obtain higher product purity and yield and solve the technical problem of large-scale preparation atpresent. The preparation method comprises the following steps: dissolving crude semaglutide synthesized by a solid-phase fragment method into an acetic acid aqueous solution; filtering by using a ceramic membrane, separating and purifying by using a reversed-phase C8 filler, collecting a semaglutide fraction, recovering the organic solvent at low temperature and reduced pressure to obtain a purified solution of semaglutide, removing salt and redundant acid radical ions by using a membrane system, further concentrating to a concentration suitable for freeze-drying, freeze-drying and packaging to obtain a high-quality semaglutide raw material.

Description

technical field [0001] The invention relates to the field of purification of polypeptide drugs, in particular to a method for purifying semaglutide. Background technique [0002] Diabetes is a metabolic disease with high incidence worldwide. There are more than 400 million type 2 diabetes patients in the world, and more than 100 million type 2 diabetes patients in my country, accounting for a very high proportion of chronic diseases. Diabetes can induce many complications, seriously affect human labor ability, and greatly endanger human health. [0003] Semaglutide, English name: Semaglutide, molecular formula: C 187 h 291 N 45 o 59 Molecular weight: 4113.64. The peptide sequence structure is as follows: [0004] H-His-Aib-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys(AEEA-AEEA-γ-Glu- Octadecanedioic Acid)-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly-OH. [0005] Semaglutide is a new generation of long-acting GLP-1 analogues developed by Novo...

Claims

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Application Information

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IPC IPC(8): C07K14/605C07K1/20C07K1/34C07K1/36
CPCC07K14/605
Inventor 何平潘俊锋于铁妹刘建
Owner SHENZHEN READLINE BIOTECH CO LTD
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