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A kind of separation and purification method of liraglutide

A technology for separation and purification of liraglutide, which is applied in the field of separation and purification, can solve the problems of low yield, difficult desalination, and low purity of liraglutide, and achieve high yield, good packing separation, and remarkable desalination effect Effect

Active Publication Date: 2021-04-27
苏州天马医药集团天吉生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides a method for separating and purifying liraglutide, which mainly solves the technical problems of low purity, low yield and difficult desalination of liraglutide in the prior art.

Method used

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  • A kind of separation and purification method of liraglutide
  • A kind of separation and purification method of liraglutide
  • A kind of separation and purification method of liraglutide

Examples

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Embodiment 1

[0027] Example 1: Separation and purification of liraglutide

[0028] The separation and purification method of liraglutide of the present invention comprises the following steps:

[0029] 1. Sample dissolution: Dissolve 10 grams of crude product (the target peptide is 4 grams of liraglutide, which also contains impurities and some solvents, which are not shown in the HPLC test results) with dilute ammonia water with a pH of 9 and 5% methanol. , and filtered through a 0.22um organic membrane to obtain a crude product solution.

[0030] 2. Primary purification: the filtrate of step (1) is separated and purified through polymethacrylate polymer filler, phase A is: 20mmol / L sodium carbonate solution (pH is adjusted to 9 with phosphoric acid), phase B is: acetonitrile, gradient 30-45%, the gradient elution time is 40min, the detection wavelength is 220nm, the flow rate is 80ml / min, room temperature, and the sample is a crude product containing 4g of the target product.

[0031] ...

Embodiment 2

[0036] Example 2: Separation and purification of liraglutide

[0037] The separation and purification method of liraglutide of the present invention comprises the following steps:

[0038] 1. Sample dissolution: Dissolve 10 grams of the crude product (the target peptide is 4 grams of liraglutide, which also contains impurities and some solvents) with dilute ammonia water with a pH of 9 and 6% methanol and sonicate, and filter with a 0.22um organic filter membrane A crude solution was obtained.

[0039] 2. Primary purification: the filtrate of step (1) is separated and purified through polymethacrylate polymer filler, phase A is: 30mmol / L sodium carbonate solution (pH is adjusted to 9 with phosphoric acid), phase B is: acetonitrile, gradient 30-45%, the gradient elution time is 40min, the detection wavelength is 220nm, the flow rate is 80ml / min, room temperature, and the sample is a crude product containing 4g of the target product.

[0040] Purification process: wash the chr...

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Abstract

The invention discloses a method for separating and purifying liraglutide, which belongs to the technical field of separation and purification. In the present invention, the crude product of liraglutide is dissolved in dilute ammonia water containing 4-6% organic solvent to obtain a crude peptide solution, filtered, and the filtrate is respectively passed through polymethacrylate polymer filler and octaalkylsilane bonded silica gel filler, and Combining the purification conditions of different systems for separation and purification, the target product is collected, and finally a product with a total purity of more than 99.5% and a maximum simple impurity of less than 0.1% is obtained. This method is simple, high in yield and high in purity, and is very suitable for mass production.

Description

technical field [0001] The invention relates to a separation and purification method of liraglutide, belonging to the technical field of separation and purification. Background technique [0002] Liraglutide is a long-acting glucagon-like peptide 1 (GLP-1) analogue for the treatment of type II diabetes. It belongs to the GLP-1 receptor agonist and is the first human high Glucagon-like polypeptide-1 (GLP-1) analogs. Developed by Novo Nordisk, it was approved by the FDA for marketing on January 25, 2010, and was approved by the SFDA for marketing in China on March 4, 2011. Liraglutide, as a new generation of incretin-based hypoglycemic drugs, not only has a long duration of action, but also fully retains multiple physiological activities of natural GLP-1, which can safely and effectively lower blood sugar and may prevent various cardiovascular risks. Factors have a protective effect, bringing new options for the treatment of type 2 diabetes. The clinical treatment effect is...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/605C07K1/36C07K1/34C07K1/16
CPCC07K14/605
Inventor 沈杰王良友孙锋谢宇黄保胜
Owner 苏州天马医药集团天吉生物制药有限公司
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