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Filler special for purifying semaglutide and purification method of semaglutide

A semaglutide and purification method technology, which is applied in the field of semaglutide purification special packing and its purification, can solve the problems of unfavorable large-scale production, unfavorable environmental protection, high cost, etc., and achieve short purification cycle, easy cleaning and regeneration, The effect of increasing the production batch

Inactive Publication Date: 2019-02-19
SOOCHOW HIGH TECH CHROMATOGRAPHY
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Problems solved by technology

[0006] The existing purification method of semaglutide has the disadvantages of cumbersome operation, long cycle, more waste liquid, unfavorable for environmental protection, high cost and unfavorable for large-scale production

Method used

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  • Filler special for purifying semaglutide and purification method of semaglutide
  • Filler special for purifying semaglutide and purification method of semaglutide

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Embodiment 1

[0035] A special filler for semaglutide purification and a purification method thereof, the steps of which are as follows:

[0036] (1) Dissolve 15 mg of semaglutide crude peptide with a purity of about 30% in 1.5 ml of 50% acetonitrile aqueous solution, dissolve it ultrasonically, and prepare a sample solution with a concentration of 10 mg / ml. The obtained semaglutide crude peptide solution is mixed with 0.22 um organic membrane filtration, and the filtrate is used for standby;

[0037] (2) Chromatographic conditions: chromatographic column: reversed phase and ion exchange packing are mixed in a certain proportion as stationary phase packing; diameter and length of chromatographic column: 4.6*250mm. The mobile phase A: 100mM ammonium bicarbonate: acetonitrile is 95:5, and the mobile phase B: 100mM ammonium bicarbonate: acetonitrile is 50:50. The flow rate is 1ml / min, and the detection wavelength is 215nm. HPLC linear elution was performed, wherein the elution gradient was a...

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Abstract

The invention relates to a filler special for purifying semaglutide and a purification method of semaglutide. The method specifically comprises the steps of dissolving crude semaglutide into an aqueous solution of acetonitrile to obtain a crude peptide solution; conducting filtering, mixing a reverse phase and an ion exchange filler into a fixed phase in a certain proportion, after a filtrate is loaded, conducting HPLC linear gradient elution simultaneously with a moving phase mixed by an organic phase and a salt phase, and collecting distillate containing semaglutide; taking the third distillate, and conducting reduced-pressure rotary evaporation concentration and freeze drying to obtain the filler. Semaglutide with the purity of 30% or so can be purified to 90% or above in one step; meanwhile, the loading quantity is high, industrial scale production is simple, the purification period is short, and the production cost of enterprises is greatly reduced.

Description

technical field [0001] The invention relates to the technical field of fillers, in particular to a special filler for semaglutide purification and a purification method thereof. Background technique [0002] Semaglutide (Semaglutide) is a new long-acting GLP-1 receptor agonist, which not only has a significant hypoglycemic effect, but also has a significant weight loss effect. This drug is also the second in Novo Nordisk's diabetes pipeline GLP-1 hypoglycemic drug (the other is liraglutide) with both hypoglycemic and weight loss effects. The molecular formula of semaglutide is C187H291N45O59, and its corresponding molecular weight is 4111.1. From the structural point of view, semaglutide needs to connect the 26-position Lys to the fatty chain of AEEA, glutamic acid and octadecanoic acid. Among them, the 8-position adopts The unnatural amino acid aminoisobutyric acid. Compared with liraglutide, semaglutide has a longer fatty chain and increased hydrophobicity, but semagluti...

Claims

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Application Information

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IPC IPC(8): C07K14/605C07K1/18C07K1/16C07K1/14C07K1/34C07K1/36
CPCC07K14/605
Inventor 戈兆松彭凯陈育拼胡荣敏
Owner SOOCHOW HIGH TECH CHROMATOGRAPHY
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