Purification method of ganirelix acetate

A technique of ganirelix and a purification method, which is applied in the field of medicinal chemistry, can solve problems such as inhomogeneous salt formation of refined peptides, toxicity of trifluoroacetic acid, unfavorable purification, etc., and achieve good elution peak shape, improved purification scale, and easy The effect of industrial production
CN102993274BActive Publication Date: 2014-08-20HYBIO PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
HYBIO PHARMA
Publication Date
2014-08-20

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Abstract

The invention provides a purification method of ganirelix acetate. The purification method comprises the steps of (1) purification of ganirelix crude peptide, wherein octadecylsilane bonded silica is adopted as a fixed phase, perchlorate / phosphoric acid solution with certain concentration is taken as an A phase and acetonitrile is taken as a B phase, the ganirelix crude peptide is purified by a gradient-elution high performance liquid chromatography (HPLC) method; (2) salt conversion and purification, wherein the alkylsilane bonded silica is taken as the fixed phase, glacial acetic acid solution with a certain concentration is taken as the A phase and the acetonitrile is taken as the B phase, salt conversion and purification are carried out by adopting the gradient elution HPLC method, and the solution collected and subjected to freeze-drying to obtain the ganirelix acetate. The invention aims at providing the purification method of the ganirelix acetate with stable and controllable process, high yield, high purity, and wide practical value and application prospect.
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Description

technical field

[0001] The invention relates to a purification method of polypeptide medicine, in particular to a purification method of ganirelix, belonging to the field of medicinal chemistry. Background technique

[0002] Ganirelix, English name Ganirelix, molecular formula C 80 h 113 ClN 18 o 13 , is a synthetic decapeptide compound similar to endogenous gonadotropin-releasing hormone (GnRH) (also known as luteinizing hormone-releasing hormone, LHRH), and is an antagonist of GnRH. The structural formula is as follows:

[0003]

[0004] This product competitively antagonizes the GnRH stimulation of gonadotropes, thereby altering the pathway and causing rapid and reversible inhibition of gonadotropin (luteinizing hormone LH and follicle-stimulating hormone FSH) secretion. It inhibits the secretion of LH from the pituitary gland more significantly than FSH, thereby reducing the production of sex hormones. By inhibiting the fluctuation of LH induced by GnRH in the mi...

Claims

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