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4-(dihydroxyacetyl-L-serine)-goserelin as well as preparation method and application thereof

A technology of goserelin and preparation, applied in the field of medicine, can solve problems such as lack of research

Pending Publication Date: 2022-06-24
SHANDONG LUYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the preparation of long-acting preparations and long-term storage of goserelin, there is a lack of research on the production of related impurities in goserelin after the addition of excipients and during its storage. Clinical use of related products urgently needs to be found in research on impurity components.

Method used

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  • 4-(dihydroxyacetyl-L-serine)-goserelin as well as preparation method and application thereof
  • 4-(dihydroxyacetyl-L-serine)-goserelin as well as preparation method and application thereof
  • 4-(dihydroxyacetyl-L-serine)-goserelin as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Preparation of 4-(diglycolyl-L-serine)-goserelin

[0037] Step 1: Add 500 mg of goserelin, 50 mg of glycolide, and 5 ml of DMF solvent to a 10 ml vial, and react at room temperature for 24 hours.

[0038] Step 2: The reaction solution in step 1 was separated by preparative high performance liquid chromatography (chromatographic column: phenomenonex, luna 5 μm, 250×21.20mm, S / N: 443257-2, flow rate 20ml / min, detection wavelength 220nm), at 0.5 % Phosphoric acid aqueous solution-acetonitrile was used as the mobile phase, the ratio of acetonitrile was 20%-40% for gradient elution, the chromatographic peak was collected with a retention time of 14.03min, and a total of 750ml of eluent was collected.

[0039] Step 3: Mix the reversed-phase silica gel with methanol, stir, homogenize and pack the column, replace the methanol with purified water, add the eluent obtained in step 2 to the reversed-phase silica gel chromatography column with a peristaltic pump, adjust th...

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Abstract

The invention provides a novel compound as well as a preparation method and application thereof. Specifically, the invention relates to a novel compound, namely 4-(dihydroxyacetyl-L-serine)-goserelin, and a goserelin long-acting preparation containing 4-(dihydroxyacetyl-L-serine)-goserelin with the weight percentage being less than 1%. The invention also discloses an application of the 4-(dihydroxyacetyl-L-serine)-goserelin as a reference substance in impurity detection of a goserelin long-acting preparation.

Description

technical field [0001] The invention belongs to the field of medicine, and specifically relates to a new compound and its preparation method and application. The new compound is 4-(diglycol-L-serine)-goserelin. Background technique [0002] Goserelin is a synthetic analog of luteinizing hormone-releasing hormone. Long-term use can inhibit the secretion of luteinizing hormone in the pituitary gland, thereby causing a decrease in serum testosterone in men and estradiol in women. Reversible after drug discontinuation. For male patients, about 21 days after the first medication, the testosterone concentration can be reduced to the post-castration level. During the treatment of 1 dose every 28 days, the testosterone concentration has been kept within the concentration range after castration. Testosterone suppression leads to regression and improvement of symptoms in most prostate tumors. In female patients, the serum estradiol concentration was suppressed about 21 days after th...

Claims

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Application Information

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IPC IPC(8): C07K7/23C07K1/16C07K1/20C07K1/02G01N30/02A61K38/09A61K9/00A61K9/52A61P35/00A61P15/00
CPCC07K7/23G01N30/02A61K9/0019A61K9/50A61P35/00A61P15/00G01N2030/047G01N2030/8872A61K38/00
Inventor 付婷婷白景贺晓艳薛英
Owner SHANDONG LUYE PHARMA CO LTD
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