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Omeprazole sodium compound and preparation thereof

A technology for omeprazole sodium and compound, which is applied in the field of preparation method of omeprazole sodium compound, can solve the problems such as influence on clinical application, poor purity of omeprazole sodium, decreased stability of preparation of omeprazole sodium and the like , to achieve the effect of improving clinical drug effect, high yield and suitable for large-scale industrial production

Inactive Publication Date: 2009-04-22
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the refining and purification method of omeprazole sodium disclosed in the prior art, the purity of the obtained omeprazole sodium is still poor, which leads to a substantial decline in the stability of the preparation of omeprazole sodium, which affects its clinical application

Method used

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  • Omeprazole sodium compound and preparation thereof
  • Omeprazole sodium compound and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Dissolve 100g of omeprazole sodium in 1000ml of water, add 2M sodium bisulfate solution, adjust the pH value to 6.8, stir to precipitate insoluble matter, filter, wash with 200ml of purified water, then add 220ml of dichloromethane to the resulting solid to make it Dissolve, add to the column filled with D101 macroporous resin to pass through, then elute the column with chloroform, collect the eluate, adjust the pH value to 10.5 with 5M sodium bicarbonate solution, precipitate solid, centrifuge, wash with 200ml ethanol , dried under vacuum at 40° C. for 6 hours to obtain 91.7 g of refined omeprazole sodium, with a yield of 91.7% and a purity of 99.9%.

Embodiment 2

[0022] Dissolve 100g of omeprazole sodium in 800ml of water, add 5M potassium hydrogen tartrate solution, adjust the pH value to 6.6, stir to precipitate insoluble matter, filter, wash with 230ml of purified water, then add 350ml of ethanol to the resulting solid to dissolve it, Add the column filled with AB-8 macroporous resin to pass through, then elute the column with chloroform, collect the eluate, adjust the pH value to 9.7 with 2M potassium bicarbonate solution, precipitate solid, centrifuge, wash with 200ml ethanol , dried under vacuum at 35°C for 10 hours to obtain 92.2 g of refined omeprazole sodium, with a yield of 92.2% and a purity of 99.9%.

Embodiment 3

[0024] Dissolve 100g of omeprazole sodium in 1200ml of water, add 1M disodium hydrogen phosphate solution, adjust the pH value to 6.5, stir to precipitate insoluble matter, filter, wash with 200ml of purified water, and then add 270ml of methanol to the obtained solid to dissolve it , add the column filled with D101 macroporous resin to pass through, then elute the column with chloroform, collect the eluate, adjust the pH value to 10.0 with 5M sodium bicarbonate solution, separate out the solid, centrifuge, wash with 300ml ethanol, Vacuum drying at 40°C for 8 hours gave 90.1 g of refined omeprazole sodium with a yield of 90.1% and a purity of 99.8%.

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Abstract

The invention relates to an omeprazole sodium compound and a method for preparing the same. The method comprises the following steps: dissolving an omeprazole sodium crude product in water, adding solution of a solid acid salt into the mixture, collecting the precipitated solid, dissolving the solid by using an organic solvent, eluting and purifying the mixture by an eluant through macroporous resin, collecting the eluate, adding an alkaline solution into the eluate to regulate the pH value to be alkaline, collecting the precipitated solid, and performing vacuum drying on the solid after washing to obtain the refined product of the omeprazole sodium. The purity of the omeprazole sodium prepared by the method is more than 99.8 percent, thus the purity and the preparation stability of the omeprazole sodium product are greatly improved.

Description

technical field [0001] The invention relates to a preparation method of omeprazole sodium compound, which belongs to the technical field of medicine. Background technique [0002] Omeprazole sodium, its chemical name is: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl} -1H-benzimidazole sodium monohydrate, the structural formula is: [0003] [0004] It is a gastric acid proton pump inhibitor widely used in the treatment of peptic ulcer in recent years. [0005] At present, many patents have been reported on the preparation method and application of omeprazole and its salts, such as US4255431A, US4689333A, EP0533264A, etc. The methods include single solvent crystallization method, mixed solvent crystallization method, acid-base method, etc. Chinese patent application 95111640.1 also discloses a method for obtaining omeprazole sodium by an ion exchange resin method; Chinese patent application 96116288.0 discloses a method for refining omeprazole sodium ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61P1/04
Inventor 邱民
Owner HAINAN LINGKANG PHARMA CO LTD
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