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Preparation method of new crystal form of dexrabeprazole sodium

A technology of rabeprazole sodium and crystal form, which is applied in the field of preparation of new crystal form of dextro-rabeprazole sodium, can solve the problems of influence of preparation bioavailability, influence on product stability and the like, and achieves the effect of good stability

Inactive Publication Date: 2015-09-16
NANJING KEFEI PINGSHENGHUI PHARMA CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

For rabeprazole sodium, it has good water solubility, but the different crystal forms will a

Method used

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  • Preparation method of new crystal form of dexrabeprazole sodium
  • Preparation method of new crystal form of dexrabeprazole sodium
  • Preparation method of new crystal form of dexrabeprazole sodium

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Embodiment 1

[0018] Preparation of new crystal form of dexrabeprazole sodium.

[0019] Add 105mL of water to a 250ml three-necked flask, and add 35g of R-2-[[[4-(3-methoxypropoxy)-3-methylpyridinyl]-2-yl]methylxanthinyl] under magnetic stirring -1H-benzimidazole, heat up to 50°C, add 3.9g of NaOH solid, stir to dissolve the solid, and naturally cool down to room temperature after obtaining a clear and transparent solution, stir in an ice bath for 1h, filter with suction, put the filter cake in a vacuum drying oven at 37°C After drying to constant weight, 28.3 g of the target crystal form product was obtained, with a yield of 80.1%.

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Abstract

The invention relates to a novel crystal form of a novel proton pump inhibitor R-Na-2-[[[4-(3-methoxypropoxy)-3-methylpyridyl]-2-yl]methylsulfinyl]-1H-benzimidazole (with the common name of dexrabeprazole sodium), and a preparation method thereof. A result of X diffraction determination of the above crystal compound shows that the X-ray powder diffraction pattern represented by (2theta +/-0.2)DEG has no characteristic diffraction peaks, and the compound is an amorphous crystal form. The preparation method concretely comprises the following steps: dissolving dexrabeprazole sodium in alkaline water, filtering, cooling for precipitating, carrying out pumping filtration, and carrying out vacuum drying.

Description

field of invention [0001] The present invention relates to a novel proton pump inhibitor R-Na-2-[[[4-(3-methoxypropoxy)-3-methylpyridinyl]-2-yl]methylxanthinyl]- A new crystal form of 1H-benzimidazole (common name: dex-rabeprazole sodium) and a preparation method thereof. Background of the invention [0002] The chemical name of dexrabeprazole sodium is R-Na-2-[[[4-(3-methoxypropoxy)-3-methylpyridinyl]-2-yl]methylxanthinyl]- 1H-benzimidazole has a structural formula as shown in formula [I]. [0003] [0004] Rabeprazole was developed and launched by Japan's Eisai Zhushi in December 1998. Its tablet was approved by SFDA in February 2000. Its product name is "Polit", and the patent expires in May 2013. D-Rabeprazole Sodium is a new type of proton pump inhibitor first developed by India Chiral Emcure (also developed and marketed S-pantorazole, Dexibuprofen, S-amlodipine, S-metoprolol, S-atenolol, etc.) pharmaceutical company on September 13, 2010. It is now on the market ...

Claims

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Application Information

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IPC IPC(8): C07D401/12
CPCC07D401/12C07B2200/13
Inventor 秦引林王伟
Owner NANJING KEFEI PINGSHENGHUI PHARMA CO LTD