Novel omeprazole sodium compound and medicinal composition thereof

A technology of omeprazole sodium and its compound, which is applied in the field of new omeprazole sodium compound and its pharmaceutical composition, can solve problems such as lack of enlightenment, improve drug safety and effectiveness, and avoid incidence , the effect of avoiding adverse reactions

Active Publication Date: 2012-02-15
周晓东
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the crystal forms of omeprazole introduced by these two patents are different from the crystal forms of omeprazole sodium prepared by the present invention, because the chemical properties such as the solubility of omeprazole and omeprazole sodium have significant differences, so , these two patents have no enlightening effect on the present invention

Method used

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  • Novel omeprazole sodium compound and medicinal composition thereof
  • Novel omeprazole sodium compound and medicinal composition thereof
  • Novel omeprazole sodium compound and medicinal composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] [embodiment 1] the preparation of new omeprazole sodium compound

[0051] (1) 1 weight part of crude omeprazole sodium was dissolved in 7.5 parts by weight of water, 0.1% by weight of activated carbon for needles was added at 25°C, stirred for 1.2 hours and then filtered to obtain solution 1;

[0052] (2) Crystal nucleation process: at a rotation speed of 50 rpm, a temperature of 25°C, and a sound field with a frequency of 17.5KHz and an output power of 125W, under a pressure of 2.5Mpa, add 1.5 Add isopropanol at a constant speed at a rate of ml / min until the solution becomes turbid to obtain solution 2;

[0053] (3) Crystal growth process: place solution 2 in the following environment to grow crystals for 2.5 hours: the rotation speed is 15 rpm, the temperature is 15°C, and it is in a sound field with a frequency of 10KHz and an output power of 225W, and a pressure of 0.75Mpa ;

[0054] (4) The solution obtained in step 3 was centrifuged, the filter cake was washed w...

Embodiment 2

[0056] [embodiment 2] the preparation of new omeprazole sodium compound

[0057] (1) 1 weight part of crude omeprazole sodium was dissolved in 7 weight parts of water, 0.1% weight part of activated carbon for needles was added at 28°C, stirred for 1.4 hours and then filtered to obtain solution 1;

[0058] (2) Crystal nucleation process: at a speed of 45 rpm, a temperature of 28°C, and a sound field with a frequency of 18KHz and an output power of 110, under a pressure of 2.8Mpa, add 1.7ml of Add isopropanol at a constant speed at a rate of 1 / min until the solution becomes turbid to obtain solution 2;

[0059] (3) Crystal growth process: place solution 2 in the following environment to grow crystals for 2.7 hours: the rotation speed is 17 rpm, the temperature is 13°C, and it is in a sound field with a frequency of 11KHz and an output power of 230W, and a pressure of 0.8Mpa ;

[0060] (4) The solution obtained in step 3 was centrifuged, the filter cake was washed with isopropa...

Embodiment 3

[0062] [embodiment 3] the preparation of new omeprazole sodium compound

[0063] (1) 1 part by weight of crude omeprazole sodium was dissolved in 8 parts by weight of water, and 0.1% by weight of activated carbon for needles was added at 22°C, stirred for 11 hours and then filtered to obtain solution 1;

[0064] (2) Crystal nucleation process: at a speed of 55 rpm, a temperature of 28°C, and a sound field with a frequency of 17KHz and an output power of 140W, under a pressure of 2.2Mpa, add 1.3ml of Add isopropanol at a constant speed at a rate of 1 / min until the solution becomes turbid to obtain solution 2;

[0065] (3) Crystal growth process: place solution 2 in the following environment to grow crystals for 2.3 hours: the rotation speed is 13 rpm, the temperature is 17°C, and it is in a sound field with a frequency of 9KHz and an output power of 220W, and a pressure of 0.7Mpa ;

[0066] (4) The solution obtained in step 3 was centrifuged, the filter cake was washed with i...

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Abstract

The invention discloses a novel omeprazole sodium compound. Characteristic peaks of the omeprazole sodium compound in an X-ray powder diffraction pattern obtained through Cu-K alpha-ray measurement are displayed when 2 theta is 3.2, 5.9, 7.6, 9.2, 10.5, 10.6, 12.3, 16.2, 18.2, 20.8, 23.4, 27.1, 30.4, 32.3 and 34.6. The omeprazole sodium compound has a new crystal form different from the prior art, has the thermodynamic stability higher than that with known crystal form, and has the advantage of not absorbing moisture basically. The invention also discloses a medicinal composition, which comprises the novel omeprazole sodium compound. Omeprazole sodium freeze-dried powder injection can be directly prepared under the condition of not adding lyoprotectants, and the omeprazole sodium freeze-dried powder injection has the advantages of high stability and high re-dissolubility.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a novel omeprazole sodium compound and a pharmaceutical composition thereof. Background technique [0002] Omeprazole sodium, chemical name: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl}- 1H-Benzimidazole sodium monohydrate, the molecular formula is C 17 h 18 N 3 NaO 3 S·H 2 O, the molecular weight is 385.41. Omeprazole sodium is a weakly alkaline substance, a proton pump inhibitor of gastric parietal cells, which can specifically inhibit the release of H on the secretory microtubules formed by the apical membrane of the parietal cells and the tubular vesicles in the cytoplasm. + 、K + -ATPase, thus effectively inhibiting the secretion of gastric acid. Omeprazole sodium has a significant effect on duodenal ulcer, gastric ulcer, reflux esophagitis, Zoller-Ellison syndrome, etc. [0003] CN1134432C discloses a kind of B-type omeprazole sodi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61K9/19A61P1/04
Inventor 周晓东
Owner 周晓东
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