Novel omeprazole compound and pharmaceutical composition thereof

A technology of omeprazole sodium and its compound, which is applied in the field of compounds and pharmaceutical compositions for treating gastric ulcer disease, can solve the problems of poor stability, chemical structure damage, low purity of omeprazole sodium, etc., and achieve improved stability Effect

Inactive Publication Date: 2013-04-24
黄明芳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The purity of omeprazole sodium obtained by the prior art is generally low, which leads to a substantial decline in the stability of the formulation of omeprazole sodium, which affects its clinical application
The existing omeprazole sodium has poor stability and is more sensitive to light, heat, oxygen, etc., especially under acidic conditions, its chemical structure can be destroyed
Moreover, adverse reactions such as nausea, diarrhea, abdominal pain, dizziness, and headache often occur in patients taking omeprazole sodium medicine, which seriously restricts the popularization and application of omeprazole sodium

Method used

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  • Novel omeprazole compound and pharmaceutical composition thereof
  • Novel omeprazole compound and pharmaceutical composition thereof
  • Novel omeprazole compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A kind of pharmaceutical composition of omeprazole sodium compound, described pharmaceutical composition is injection, and described injection is prepared by the following steps:

[0019] (1) Take 400ml of water for injection and place it in a container, then add 250mg of sodium glutamate, 40mg of sodium tartrate and 70mg of vitamin C, dissolve and add activated carbon, filter to form solution A;

[0020] (2) Take 200 ml of water for injection and place it in another container, slowly add 900 mg of omeprazole sodium, and stir until the omeprazole sodium is completely dissolved to form solution B;

[0021] (3) Add solution B to solution A, add water for injection to 1000ml, add activated carbon again, stir and filter to form solution C;

[0022] (4) Detect the content of omeprazole sodium in solution C, and the qualified solution can be packaged after fine filtration, potting and sterilization to form a pharmaceutical composition injection of omeprazole sodium.

Embodiment 2

[0024] A kind of pharmaceutical composition of omeprazole sodium compound, described pharmaceutical composition is injection, and described injection is prepared by the following steps:

[0025] (1) Take 400ml of water for injection and put it in a container, then add 100mg of sodium glutamate, 10mg of sodium tartrate and 120mg of vitamin C, dissolve and add activated carbon, filter to form solution A;

[0026] (2) Take 100 ml of water for injection and place it in another container, slowly add 620 mg of omeprazole sodium, and stir until the omeprazole sodium is completely dissolved to form solution B;

[0027] (3) Add solution B to solution A, add water for injection to 1000ml, add activated carbon again, stir and filter to form solution C;

[0028] (4) Detect the content of omeprazole sodium in solution C, and the qualified solution can be packaged after fine filtration, potting and sterilization to form a pharmaceutical composition injection of omeprazole sodium.

Embodiment 3

[0030] A kind of pharmaceutical composition of omeprazole sodium compound, described pharmaceutical composition is injection, and described injection is prepared by the following steps:

[0031] (1) Take 400ml of water for injection and place it in a container, then add 180mg of sodium glutamate, 20mg of sodium tartrate and 100mg of vitamin C, dissolve and add activated carbon, filter to form solution A;

[0032] (2) Take 150 ml of water for injection and place it in another container, slowly add 700 mg of omeprazole sodium, and stir until the omeprazole sodium is completely dissolved to form solution B;

[0033] (3) Add solution B to solution A, add water for injection to 1000ml, add activated carbon again, stir and filter to form solution C;

[0034] (4) Detect the content of omeprazole sodium in solution C, and the qualified solution can be packaged after fine filtration, potting and sterilization to form a pharmaceutical composition injection of omeprazole sodium.

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Abstract

The invention discloses a novel omeprazole compound. The purity of the novel omeprazole compound reaches more than 99.8%. Meanwhile, the invention also discloses a pharmaceutical composition of the novel omeprazole compound. The pharmaceutical composition comprises the following components in parts by weight: 62-90 parts of omeprazole sodium, 10-25 parts of sodium glutamate, 1-4 parts of sodium tartrate and 7-12 parts of vitamin C. According to the pharmaceutical composition of the novel omeprazole compound, a synergistic effect is generated between sodium glutamate and sodium tartrate, so that the stability of omeprazole sodium is remarkably improved, and the pharmaceutical composition has important significance for omeprazole sodium in clinical popularization and application.

Description

technical field [0001] The invention relates to a compound and its pharmaceutical composition for treating gastric ulcer disease, especially a novel omeprazole sodium compound and its pharmaceutical composition. 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 is a gastric acid proton pump inhibitor widely used in the treatment of peptic ulcer in recent years. The purity of the omeprazole sodium obtained in the prior art is generally low, which leads to a substantial decline in the stability of the preparation of the omeprazole sodium, which affects its clinical application. The existing omeprazole sodium has poor stability and is sensitive to light, heat, oxygen, etc., and its chemical structure can be destroyed especially under acidic conditions. Moreover, adverse reactions such as nausea, diarrhea, abdominal pain, dizziness, and headache often occ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K31/4439A61K47/18A61K47/12A61K47/22A61P1/04
Inventor 黄明芳
Owner 黄明芳
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