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Novel pantoprazole sodium compound and pharmaceutical composition thereof

A kind of technology of pantoprazole sodium and compound, applied in the field of novel pantoprazole sodium compound and pharmaceutical composition thereof, can solve the problems of chemical structure destructive change, discoloration, low purity of pantoprazole sodium, etc., and achieve improvement The effect of stability

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 the pantoprazole sodium that prior art obtains is generally low, causes the preparation stability of pantoprazole sodium to drop substantially, has influenced its clinical application
Existing pantoprazole sodium has poor stability and is more sensitive to light, heat, oxygen, etc., especially under acidic conditions, its chemical structure can undergo destructive changes, and discoloration and polymerization phenomena can occur
And existing adverse reactions such as dizziness, insomnia, drowsiness, nausea, diarrhea, constipation, erythra and myalgia often appear in the patient who takes Pantoprazole Sodium medicine, have seriously restricted the popularization and application of Pantoprazole Sodium

Method used

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  • Novel pantoprazole sodium compound and pharmaceutical composition thereof
  • Novel pantoprazole sodium compound and pharmaceutical composition thereof
  • Novel pantoprazole sodium compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A kind of pharmaceutical composition of pantoprazole 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 put it in a container, then add 500mg of disodium edetate, 5mg of sodium tartrate and 520mg of mannitol, dissolve and add activated carbon, filter to form solution A;

[0020] (2) Take 100 ml of water for injection and place it in another container, slowly add 450 mg of pantoprazole sodium, and stir until the pantoprazole 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 pantoprazole sodium in the solution C, and the qualified solution can be packaged after fine filtration, potting and sterilization to form a pharmaceutical composition injection of pantoprazole sodium...

Embodiment 2

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

[0025] (1) Take 200ml of water for injection and place it in a container, then add 30mg of disodium edetate, 30mg of sodium tartrate and 40mg of mannitol, dissolve and add activated carbon, filter to form solution A;

[0026] (2) Take 200 ml of water for injection and place it in another container, slowly add 800 mg of pantoprazole sodium, and stir until the pantoprazole 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 pantoprazole sodium in the solution C, and the qualified solution can be packaged after fine filtration, potting and sterilization to form a pharmaceutical composition injection of pantoprazole sodiu...

Embodiment 3

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

[0031] (1) Take 200ml of water for injection and put it in a container, then add 120mg of disodium edetate, 20mg of sodium tartrate and 30mg of mannitol, 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 600 mg of pantoprazole sodium, and stir until the pantoprazole 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 pantoprazole sodium in the solution C, and the qualified solution can be packaged after fine filtration, potting and sterilization to form a pharmaceutical composition injection of pantoprazole sodium...

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Abstract

The invention discloses a novel pantoprazole sodium compound. The purity of the novel pantoprazole sodium compound reaches more than 99.8%. Meanwhile, the invention also discloses a pharmaceutical composition of the novel pantoprazole sodium compound. The pharmaceutical composition comprises the following components in parts by weight: 45-80 parts of pantoprazole sodium, 3-20 parts of ethylene diamine tetraacetic acid, 0.5-3 parts of sodium tartrate and 4-52 parts of mannitol. According to the pharmaceutical composition of the novel pantoprazole sodium compound, a synergistic effect is generated between ethylene diamine tetraacetic acid and sodium tartrate, so that the stability of pantoprazole sodium is remarkably improved, and the pharmaceutical composition has important significance for pantoprazole 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 pantoprazole sodium compound and its pharmaceutical composition. Background technique [0002] Pantoprazole sodium, its chemical name is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)-methyl]-sulfinyl-1H-benzimidazole Sodium salt monohydrate is a proton pump inhibitor, suitable for acute upper gastrointestinal bleeding such as duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, and compound gastric ulcer. The purity of the pantoprazole sodium that prior art obtains is generally low, causes the formulation stability of pantoprazole sodium to decline substantially, has influenced its clinical application. Existing pantoprazole sodium has poor stability and is more sensitive to light, heat, oxygen, etc., especially under acidic conditions, its chemical structure may undergo destructive changes, and discoloration and poly...

Claims

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Application Information

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IPC IPC(8): C07D401/12A61K31/4439A61P1/04
Inventor 黄明芳
Owner 黄明芳
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