Omeprazole freeze-dried powder injection and preparation method thereof

A technology of omeprazole sodium and freeze-dried powder injection, which is applied in the field of omeprazole sodium freeze-dried powder injection and its preparation, and can solve the problems of large pH value changes, inconvenient clinical use, poor solution clarity, etc. , to achieve stable color, solve the problem of clarity, and good stability

Inactive Publication Date: 2008-10-15
海南瑞基药物研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Omeprazole Sodium for Injection has been marketed in China, the specification is 40mg (calculated as omeprazole), and it is equipped with a special solvent, which has the problems of inconvenient clinical use and easy cross-contamination
[0005] In Published Patent Application No. 200610042004.1 "A Stable Omeprazole Sodium Preparation", it is mentioned that mannitol is used as a skeleton agent and a disodium edetate metal ion complexing agent is used, and its stability is relatively poor , there is discoloration in the aqueous solution for 2-4 hours, the clarity of the solution after reconstitution is poor, and the pH value changes greatly, and after intravenous injection of disodium edetate into the human body, it will cause complexation with calcium ions in the blood Potential Side Effects of Bone Calcium Loss

Method used

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  • Omeprazole freeze-dried powder injection and preparation method thereof
  • Omeprazole freeze-dried powder injection and preparation method thereof
  • Omeprazole freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: Omeprazole powder injection preparation I prepared by the present invention

[0032] Preparation composition:

[0033] Omeprazole sodium (calculated as omeprazole) 20g

[0034] Mannitol 100g

[0035] Edetate Calcium Sodium 0.2g

[0036] Hydroxypropyl-β-cyclodextrin 100g

[0037] Sodium sulfite 4g

[0038] Appropriate amount of borax-sodium carbonate buffer solution

[0039] Add water for injection to 2000ml

[0040] Makes 1000 bottles

[0041] Preparation:

[0042] (1) Weigh the prescribed amount of calcium sodium edetate, hydroxypropyl-β-cyclodextrin, sodium sulfite and mannitol, add 80% of the total volume of water for injection and stir to dissolve it completely, then add the prescribed amount of Ogilvy Sodium prazole, stirred to dissolve completely;

[0043] (2) Add medicinal charcoal with a total volume of 0.1% (g / ml), stir and adsorb for 20 minutes, filter for decarburization, add borax-sodium carbonate buffer solution to adjust the pH value...

Embodiment 2

[0048] Embodiment 2: Omeprazole powder injection preparation II prepared by the present invention

[0049] Preparation composition:

[0050] Omeprazole sodium (calculated as omeprazole) 20g

[0051] Mannitol 200g

[0052] Edetate Calcium Sodium 0.4g

[0053] Hydroxypropyl-β-cyclodextrin 200g

[0054] Sodium sulfite 8g

[0055] Appropriate amount of borax-sodium carbonate buffer solution

[0056] Add water for injection to 4000ml

[0057] Makes 1000 bottles

[0058] Preparation:

[0059] (1) Weigh the prescribed amount of calcium sodium edetate, hydroxypropyl-β-cyclodextrin, sodium sulfite and mannitol, add 80% of the total volume of water for injection and stir to dissolve it completely, then add the prescribed amount of Ogilvy Sodium prazole, stirred to dissolve completely;

[0060](2) Add medicinal charcoal with a total volume of 0.2% (g / ml), stir and adsorb for 20 minutes, filter for decarburization, add borax-sodium carbonate buffer solution to adjust the pH value...

Embodiment 3

[0065] Embodiment 3: Omeprazole powder injection preparation III prepared by the present invention

[0066] Preparation composition:

[0067] Omeprazole sodium (calculated as omeprazole) 20g

[0068] Dextran 50g

[0069] Edetate Calcium Disodium 0.1g

[0070] β-cyclodextrin 50g

[0071] Sodium Metabisulfite 2g

[0072] Appropriate amount of sodium hydroxide

[0073] Add water for injection to 1000ml

[0074] Makes 1000 bottles

[0075] Preparation:

[0076] (1) Weigh edetate calcium disodium, β-cyclodextrin, sodium metabisulfite and dextran of the prescribed amount, add 80% of the total volume of water for injection and stir to make it dissolve completely, then add the prescribed amount of omeprazole sodium , stir to dissolve completely'

[0077] (2) Add medicinal charcoal with a total volume of 0.1% (g / ml), stir and adsorb for 30 minutes, filter and decarburize, add sodium hydroxide buffer solution to adjust the pH value to 10.9, add water for injection to the full a...

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PUM

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Abstract

The invention provides an omeprazole sodium lyophilized powder for injection (pH of 10.8-11.2), comprising omeprazole sodium as the main active component, as well as excipient, metal ion complexing agent, stabilizer, antioxidant and pH regulator. The omeprazole sodium lyophilized powder for injection has higher active component content than that of the conventional omeprazole sodium injection, solves solution clarity problem, and effectively prevents loss of bone calcium due to complexation with calcium ion. The omeprazole sodium lyophilized powder for injection also has the advantages of stable color and properties, low side effects, good stability, good redissolution, and convenient application.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, and relates to a freeze-dried powder injection, in particular to a freeze-dried powder injection of omeprazole sodium and a preparation method thereof. Background technique [0002] Omeprazole sodium, chemical name: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl}- 1H-benzimidazole sodium salt. 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. [0003] Omeprazole Sodium for Injection is mainly used for peptic ulcer bleeding and anastomotic ulcer bleeding; acute gastric mucosal damage complicated by stress and acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs;...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/40A61P1/04
Inventor 陶灵萍
Owner 海南瑞基药物研究有限公司
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