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Omeprazole sodium 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 problems such as poor stability

Pending Publication Date: 2021-05-18
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing omeprazole sodium freeze-dried powder injection is easy to degrade under high temperature, oxidation, light and acidic conditions, and the stability is not good. powder injection stability

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The preparation method of omeprazole sodium freeze-dried powder injection comprises the following steps:

[0025] (1) adding sodium xylenesulfonate and sodium bisulfite to sterile water for injection at 75°C, stirring and dissolving to obtain the first mixed solution;

[0026] (2) adding omeprazole sodium to sterile water for injection, the mass ratio of omeprazole sodium and sterile water for injection is 1:5, stirring and dissolving at normal temperature to obtain the second mixed solution;

[0027] (3) Add the first mixed solution of step (1) to the second mixed solution of step (2) to obtain the total mixed solution, add sterile water for injection, then add sodium citrate to adjust the pH value, stir and dissolve, and the total mixed solution The mass ratio with sterile water for injection is 1:8;

[0028] (4) Filter the mixed solution prepared in step (3), pour the filtered mixed solution into a glass bottle, and freeze-dry to obtain omeprazole sodium freeze-drie...

Embodiment 2

[0034] The preparation method of omeprazole sodium freeze-dried powder injection comprises the following steps:

[0035] (1) adding sodium xylene sulfonate and sodium bisulfite to 80°C sterile water for injection, stirring and dissolving to obtain the first mixed solution;

[0036] (2) adding omeprazole sodium to sterile water for injection, the mass ratio of omeprazole sodium and sterile water for injection is 1:6, stirring and dissolving at normal temperature to obtain the second mixed solution;

[0037] (3) Add the first mixed solution of step (1) to the second mixed solution of step (2) to obtain the total mixed solution, add sterile water for injection, then add sodium citrate to adjust the pH value, stir and dissolve, and the total mixed solution The mass ratio with sterile water for injection is 1:10;

[0038] (4) Filter the mixed solution prepared in step (3), pour the filtered mixed solution into a glass bottle, and freeze-dry to obtain omeprazole sodium freeze-dried...

Embodiment 3

[0044] The preparation method of omeprazole sodium freeze-dried powder injection comprises the following steps:

[0045] (1) Add sodium xylenesulfonate and sodium bisulfite into sterile water for injection, stir and dissolve to obtain the first mixed solution, and the temperature of the sterile water for injection is 80°C;

[0046] (2) adding omeprazole sodium to sterile water for injection, stirring and dissolving at normal temperature to obtain the second mixed solution, the mass ratio of said omeprazole sodium and sterile water for injection is 1:8;

[0047] (3) Add the first mixed solution of step (1) to the second mixed solution of step (2) to obtain the total mixed solution, add sterile water for injection, then add sodium citrate to adjust the pH value, stir and dissolve, and the total mixed solution The mass ratio with sterile water for injection is 1:8;

[0048] (4) Filter the mixed solution prepared in step (3), pour the filtered mixed solution into a glass bottle, ...

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Abstract

The invention provides an omeprazole sodium freeze-dried powder injection and a preparation method thereof. The preparation method comprises the following steps of: (1) adding sodium xylene sulfonate and sodium hydrogen sulfite into sterile injection water, stirring and dissolving to obtain first mixed solution; (2) adding omeprazole sodium into the sterile injection water, stirring and dissolving at the normal temperature to obtain second mixed solution; (3) adding the first mixed solution obtained in the step (1) into the second mixed solution obtained in the step (2) to obtain total mixed solution, adding the sterile injection water, then adding sodium citrate to adjust the pH value, and carrying out stirring and dissolving, wherein the mass ratio of the total mixed solution to the sterile injection water is 1: (8-12); and (4) filtering the mixed solution prepared in the step (3), pouring the filtered mixed solution into a glass bottle, and freeze-drying to obtain the omeprazole sodium freeze-dried powder injection. The omeprazole sodium freeze-dried powder injection prepared by the invention is clear in solution, good in stability and high in main drug content.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a freeze-dried powder injection of omeprazole sodium and a preparation method thereof. Background technique [0002] Omeprazole sodium is a proton pump inhibitor of gastric parietal cells, which can specifically inhibit the H+, K+-ATPase on the secretory microtubules formed by the apical membrane of the parietal cells and the tubular vesicles in the cytoplasm, thereby effectively inhibiting gastric acid production. secretion. Since H+, K+-ATPase is the last process of parietal cell acid secretion, omeprazole sodium has a strong ability to suppress acid. Omeprazole Sodium for Injection is widely used clinically, with rapid drug effect, which can reduce the irritation of gastrointestinal mucosa, and the freeze-dried powder injection is easy to store, convenient to transport and can ensure sterility and no pyrogen. Existing omeprazole sodium freeze-dried powder injection is ea...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/02A61K47/12A61K47/20A61P1/04
CPCA61K9/19A61K31/4439A61K47/02A61K47/12A61K47/20A61P1/04
Inventor 刘景萍刘全国陈克领李党王家韩玉燕陈俞竹吴玉涵纪子珍吴伟贞
Owner HAINAN HULUWA PHARMA GRP CO LTD
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