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Omeprazole sodium for injection and preparation method thereof

A technology for omeprazole sodium and injection, which is applied in the field of medicine and can solve the problems of small effect and poor clarity

Inactive Publication Date: 2011-03-23
SHANGHAI CHENPON PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, tests have shown that although citric acid has a certain chelation effect, the effect is small, and the freeze-dried powder has disadvantages such as poor clarity after being formulated into a solution.

Method used

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  • Omeprazole sodium for injection and preparation method thereof
  • Omeprazole sodium for injection and preparation method thereof
  • Omeprazole sodium for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Omeprazole sodium preparation for injection consists of the following formulations:

[0041] Omeprazole sodium (calculated as omeprazole) 40g

[0042] Disodium edetate 0.5g

[0043] Add sterile water for injection to 2000mL

[0044] Freeze-dried to make 1000 bottles

[0045] Preparation steps include:

[0046] 1) Add omeprazole sodium and edetate disodium into sterile water for injection, dissolve completely, add sterile water for injection to 2000mL, and prepare omeprazole sodium solution;

[0047] 2) Adjust the pH value of the solution obtained in step 1) to 11.10 with 0.5 mol / L sodium hydroxide, add activated carbon with a volume of 0.1% of the solution, and obtain the filtrate after fine filtration;

[0048] 3) The filtrate obtained in step 2) is divided into bottles and freeze-dried to obtain omeprazole sodium freeze-dried powder injection. The freeze-drying process is as follows:

[0049] Samples were pre-frozen at -45°C for 2 hours and samples were snap-fro...

Embodiment 2

[0052] Omeprazole sodium preparation for injection consists of the following formulations:

[0053] Omeprazole sodium (calculated as omeprazole) 40g

[0054] Disodium edetate 0.5g

[0055] Add sterile water for injection to 2000mL

[0056] Freeze-dried to make 1000 bottles

[0057] Preparation steps include:

[0058] 1) Add omeprazole sodium and edetate disodium into sterile water for injection, dissolve completely, add sterile water for injection to 2000mL, and prepare omeprazole sodium solution;

[0059] 2) Adjust the pH value of the solution obtained in step 1) to 10.60 with 0.5 mol / L sodium hydroxide, add activated carbon with a solution volume of 0.15%, and obtain the filtrate after fine filtration;

[0060] 3) The filtrate obtained in step 2) is divided into bottles and freeze-dried to obtain omeprazole sodium freeze-dried powder injection. The freeze-drying process is as follows:

[0061] Samples were pre-frozen at -45°C for 2.5 hours and samples were snap frozen ...

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PUM

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Abstract

The invention relates to an omeprazole sodium preparation for injection and a preparation method thereof. The omeprazole sodium preparation for injection is prepared from omeprazole sodium, ethylene diamine tetraacetic acid disodium and sterile water for injection by freeze-drying. The preparation method comprises the following steps of: dissolving the omeprazole sodium and the ethylene diamine tetraacetic acid disodium in the sterile water for injection, adding the sterile water for injection until the volume is 2,000ml, regulating pH value, decolorizing by using activated carbon, performing fine filtration and freeze-drying. The omeprazole sodium for injection provided by the invention has the characteristics of low moisture content, high stability and the like.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a pharmaceutical preparation and a preparation method thereof, in particular to a preparation of omeprazole sodium for injection and a preparation method thereof. Background technique [0002] Omeprazole sodium for injection, its chemical name is: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinic acid Acyl}-1H-benzimidazole sodium salt monohydrate, its structural formula is as follows: [0003] [0004] Omeprazole 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 the secretion of gastric acid . Due to its strong acid-suppressing effect, it can not only non-competitively inhibit gastric acid secretion caused by gastrin, histamine, choline and food, stimulate the vag...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/18A61K9/19A61P1/00A61P1/04
Inventor 吴晓毅杨世霆杜狄峥
Owner SHANGHAI CHENPON PHARM TECH CO LTD
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