Sodium rebeprazole freeze-dried injection

A technology of rabeprazole sodium and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, powder transportation, medical preparations of non-active ingredients, etc., to achieve considerable economic and social benefits, uniform and stable quality, and convenient storage and transportation Effect

Inactive Publication Date: 2008-08-27
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a kind of rabeprazole sodium freeze-dried powder injection for the above deficiencies, the rabeprazole sodium freeze-dried powder injection prepared by the technical scheme of the present invention solves the problem of adding rabeprazole sodium diluent The problem of excessive insoluble particles caused by fine precipitation in sodium chloride and gluc

Method used

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  • Sodium rebeprazole freeze-dried injection
  • Sodium rebeprazole freeze-dried injection

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0022] Example 1:

[0023] prescription

[0024] Rabeprazole Sodium 21.3g

[0025] Meglumine 2g

[0026] Add water for injection to 2000ml

[0027]

[0028] 1,000 bottles total

[0029] Take the prescription amount of meglumine and place it in a sterile container, add water for injection to dissolve and mix uniformly, then add rabeprazole sodium, stir to dissolve and mix uniformly, determine the content of intermediates, and after passing the test in aseptic conditions Bottom, filter with 0.22μm microporous filter membrane until clear, fill the filtrate in a sterile vial, partially plugged with butyl rubber stopper, plate, freeze-dry, stopper, discharge, crimp, quality inspection, Rabeprazole sodium freeze-dried powder injection can be obtained in the package.

Example Embodiment

[0030] Example 2:

[0031] prescription

[0032] Rabeprazole Sodium 21.3g

[0033] Meglumine 4g

[0034] Sodium sulfite 2g

[0035] Add water for injection to 2000ml

[0036]

[0037] 1,000 bottles total

[0038] Take the prescription amount of meglumine and place it in a sterile container, add water for injection to dissolve and mix uniformly, then add rabeprazole sodium and sodium sulfite, stir to dissolve and mix uniformly, determine the intermediate content. Under the condition of bacteria, filter with 0.22μm microporous filter membrane to clear, fill the filtrate in sterile vials, partially plugged with butyl rubber stopper, plate, freeze-dry, stopper, take out the box, crimp, quality After inspection, the package is ready to get rabeprazole sodium freeze-dried powder injection.

Example Embodiment

[0039] Example 3:

[0040] prescription

[0041] Rabeprazole Sodium 21.3g

[0042] Meglumine 6g

[0043] Mannitol 10g

[0044] Sodium bisulfite 2g

[0045] Add water for injection to 2000ml

[0046]

[0047] 1,000 bottles total

[0048] Take the prescription amount of meglumine and place it in a sterile container, add water for injection to dissolve and mix well, then add rabeprazole sodium, mannitol and sodium bisulfite, stir to dissolve and mix well, determine the intermediate Content, after qualified, filter with 0.22μm microporous filter membrane to clear under aseptic conditions, fill the filtrate in sterile vials, partially stopper with butyl rubber stopper, plate, freeze-dry, stopper, and discharge Box, crimping, quality inspection, and packaging to get rabeprazole sodium freeze-dried powder injection.

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Abstract

The invention relates to rabeprazole sodium lyophilized powder for injection, which is used to treat gastric ulcer, duodenal ulcer, stomal ulcer, reflux esophagitis and Zollinger-Ellison syndrome. The freeze-dried powder for injection contains rabeprazole sodium and meglumine in the mass ratio of 1:0.1-1. The preparation method of the freeze-dried powder for injection comprises the following steps of putting the meglumine in an aseptic container, adding water for injection for dissolution and homogenization, adding the rabeprazole sodium and other adjuvant materials, stirring for dissolution and homogenization, measuring intermediate content, filtering with a microporous membrane with a particle size of 0.22 mum under aseptic conditions if the intermediate content is qualified until filtrate is clarified, filling the filtrate in aseptic vials, sealing the vials partially with butyl rubber stoppers, loading on a disk, freeze-drying, boxing, sealing, testing quality and packaging.

Description

Technical field [0001] The present invention relates to a freeze-dried powder injection of rabeprazole sodium. The freeze-dried powder injection of rabeprazole sodium prepared by the technical scheme of the present invention can be used to treat gastric ulcer, duodenal ulcer and anastomotic ulcer. Reflux is an indication for esophagitis, Zhuo-Eye's syndrome and other indications. Background technique [0002] Digestive system disease is one of the common frequently-occurring diseases, among which ulcer disease is the most common. Its total incidence is about 10-12% of the total population, and the main age of onset is 30-50 years old. 400,000 people in the United States suffer from peptic ulcer each year, mainly due to smoking, drinking, emotional stress, and drug stimulation (such as ASP, indomethacin, Yantongxikang, etc.). The incidence rate is 10% for men in the United States and 5 for women. %. The gastrointestinal morbidity rate is 5-10% in Japan and 12.3% in Germany. Accord...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
Inventor 李晓昕戴建国叶东戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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