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Famotidine composition for injection and preparation method thereof

A famotidine and composition technology, applied in the field of famotidine composition for injection and preparation thereof, can solve the problems of no improvement and the like, and achieve the effects of improving molding performance, good stability, and uniform and stable quality

Inactive Publication Date: 2012-02-01
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] None of the existing known technologies propose improvements to the above defects

Method used

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  • Famotidine composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] prescription:

[0047] Famotidine 200g

[0048] L-Aspartic Acid 80g

[0049] Add water for injection to 20Kg

[0050] Preparation:

[0051] Put famotidine and L-aspartic acid in a preparation tank, add water for injection to 20Kg, stir to completely dissolve and mix evenly;

[0052] Sterile filtration and packaging:

[0053] Filter the famotidine solution through a microporous membrane into a sterile room, divide it into a vial in a volume of 2ml / piece, and half stopper;

[0054] Vacuum Freeze Drying:

[0055] a. Pre-freezing: put the subpackaged famotidine liquid in the freeze dryer, lower the temperature of the front box to below -30°C, and keep warm until the famotidine liquid is completely frozen;

[0056] b. Rear box cooling: use the compressor to cool the rear box cold trap, and keep the rear box cold trap temperature below –45℃;

[0057] c. Drying: Turn on the vacuum pump and the partition valve, start heating, sublimation and drying, and the f...

Embodiment 2

[0059] prescription:

[0060] Famotidine 200g

[0061] L-Aspartic Acid 80g

[0062] Water for injection added to 40Kg

[0063] Preparation:

[0064] Put famotidine and L-aspartic acid in a preparation tank, add water for injection to 40Kg, stir to completely dissolve and mix evenly;

[0065] Sterile filtration and packaging:

[0066] Filter the famotidine solution through a microporous membrane into a sterile room, divide it into a vial in a volume of 4ml / piece, and half stopper;

[0067] Vacuum Freeze Drying:

[0068] a. Pre-freezing: put the subpackaged famotidine liquid in the freeze dryer, lower the temperature of the front box to below -30°C, and keep warm until the famotidine liquid is completely frozen;

[0069] b. Rear box cooling: use the compressor to cool the rear box cold trap, and keep the rear box cold trap temperature below –45℃;

[0070] c. Drying: Turn on the vacuum pump and the partition valve, start heating, sublimation and drying, and the...

Embodiment 3

[0072] prescription:

[0073] Famotidine 200g

[0074] Mannitol 400g

[0075] L-Aspartic Acid 80g

[0076] Add water for injection to 20Kg

[0077] Preparation:

[0078] Put famotidine, mannitol and L-aspartic acid in a preparation tank, add water for injection to 20Kg, stir to dissolve completely and mix well;

[0079] Sterile filtration and packaging:

[0080] Filter the famotidine solution through a microporous membrane into a sterile room, divide it into a vial in a volume of 2ml / piece, and half stopper;

[0081] Vacuum Freeze Drying:

[0082] a. Pre-freezing: put the subpackaged famotidine liquid in the freeze dryer, lower the temperature of the front box to below -30°C, and keep warm until the famotidine liquid is completely frozen;

[0083] b. Rear box cooling: use the compressor to cool the rear box cold trap, and keep the rear box cold trap temperature below –45℃;

[0084] c. Drying: Turn on the vacuum pump and the partition valve, start heatin...

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Abstract

The invention relates to a famotidine composition for injection. The famotidine composition comprises famotidine and L-aspartic acid; and the preparation method of the composition comprises the following steps of: 1) preparing: placing the famotidine and the L-aspartic acid in a preparation tank in a weight proportion of 1 to 0.4, filling injection water, stirring to completely dissolve the materials and uniformly mixing; 2) performing aseptic filtration, sub-packaging and partially stoppering; and 3) freeze-drying under vacuum to prepare the composition. The composition has a simple formula,an advanced process, good appearance molding, uniform and stable quality, uniform and accurate content, no moisture and high stability.

Description

technical field [0001] The invention relates to a famotidine composition for injection and a preparation method thereof. The famotidine composition prepared by the method can be used for gastric and duodenal ulcers, reflux esophagitis, Treatment of upper gastrointestinal hemorrhage (due to peptic ulcer, acute stress ulcer, hemorrhagic gastritis), Zoe's syndrome and other diseases. Background technique [0002] The chemical name for famotidine is 3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-N-sulfamoylpropionamidine. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 8 H 15 N 7 O 2 S 3 [0006] Molecular weight: 337.45. [0007] Peptic ulcer, including gastric and duodenal ulcers, is a common disease with an average incidence of 8 to 10% in the population. For the treatment of peptic ulcer, we should not put too much emphasis on eliminating the attacking effect of gastric acid and pepsin, but should focus on adjusting the bala...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/426A61P1/04A61P1/00A61J3/02
Inventor 赵小伟叶东李晓昕
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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