Famotidine composition for injection and preparation method thereof

A famotidine and composition technology, which is applied to the famotidine composition for injection and the field of preparation thereof, can solve the problems such as no improvement, and achieve the effects of improving molding performance, uniform and accurate content, and good stability

Inactive Publication Date: 2011-02-16
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 technologi

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 the preparation tank, add water for injection to 20Kg, stir to dissolve completely and mix evenly;

[0052] Sterile filtration, packing:

[0053] Filter the famotidine solution through a microporous membrane into a sterile room, dispense it into cillin bottles at a volume of 2ml / bottle, and half-stopper;

[0054] Vacuum Freeze Drying:

[0055] a. Pre-freezing: Put the subpackaged famotidine liquid into 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 refrigeration: use the compressor to cool the rear box cold trap, and keep the temperature of the rear box cold trap below -45°C;

[0057] c. Drying: Turn on the vacuum pump and the septum valve, start the sublimation dryin...

Embodiment 2

[0059] prescription:

[0060] Famotidine 200g

[0061] L-Aspartic Acid 80g

[0062] Add water for injection to 40Kg

[0063] Preparation:

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

[0065] Sterile filtration, packing:

[0066] Filter the famotidine solution into a sterile room through a microporous membrane, dispense it into cillin bottles at a volume of 4ml / bottle, and half-stopper;

[0067] Vacuum Freeze Drying:

[0068] a. Pre-freezing: Put the subpackaged famotidine liquid into 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 refrigeration: use the compressor to cool the rear box cold trap, and keep the temperature of the rear box cold trap below -45°C;

[0070] c. Drying: Turn on the vacuum pump and the septum valve, start the sublimation dryin...

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 evenly;

[0079] Sterile filtration, packing:

[0080] Filter the famotidine solution through a microporous membrane into a sterile room, dispense it into cillin bottles at a volume of 2ml / bottle, and half-stopper;

[0081] Vacuum Freeze Drying:

[0082] a. Pre-freezing: Put the subpackaged famotidine liquid into 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 refrigeration: use the compressor to cool the rear box cold trap, and keep the temperature of the rear box cold trap below -45°C;

[0084] c. Drying: Turn on the vacuum pump and the septu...

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PUM

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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 present 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 bleeding (caused by peptic ulcer, acute stress ulcer, hemorrhagic gastritis), Zoe-Ellison syndrome and other diseases. Background technique [0002] The chemical name of 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 rate of 8-10% in the population. For the treatment of peptic ulcer, the elimination of the attacking effect of gastric acid and pepsin should not be emphasized too much, but the balance betw...

Claims

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Application Information

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