Famotidine composition for injection and preparation method thereof

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...

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