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Mosapride citrate tablet and preparation method thereof

A technology of mosapride citrate and citric acid, which is applied in the field of medicine, can solve the problems of low mosapride citrate, low bioavailability, and slow dissolution, and achieve rapid drug dissolution and simple preparation process Effect

Active Publication Date: 2014-12-10
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because mosapride citrate is an insoluble drug, it is almost insoluble in water, often encounters the problem that the dissolution rate is low or even unqualified in the actual production of mosapride citrate oral solid preparation; and because citric acid The content of mosapride in the preparation is low, and it is difficult to fully mix during preparation. When performing dissolution testing, there are often problems of high and low, and large differences in dissolution between tablets
When there is an urgent need for quick-acting and high-efficiency preparations in clinical practice, solving the problem of low bioavailability of insoluble drugs due to low solubility and slow dissolution has always been a major problem in the pharmaceutical industry
[0007] In the prior art, there is no report on the problem of improving the solubility of mosapride citrate, but for the insoluble drug mosapride citrate, as long as the solubility can be improved, the dissolution rate should have a corresponding increase. improve

Method used

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  • Mosapride citrate tablet and preparation method thereof
  • Mosapride citrate tablet and preparation method thereof
  • Mosapride citrate tablet and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0022]

[0023]

[0024] Preparation Process:

[0025] Dissolve the recipe amount of citric acid in ethanol, add the recipe amount of mosapride citrate raw material, stir to dissolve, and dry the solution under reduced pressure at 50°C to obtain citric acid and mosapride citrate The mixture; the mixture is passed through a 16-mesh sieve, then mixed with the mixed powder of microcrystalline cellulose and sodium carboxymethyl starch, mixed with magnesium stearate, and compressed into tablets.

Embodiment 2

[0027]

[0028] Preparation Process:

[0029] Dissolve the recipe amount of citric acid in ethanol, add the recipe amount of mosapride citrate raw material, stir to dissolve, and dry the solution under reduced pressure at 55°C to obtain a mixture containing citric acid and mosapride citrate The mixture; the mixture is passed through a 20-mesh sieve, then mixed evenly with the mixed powder of microcrystalline cellulose, lactose, sodium carboxymethyl starch and crospovidone, mixed with magnesium stearate, and compressed into tablets.

Embodiment 3

[0031]

[0032] Preparation Process:

[0033] Dissolve the recipe amount of citric acid in ethanol, add the recipe amount of mosapride citrate raw material, stir to dissolve, and dry the solution under reduced pressure at 55°C to obtain a mixture containing citric acid and mosapride citrate The mixture; the mixture is passed through a 20-mesh sieve, then mixed evenly with the mixed powder of microcrystalline cellulose and crospovidone, mixed with magnesium stearate, and compressed into tablets.

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Abstract

The invention discloses a mosapride citrate tablet. The preparation method comprises the following steps: dissolving citric acid in ethanol, adding raw materials of mosapride citrate, stirring until the raw materials are dissolved, and drying the solution to obtain a mixture; mixing the mixture with pharmaceutically acceptable accessories and tabletting. Compared with the prior art, the tablet disclosed by the invention can be rapidly dissolved in water; and the preparation process is simple.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a mosapride citrate tablet and a preparation method thereof. Background technique [0002] Mosapride Citrate (Mosapride Citrate), the chemical name is 4-amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholinyl]methanol Base] benzamide citrate, white or off-white crystalline powder, odorless, slightly bitter. The melting point is 143-145°C. Soluble in dimethylformamide and pyridine, slightly soluble in methanol, insoluble in 95% ethanol, insoluble in water or ether. [0003] Mosapride citrate is a new third-generation gastric motility drug, mainly used for functional dyspepsia with heartburn, belching, nausea, vomiting, early satiety, upper abdominal distension and other gastrointestinal symptoms. The drug can enhance gastrointestinal motility, but does not affect gastric acid secretion, and has no side effects such as extrapyramidal reaction and diarrhea, and is well tol...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5375A61K47/10A61K47/12A61P1/14A61P1/00A61P1/08
Inventor 赵志全郝贵周荣维燕冯中
Owner LUNAN PHARMA GROUP CORPORATION
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