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Mosapride citrate preparation and preparation method thereof

A mosapride citrate and lubricant technology, which is applied in the field of medicine, can solve the problems of complex preparation process, slow dissolution, poor stability, etc., and achieve the effects of good taste, increased absorption, and guaranteed stability

Active Publication Date: 2018-02-13
LUNAN BETTER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It solves the problems of slow dissolution, poor stability and complex preparation process in the prior art

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030]

[0031] Preparation Process:

[0032] (1) The preparation method of 12kg hydroxypropyl-β-cyclodextrin and 4kg mosapride citrate to form an inclusion compound: take 12kg hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make saturated Aqueous solution, 4kg mosapride citrate is passed through 120 mesh sieves, is dissolved in the dehydrated ethanol solution of citric acid with an appropriate pH value of 6.0, under magnetic stirring, the mosapride citrate alcohol solution is slowly Slowly add the saturated aqueous solution of hydroxypropyl-β-cyclodextrin, continue to stir at room temperature for 2-4 hours after all the addition is complete, and remove most of the ethanol by rotary evaporation at 40-45°C. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hours and the temperature is -50°C. When the temperature of the cold trap in the freeze-drying box reaches -50°C, put the sample in, vac...

Embodiment 2

[0035]

[0036]

[0037] Preparation Process:

[0038] (1) The preparation method of mosapride citrate inclusion compound is with embodiment 1.

[0039] (2) Mix the obtained clathrate, lactose, pregelatinized starch low-substituted hydroxypropyl cellulose evenly, add 2% hydroxypropyl cellulose and 50% ethanol solution to make a soft material, and use a 18-mesh sieve to make granules; The granules are dried at 50°C for 5 minutes; after the granules are dried, low-substituted hydroxypropyl cellulose and magnesium stearate are added and mixed, sieved with a 20-mesh sieve, and finally compressed into tablets.

Embodiment 3

[0041]

[0042] Preparation Process:

[0043] (1) The preparation method of mosapride citrate inclusion compound is with embodiment 1.

[0044] (2) Mix the obtained clathrate, lactose, pregelatinized starch, and low-substituted hydroxypropyl cellulose evenly, add 2% hydroxypropyl cellulose and 50% ethanol solution to make a soft material, and use a 18-mesh sieve to make granules; The granules are dried at 60°C for 20 minutes; after the granules are dried, low-substituted hydroxypropyl cellulose and magnesium stearate are added and mixed, sieved with a 20-mesh sieve, and finally compressed into tablets.

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Abstract

The invention provides a mosapride citrate preparation and a preparation method thereof. The method comprises the following steps: firstly, forming an inclusion compound by hydroxypropyl-beta-cyclodextrin and mosapride citrate; then uniformly mixing the inclusion compound and pharmaceutical excipients; adding a proper amount of a binding agent to prepare a soft material; after granulating and drying, adding a lubricant; pelleting and carrying out tabletting. Mosapride citrate dispersed tablets prepared by the preparation method have the advantages of rapid disintegration speed and good stability, good mouthfeel, simple prescription, good flowability of mixed powder in the prescription, no sticking in a tabletting process and the like and the mosapride citrate preparation is widely appliedto the field of preparations of the mosapride citrate dispersed tablets. The preparation method has the advantages that a technological flow is effectively shortened, the production period is shortened and the exposure time of medicines in the air is reduced so that the stability of the medicines is ensured, and furthermore, the quality of products is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a mosapride citrate preparation and a preparation method thereof, in particular to a mosapride citrate dispersible 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, the structural formula is [0003] [0004] Mosapride citrate is 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. [0005] 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 enh...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5375A61K47/69A61P1/08A61P1/14
CPCA61K9/2059A61K31/5375
Inventor 张贵民刘阿利秦启飞
Owner LUNAN BETTER PHARMA
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