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Mosapride citrate tablet and preparation method thereof

A technology of mosapride citrate and tablet is applied to the field of tablet containing mosapride citrate and its preparation field, and can solve the problems of low dissolution rate, low melting point of citric acid, low bioavailability, etc. problem, to achieve the effect of less demanding particle size requirements, rapid drug dissolution, and simple preparation method

Active Publication Date: 2015-05-20
SHANGHAI PUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because mosapride citrate is a poorly soluble drug and is almost insoluble in water, the actual production of mosapride citrate oral solid preparations often encounters the problem of low dissolution rate or even unqualified
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
[0005] CN101816639B discloses a tablet containing mosapride citrate and a preparation method thereof. The method comprises adding mosapride citrate into absolute ethanol, heating in a water bath at 60°C to 65°C until completely dissolved, and then adding The water-soluble carrier material is stirred to dissolve, and then the solution is transferred to a rotary evaporator, and the ethanol is evaporated under reduced pressure at 60°C to form a solid dispersion, and then further processed into tablets, the process is relatively complicated
This patented technology uses citric acid as a solubilizer, but due to the low melting point of citric acid, it is easy to stick and punch during tablet compression

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020]

[0021] Preparation:

[0022] Dissolve the prescribed amount of povidone K15 in an appropriate amount of water, add the prescribed amount of mosapride citrate, stir to dissolve, and then use this solution as a binder, add lactose, microcrystalline cellulose and cross-linked polyvinyl chloride The mixed powder of ketone is granulated, dried at 60°C, granulated with a 14-mesh sieve, added with the prescribed amount of magnesium stearate, mixed evenly, and compressed into tablets.

Embodiment 2

[0024]

[0025] Preparation:

[0026] Dissolve the prescribed amount of povidone K15 in an appropriate amount of water, add the prescribed amount of mosapride citrate, stir to dissolve, and then use this solution as a binder to mix microcrystalline cellulose, pregelatinized starch and carboxylate The mixed powder of sodium methyl starch is granulated, dried at 55°C, sieved with a 20-mesh sieve, and the prescription amount of sodium stearate fumarate is added, mixed evenly, and compressed into tablets.

Embodiment 3

[0028]

[0029] Preparation:

[0030] Dissolve the prescribed amount of povidone K15 in an appropriate amount of water, add the prescribed amount of mosapride citrate, stir to dissolve, and then use this solution as a binder, add lactose, microcrystalline cellulose and cross-linked polyvinyl chloride The mixed powder of ketone is granulated, dried at 60°C, granulated through a 18-mesh sieve, added with prescribed amount of magnesium stearate, mixed evenly, and compressed into tablets.

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Abstract

The invention discloses a mosapride citrate tablet and a preparation method thereof. The tablet is obtained by virtue of wet granulation and tableting; a binder adopted for wet granulation is the aqueous solution of mosapride citrate and povidone K15. Compared with the prior art, the mosapride citrate tablet is quick in drug dissolution, stable in quality, simple in preparation process without complex preparation equipment, and prone to industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid oral preparation, in particular to a tablet containing mosapride citrate 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, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5375A61K47/32A61P1/14A61P1/08
Inventor 孙巧玲
Owner SHANGHAI PUKANG PHARMA
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