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Capsule containing mosapride citrate and preparation method thereof

A technology of mosapride citrate and capsules, which is applied in the field of pharmaceutical preparations, can solve the problems of unqualified, low dissolution rate and the like, and achieves the effects of low production cost, high dissolution rate and rapid dissolution

Active Publication Date: 2018-07-27
科贝源(北京)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Since mosapride citrate is a poorly soluble drug, the actual production of mosapride citrate oral solid preparations often encounters the problem of low dissolution rate or even unqualified
Therefore, it is necessary to promote the dissolution of the drug, solve the problem of low dissolution rate of the mosapride citrate preparation, and improve the bioavailability of the drug

Method used

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  • Capsule containing mosapride citrate and preparation method thereof
  • Capsule containing mosapride citrate and preparation method thereof
  • Capsule containing mosapride citrate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029]

[0030] Preparation process: take the prescribed amount of mosapride citrate dihydrate (particle size D90 is 9.56 μm), lactose, microcrystalline cellulose, and croscarmellose sodium are mixed in a wet mixing granulator After 10 minutes, add 10% povidone aqueous solution to make soft material, pass through a 24-mesh sieve to granulate, dry at 60°C, pass the dry granules through a 24-mesh sieve for granulation, add the prescribed amount of magnesium stearate and silicon dioxide to mix Uniform, determine the content of intermediates.

[0031] The filling volume is converted according to the content, and the capsules are filled to control the filling volume difference to be no more than 7.5%.

Embodiment 2

[0033]

[0034] Preparation process: take the prescribed amount of mosapride citrate dihydrate (particle size D90 is 9.56 μm), lactose, microcrystalline cellulose, and croscarmellose sodium are mixed in a wet mixing granulator After 10 minutes, add 10% povidone aqueous solution to make soft material, pass through a 24-mesh sieve to granulate, dry at 60°C, pass the dry granules through a 24-mesh sieve for granulation, add the prescribed amount of magnesium stearate and silicon dioxide to mix Uniform, determine the content of intermediates.

[0035] The filling volume is converted according to the content, and the capsules are filled to control the filling volume difference to be no more than 7.5%.

Embodiment 3

[0037]

[0038] Preparation process: take the prescribed amount of mosapride citrate dihydrate (particle size D90 is 13.93 μm), lactose, starch, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose in a wet mixing granulator Mix for 10 minutes, add 10% hydroxypropyl cellulose aqueous solution to make soft material, granulate through a 24-mesh sieve, dry at 60°C, pass the dry granules through a 24-mesh sieve for granulation, add magnesium stearate and talcum powder in the prescribed amount Mix well and measure the content of intermediates.

[0039] The filling volume is converted according to the content, and the capsules are filled to control the filling volume difference to be no more than 5.0%.

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Abstract

The invention relates to a capsule containing mosapride citrate and a preparation method thereof. The capsule includes drug granules and a capsule casing. The drug granules contain the mosapride citrate and / or a mosapride citrate dihydrate, a diluent, a binder, a disintegrating agent and a lubricant. The mosapride citrate in the capsule can be quickly dissolved out at high dissolution rate, so that bioavailability is increased. The formula and the preparation method are simple, have high controllability and low production cost, and are easy to achieve in industrial production.

Description

technical field [0001] The invention relates to a capsule containing mosapride citrate and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Mosapride citrate is a selective serotonin 4 (5-HT 4 ) receptor agonist, by stimulating 5-HT of cholinergic interneurons and myenteric plexuses in the gastrointestinal tract 4 receptors, promote the release of acetylcholine, thereby enhancing gastrointestinal motility, improving gastrointestinal symptoms in patients with functional dyspepsia, it does not affect the secretion of gastric acid, and has no side effects such as extrapyramidal system reactions and diarrhea, and is well tolerated good. [0003] Since mosapride citrate is a poorly soluble drug, the actual production of mosapride citrate oral solid preparations often encounters the problem of low dissolution rate or even failure. Therefore need to promote the dissolution of medicine, solve the problem of low dis...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/5375A61P1/14A61K9/16
CPCA61K9/1652A61K9/4816A61K9/4825A61K9/485A61K9/4858A61K31/5375A61K47/36A61K47/38
Inventor 满艳哲张建维
Owner 科贝源(北京)生物医药科技有限公司
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