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A kind of itopride hydrochloride composition

A technology of itopride hydrochloride and tablet cores, applied in the field of itopride hydrochloride controlled-release tablet composition, can solve the problems that the release degree cannot reach 70%, cannot meet the clinical requirements of controlled-release preparations, etc. high rate effect

Active Publication Date: 2019-07-12
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the process of preparing the controlled-release preparation, we found that the single-chamber controlled-release preparation of itopride has the problem that the late release rate cannot reach 70%, which cannot meet the clinical requirements of the controlled-release preparation.

Method used

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  • A kind of itopride hydrochloride composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1, itopride hydrochloride 75g, polyethylene glycol 1000 60g, lactose 50g, mannitol 20g, micropowder silica gel 5g, povidone K30 8g. According to the preparation method described in the technical solution part of the present invention, 1000 tablet cores are prepared.

[0031] Coating layer: The mass ratio of ethyl cellulose to hypromellose is 35:10, dissolved in 90% ethanol, the weight of the coating is increased by 11%, dried, and laser-drilled with a pore size of 0.5 mm.

Embodiment 2

[0032] Example 2, Itopride hydrochloride 150g, polyethylene glycol 1000 90g, lactose 80g, mannitol 40g, micronized silica gel 9g, povidone K30 10g. According to the preparation method described in the technical solution part of the present invention, 1000 tablet cores are prepared.

[0033] The mass ratio of ethyl cellulose to hypromellose is 35:10, dissolved in 90% ethanol, and the weight of the coating is increased by 10%. Drying, laser drilling, hole diameter 0.5mm.

Embodiment 3

[0034] Example 3, Itopride hydrochloride 100g, polyethylene glycol 1000 75g, lactose 70g, mannitol 30g, micronized silica gel 7g, povidone K30 9g. According to the preparation method described in the technical solution part of the present invention, 1000 tablet cores are prepared.

[0035] The mass ratio of ethyl cellulose to hypromellose is 35:10, dissolved in 90% ethanol, and the weight gain of the coating is 10.5%. Drying, laser drilling, hole diameter 0.5mm.

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Abstract

The invention relates to an itopride hydrochloride controlled-release tablet combination. The technical scheme includes that an itopride hydrochloride controlled-release tablet comprises a tablet core and a coating layer; the itopride hydrochloride controlled-release tablet is characterized in that the tablet core contains itopride hydrochloride, polyethylene glycol 1000, lactose, mannitol, aerosil and povidone K30, and the coating layer contains ethyl cellulose and hydroxypropyl methyl cellulose. By the technical scheme, the problem that release rate of single-chamber itopride controlled-release tablets can reach about 70% only is solved, and a pharmaceutical which is safe, effective and high in utilization rate is provided for clinical medication.

Description

technical field [0001] The invention relates to an itopride hydrochloride controlled-release tablet composition. Background technique [0002] Itopride hydrochloride increases the release of acetylcholine through the antagonism of dopamine D2 receptors, and at the same time inhibits the decomposition of released acetylcholine through the inhibition of acetylcholinease, thereby enhancing the motility of the stomach and duodenum. This product has a good gastric motility effect and is suitable for various symptoms caused by functional dyspepsia. It can enhance the contractility of the stomach and duodenum, accelerate gastric emptying, and have the effect of inhibiting vomiting. [0003] The commercially available itopride preparation is a regular-release dosage form, 50 mg per tablet, 1 tablet each time, 3 times a day for patients. No controlled-release itopride tablets are marketed. [0004] Ordinary itopride tablets are taken 3 times a day, and the blood drug concentration ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/22A61K31/166A61K47/32A61K47/38A61K47/26A61K47/10A61K47/04A61P1/00A61P1/08A61P1/14
Inventor 付玉麦常秀娟邹元华
Owner DISHA PHARMA GRP
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