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Domperidone maleate tablet and preparation process thereof

A technology of perperidone tablet and maleic acid, applied in the field of domperidone maleate tablet and preparation thereof, can solve the problems of inconvenient taking of ordinary tablets, drug precipitation, increase production cost and the like, achieve the effect of improving dissolution, increase Stability and superior quality

Active Publication Date: 2015-01-07
NANJING CHANGAO PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, domperidone has common tablets and suspensions, but these preparations have defects in varying degrees. The common tablets are not convenient enough to take, and the suspensions will be precipitated when stored for a long time, which will affect the absorption of the medicine. Due to the above dosage forms There are above obvious deficiencies, and there is an urgent need to develop new oral preparations with better effects
[0005] CN 1850079A discloses a preparation method of domperidone maleate, but the method is mainly to provide bioavailability by micronizing the raw material, in order to realize the micronization, extra unconventional equipment must be used, which increases the production cost

Method used

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  • Domperidone maleate tablet and preparation process thereof
  • Domperidone maleate tablet and preparation process thereof
  • Domperidone maleate tablet and preparation process thereof

Examples

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reference example 1

[0017]

[0018] Preparation Process

[0019] Pass domperidone maleate and all auxiliary materials through a 100-mesh sieve, and set aside; weigh the prescribed amount of microcrystalline cellulose, starch, sodium carboxymethyl starch, pass through a 80-mesh sieve and mix with the main ingredient, and add povidone K30 The pure aqueous solution made of 38ml of pure water is a binder soft material, granulated with a 16-mesh sieve, dried at 65°C for 1 hour, and granulated at 16 mesh; Slice and serve.

reference example 2

[0021]

[0022] Preparation Process

[0023] Pass domperidone maleate and all auxiliary materials through a 100-mesh sieve respectively, and set aside; weigh the prescribed amount of microcrystalline cellulose, starch, and half of the sodium carboxymethyl starch, pass through a 80-mesh sieve and mix with the main ingredient, and use polyvinyl chloride The pure aqueous solution prepared by adding 38ml of pure water to ketone K30 is a soft material made of adhesive, granulated with a 16-mesh sieve, dried at 65°C for 1 hour, and granulated with a 16-mesh; weigh the prescribed amount of silicon dioxide, magnesium stearate and Half of the prescription amount of sodium carboxymethyl starch is blended and compressed into tablets.

Embodiment 1

[0025]

[0026] Preparation Process

[0027] Pass domperidone maleate and all auxiliary materials through a 100-mesh sieve respectively, and set aside; weigh the prescribed amount of microcrystalline cellulose, starch, and half of the sodium carboxymethyl starch, pass through a 80-mesh sieve and mix with the main ingredient, and use polyvinyl chloride The pure aqueous solution prepared by adding 38ml of pure water to ketone K30 is a soft material made of adhesive, granulated with a 16-mesh sieve, dried at 65°C for 1 hour, and granulated with a 16-mesh; weigh the prescribed amount of silicon dioxide, magnesium stearate and Half of the prescription amount of sodium carboxymethyl starch is blended and compressed into tablets.

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Abstract

The invention discloses a tablet consisting of domperidone maleate serving as an active component, diluent from microcrystalline cellulose and starch, disintegrating agent from sodium carboxymethyl starch, adhesive agent from povidone, glidant from silicon dioxide, and magnesium stearate from lubricant. The domperidone maleate table is quick in disintegration, so that the dissolution effect can be remarkably improved, and the stability can be improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a domperidone maleate tablet and a preparation process thereof. Background technique [0002] Domperidone is a drug for digestive system diseases developed by the Belgian Janssen Pharmaceutical Company. This product is a peripheral dopamine receptor antagonist with strong effect, acts directly on the gastrointestinal wall, can moderately increase the tension of the lower esophageal sphincter, prevent gastro-esophageal reflux, regulate and restore the movement of the upper part of the gastrointestinal tract; Suppresses nausea, vomiting. Does not affect gastric acid secretion. Absorbed rapidly after oral administration. [0003] According to literature reports, domperidone is not only used for chronic gastritis, atrophic gastritis, biliary reflux meteor gastritis and reflux esophagitis for indigestion, nausea, vomiting, stomach burning sensation; it is also used for fu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/454A61K47/38A61K47/32A61P1/08A61P1/04A61P1/14
Inventor 吴小涛吴苏敏宋祥珍薛晓兵朱月刘经辉曹芳李纬黄海燕杨晓兵
Owner NANJING CHANGAO PHARM CO LTD
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