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Drug composition containing domperidone

A technology for domperidone and medicines, applied in the field of pharmaceutical preparations, can solve the problems of the combined oral dosage forms of domperidone and ilaprazole sodium that have not yet been reported, and achieve the effects of being convenient for long-term storage, easy to use, and good stability

Inactive Publication Date: 2015-01-21
GUANGZHOU WEIXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no report on the combined oral dosage form of domperidone and ilaprazole sodium

Method used

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  • Drug composition containing domperidone
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  • Drug composition containing domperidone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] (1) Drug core prescription

[0021]

[0022] Drug core preparation process: (1) Weigh half of the prescribed amount of cefdinir and pregelatinized starch, and mix through a 60-mesh sieve; weigh the prescribed amount of ilaprazole sodium and sodium hydroxide, and mix through a 60-mesh sieve sieve; mix the above two;

[0023] (2) Take by weighing half of the cefdinir of the prescription quantity, domperidone and maltodextrin of the prescription quantity, and mix through a 60 mesh sieve;

[0024] (3) Weigh 5 cp of hydroxypropyl methylcellulose (HPMC) in the prescribed amount, disperse with a small amount of hot water, add an appropriate amount of water to dissolve, and make pulp (8% (m / m)). The above-mentioned mixed material, magnesium stearate and slurry are made into a soft material, and the soft material is extruded and spheronized.

[0025] (2) Enteric coating

[0026]

[0027] Enteric coating layer preparation method: add 4% (m / v) sodium hydroxide aqueous sol...

Embodiment 2

[0029] (3) Drug core prescription

[0030]

[0031]

[0032] Drug core preparation process: (1) Weigh half of the prescribed amount of cefdinir and pregelatinized starch, and mix through a 60-mesh sieve; weigh the prescribed amount of ilaprazole sodium and sodium hydroxide, and mix through a 60-mesh sieve sieve; mix the above two;

[0033] (2) Take by weighing half of the cefdinir of the prescription quantity, domperidone and maltodextrin of the prescription quantity, and mix through a 60 mesh sieve;

[0034] (3) Weigh 5 cp of hydroxypropyl methylcellulose (HPMC) in the prescribed amount, disperse with a small amount of hot water, add an appropriate amount of water to dissolve, and make pulp (8% (m / m)). The above-mentioned mixed material, magnesium stearate and slurry are made into a soft material, and the soft material is extruded and spheronized.

[0035] (4) Enteric coating

[0036]

[0037] Enteric coating layer preparation method: add 4% (m / v) sodium hydroxide...

Embodiment 3

[0039] Embodiment 3: The optimum ratio screening test of ilaprazole and domperidone in the combination medicine of the present invention

[0040] In the comparative experiment, the active ingredients in the drug core of the present invention: domperidone and ilaprazole sodium were prepared into preparations of different specifications in different proportions, and the single PPI or H2-receptor antagonist was orally treated twice a day. For gastric ulcer and duodenal ulcer that cannot be effectively treated, the treatment effect data are as follows:

[0041] Table 1: Screening test for optimal ratio of ilaprazole and domperidone

[0042] Specification The overall cure rate of gastric ulcer Overall cure rate of duodenal ulcer Ilaprazole Sodium 150g / Domperidone 50g 70.2％ 71.5％ Ilaprazole Sodium 150g / Domperidone 100g 72.3％ 72.6％ Ilaprazole Sodium 150g / Domperidone 150g 74.0％ 73.0％ Ilaprazole Sodium 50g / Domperidone 100g 80.1％ 82.9％ I...

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Abstract

The invention relates to an enteric-coated oral drug containing domperidone. A drug core mainly contains 10-20% of domperidone, 4-8% of ilaprazole sodium, 15-25% of cefdinir, 15-25% of pregelatinized starch, 3-6% of magnesium stearate, 8-16% of sodium hydroxide, 10-20% of maltodextrin and 8-16% of hydroxypropyl methyl cellulose; a coating layer is mainly composed of 150 parts of micro pill cores containing active components, 150 parts of a component of which the brand is Eudragit L30D-55, 15 parts of hydroxypropyl methyl cellulose E5, 70 parts of a talcum powder, 15 parts of triethyl citrate, 1.5 parts of glyceryl monostearate and 500 parts of a 85% (v / v) ethanol-water solution; the drug is the enteric-coated oral drug used in treatment of gastric ulcer, duodenal ulcer, gastroesophageal reflux disease or functional dyspepsia.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition preparation containing domperidone. Background technique [0002] Domperidone is a dopamine receptor antagonist that specifically acts on the upper gastrointestinal tract and can effectively relieve symptoms of motility disorders in the upper gastrointestinal tract, especially for symptoms such as acid reflux, regurgitation, abdominal distension, and belching. Chinese patent application 031190421.1 provides a Dopan orally disintegrating tablet preparation, which consists of pharmaceutical active ingredients, fillers, flavoring agents, disintegrants, lubricants, and glidants. The pharmaceutical active ingredient of the application is a gastric motility drug; the disintegrant is selected from cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, cefdinir or their mixture; the corrective agent is selected from aspartame. And Chinese ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/454A61K9/16A61P1/14A61P1/04A61K31/4439
CPCA61K31/4439A61K31/454A61K31/546A61K2300/00
Inventor 李伟
Owner GUANGZHOU WEIXI PHARMA
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