Esomeprazole magnesium enteric capsule and preparation method thereof

A technology for enteric coating of esomeprazole magnesium and esomeprazole, which is applied in the field of pharmaceutical preparations, can solve the problems of poor solubility of esomeprazole magnesium, influence on stability, influence on illumination, etc. Ensure safety and stable blood concentration

Inactive Publication Date: 2015-09-30
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the stability of esomeprazole magnesium is also affected by humidity, heat, organic solvents, and to a lesser extent, light.
Even under normal storage and use conditions, the discolorati

Method used

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  • Esomeprazole magnesium enteric capsule and preparation method thereof

Examples

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Example Embodiment

[0021] Example 1

[0022] An enteric-coated capsule of esomeprazole magnesium, which is made by mixing and filling immediate-release enteric-coated pellets and sustained-release enteric-coated pellets, and the composition of each component is as follows by weight percentage: immediate-release enteric-coated pellets 13.0% of pellets, 87.0% of slow-release enteric-coated pellets; both the quick-release enteric-coated pellets and the slow-release enteric-coated pellets include a core, a drug-coated layer, an isolation layer, and an enteric-coated layer.

[0023] The drug layer formula of the immediate-release enteric-coated pellets: microcrystalline cellulose seed core: 50g, esomeprazole magnesium: 400g, hypromellose: 133g, purified water: 1771g. Immediate-release enteric-coated pellets isolation layer formula: upper drug layer pellets: 250g, hydroxypropyl cellulose: 21g, talcum powder: 38g, magnesium stearate: 3g, purified water: 522g. Enteric-coated layer formula of immediate-...

Example Embodiment

[0027] Example 2

[0028] An enteric-coated capsule of esomeprazole magnesium, which is made by mixing and filling immediate-release enteric-coated pellets and sustained-release enteric-coated pellets, and the composition of each component is as follows by weight percentage: immediate-release enteric-coated pellets 32.0% of pellets, 68.0% of sustained-release enteric-coated pellets; both the rapid-release enteric-coated pellets and the sustained-release enteric-coated pellets include a pellet core, a drug-coated layer, an isolation layer, and an enteric-coated layer.

[0029] Drug layer formula of immediate-release enteric-coated pellets: microcrystalline cellulose seed core: 250g, esomeprazole magnesium: 500g, hypromellose: 167g, purified water: 2214g. The formulation of the isolation layer of the immediate-release enteric-coated pellets: upper drug layer pellets: 250g, hydroxypropyl cellulose: 19g, talcum powder: 34g, magnesium stearate: 3g, purified water: 466g. Enteric-co...

Example Embodiment

[0033] Example 3

[0034] An enteric-coated capsule of esomeprazole magnesium, which is made by mixing and filling immediate-release enteric-coated pellets and sustained-release enteric-coated pellets, and the composition of each component is as follows by weight percentage: immediate-release enteric-coated pellets 51.0% of pellets, 49.0% of sustained-release enteric-coated pellets; both the rapid-release enteric-coated pellets and the sustained-release enteric-coated pellets include a core, a drug-coated layer, an isolation layer, and an enteric-coated layer.

[0035] Drug layer formula of immediate-release enteric-coated pellets: microcrystalline cellulose seed core: 250g, esomeprazole magnesium: 600g, hypromellose: 200g, purified water: 2657g. Immediate-release enteric-coated pellets isolation layer formula: upper drug layer pellets: 250g, hydroxypropyl cellulose: 16g, talcum powder: 29g, magnesium stearate: 2g, purified water: 395g. Enteric-coated layer formula of immediate...

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Abstract

The invention discloses an esomeprazole magnesium enteric capsule and a preparation method thereof. The esomeprazole magnesium enteric capsule is prepared from quick release enteric pellets and slow release enteric pellets through blending and filling, and comprises the following components by weight percent: 13.0-51.3% of quick release enteric pellets and 48.7-87.0% of slow release enteric pellets, wherein all the quick release enteric pellets and the slow release enteric pellets comprise pellet cores, upper medicine layers, isolated layers and enteric layers. According to the esomeprazole magnesium enteric capsule and the preparation method thereof, the drug release behavior of the multiple-unit type preparation is the sum of the drug release behaviors of a plurality of pellets forming a dose, and the defect in the preparation of an individual pellet cannot cause serious effects to the drug release behavior of the whole preparation, so that the security of clinical medicine use is guaranteed; the medicine taking times for patients are decreased, the irritation of the medicine to the intestinal canal is reduced, the blood-medicine concentration is stable, and the peak-valley phenomenon is avoided.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a capsule of esomeprazole magnesium, in particular to an esomeprazole magnesium sustained-release enteric-coated capsule. Background technique [0002] Esomeprazole magnesium is a proton pump inhibitor antiulcer drug, which has a good therapeutic effect on peptic ulcer, can treat duodenal ulcer, gastric ulcer and esophagitis, and can eliminate refractory ulcer crisis. It is also effective in the treatment of Zoelberger syndrome. The effect is remarkable, and it has excellent curative effect on peptic ulcer and severe esophageal reflux ulcer that cannot be effectively treated by conventional therapy, and the side effects are rare. [0003] The chemical name of esomeprazole magnesium is 2-(S-5-methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl-1H -Benzimidazole magnesium trihydrate, the structural formula is as follows: [0004] [000...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K31/4439A61P1/04
Inventor 吕旭幸王丽云周亚健冯超敏戴兴祥陈洁
Owner ZHEJIANG YATAI PHARMA
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