Esomeprazole magnesium enteric capsule and preparation method thereof

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...

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 discoloration of the preparation can be found due to the degradation of esomeprazole magnesium; at the same time, the solubility of esomeprazole magnesium is poor, and there is a problem of slow onset of action

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