Esomeprazole magnesium enteric pill coated tablet and preparation method thereof

A technology of esomeprazole magnesium pellets and esomeprazole magnesium is applied in the directions of pill delivery, sugar-coated pills, pharmaceutical formulations, etc., and can solve the poor solubility of esomeprazole magnesium, the influence of stability, and the influence of light. and other problems, to achieve good drug content uniformity, ensure safety, and facilitate absorption.

Inactive Publication Date: 2015-05-06
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 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

Method used

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  • Esomeprazole magnesium enteric pill coated tablet and preparation method thereof
  • Esomeprazole magnesium enteric pill coated tablet and preparation method thereof
  • Esomeprazole magnesium enteric pill coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] A kind of preparation method of esomeprazole magnesium micropill enteric-coated tablet of the present embodiment, comprises the following steps: 1) preparation of quick-release enteric-coated micropill and slow-release enteric-coated micropill, wherein said quick-release enteric-coated micropill Both the pellets and the sustained-release enteric-coated pellets are composed of a drug-coated layer, an isolation layer, and an enteric-coated layer. The drug-coated layer, the isolation layer, and the enteric-coated layer are uniformly coated on the The seed core surface of the starting carrier; the drug-coated layer gain of the described immediate-release enteric-coated pellets is 213.2%, and the drug-coated layer gain of the described sustained-release enteric-coated pellets is 160%; the quick-release enteric-coated pellets The weight gain of the barrier layer of the enteric-coated pellets was 24.8%, and the weight gain of the barrier layer of the slow-release enteric-coated...

Embodiment 2

[0053] A kind of preparation method of esomeprazole magnesium micropill enteric-coated tablet of the present embodiment, comprises the following steps: 1) preparation of quick-release enteric-coated micropill and slow-release enteric-coated micropill, wherein said quick-release enteric-coated micropill Both the pellets and the sustained-release enteric-coated pellets are composed of a drug-coated layer, an isolation layer, and an enteric-coated layer. The drug-coated layer, the isolation layer, and the enteric-coated layer are uniformly coated on the The seed core surface of the initial carrier; the drug-coated layer gain of the described immediate-release enteric-coated pellets is 266.8%, and the drug-coated layer gain of the described sustained-release enteric-coated pellets is 160%; the quick-release enteric-coated pellets The weight gain of the barrier layer of the enteric-coated pellets is 22.4%, and the weight gain of the barrier layer of the slow-release enteric-coated p...

Embodiment 3

[0086] A kind of preparation method of esomeprazole magnesium micropill enteric-coated tablet of the present embodiment, comprises the following steps: 1) preparation of quick-release enteric-coated micropill and slow-release enteric-coated micropill, wherein said quick-release enteric-coated micropill Both the pellets and the sustained-release enteric-coated pellets are composed of a drug-coated layer, an isolation layer, and an enteric-coated layer. The drug-coated layer, the isolation layer, and the enteric-coated layer are uniformly coated on the The seed core surface of the starting carrier; the weight gain of the drug layer of the quick-release enteric-coated pellets is 320%, and the weight gain of the drug layer of the slow-release enteric-coated pellets is 266.8%; The weight gain of the barrier layer of the enteric-coated pellets is 18.8%, and the weight gain of the barrier layer of the slow-release enteric-coated pellets is 19.8%; The weight gain of the coating of the...

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Abstract

The invention discloses an esomeprazole magnesium enteric pill coated tablet. The esomeprazole magnesium enteric pill coated tablet is prepared from the following raw materials in percentage by mass: 4.7-19.7% of a quick-release enteric coated pill, 18.6-30.9% of a slow-release enteric coated pill, 60.7-66.4% of a buffer adjuvant, 1.0% of a lubricant and 2-3% of a thin film coating. The esomeprazole magnesium enteric pill coated tablet is less frequently taken by patients, is reduced in stimulation to the enteric canal, is stable in plasma concentration and is free from peak-valley phenomenon.

Description

technical field [0001] The invention relates to an enteric-coated tablet of esomeprazole magnesium pellets and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. 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-pyridine)methyl)sulfinyl-1H- Benzimidazole) magnesium trihydrate, the structural formula is as follows: [0004] [0005] Esomeprazole magnesium is easily degraded...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K31/4439A61P1/04
Inventor 吕旭幸戴兴祥冯超敏王丽云
Owner ZHEJIANG YATAI PHARMA
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