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Esomeprazole magnesium enteric pellet capsule and preparation method thereof

A technology of esomeprazole magnesium enteric-coated pellets and meprazole magnesium enteric-coated pellets, which is applied in the field of enteric-coated pellets and capsules and its preparation, and can solve the problems of poor preparation stability, insufficient oral release, and easy degradation. problems, to achieve good acid resistance, good release effect

Inactive Publication Date: 2015-12-09
广东彼迪药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Based on this, in order to overcome the defects of the above-mentioned prior art, the invention provides a kind of esomeprazole magnesium enteric-coated pellet capsule and a new preparation method thereof, which effectively solves the problem of esomeprazole magnesium and its hydrate encountering acid Easy to degrade, poor preparation stability, insufficient oral release, complicated operation process, etc.

Method used

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  • Esomeprazole magnesium enteric pellet capsule and preparation method thereof
  • Esomeprazole magnesium enteric pellet capsule and preparation method thereof
  • Esomeprazole magnesium enteric pellet capsule and preparation method thereof

Examples

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Embodiment 1～4 comparative example 1

[0043] Examples 1-4 Comparative Examples 1-2 Esomeprazole magnesium enteric-coated pellets capsules and preparation method thereof

[0044] The formulations of esomeprazole magnesium enteric-coated pellets and capsules in Examples 1-4 and Comparative Examples 1-2 are as described in Table 1. The particle size distribution diagrams of the active pharmaceutical ingredients in the following examples 1 to 4 are as follows figure 1 shown.

[0045] The formula (unit: g) of the esomeprazole magnesium enteric-coated pellet capsule of table 1 embodiment 1~4

[0046]

[0047] see figure 2 Schematic diagram of the coating basic process, the preparation method of the pellet capsules of the above examples 1-4 and comparative examples 1-2 is as follows:

[0048] 1. Preparation of drug-loaded layer pellets

[0049] (1) Preparation of the drug-loaded layer coating solution: weigh each component of the drug-loaded layer composition according to the prescription in Table 1, take part of...

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Abstract

The invention discloses an esomeprazole magnesium enteric pellet capsule and a preparation method thereof. The esomeprazole magnesium enteric pellet capsule is formed by filling a capsule with enteric pellets, and each enteric pellet sequentially comprises a blank pellet core, a drug carrying layer, an isolating layer, an enteric layer and a protecting layer from inside to outside. Grain particle and pH value of active drug ingredients of each drug carrying layer are controlled, degradation caused by the fact that active ingredients are combined with acidic enteric coatings is prevented due to using of each isolating layer, adhesion of the enteric pellets is avoided due to using of each protecting layer, and fluidized bed coating technology is adopted, so that the esomeprazole magnesium enteric pellet capsule is high in stability and release degree, remarkable in gastric acid inhibiting effect and supportive of being widely applied in treatment of gastroesophageal reflux disease and digestive ulcer with positive helicobacter pylori. The preparation method is simple, low in production cost, environment friendly and suitable for industrialized production of the esomeprazole magnesium enteric pellet capsule.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. More specifically, the invention relates to an enteric-coated pellet capsule with esomeprazole magnesium as an active ingredient and a preparation method thereof. Background technique [0002] With the accelerated pace of modern life, people's diet rules cannot be guaranteed, and the incidence of stomach problems is getting higher and higher. Acute or chronic stomach problems will almost always occur to varying degrees in a person's life. Gastrointestinal diseases are common diseases and frequently-occurring diseases, and the total incidence rate accounts for about 20% of the population. The older you are, the higher the incidence rate is, especially the middle-aged and elderly people over 50 years old. It is more common in men than in women. If it is not treated in time, it will recur for a long time and easily transform into cancer. Gastrointestinal diseases have always been regarded...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/4439A61K47/02A61K47/38A61K47/32A61P1/04
Inventor 谭银合余思琴杨松明杨新明
Owner 广东彼迪药业有限公司
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