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Omeprazole quick-release solid preparation and preparation method thereof

An omeprazole and preparation technology, which is applied to the oral immediate-release solid preparation containing omeprazole and the field of preparation thereof, can solve the problems of high process requirements, slow onset of drug effect, increased production cost and the like

Active Publication Date: 2010-09-01
JILIN LIHUA DRUG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to avoid the decomposition and damage of gastric juice, the existing proton pump inhibitors are mostly oral enteric-coated preparations, which need to be coated with enteric coating during production. This design has several disadvantages: (1) special packaging is required in the production process (2) Most of the enteric coating preparations are moisture sensitive; (3) Due to the release in the intestinal fluid, the onset of the drug slows down and the time to peak is delayed

Method used

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  • Omeprazole quick-release solid preparation and preparation method thereof
  • Omeprazole quick-release solid preparation and preparation method thereof
  • Omeprazole quick-release solid preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1-6

[0024] The preparation process is as follows:

[0025] 1) Pass the original and auxiliary materials through a 100-mesh sieve respectively and set aside.

[0026] 2) Make 5% Povidone K 30 Ethanol solution or 5% povidone K 30 Aqueous solution or 5% hypromellose aqueous solution, set aside.

[0027] 3) Get 100g of sodium bicarbonate and the recipe quantity omeprazole and recipe quantity Sodium Lauryl Sulfate or Polysorbate 80 and mix, combined with grinding and micronization treatment, denoted as Intermediate 1, measure the content of Intermediate 1 and Dissolution (measured by the internal control dissolution measurement method, when the dissolution reaches more than 75%, the material can be fed).

[0028] 4) Take intermediate 1 with 5% povidone K 30 Ethanol solution or 5% povidone K 30 The aqueous solution or 5% hydroxypropyl methylcellulose aqueous solution was granulated twice with 60 mesh, dried, and recorded as Intermediate 2, and the content and dissolution rate of In...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to an oral quick-release solid preparation containing omeprazole and a preparation method thereof. The preparation is a quick-acting proton pump inhibitor which is prepared from omeprazole, sodium bicarbonate and pharmaceutical auxiliary materials, wherein the sodium bicarbonate not only has the direct effect of inhibiting the secretion gastric acid, but also can prevent the omeprazole from being degraded by the gastric acid. The preparation of the invention has the advantages of quick action and long duration.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral immediate-release solid preparation containing omeprazole and a preparation method thereof. Background technique [0002] Omeprazole is an alternative to benzimidazole and the first proton pump inhibitor used in clinic. It can inhibit gastric acid secretion by specifically inhibiting the secretion of enzymes from gastric parietal cells. Clinically used for gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zollinger-Ellison syndrome (gastrinoma). [0003] But omeprazole is acid-sensitive, so it is rapidly degraded by stomach acid. In order to avoid the decomposition and destruction of gastric juice, the existing proton pump inhibitors are mostly oral enteric preparations, which need to be enteric-coated during production. This design has several shortcomings: (1) special packaging is required in the production process. (2) Most enteric-coated...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61P1/04
Inventor 关屹闫冬
Owner JILIN LIHUA DRUG
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