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Omeprazole enteric-coated capsules and preparation method thereof

A technology of omeprazole intestine and omeprazole, which is applied in the field of pharmaceutical preparations, can solve the problems of acid resistance and stability that need to be further improved, and achieve the effects of easy operation, good reproducibility and good acid resistance

Active Publication Date: 2011-12-14
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the capsule has the advantage of rapid release in the small intestine, its acid resistance and stability need to be further improved

Method used

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  • Omeprazole enteric-coated capsules and preparation method thereof
  • Omeprazole enteric-coated capsules and preparation method thereof
  • Omeprazole enteric-coated capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 The preparation of omeprazole enteric-coated capsules

[0035] Prescription composition:

[0036]

[0037]

[0038] Preparation Process:

[0039] (1) After preparing a saturated aqueous solution of hydroxypropyl-β-cyclodextrin, pour it into a high-speed milk mixer at a speed of 3000r / min, stir at 35-38°C for 15min, add ammonium bicarbonate, and stir to dissolve;

[0040] (2) After dissolving omeprazole with ethanol, add it dropwise in a high-speed emulsion mixer, stirring at a rotating speed of 3000r / min for 55min;

[0041] (3) The resulting mixed solution is dried by spray drying, and the omeprazole cyclodextrin inclusion compound is collected, wherein the spray drying parameters are: inlet temperature 40°C-45°C, spray speed 5ml / min, and spray pressure of 5 bar;

[0042] (4) Add omeprazole inclusion compound and hydroxypropyl methylcellulose phthalate to 50% ethanol solution, stir and dissolve at 40-50°C, keep 45-50°C for rotary evaporation under ...

Embodiment 2

[0045] Example 2 Preparation of Omeprazole Enteric-Coated Capsules

[0046] Prescription composition:

[0047]

[0048] Preparation Process:

[0049] (1) After preparing a saturated aqueous solution of hydroxypropyl-β-cyclodextrin, pour it into a high-speed milk mixer at a speed of 2800r / min, stir at 35-38°C for 18min, add ammonium bicarbonate, and stir to dissolve;

[0050] (2) Omeprazole is dissolved in ethanol and then added dropwise to a high-speed emulsion mixer, stirring at a speed of 2500r / min for 50min;

[0051] (3) The resulting mixed solution is dried by spray drying, and the inclusion compound of omeprazole cyclodextrin is collected, wherein the spray drying parameters are: inlet temperature 40°C-45°C, spray speed 8ml / min, and spray pressure of 3 bar;

[0052] (4) Add omeprazole inclusion compound and hydroxypropyl methylcellulose phthalate to 50% ethanol solution, stir and dissolve at 40-50°C, keep 40-45°C for rotary evaporation under reduced pressure solven...

Embodiment 3

[0055] Example 3 Preparation of Omeprazole Enteric-Coated Capsules

[0056] Prescription composition:

[0057]

[0058] Preparation Process:

[0059] (1) After preparing a saturated aqueous solution of hydroxypropyl-β-cyclodextrin, pour it into a high-speed milk mixer at a speed of 3000r / min, stir at 35-38°C for 15min, add ammonium bicarbonate, and stir to dissolve;

[0060] (2) Omeprazole is dissolved in ethanol and then added dropwise to a high-speed emulsion mixer, stirring at a speed of 3000r / min for 50min;

[0061] (3) The resulting mixed solution is dried by spray drying, and the inclusion compound of omeprazole cyclodextrin is collected, wherein the spray drying parameters are: inlet temperature 40°C-45°C, spray speed 5ml / min, and spray pressure of 2 bar;

[0062] (4) Add omeprazole clathrate and hydroxypropyl methylcellulose phthalate to 50% ethanol solution, stir and dissolve at 40-50°C, keep 42-45°C for rotary evaporation under reduced pressure solvent to obta...

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Abstract

The invention discloses an omeprazole enteric-coated capsule, containing omeprazole, hydroxypropyl-beta-cyclodextrin, hydroxypropyl methylcellulose phthalate, mannitol and hydroxypropyl methylcellulose, wherein the mole ratio of omeprazole to hydroxypropyl-beta-cyclodextrin is 1: (0.8-2); and the weight ratio of omeprazole to hydroxypropyl methylcellulose phthalate to mannitol is 1: (10-18): (12-20). The omeprazole enteric-coated capsule disclosed by the invention has good acid resistance, dissolution and stability; and the preparation method has simple process, easiness in operation and goodreproducibility and is applicable for industrialization production.

Description

technical field [0001] The invention relates to a capsule of omeprazole and a preparation method thereof, in particular to an omeprazole enteric-coated capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Peptic ulcer is a common and frequently-occurring disease, and about 5% to 6% of people in the world have suffered from it. Although the drugs for the treatment of peptic ulcers have developed rapidly in recent years, the oldest antacids still have a corresponding status in the treatment of peptic ulcers. Antacids are mainly some inorganic weak bases. Commonly used drugs include sodium bicarbonate, magnesium hydroxide, magnesium trisilicate, etc., which can directly neutralize gastric acid after oral administration, and reduce or relieve the stimulation and corrosion effect of gastric acid on the ulcer surface; in the 1970s The emergence of H2 receptor antagonists such as cimetidine has sig...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/48A61P1/04
Inventor 不公告发明人
Owner YOUCARE PHARMA GROUP
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