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Omeprazole-containing enteric coated tablets

A technology for omeprazole and enteric-coated tablets, applied in the field of pharmaceutical preparations, can solve the problems of acid resistance and stability to be further improved, and achieve the effects of easy operation, good stability and good acid resistance

Active Publication Date: 2012-03-21
贝克诺顿(浙江)制药有限公司
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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 smal...

Method used

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  • Omeprazole-containing enteric coated tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The preparation of embodiment one enteric-coated tablet containing omeprazole

[0027] Prescription composition:

[0028]

[0029] Preparation Process:

[0030] (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;

[0031] (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;

[0032] (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 5 bar;

[0033] (4) Add omeprazole clathrate and cellulose acetate phthalate to 50% ethanol solution, stir and dissolve at 40-50°C, and keep 45-50°C to rotate the solvent under reduced pr...

Embodiment 2

[0036] The preparation of embodiment two enteric-coated tablets containing omeprazole

[0037] Prescription composition:

[0038]

[0039] Preparation Process:

[0040] (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;

[0041] (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;

[0042] (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;

[0043] (4) Add omeprazole clathrate and cellulose acetate phthalate into 50% ethanol solution, stir and dissolve at 40-50°C, keep 40-45°C to rotate and evaporate the solvent under reduc...

Embodiment 3

[0045] The preparation of embodiment three enteric-coated tablets containing omeprazole

[0046] Prescription composition:

[0047]

[0048]

[0049] Preparation Process:

[0050] (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;

[0051] (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;

[0052] (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;

[0053] (4) Add omeprazole clathrate and cellulose acetate phthalate into 50% ethanol solution, stir and dissolve at 40-50°C, keep 42-45°C to rotate and evaporate the solvent...

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Abstract

The invention relates to omeprazole-containing enteric coated tablets, which contain omeprazole, hydroxypropyl-beta-cyclodextrin, cellulose acetate phthalic ester, mannitol and hydroxypropyl methylcellulose, wherein the molar ratio of the omeprazole to the hydroxypropyl-beta-cyclodextrin is 1:(0.8-2), and the weight ratio of the omeprazole to hydroxypropyl methylcellulose phthalate to the mannitol is 1:(8-15):(12-20). The omeprazole enteric coated capsules have high acid resistance, dissolution rates and stability, and a preparation process is simple, easy to operate and high in repeatabilityand is suitable for industrial production.

Description

technical field [0001] The invention relates to a solid preparation containing omeprazole, in particular to an enteric-coated tablet containing omeprazole, and belongs 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 significantly reduced the incidence of ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4439A61K47/40A61P1/04
Inventor 不公告发明人
Owner 贝克诺顿(浙江)制药有限公司
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