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Omeprazole enteric coated tablet and preparation method thereof

An omeprazole and enteric-coated tablet technology, applied in the field of medicine, can solve the problems of affecting the release speed and release uniformity of the drug, adverse effects on human health, and difficulty in controlling the dosage, and achieves improved bioavailability, enhanced stability, The effect of reducing dosage

Active Publication Date: 2010-06-23
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The preparation process disclosed above has the following problems: a large amount of alkaline materials and hydrophobic auxiliary materials are used, and long-term use is likely to have adverse effects on human health; too many inert auxiliary materials are likely to affect the release rate and uniformity of the drug
Sodium hydroxide is a strong base, it is difficult to control the dosage in actual medicine, and it is easy to cause gastrointestinal damage

Method used

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  • Omeprazole enteric coated tablet and preparation method thereof
  • Omeprazole enteric coated tablet and preparation method thereof
  • Omeprazole enteric coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]

[0035] Preparation Process:

[0036] (1) Preparation of omeprazole β-cyclodextrin inclusion compound:

[0037] Take the prescribed amount of β-cyclodextrin to make a saturated aqueous solution at 35°C, pour it into a high-speed milk mixer, stir and keep it warm for 15 minutes, add 1 gram of ammonium bicarbonate, dissolve omeprazole with an appropriate amount of ethanol, and slowly add it to the In the mixer, the speed is 5ml / min, the high speed is stirred for 45min, and the rotation speed is 3000r / min. After the inclusion complex is completed, it is spray-dried to obtain the inclusion complex of omeprazole β-cyclodextrin, which is passed through a 100-mesh sieve for later use.

[0038] (2) Preparation of tablet core:

[0039] Mix the prepared omeprazole β-cyclodextrin inclusion compound with the prescription amount of diluent and disintegrant evenly, then granulate with 2% hypromellose aqueous solution, and compress into tablets to obtain omeprazole Chips.

[0...

Embodiment 2

[0043]

[0044] Preparation Process:

[0045] (1) Preparation of omeprazole cyclodextrin inclusion compound:

[0046] Take the prescribed amount of β-cyclodextrin in a colloid mill, add an appropriate amount of purified water at 35°C and grind it into a paste, keep it warm for 15 minutes, add 0.5 g of ammonium bicarbonate, make omeprazole into a saturated ethanol solution, and then add it slowly Into the colloid mill, speed 5ml / min, grind for 30min. After completion of inclusion, freeze-dry to obtain omeprazole β-cyclodextrin inclusion compound, pass through a 100-mesh sieve, and set aside.

[0047] (2) Preparation of tablet core:

[0048] The omeprazole beta-cyclodextrin inclusion compound is evenly mixed with the remaining auxiliary materials, and then directly compressed into tablets to obtain the omeprazole tablet core.

[0049] (3) Enteric coating:

[0050] Dissolve acrylic resin EuS100 in 75% ethanol to form a solution with a concentration of 8% as an enteric coat...

Embodiment 3

[0052]

[0053] Preparation Process:

[0054] (1) Preparation of omeprazole α-cyclodextrin inclusion compound:

[0055] Take the prescribed amount of α-cyclodextrin in a high-speed homogenizer, add an appropriate amount of purified water at 35°C to make a saturated aqueous solution, keep it warm for 15 minutes, add 0.1 g of ammonia water, make omeprazole into a saturated ethanol solution, and slowly add it to the In the milk homogenizer, the speed is 5ml / min, stirring for 60min, 2500r / min, spray drying after completion of inclusion, to obtain omeprazole α-cyclodextrin inclusion complex, pass through a 100-mesh sieve, and set aside.

[0056] (2) Preparation of tablet core:

[0057] The omeprazole α-cyclodextrin inclusion compound is evenly mixed with the remaining auxiliary materials, and then directly compressed into tablets to obtain the omeprazole tablet core.

[0058] (3) Enteric coating:

[0059] Dissolve acrylic resin EuS100 in 90% ethanol to form a solution with a ...

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Abstract

The invention provides an omeprazole enteric coated tablet and a preparation method thereof. The enteric coated tablet is formed by an inner tablet core and an outer enteric coating, wherein the inner tablet core takes omeprazole as active constituent. No protective isolating layer is arranged between the tablet core and the enteric coating. The inner tablet core is made of omeprazole cyclodextrin inclusion compound and other pharmaceutically acceptable auxiliary materials. The enteric coating contains no plasticizer and the dosage of the enteric coating accounts for 5 percent to 15 percent of the weight of the tablet. The invention has the advantages that the stability and the dissolution of omeprazole are improved, the dosage of basic materials and the dosage of all kinds of inert auxiliary materials are greatly reduced, omeprazole can be stably and rapidly released in the intestinal tract and the bioavailability is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an enteric-coated tablet of omeprazole and a preparation method thereof. Background technique [0002] Omeprazole is the first proton pump inhibitor created by Astra in Sweden, which can specifically act on the parietal cells of the gastric mucosa and reduce H in the parietal cells. + , K + -ATPase activity, thereby inhibiting basal gastric acid and stimulating gastric acid secretion. In 1988, it was first listed in Sweden under the trade name Losec. Omeprazole is used to treat duodenal ulcer, gastric ulcer and esophagitis, and can eliminate refractory ulcer crisis. It is also very effective in the treatment of Zoller-Ellison syndrome. Proton pump inhibitors vs histamine H 2 Receptor blockers (such as ranitidine) have more powerful and long-lasting acid-suppressing effects, and have excellent curative effect on peptic ulcers and severe esophageal reflux ulcers th...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K31/4439A61K47/48A61P1/04A61K47/69
Inventor 赵志全张庆华
Owner SHANDONG NEWTIME PHARMA
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