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Method for preparing omeprazole enteric fast-release tablet

A technology of omeprazole enteric and omeprazole is applied in the field of preparation of omeprazole enteric-coated immediate-release tablets, and can solve the problems of acid resistance and immediate-release limitation and the like

Active Publication Date: 2009-11-18
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In the prior art, when omeprazole is made into an enteric-coated immediate-release preparation, there are still certain limitations in terms of acid resistance and immediate release

Method used

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  • Method for preparing omeprazole enteric fast-release tablet
  • Method for preparing omeprazole enteric fast-release tablet
  • Method for preparing omeprazole enteric fast-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 20mg omeprazole enteric-coated immediate release tablet

[0024]

[0025]

[0026] Preparation:

[0027] Example 1: Dissolve hydroxypropyl cellulose and sodium dodecyl sulfonate in an appropriate amount of purified water, add magnesium oxide to disperse, and then disperse omeprazole in the above solution to disperse evenly. Using lactose as a support agent, the fluidized bed top spray granulation, the particle size is over 80 mesh. The granules are added with sodium carboxymethyl starch and magnesium stearate and mixed uniformly, and the tablet core is pressed, and the tablet core is covered with an isolation layer and then with an enteric coating layer.

Embodiment 2

[0033] 10mg Omeprazole Enteric Immediate Release Tablets

[0034]

[0035] Preparation:

[0036] Example 2: Dissolve hydroxypropyl cellulose and sodium dodecyl sulfonate in an appropriate amount of purified water, add aluminum magnesium carbonate to disperse, and then disperse omeprazole in the above solution to disperse evenly. Using lactose as a support agent, the fluidized bed top spray granulation, the particle size is over 100 mesh. The granules are added with sodium carboxymethyl starch and magnesium stearate and mixed uniformly, and the tablet core is pressed, and the tablet core is covered with an isolation layer and then with an enteric coating layer.

Embodiment 3

[0043] 10mg Omeprazole Enteric Immediate Release Tablets

[0044]

[0045] Preparation:

[0046]Example 3: Dissolve hydroxypropyl cellulose and sodium dodecyl sulfonate in an appropriate amount of purified water, add aluminum magnesium carbonate to disperse, and then disperse omeprazole in the above solution to disperse evenly. Using lactose as a support agent, the fluidized bed top spray granulation, the particle size is over 100 mesh. The granules are added with sodium carboxymethyl starch and magnesium stearate and mixed uniformly, and the tablet core is pressed, and the tablet core is covered with an isolation layer and then with an enteric coating layer.

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a method for preparing an omeprazole enteric fast-release tablet, which is characterized in that in the preparing process with a conventional method, omeprazole is dispersed in binding agent suspension solution, the mixture is granulated by a fluidized bed through top spraying, and the grain size is between 80 and 120 meshes. Besides, a sealing coat of the omeprazole enteric fast-release tablet comprises a first sealing coat and a second sealing coat, wherein the first sealing coat contains hydroxypropyl methylcellulose and a basifier, and the second sealing coat contains the hydroxypropyl methylcellulose, smoothers and titanium dioxide. An in vitro dissolution experiment shows that the omeprazole enteric fast-release preparation prepared by the method is dissolved for 100 percent at the 15th minute; and an acid resistance test shows that a coating tablet has no obvious change in two hours in an environment of which the pH is 1.2.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of an omeprazole enteric-coated immediate-release tablet. Background technique [0002] Omeprazole: English name is Omeprazole, chemical name is (R, S)-5-methoxy-2-(4-methoxy-3,5-dimethyl-pyridine-2-methylsulfinyl acyl)-1H-benzimidazole. Also known as Losec, Oak, Losec. Its chemical structure is as follows: [0003] [0004] Omeprazole is white or off-white crystal, easily soluble in dimethylformamide, soluble in methanol, insoluble in water, unstable in aqueous solution, and unstable to strong acid, so it should be stored at low temperature and away from light. [0005] Omeprazole is a proton pump inhibitor. It has a strong inhibitory effect on gastric acid secretion and has less side effects. After oral administration, it is absorbed in the duodenum, and can selectively accumulate in gastric parietal cells. It can persist in gastric parietal...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4439A61K47/38A61K47/02A61P1/04
Inventor 李远福廖志勇王衣谷
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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