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Omeprazole enteric capsule and prepared method thereof

A technology of omeprazole enteric and omeprazole pellets, which is applied in the field of omeprazole enteric-coated capsules and its preparation, can solve the problems of poor stability, insufficient and timely release of omeprazole enteric-coated capsules, etc. To achieve the effect of guaranteed dissolution

Active Publication Date: 2013-06-05
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to solve the problem of insufficient and timely release or poor stability of the existing omeprazole enteric-coated capsules after oral administration, and to provide a kind of omeprazole enteric-coated capsules

Method used

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  • Omeprazole enteric capsule and prepared method thereof

Examples

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Effect test

Embodiment 1

[0059] This embodiment provides an omeprazole enteric-coated capsule, comprising: a capsule shell and omeprazole pellets contained in the capsule shell, the particle size of the pellets is 15-30 mesh, and the omeprazole pellets From the inside to the outside, it is the core layer, the alkali layer, the isolation layer, the enteric layer and the outer layer. The mass ratio is 1:0.1:0.15:1.5:0.01, based on 10 parts by mass of omeprazole, Ogilvy & Mather The prescription of prazol pellets is shown in Table 1.

[0060] The above-mentioned preparation method of omeprazole enteric-coated capsules includes the following steps:

[0061] S1) Preparation of pellet core

[0062] Weigh omeprazole, lactose as a filler, hypromellose as a disintegrant, sodium carbonate as an alkaline sodium salt, and hypromellose as a binder according to the prescription in Table 1. A 120-mesh sieve is mixed to obtain a pellet core mixed powder.

[0063] Prepare the binder solution: Dissolve hypromellose in water ...

Embodiment 2

[0083] This embodiment provides an omeprazole enteric-coated capsule, comprising: a capsule shell and omeprazole pellets contained in the capsule shell, the particle size of the pellets is 15-30 mesh, and the omeprazole pellets From the inside to the outside, it is the core layer, the alkali layer, the isolation layer, the enteric layer and the outer layer. The mass ratio is 1:0.1:0.15:1.5:0.01, based on 10 parts by mass of omeprazole, Ogilvy & Mather The prescription of prazol pellets is shown in Table 1.

[0084] The above-mentioned preparation method of omeprazole enteric-coated capsules includes the following steps:

[0085] S1) Preparation of pellet core

[0086] According to the prescription in Table 1, weigh omeprazole, dextrin as a filler, sodium carboxymethyl starch as a disintegrant, sodium dihydrogen phosphate as an alkaline sodium salt, and povidone as a binder. A 120-mesh sieve is mixed to obtain a pellet core mixed powder.

[0087] Prepare the adhesive solution: Dissol...

Embodiment 3

[0103] This embodiment provides an omeprazole enteric-coated capsule, comprising: a capsule shell and omeprazole pellets contained in the capsule shell, the particle size of the pellets is 15-30 mesh, and the omeprazole pellets From the inside to the outside, it is the core layer, the alkali layer, the isolation layer, the enteric layer and the outer layer. The mass ratio is 1:0.1:0.15:1.5:0.01, based on 10 parts by mass of omeprazole, Ogilvy & Mather The prescription of prazol pellets is shown in Table 1.

[0104] The above-mentioned preparation method of omeprazole enteric-coated capsules includes the following steps:

[0105] S1) Preparation of pellet core

[0106] Weigh omeprazole, dibasic calcium phosphate as a filler, croscarmellose sodium as a disintegrant, disodium hydrogen phosphate as an alkaline sodium salt, and hydroxyl as a binder according to the prescription in Table 1. The propyl methyl cellulose is passed through a 120-mesh sieve and mixed to obtain a pellet core m...

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Abstract

The invention provides an omeprazole enteric capsule and a prepared method thereof and belongs to the field of medicinal preparation. The omeprazole enteric capsule can solve the problem that an existing omeprazole enteric capsule cannot be fully and timely released and is poor in stability after being taken orally. The omeprazole enteric capsule is composed of a pill core, an alkali layer, an isolating layer, an enteric layer and an outer layer from inside to outside in sequence. By means of the addition of the alkali layer, formula of each layer is optimized and full and timely release and stability of the omeprazole enteric capsule are guaranteed.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to an omeprazole enteric-coated capsule and a preparation method thereof. Background technique [0002] Omeprazole as a proton pump inhibitor has been widely used in the treatment of peptic ulcer diseases such as gastric ulcer, duodenal ulcer, reflux esophagitis, gastrinoma. [0003] Omeprazole is extremely stable under neutral and alkaline conditions with a half-life of 17 hours; but it is easily degraded in an acidic environment, and is very unstable when the pH is close to the acidity of gastric juice (pH=1), with a half-life of about 2 minutes . In addition, omeprazole is also sensitive to humidity, temperature and light, which tends to reduce its stability. In order to maintain the pharmacological activity of omeprazole after taking it, most of the omeprazole currently marketed in China is enteric-coated preparations. [0004] Enteric-coated preparations generall...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61P1/04
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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