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Omeprazole enteric capsule and preparation method thereof

A technology of omeprazole enteric and omeprazole, which is applied in the field of omeprazole enteric-coated capsules and its preparation, can solve the problems of difference between onset time and clinical curative effect, increased production cost, and delayed peak time, etc. Achieve easy operation, good acid resistance and good stability

Inactive Publication Date: 2017-11-24
NANJING ZHENGKUAN MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the onset time and clinical efficacy of omeprazole enteric-coated capsules marketed at home and abroad vary greatly
In addition, the multi-layer coating technology will delay the rapid release and absorption of the drug in the duodenum, as well as delay the initial inhibitory effect on gastric acid, slow down the onset of the drug, delay the peak time, and increase the process requirements , which increases the production cost

Method used

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  • Omeprazole enteric capsule and preparation method thereof
  • Omeprazole enteric capsule and preparation method thereof
  • Omeprazole enteric capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Embodiment 1: Take omeprazole by weight ratio: lactose: anhydrous calcium hydrogen phosphate: enteric-coated material: corn starch: methylcellulose=1: 5: 6: 8: 5: 4, enteric-coated material It is cellulose acetate phthalate and polyacrylic resin No. Ⅱ, by weight ratio, cellulose acetate phthalate: polyacrylic resin No. Ⅱ = 1:1.2, passing through 80 mesh sieve, using methyl cellulose as the binding agent Preparation, making soft material, passing through 20 mesh sieves to make wet granules, fully drying the wet granules at 45-60°C, mixing with 0.2 part of magnesium stearate and then packing into capsule shells to obtain omeprazole enteric-coated capsules.

Embodiment 2

[0012] Embodiment 2: Take omeprazole by weight ratio: lactose: anhydrous calcium hydrogen phosphate: enteric-coated material: corn starch: methylcellulose=1: 8: 4: 12: 3: 6, enteric-coated material It is cellulose acetate phthalate and polyacrylic resin No. Ⅱ, by weight ratio, cellulose acetate phthalate: polyacrylic resin No. Ⅱ = 1:1.2, passing through 80 mesh sieve, using methyl cellulose as the binding agent Preparation, make soft material, pass 20 mesh sieves to make wet granules, fully dry the wet granules at 45~60°C, mix with 0.3 part of magnesium stearate and pack into capsule shells to obtain omeprazole enteric-coated capsules.

Embodiment 3

[0013] Embodiment 3: Take omeprazole by weight ratio: lactose: anhydrous calcium hydrogen phosphate: enteric-coated material: corn starch: methylcellulose=1: 6: 5: 10: 4: 5, enteric-coated material It is cellulose acetate phthalate and polyacrylic resin No. Ⅱ, by weight ratio, cellulose acetate phthalate: polyacrylic resin No. Ⅱ = 1:1.2, passing through 80 mesh sieve, using methyl cellulose as the binding agent Preparation, making soft material, passing 20 mesh sieves to make wet granules, fully drying the wet granules at 45-60°C, mixing with 0.4 part of magnesium stearate and then packing into capsule shells to obtain omeprazole enteric-coated capsules.

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Abstract

An omeprazole enteric capsule comprises omeprazole, lactose, anhydrous calcium hydrogen phosphate, an enteric material, cereal starch, and methyl cellulose; wherein the weight ratio of omeprazole to lactose to anhydrous calcium hydrogen phosphate to enteric material to cereal starch to methyl cellulose is 1:5-8:4-6:8-12:3-5:4-6. The provided omeprazole enteric capsule has the advantages of good performance on resisting acid, good stability, high dissolution rate, simple preparation technology, easy operation, good repeatability, and suitability for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an omeprazole enteric-coated capsule and a preparation method thereof. Background technique [0002] Omeprazole is mainly used for duodenal ulcer and Zoller-Ellison syndrome, and can also be used for gastric ulcer and reflux esophagitis; intravenous injection can be used for the treatment of acute bleeding of peptic ulcer. Combined with amoxicillin and clindamycin or metronidazole and clarithromycin to kill Helicobacter pylori. It is a proton pump inhibitor and a fat-soluble weakly basic drug. It is easy to concentrate in an acidic environment, and specifically acts on the secretory microtubules formed by the apical membrane of the gastric parietal cells and the tubular vesicles in the cytoplasm, which is where the proton pump (H+, K+-ATPase) of the gastric parietal cells is located. And converted into the active form of sulfenamide, irreversibly...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/4439A61K47/38A61K47/32A61P1/04
CPCA61K9/1635A61K9/1652A61K31/4439
Inventor 李洋
Owner NANJING ZHENGKUAN MEDICAL TECH
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