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Preparation method of esomeprazole magnesium enteric-coated pellets

A technology for esomeprazole magnesium and enteric-coated pellets, which is applied in the field of pharmaceutical preparations, can solve the problems of long coating time, waste of manpower, material resources, and decreased drug-carrying efficiency, so as to reduce usage and facilitate adhesion. The effect of forming and improving drug loading efficiency

Active Publication Date: 2018-08-07
乐清市然景电气有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, adding an alkalizing agent to the drug-containing layer will lead to a decrease in the drug-loading efficiency of the drug, and at the same time, the coating time is too long, which wastes manpower and material resources.

Method used

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  • Preparation method of esomeprazole magnesium enteric-coated pellets
  • Preparation method of esomeprazole magnesium enteric-coated pellets
  • Preparation method of esomeprazole magnesium enteric-coated pellets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] First disperse 2 parts by weight of modified hydroxypropyl cellulose in 50 parts by weight of medicinal ethanol, add 50 parts by weight of purified water, and add 30 parts by weight of 20 μm Angstrom after the modified hydroxypropyl cellulose is completely swollen. Someprazole magnesium trihydrate was used to prepare the drug-containing coating solution. In the fluidized bed, the drug-containing coating solution is spray-coated onto 180 parts by weight of sucrose ball cores in a bottom spray mode to form drug-containing core cores;

[0033] Add HPMC E5 to an appropriate amount of 65% ethanol, stir slowly in a water bath at 50-60°C to fully dissolve it, then add talcum powder to the remaining 65% ethanol, and homogenize for 10 minutes with a high-shear homogenizer ( Rotating speed is 3500rpm), talcum powder and magnesium oxide suspension are slowly poured in the HPMC solution and fully stirred, cross 80 mesh sieves, obtain the coating solution of the isolation layer, use...

Embodiment 2

[0036] Prepared in the same way as in Example 1, oxidized polyethylene wax: iron oxide: the ratio of formyl triethyl citrate is changed to (0.5:1:1)

Embodiment 3

[0038] Prepared in the same way as in Example 1, oxidized polyethylene wax: iron oxide: the ratio of formyl triethyl citrate is changed to (0.5:2:1)

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Abstract

The invention discloses a preparation method of esomeprazole magnesium enteric-coated pellets and belongs to the field of medicinal preparations. The preparation method comprises the following steps:(1) preparing pill cores of the pellets; spraying and coating 100 to 200 weight parts of sucrose pill cores with a medicine-containing coating solution in a fluidized bed by utilizing a bottom spraying manner, so as to form medicine-containing pill cores; (2) coating an isolation coating layer; coating the medicine-containing pill cores with the isolation coating in the fluidized bed by utilizingthe bottom spraying manner; (3) coating an enteric coating layer; coating the medicine-containing pill cores covered with the isolation coating with the enteric coating in the fluidized bed by utilizing the bottom spraying manner, so as to obtain the enteric-coated pellets with the size of 18 to 20 mesh.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical preparation with esomeprazole magnesium as an active ingredient, in particular to an esomeprazole magnesium enteric-coated pellet preparation and a preparation method thereof. Background technique [0002] Esomeprazole (Esomeprazole) is the L-isomer of omeprazole, and is the world's first single-isomer proton pump inhibitor (PPI) developed by AstraZeneca, which mainly inhibits gastric parietal cytoplasmic Sub-pump, thereby reducing gastric acid secretion to treat gastroesophageal reflux disease (GERD), Helicobacter pylori (HP) positive peptic ulcer and digestive system disorders related to gastric acid. In 2002, the original research company launched the replacement product of omeprazole——esomeprazole. Compared with omeprazole, it has a lower liver metabolism rate, higher blood concentration and bioavailability, and is acid-suppressing. The eff...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/4439A61K47/38A61K47/32A61P1/04
CPCA61K9/5026A61K9/5047A61K9/5078A61K9/5089A61K31/4439A61P1/04
Inventor 黄海领
Owner 乐清市然景电气有限公司
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