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A kind of pantoprazole sodium enteric-coated tablet and preparation method thereof

A technology of pantoprazole sodium and enteric-coated tablets, which is applied in the directions of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of unstable pantoprazole sodium and poor release rate. Stability, easy discoloration of tablets and other issues, to achieve the effect of improving bioavailability, ensuring safety and effectiveness, and avoiding moisture absorption and decomposition

Active Publication Date: 2015-09-30
JINAN LIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Pantoprazole sodium is unstable under neutral and acidic conditions, and is easy to change color; hygroscopicity is strong, and it is relatively sensitive to light and heat, so the preparation method of conventional plain tablet bag enteric coating is adopted, and the tablet is easy to change color, release Unstable

Method used

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  • A kind of pantoprazole sodium enteric-coated tablet and preparation method thereof
  • A kind of pantoprazole sodium enteric-coated tablet and preparation method thereof
  • A kind of pantoprazole sodium enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1, a kind of pantoprazole sodium enteric-coated tablet, the composition of every 1000 is as follows,

[0044] Chip:

[0045]

[0046] Barrier layer and enteric layer film coating:

[0047]

[0048] The preparation process is as follows:

[0049] (1) first cross 100 mesh sieves after anhydrous sodium carbonate is pulverized, and hydroxypropyl cellulose (HPC) crosses 100 mesh sieves; calculate the amount of required raw materials according to prescription and batch, take raw material pantoprazole sodium, Mix with auxiliary materials such as anhydrous sodium carbonate, hydroxypropyl cellulose, mannitol, crospovidone, etc. in a wet mixing granulator, and the mixing time is 3 minutes;

[0050] (2) Add purified water to make soft materials, wet mixing time is 60 seconds, release wet granules from the wet mixing granulator, and pass through a 16-mesh sieve to make granules;

[0051] (3) Dry the wet granules at 50°C, and pass the dried granules through a 18-...

Embodiment 2

[0056] Embodiment 2, a kind of pantoprazole sodium enteric-coated tablet, the composition of every 1000 is as follows,

[0057] Chip:

[0058]

[0059]

[0060] Barrier layer and enteric layer film coating:

[0061]

[0062] The preparation process is the same as in Example 1.

Embodiment 3

[0063] Embodiment 3, a kind of pantoprazole sodium enteric-coated tablet, the composition of every 1000 is as follows,

[0064] Chip:

[0065]

[0066] Barrier layer and enteric layer film coating:

[0067]

[0068] The preparation process is the same as in Example 1.

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Abstract

The present invention discloses a pantoprazole sodium enteric coated tablet and a preparation method thereof. In the invention, an optimal prescription, an optimal process prescription and optimal isolation layer and enteric coating process choices are obtained by researching the prescription and production technology of the core of the pantoprazole sodium enteric coated tablet, and processes of the isolation layer and the enteric coating. The pantoprazole sodium enteric coated tablet prepared on the basis of the above optimal prescription, production technology, isolation layer and enteric coating has the advantages of good stability, good acid resistance, good release, and bioavailability improvement. The preparation method is simple and stable, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pantoprazole sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] Pantoprazole (Pantoprazole), its chemical name is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzo Imidazole has the chemical structural formula as follows: [0003] [0004] Molecular formula: C 16 h 15 f 2 N 3 o 4 S molecular weight: 383.37. It is the third PPI drug developed by Byk Gulden Pharmaceutical Company in Germany. It was first launched in Germany in October 1995. Pantoprazole specifically acts on the parietal cells of the gastric mucosa and reduces H in the parietal cells. + -K + -ATPase activity, thereby effectively inhibiting gastric acid secretion. It is clinically used in the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis. [0005] Pantoprazole on proton pump H + -K + -ATPase has a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K47/36A61K47/38A61K31/4439A61P1/04
Inventor 曹悦兴王翠莲周爱霞
Owner JINAN LIMIN PHARMA
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