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Preparation method of pantoprazole sodium enteric-coated tablets

A technology for pantoprazole sodium and enteric-coated tablets is applied in the field of preparation of pandoprazole sodium enteric-coated tablets, and can solve the problems of large mixing difficulty, large difference in tablet weight, poor particle fluidity and the like

Inactive Publication Date: 2020-04-24
HUNAN JIUDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The raw material is added to blank granules in the form of powder, which is difficult to mix, and there are too many fine powders in the granules, and the fluidity of the granules is poor, which easily leads to large differences in tablet weight during tablet compression.

Method used

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  • Preparation method of pantoprazole sodium enteric-coated tablets
  • Preparation method of pantoprazole sodium enteric-coated tablets
  • Preparation method of pantoprazole sodium enteric-coated tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-11

[0039] Embodiment 1-11 preparation method of pantoprazole sodium enteric-coated tablet

[0040] Step 1. Adhesive is pulverized through a 120 mesh sieve and set aside;

[0041] Step 2. Weighing: Weigh the main ingredient, pH regulator (internal addition), disintegrant (internal addition), filler and adhesive processed in step 1 according to the prescription, and set aside;

[0042] Step 3. Wetting agent preparation: Weigh an appropriate amount of purified water, formulate the amount of pH regulator (wetting agent), dissolve the pH regulator (wetting agent) in purified water, and set aside;

[0043] Step 4. Granulation: put the powder weighed in step 2 into a special wet granulator, mix for 4 minutes until uniform, use a spray device, spray speed 0.5~3kg / min, spray pressure 0.2~2Mpa, spray into the step 3. The prepared wetting agent is granulated, wetted with an 18-mesh sieve, dried, and set aside;

[0044] Step 5. Sizing, blending, and tableting: Add the prescribed amount of ...

Embodiment 11

[0047]Embodiment 11: use embodiment 1 prescription, use wet granulator to prepare pantoprazole tablet

[0048] Step 1. Adhesive is pulverized through a 120 mesh sieve and set aside;

[0049] Step 2. Weighing: Weigh the main ingredient, pH regulator (internal addition), disintegrant (internal addition), filler and adhesive processed in step 1 according to the prescription, and set aside;

[0050] Step 3. Wetting agent preparation: Weigh an appropriate amount of purified water, formulate the amount of pH regulator (wetting agent), dissolve the pH regulator (wetting agent) in purified water, and set aside;

[0051] Step 4. Granulation: put the powder weighed in step 2 into a wet granulator, mix for 4 minutes until uniform, add the wetting agent prepared in step 3 directly from the slurrying part of the wet granulator to granulate, and use a 18-mesh sieve The net is wet-trimmed, dried, and set aside;

[0052] Step 5. Sizing, blending, and tableting: Add the prescribed amount of ...

Embodiment 12

[0053] Embodiment 12: use embodiment 2 prescription, use wet granulator to prepare pantoprazole sodium plain tablet

[0054] Step 1. Weighing: Weigh the main drug, PH regulator (internal addition), disintegrant (internal addition), filler according to the prescription amount, and set aside;

[0055] Step 2. Preparation of adhesive solution: Weigh an appropriate amount of purified water, the prescribed amount of pH regulator (wetting agent), and adhesive, respectively dissolve the pH regulator (wetting agent) and adhesive in purified water, and set aside ;

[0056] Step 3. Granulation: put the powder weighed in step 1 into a high-efficiency mixing granulator, mix for 4 minutes until uniform, add the binder solution prepared in step 2 directly from the wet granulator to granulate, and use 18-mesh sieve is wetted, dried and set aside;

[0057] Step 4. Sizing, blending, and tableting: Add the prescribed amount of lubricant to the granules, sieve the granules with an 18-mesh scre...

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Abstract

The invention discloses a preparation method and special preparation equipment of pantoprazole sodium enteric-coated tablets. The method comprises the following steps: uniformly mixing pantoprazole sodium, a filler, a disintegrating agent, an adhesive and a pH regulator, additionally arranging an atomizing device on a wet granulator, adding a wetting agent in a spraying manner, granulating, performing wet finishing, drying, adding a lubricant, granulating, adding a disintegrating agent, mixing, and tabletting to obtain the pantoprazole sodium tablets. The method provided by the invention is simple to operate, and pantoprazole sodium enteric-coated tablets meeting the quality standard can be prepared by a traditional wet granulation production line.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical preparation and specially designed equipment for implementing the method, in particular to a preparation method of pantoprazole sodium enteric-coated tablets and the preparation equipment thereof. Background technique [0002] Pantoprazole is a new type of proton pump inhibitor used to treat gastric acid-related diseases such as gastric ulcer, duodenal ulcer and reflux esophagitis. In the listed pantoprazole preparations, its sodium salt is mainly used as the active ingredient. Pantoprazole sodium is white or off-white crystalline powder, easily soluble in water, unstable in acidic environment, easily degraded by acidic compounds, but stable in alkaline condition. Therefore, in order to avoid the degradation of pantoprazole sodium in the gastric acid environment, the oral preparations of pantoprazole sodium listed at home and abroad are mainly characterized by enteric coating. [0003]...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K31/4439A61P1/04
CPCA61K9/284A61K9/2866A61K9/2886A61K31/4439A61P1/04
Inventor 钟海宝肖稳定何莉雷文枚
Owner HUNAN JIUDIAN PHARMA