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Pantoprazole sodium enteric-coated tablet and preparation method thereof

A technology of pantoprazole sodium and enteric-coated tablets is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, medical preparations containing active ingredients, etc. Release degree, good acid resistance, beneficial to clinical application

Inactive Publication Date: 2016-03-09
世贸天阶制药(江苏)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pantoprazole sodium enteric-coated tablets are made of pantoprazole sodium plain tablets with enteric coating. According to clinical observations, the existing enteric-coated tablets still have the problems of low acid resistance and release. In order to ensure the efficacy of the drug , to meet the medication needs of clinical patients, improve the compliance of clinical medication, and increase the choice of medication for clinicians. There is still room for further improvement in the preparation method of pantoprazole sodium enteric-coated tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Based on the production of 1000 tablets, the prescription quantity is as follows:

[0026] Pantoprazole sodium (as C 16 h 15 f 2 N 3 o 4 Calcium carbonate 100g; crospovidone 13g; croscarmellose sodium 15g; sodium carboxymethyl starch 10g; magnesium stearate 2g.

[0027] Concrete preparation steps are as follows:

[0028] 1. Preparation of plain tablets:

[0029] The raw material pantoprazole sodium, auxiliary material calcium carbonate, crospovidone, croscarmellose sodium, carboxymethyl starch sodium, and magnesium stearate are passed into the pulverizing and sieving room for processing in the prescribed amount. The auxiliary materials are crushed through a 100-mesh sieve. Add the prepared ingredients: calcium carbonate, crospovidone, croscarmellose sodium, and carboxymethyl starch sodium into the high-efficiency wet granulator, close the cylinder head, start stirring at low speed first, and then start Dry mix at high speed for a total of 5 minutes, add 40ml o...

Embodiment 2

[0035] Production prescription quantity and plain tablet preparation process are the same as embodiment 1, and the coating process is carried out as follows:

[0036] According to the prescription amount, the theoretical weight gain is about 12%, and the stomach-soluble film coating premix is ​​weighed, mixed with a mass concentration of 70% ethanol to make a 10% solution in a mixing tank, and the coating solution for the isolation layer is prepared; according to the prescription The theoretical weight gain is about 11%. Weigh the enteric-coating film coating premix, mix it with 80% ethanol in a mixing tank to make a 7% solution, and prepare the enteric coating solution.

[0037] Stir the above coating solution for more than half an hour, adjust the spray gun to make it 35cm away from the tablet bed, preheat the tablet core to make the temperature 45°C, adjust the spray speed to 40ml / min, the spray pressure to 0.5MPa, and the speed of the coating pan to 6 rpm , first wrap the ...

Embodiment 3

[0039] Production prescription quantity and plain tablet preparation process are the same as embodiment 1, and the coating process is carried out as follows:

[0040] According to the prescription amount, the theoretical weight gain is about 12%, and the stomach-soluble film coating premix is ​​weighed, mixed with a mass concentration of 70% ethanol to make a 10% solution in a mixing tank, and the coating solution for the isolation layer is prepared; according to the prescription The theoretical weight gain is about 11%. Weigh the enteric-coating film coating premix, mix it with 80% ethanol in a mixing tank to make a 7% solution, and prepare the enteric coating solution.

[0041] Stir the above coating solution for more than half an hour, adjust the spray gun to make it 32cm away from the tablet bed, preheat the tablet core to make the temperature 35°C, adjust the spray speed to 40ml / min, the spray pressure to 0.45MPa, and the speed of the coating pan to 8 rpm , first wrap the...

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PUM

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Abstract

The invention provides a pantoprazole sodium enteric-coated tablet. Based on the weight of 1000 tablets, the pantoprazole sodium enteric-coated tablet is prepared from the following components: 40g of pantoprazole sodium, 100g of calcium carbonate, 13g of polyvinylpolypyrrolidone, 15g of croscarmellose sodium, 10g of sodium carboxymethyl starch and 2g of magnesium stearate. The invention further provides a method for preparing the pantoprazole sodium enteric-coated tablet. The method comprises the steps of preparing a white tablet and coating the white tablet, wherein, in the coating operation, a coating liquid spray gun is 30-35cm away from the tablet bed, the tablet core temperature is 35-45 DEG C, the spraying speed is 40-45ml / min, the spray pressure is 0.4-0.5MPa, and the rotating speed of a coating pan is 5-6 revolution / minute. The pantoprazole sodium enteric-coated tablet prepared by the method has good acid resistance and good release degree, and the release rate of a finished product is over 75 percent; and the preparation method has high production efficiency, is suitable for industrial production and has a great application value.

Description

technical field [0001] The invention belongs to the technical field of medicine manufacture, in particular to a preparation method of pantoprazole sodium enteric-coated tablets. Background technique [0002] Pantoprazole sodium is a new type of proton pump inhibitor, which has been clearly proven to be a drug at the molecular level. By acting on the parietal cells of the gastric gland, inhibiting the activity of H+, K+-ATPase, making the H in the parietal cells + It cannot be transported into the stomach, thereby inhibiting the secretion of gastric acid, reducing the secretion of gastric juice and inhibiting the secretion and activity of pepsin. [0003] Pantoprazole sodium is mainly used for: (1) active peptic ulcer (stomach, duodenal ulcer); (2) reflux esophagitis; (3) Zoller-Ellison syndrome. For duodenal ulcer, gastric ulcer and reflux esophagitis, take one tablet orally every morning. The course of treatment for duodenal ulcer is usually 2 to 4 weeks, and the course ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4439A61K47/38A61P1/04
CPCA61K9/2886A61K9/2059A61K31/4439
Inventor 宋国芳张慧君陈太标孙开阳赵曙霞
Owner 世贸天阶制药(江苏)有限责任公司