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Esomeprazole magnesium enteric-coated tablets and preparation method thereof

A technology of esomeprazole magnesium enteric-coated tablets and esomeprazole magnesium applied in the field of pharmaceutical preparations to achieve the effects of good reproducibility and stability, large production capacity and low equipment requirements

Inactive Publication Date: 2016-05-04
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are technical difficulties in pellet compression. It is necessary to ensure the uniform distribution of the pellets in each tablet and ensure that the coating film of the pellets is not damaged after tableting.

Method used

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  • Esomeprazole magnesium enteric-coated tablets and preparation method thereof
  • Esomeprazole magnesium enteric-coated tablets and preparation method thereof
  • Esomeprazole magnesium enteric-coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Prescription composition:

[0020]

[0021] Preparation Process:

[0022] (1) Preparation of tablet core

[0023] Weigh the main ingredient, pregelatinized starch, lactose, and croscarmellose sodium according to the prescription quantity, mix well, use an appropriate amount of PVPk30 aqueous solution as a binder to make a soft material, granulate, dry, granulate, and add the prescription quantity Magnesium stearate, mixed evenly and compressed into tablet cores.

[0024] (2) Isolation layer coating

[0025] Add HPMCE5 to an appropriate amount of purified water, stir to dissolve, add talcum powder to prepare a suspension solution, sieve, and stir for later use. Place the tablet cores in the coating pan and wrap the isolation layer.

[0026] (3) Enteric layer coating

[0027] Disperse Acryl-EZE 93F19255 in an appropriate amount of purified water to prepare a suspension solution with a solid content of 20%, sieve, and stir for later use. Place the isolation tablet...

Embodiment 1-4

[0028] The assay method of embodiment 1-4 release degree:

[0029] With reference to the import standard of Esomeprazole Magnesium Enteric-coated Tablets, the second method of release measurement method was adopted, and the preparation was tolerated in 0.1mol / L hydrochloric acid solution for 2 hours, and then lye was added to prepare a phosphate buffer solution with a pH of 6.8. , continue to release for 45 minutes. After 2 hours of hydrochloric acid medium resistance, the sampling time points are 5min, 10min, 15min, 20min, 30min, 45min. Sampling 5mL at each time point was filtered with a 0.45μm filter membrane, and an equal amount of fresh medium was added immediately, and the filtrate was mixed with an alkalinizing agent in equal proportions, and 20μL of the mixed solution was injected into a high-performance liquid chromatograph to determine esomemera The peak area of ​​azole was used to calculate the cumulative release. Select commercially available esomeprazole magnesiu...

Embodiment 2

[0032] Prescription composition:

[0033]

[0034]

[0035] Preparation Process:

[0036] (1) Preparation of tablet core

[0037] Weigh the main ingredient, pregelatinized starch, lactose, and croscarmellose sodium according to the prescription quantity, mix well, use an appropriate amount of PVPk30 aqueous solution as a binder to make a soft material, granulate, dry, granulate, and add the prescription quantity Magnesium stearate, mixed evenly and compressed into tablet cores.

[0038] (2) Isolation layer coating

[0039] Add HPMCE5 to an appropriate amount of purified water, stir to dissolve, add talcum powder to prepare a suspension solution, sieve, and stir for later use. Place the tablet cores in the coating pan and wrap the isolation layer.

[0040] (3) Enteric layer coating

[0041] Take the prescribed amount of purified water into the liquid mixing container, add PEG6000, stir until dissolved, add talcum powder and stir evenly; add it to Eudragit L30D-55, st...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to esomeprazole magnesium enteric-coated tablets and a preparation method thereof. Each esomeprazole magnesium enteric-coated tablet comprises (1) a table core comprising esomeprazole magnesium and pharmaceutical excipients, (2) an isolation layer comprising a coating material and an anti-adherent and (3) an enteric coating layer comprising a methacrylic acid copolymer and pharmaceutical excipients. The esomeprazole magnesium enteric-coated tablets adopt a simple preparation process and have the advantages of low requirement for equipment, high throughput, controllable product quality, good reproducibility, good stability and applicability to industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an esomeprazole magnesium enteric-coated tablet and a preparation method thereof. Background technique [0002] With the acceleration of modern people's life rhythm, increasing pressure, irregular life and other health damage factors, the incidence of stomach diseases is also increasing. Chronic or acute gastrointestinal diseases will almost occur in varying degrees in people's life, age The larger, the higher the incidence. Gastroesophageal reflux disease (Gastroesophageal Reflux Disease, GERD) is one of the common stomach diseases. tissue damage. [0003] Proton pump inhibitors (protonpumpinhibitors, PPIs) are one of the first-choice drugs for the treatment of peptic ulcer, and their mechanism of action is to interact with gastric parietal cell H + -K + ATPase is covalently bound to inhibit the activity of the enzyme and the secretion of gastric acid. Esomeprazol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/28A61K47/38A61K47/34A61K47/36A61P1/04
CPCA61K31/4439A61K9/2054A61K9/2059A61K9/2846A61K9/2866
Inventor 尹莉芳朱春莉顾念李博王广基唐鹤松狄斌秦超罗静
Owner CHINA PHARM UNIV
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