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Esomeprazole-magnesium-containing enteric pellet capsule

A technology of enteric-coated pellets and capsules of esomeprazole magnesium, which is applied in the field of pharmaceutical preparations and can solve the problems of high content of degradation impurities, poor quality stability, and low content of impurities

Active Publication Date: 2016-01-27
CHENGDU GUOHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that even if the esomeprazole magnesium enteric-coated pellets capsules prepared by the prior art are stored for 2 years for a long time, there are generally problems of high content of degraded impurities and poor quality stability. Prazole magnesium enteric-coated micropill capsules degrade during long-term storage to obtain esomeprazole magnesium enteric-coated micropill capsules with low impurity content as much as possible and stable quality, and suitable for large-scale industrial production in China today and its preparation method is very necessary

Method used

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  • Esomeprazole-magnesium-containing enteric pellet capsule
  • Esomeprazole-magnesium-containing enteric pellet capsule
  • Esomeprazole-magnesium-containing enteric pellet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0175]

[0176] In this example, the blank pellet core is a sucrose-type pellet core purchased from Hangzhou Gaocheng Bio-Nutrition Technology Co., Ltd.

[0177] Preparation method: Dry mix esomeprazole magnesium, part of hypromellose, lactose, sodium lauryl sulfate and disodium hydrogen phosphate to obtain a powder. In the centrifugal fluid coating granule machine, the blank ball core is primed with powder, and the hypromellose aqueous solution is sprayed at the same time. The prepared pill core containing medicine is dried, and wrapped with an isolation layer in a centrifugal fluid coating granulator, and a fluidized bed device is used to prepare an enteric coating layer and a modified coating layer, and finally the pellets are filled into the seaweed polysaccharide capsule shell, The esomeprazole magnesium enteric-coated pellets and capsules are obtained.

Embodiment 2

[0179]

[0180] In this example, the blank pellet core is a microcrystalline cellulose pellet core purchased from Haining Weijing Pharmaceutical Excipient Technology Development Co., Ltd.

[0181] Preparation method: dry mix esomeprazole magnesium and part of hydroxypropyl cellulose to obtain powder. In the centrifugal fluid coating granule machine, the blank ball core is primed with powder, and the hydroxypropyl cellulose aqueous solution is sprayed at the same time. The prepared pill core containing medicine is dried, and wrapped with an isolation layer in a centrifugal fluid coating granulator, and a fluidized bed device is used to prepare an enteric coating layer and a modified coating layer, and finally the pellets are filled into the seaweed polysaccharide capsule shell, The esomeprazole magnesium enteric-coated pellets and capsules are obtained.

Embodiment 3

[0183]

[0184] Blank ball core is Suglets in the present embodiment ? CP-405E sucrose pellet core.

[0185] Preparation method: dry mix esomeprazole magnesium with part of sodium carboxymethylcellulose and Tween 80 to obtain a powder. In the centrifugal fluid coating granulator, the blank ball core is primed with powder, and the aqueous solution of sodium carboxymethylcellulose is sprayed at the same time. The prepared pill core containing medicine is dried, and wrapped with an isolation layer in a centrifugal fluid coating granulator, and a fluidized bed device is used to prepare an enteric coating layer and a modified coating layer, and finally the pellets are filled into the seaweed polysaccharide capsule shell, The esomeprazole magnesium enteric-coated pellets and capsules are obtained.

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Abstract

A related esomeprazole-magnesium-containing enteric pellet capsule is characterized in that the capsule casing contains algal polysaccharides and also satisfies the demand that a pellet enteric layer is coated by a decoration coating. The invention also provides a preparation method for the enteric capsule. The provided prescription and the preparation method for the capsule enable the capsule to be low in impurity content and good in medicine stability after being stored for a long time, and the capsule is suitable for large-scale industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an enteric-coated pellet capsule containing esomeprazole magnesium. Background technique [0002] Esomeprazole (Esomeprazole, 5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl-1H -benzimidazole) is the S-isomer of omeprazole, which is a new generation of proton pump inhibitors for the treatment of gastric ulcer, gastroesophageal reflux disease, erosive reflux esophagitis, etc., and its mechanism of action It reduces gastric acid secretion through a specific targeting mechanism, and has a specific inhibitory effect on H+ / K+-ATPase (proton pump) in parietal cells.Compared with omeprazole, esomeprazole is CYP2C19 dependent It has low toxicity, high and long-lasting active drug concentration in plasma, little interaction with other drugs, high ratio of bioavailability to blood drug concentration, prolonged half-life, and better acid suppression ability th...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K31/4439A61P1/04
Inventor 汪飞郭礼新郭晖
Owner CHENGDU GUOHONG PHARMA
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