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Esomeprazole magnesium enteric-coated pellet, capsule and preparation method thereof

A technology for azole magnesium enteric-coated pellets and enteric-coated pellets, which is applied in the pharmaceutical field, can solve the problems of many types of required excipients, complicated preparation processes, etc., and achieves the effects of healthy formula and process, simple process operation and few types.

Inactive Publication Date: 2021-07-13
浙江康德药业集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, in order to improve the stability of the medicine in the esomeprazole magnesium enteric-coated pellets, for example, the pH value of the blank ball core is adjusted in the patent document CN105106168B, so that the pH value of the ball core auxiliary material is at 9-11; Alkaline stabilizers and antioxidants are added to the formulation of the drug-loaded layer; two layers of isolation layers are designed and the pH values ​​of the two layers of isolation layers are adjusted to 9-11 and 8-10 respectively with an alkaline regulator; Surfactants and opacifiers are added to the coating layer; a gastric-soluble film coating layer is also added to the outermost layer; there are too many types of excipients required and the preparation process is complicated

Method used

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  • Esomeprazole magnesium enteric-coated pellet, capsule and preparation method thereof
  • Esomeprazole magnesium enteric-coated pellet, capsule and preparation method thereof
  • Esomeprazole magnesium enteric-coated pellet, capsule and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0058] A kind of esomeprazole magnesium enteric-coated pellet, is made up of blank core, blank core coating layer, drug-loading layer, isolation coating layer, enteric coating layer (1) from inside to outside, wherein, blank The particle diameter of the pellet core is 0.25-0.355mm, the weight gain of the blank core coating layer is 3%, the weight gain of the drug-loaded layer is 61%, the weight gain of the isolation coat layer is 15%, and the weight gain of the enteric coating layer (1) is 44%. %, wherein, the coating layer of the blank pellet core is composed of hypromellose; the drug-loading layer is composed of esomeprazole magnesium and hypromellose; the isolation coating layer is composed of hypromellose, hypromellose , talcum powder and magnesium stearate; the enteric coating layer (1) is composed of Eudragit LD30-55 aqueous dispersion, triethyl citrate and talc powder. The esomeprazole magnesium enteric-coated pellets are calculated as 1000 finished products, and their ...

Embodiment 2

[0083] A kind of esomeprazole magnesium enteric-coated pellet, is made up of blank core, blank core coating layer, drug-loading layer, isolation coating layer, enteric coating layer (1) from inside to outside, wherein, blank Ball core particle size 0.1-0.25mm The weight gain of the blank core coating layer is 3%, the weight gain of the drug-loaded layer is 61%, the weight gain of the isolation coat layer is 15%, and the weight gain of the enteric coating layer (1) is 52%. , wherein the coating layer of the blank pellet core is composed of hypromellose; the drug-loading layer is composed of esomeprazole magnesium and hypromellose; the isolation coating layer is composed of hypromellose, hypromellose, Composed of talcum powder and magnesium stearate; the enteric coating layer (1) is composed of Eudragit LD30-55 aqueous dispersion, triethyl citrate, glyceryl monostearate and Tween-80. The esomeprazole magnesium enteric-coated pellets are calculated as 1000 finished products, and ...

Embodiment 3

[0086] A kind of esomeprazole magnesium enteric-coated pellet, is made up of blank core, blank core coating layer, drug-loading layer, isolation coating layer, enteric coating layer (1) from inside to outside, wherein, blank The particle diameter of the pellet core is 0.355-1.0mm, the weight gain of the blank core coating layer is 3%, the weight gain of the drug-loaded layer is 61%, the weight gain of the isolation coat layer is 15%, and the weight gain of the enteric coating layer (1) is 79%. %, wherein, the coating layer of the blank pellet core is composed of hypromellose; the drug-loading layer is composed of esomeprazole magnesium and hypromellose; the isolation coating layer is composed of hypromellose, hypromellose , talcum powder and magnesium stearate; the enteric coating layer (1) is composed of Eudragit LD30-55 aqueous dispersion, triethyl citrate, glyceryl monostearate and Tween-80.

[0087] The esomeprazole magnesium enteric-coated pellets are calculated as 1000 f...

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Abstract

The invention relates to an esomeprazole magnesium enteric-coated pellet, capsule and preparation method thereof, and belongs to the pharmaceutical technology, the esomeprazole magnesium enteric-coated pellet comprises a blank pellet core, a blank pellet core coating layer, a drug carrying layer, an isolation coating layer and an enteric coating layer (1) from inside to outside; the particle size of the blank pellet core is 0.25-0.355 mm, and the blank pellet core does not contain drugs; the weight of the blank pellet core coating layer is increased by 2%-4%, the weight of the medicine carrying layer is increased by 60%-260%, the weight of the isolation coating layer is increased by 20%-25%, and the weight of the enteric coating layer (I) is increased by 38%-65%. The esomeprazole magnesium enteric-coated pellet has the advantages of few types of auxiliary materials, small dosage, excellent stability and release rate, simplified process and suitability for large-scale production, and the obtained medicine meets the clinical medication requirement.

Description

technical field [0001] The invention belongs to the pharmaceutical technology, and in particular relates to an esomeprazole magnesium enteric-coated pellet, a capsule and a preparation method thereof. Background technique [0002] Gastroesophageal reflux disease (GERD) refers to a disease in which gastroduodenal contents reflux into the esophagus, causing discomfort symptoms and / or complications, including non-erosive reflux disease (non-erosive reflux disease). erosive reflux disease, NERD), reflux esophagitis (reflux esophagitis, RE) and Barrett's esophagus (Barret's esophagus, BE). Its typical symptoms are heartburn and reflux, abdominal fullness and discomfort, nausea and vomiting, shortness of breath and other related symptoms have a significant negative impact on the quality of life of patients. The incidence rate of GERD in western countries is 10-20%. However, with the westernization of lifestyle and the increase of obese population, this disease has shown a rising ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K47/38A61K47/02A61K47/12A61K47/32A61K47/14A61K47/26A61K31/4439A61P1/04
CPCA61K9/5089A61K9/5078A61K9/5047A61K9/501A61K9/5015A61K9/5026A61K31/4439A61P1/04
Inventor 胡增仁邵良碧于庆明冯荣权余红伟
Owner 浙江康德药业集团股份有限公司