Esomeprazole magnesium enteric-coated pellet and preparation method thereof

A technology of esomeprazole magnesium enteric-coated pellets and esomeprazole magnesium, which is applied in the field of pharmacy, can solve the problems of low yield, high material loss, long working hours, etc., and achieves stability, discoloration, reduction of Surface area, efficient absorption

Active Publication Date: 2012-09-19
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent 201110007462.2 uses a centrifuge to sprinkle powder and granulate pellets. The yield is low, the material loss is large, the environment is polluted, the working hours are long, and the production process has a lot of factors affecting product quality.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Embodiment 1, esomeprazole magnesium enteric-coated pellets

[0092] The drug-containing layer consists of the following components

[0093] Drug-containing layer

Dosage

Esomeprazole Magnesium

60

Medicinal pellet core

400

Anhydrous sodium sulfite

2.5

sodium phosphate

2.5

Poloxamer

12.5

Hypromellose

12.5

water

378

[0094] The isolation layer consists of the following components:

[0095] Isolation layer

Dosage

esomeprazole magnesium containing pills

500

Anhydrous sodium sulfite

1.5

sodium phosphate

7

polyethylene glycol

3.5

Titanium dioxide

7

Hypromellose

35

water

450

[0096] The enteric layer consists of the following ingredients:

[0097] Enteric layer

Dosage

Esomeprazole Magnesium Barrier Pills

500

Aqueous dis...

Embodiment 2

[0118] Esomeprazole magnesium drug-containing layer

[0119] prescription:

[0120] Raw materials

Dosage(kg)

Esomeprazole Magnesium

14.8

Medicinal pellet core

101.9

Anhydrous sodium sulfite

0.6

sodium phosphate

0.6

Poloxamer

3.1

Hypromellose

3.1

water

95.5

[0121] esomeprazole magnesium barrier

[0122] prescription:

[0123] Raw materials

Dosage(kg)

esomeprazole magnesium containing pills

124.1

Anhydrous sodium sulfite

0.3

sodium phosphate

1.4

polyethylene glycol

0.7

Titanium dioxide

1.4

Hypromellose

7.4

water

95.7

[0124] Esomeprazole Magnesium Enteric Coated Layer

[0125] prescription:

[0126] Raw materials

Dosage(kg)

Esomeprazole Magnesium Barrier Pills

135.1

Aqueous dispersion methacrylic acid / ethyl acrylate...

Embodiment 3

[0145] Embodiment 3, esomeprazole magnesium enteric-coated pellets

[0146]

[0147]

[0148] Preparation method is the same as embodiment 1

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Abstract

The invention belongs to the field of pharmacy and relates to a medicinal preparation taking esomeprazole magnesium as an active ingredient, in particular to an esomeprazole magnesium enteric-coated pellet and a preparation method thereof. According to the esomeprazole magnesium enteric-coated pellet, medicines can be rapidly released in intestinal tracts. The esomeprazole magnesium enteric-coated pellet comprises the following structural layers in sequence from inside to outside: a medicine-contained layer, an isolation layer and an enteric-coated layer.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a pharmaceutical preparation with esomeprazole magnesium as an active ingredient, in particular to an esomeprazole magnesium enteric-coated pellet and a preparation method thereof. Background technique [0002] The structural formula of esomeprazole magnesium is: [0003] [0004] Esomeprazole is the left-handed isomer of omeprazole, and is the first pure left-handed optical isomer proton pump inhibitor (PPI). It was approved for marketing in the United States and European countries in 2001. The original research company Aspen Tera applied for a compound patent (ZL94190335.4) in my country. The original research company launched esomeprazole, a replacement product of omeprazole, in 2002, another optical isomer of esomeprazole and omeprazole ( Compared with R)-omeprazole, only a small part is metabolized by CYP2C19, so esomeprazole exhibits low metabolic rate and high plasma concentration....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61K47/14A61K47/32A61K47/34A61K47/38A61P1/04A61K47/10A61K47/26
Inventor 杨冬张志刚莫泽艺陈新民
Owner 珠海润都制药股份有限公司
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