Esomeprazole magnesium enteric capsules and preparation method thereof

A technology for enteric-coated esomeprazole magnesium and esomeprazole magnesium, which is applied in the field of esomeprazole magnesium enteric-coated capsules and the preparation thereof, can solve problems such as oxidative degradation of medicines, and achieves prevention of oxidative degradation and protection of The effect of dissolving, facilitating market promotion and clinical medication

Active Publication Date: 2015-12-02
DEZHOU DEYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese invention patent CN102670521A discloses a kind of esomeprazole magnesium enteric-coated pellets and its preparation method. The enteric-coated pellets use acid-base regulators in the drug-containing layer and the isolation layer to adjust the pH value and enhance the esomeprazole magnesium enteric-coated pellets. The stability of meprazole magnesium, but no antioxidant is added in the drug layer, the drug is easy to cause oxidative degradation during preparation and storage

Method used

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  • Esomeprazole magnesium enteric capsules and preparation method thereof
  • Esomeprazole magnesium enteric capsules and preparation method thereof
  • Esomeprazole magnesium enteric capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation of embodiment 1 esomeprazole magnesium enteric-coated pellets

[0024] (1) Preparation of blank pellet cores

[0025] Starch 400g

[0026] Sucrose 477g

[0027] Sodium hydroxide 30g

[0028] Syrup (60%) 200g

[0029] It is prepared with production equipment such as centrifugal granulator, extrusion extrusion spheronizer, high-efficiency coating machine and fluidized bed coating granulator. The prepared blank pellet cores are screened, and pellets with a particle diameter of 0.4-0.6 mm are selected for drug packaging.

[0030] (2) Preparation of the drug-loaded layer

[0031] Esomeprazole Magnesium 1000g

[0032] Microcrystalline cellulose 300g

[0033] Sodium hydroxide 50g

[0034] Polysorbate 8010g

[0035] Hydroxypropyl methylcellulose 150g

[0036] Water 10000g

[0037]Pass esomeprazole magnesium through a 200-mesh sieve for later use, dissolve sodium hydroxide in about 2kg of water, disperse the hypromellose with hot water, add the remaini...

example 1

[0084] Influencing factors test results

[0085]

example 2

[0087] Take the example sample and carry out acceleration (at a temperature of 40°C±2°C and a relative humidity of 75%±5%) for 6 months and long-term (at a temperature of 25°C±2°C and a relative humidity of 60%±5%) according to the package on the market. 10% condition) 6-month pilot study.

[0088] Accelerated test (temperature: 40°C±2°C, relative humidity: 75%±5%) test results for 6 months

[0089]

[0090] Long-term (temperature 25℃±2℃, relative humidity 60%±10%) test results for 6 months

[0091]

[0092] According to the experimental data, according to the test results of the influencing factors of this product, the appearance of the sample has not changed, and the measured indicators have no obvious changes. It has been placed under high temperature, high humidity and light conditions for 10 days, except for a slight increase in related substances under light conditions. There was no significant change in other indicators. Accelerated tests and long-term tests wer...

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Abstract

The invention discloses esomeprazole magnesium enteric capsules and a preparation method thereof. Esomeprazole magnesium is prepared into enteric coated pellets, and the enteric coated pellets are filled into gastric coated capsules. Each enteric coated pellet consists of an empty pellet core, a medicine carrying layer, two isolating layers, an enteric coated layer and a film coating layer. In order to guarantee stability of medicines, alkaline materials are added in the empty pellet cores; alkali stabilizers and antioxidant are added in the medicine carrying layer; and a high-alkalinity modifier and a low-alkalinity modifier are respectively added in the two isolating layers of each enteric coated pellet. In order to guarantee a dissolution effect, surfactant is added in the enteric coated layers; and stability of products is improved owing to the film coating layers wrapping the outer layers of the enteric coated pellets. Owing to optimized formulation and technology of the pellets, smoothness of a technology is improved, work efficiency is also improved, coating time is shortened, consumption of labor and materials is reduced, and production cost is reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical preparation with esomeprazole magnesium as an active ingredient, in particular to an esomeprazole magnesium enteric-coated capsule and a preparation method thereof. Background technique [0002] Esomeprazole is the left-handed isomer of omeprazole and the world's first single-isomer proton pump inhibitor (PPI) developed by AstraZeneca. Esomeprazole magnesium trihydrate, the molecular formula is C34H36N6O6S2Mg 3H2O, the chemical name is 5-methoxy-2-[(S)-[(4-methoxy-3,5-lutidine-2 -yl)methyl]sulfinyl]-benzimidazole magnesium salt (2:1) trihydrate, the structural formula is shown below. [0003] [0004] Gastric ulcer is a common and frequently-occurring disease. The drugs used to treat gastric ulcer mainly include proton pump inhibitors (PPIs), H2 receptor antagonists, antacids, gastric mucosal protective drugs, and anti-Helicobacter pylori....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/02A61K47/10A61K47/18A61K47/20A61K47/34A61P1/04
Inventor 卞建钢李成文王文波刘秀朋张庆霞高荣静彭杰
Owner DEZHOU DEYAO PHARMA
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