A preparation process and application method of esomeprazole enteric-coated liquid

A technology of esomeprazole sausage and meprazole sausage, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., to avoid degradation and damage, good release and absorption, and good acid resistance force effect

Active Publication Date: 2019-03-01
HEBEI SHINEWAY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent CN102846571A uses methacrylic acid copolymer Eudragit L100 as film-forming agent, triethyl citrate as plasticizer, glycerol monostearate and polysorbate as anti-adhesive agent, also does not use talcum powder

Method used

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  • A preparation process and application method of esomeprazole enteric-coated liquid
  • A preparation process and application method of esomeprazole enteric-coated liquid
  • A preparation process and application method of esomeprazole enteric-coated liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Esomeprazole pellets consist of a drug-loaded pellet core, an isolation layer, and an enteric-coated layer, among which:

[0038] Drug-loaded pill core formula:

[0039]

[0040] Preparation method of drug-loaded pellet core: adopt fluidized spray drying technology, spray esomeprazole magnesium in the form of aqueous suspension of binder containing solvent onto sucrose pellet core to form drug-loaded pellet core, wherein the diameter of the pellet core is 0.3 mm, the weight gain of the pellet core is 213%, and the particle size of esomeprazole magnesium is below 5 μm.

[0041] The isolation pellets are:

[0042]

[0043] The preparation method of the isolation layer pellets: the fluidized spray drying technology is adopted, and the drug-loaded pellet core pellets are coated with an isolation layer with a solution containing talcum powder and hypromellose to form isolation layer pellets, and the weight gain of the isolation layer is 24.5%.

[0044] Enteric-coated p...

Embodiment 2

[0054] Esomeprazole pellets consist of a drug-loaded pellet core, an isolation layer, and an enteric-coated layer, among which:

[0055] Drug-loaded pill core formula:

[0056]

[0057] Preparation method of drug-loaded pellet core: adopt fluidized spray drying technology, spray esomeprazole magnesium in the form of aqueous suspension of binder containing solvent onto sucrose pellet core to form drug-loaded pellet core, wherein the diameter of the seed core is 0.3 mm, the weight gain of the seed core is 266.8%, and the particle size of esomeprazole magnesium is below 5 μm.

[0058] The isolation pellets are:

[0059]

[0060] The preparation method of the isolation layer pellets: the fluidized spray drying technology is adopted, and the drug-loaded core pellets are coated with an isolation layer with a solution containing talcum powder and hydroxypropyl cellulose to form isolation layer pellets, and the weight gain of the isolation layer is 22.4%.

[0061] Enteric-coat...

Embodiment 3

[0071] Esomeprazole pellets consist of a drug-loaded pellet core, an isolation layer, and an enteric-coated layer, among which:

[0072] Drug-loaded pill core formula:

[0073]

[0074] Preparation method of drug-loaded pellet core: adopt fluidized spray drying technology, spray esomeprazole magnesium in the form of aqueous suspension of binder containing solvent onto sucrose pellet core to form drug-loaded pellet core, wherein the diameter of the seed core is 0.3 mm, the weight gain of the seed core is 320%, and the particle size of esomeprazole magnesium is below 5 μm.

[0075] The isolation pellets are:

[0076]

[0077] The preparation method of the separation layer pellets: adopt the fluidized spray drying technology, use the hydroxypropyl methylcellulose solution containing titanium dioxide and talcum powder to coat the drug-loaded core pellets with the separation layer to form the separation layer pellets, and the weight gain of the separation layer is 18.8 %. ...

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Abstract

The invention relates to the technical field of drug preparations, relates to esomeprazole and a drug preparation taking the salt of the esomeprazole as an active ingredient, and in particular relates to the esomeprazole, a salt enteric mini-pill preparation thereof and a preparation method of the salt enteric mini-pill preparation. The enteric coating solution prepared by the preparation process for the enteric coating solution is simple in coating process, and the prepared enteric preparation is high in acid tolerance and good in releasing rate, can be expected to be well released and absorbed in the intestinal tract, and is higher in bioavailability and stable in quality.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical preparation in which esomeprazole and its salt are active ingredients, in particular to an enteric-coated pellet preparation of esomeprazole and its salt and a preparation method thereof. Background technique [0002] Esomeprazole (Esomeprazole, EMS) (see formula 1 for molecular structure) is the world's first single isomer proton pump inhibitor (proton pump inhibitor, PPI) developed by Ariscon, which is mainly used to treat gastric cancer. Esophageal reflux disease, HP (Helicobacter pylori) positive peptic ulcer and digestive system disorders related to gastric acid, the oral liver metabolism rate is low, the blood concentration and bioavailability of omeprazole or R- The isomer is high, and the acid-suppressing effect is stronger. As shown in Formula 1, there is a sulfoxide group in the molecular structure of esomeprazole, so it is very sensi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/4439A61K47/32A61K47/14A61K47/26A61P1/04
Inventor 张泽孔德宪周立伟巴晓雨赵淑欣刘艳丽李志刚张纲关秀伟
Owner HEBEI SHINEWAY PHARMA
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