Proton pump inhibitor enteric coated pellet and preparation and preparation method thereof

A proton pump inhibitor, proton pump technology, applied in the direction of pharmaceutical formulations, non-active ingredients of polymer compounds, medical preparations containing active ingredients, etc. And other issues

Active Publication Date: 2013-10-23
KANGBOSHI PHARMA LIAONING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If omeprazole enteric-coated capsules (pellet type) are kept in a relatively humid environment for a long time, it will cause the drug to absorb moisture and degrade, and the related substances will increase, which will directly affect the quality and stability of the drug

Method used

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  • Proton pump inhibitor enteric coated pellet and preparation and preparation method thereof
  • Proton pump inhibitor enteric coated pellet and preparation and preparation method thereof
  • Proton pump inhibitor enteric coated pellet and preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0144] The preparation of embodiment 1 omeprazole enteric-coated pellets

[0145]Add 58.4g of HPMC to 500g of purified water at 25°C, stir and swell until clear and ready for use; weigh 12.2g of disodium hydrogen phosphate and 12.2g of sodium phosphate and dissolve them in 50g of purified water, and add the above-mentioned hydrogen phosphate in turn while stirring the HPMC solution Disodium solution and sodium phosphate solution; 8.5 g of Tween 80 and 13.5 g of silicon dioxide were added while stirring; 170.0 g of omeprazole was added and stirred evenly to obtain a suspension. Pass the above suspension through a 80-mesh sieve, rinse it with 100 g of purified water, add 272.0 g of purified water, and stir evenly to obtain a drug-loaded layer solution. Fill 800g of sucrose-starch microspheres (particle size 0.6~0.8mm) into the fluidized bed granulation coating machine, fan frequency 20~40Hz, air inlet temperature 50~70℃, material temperature 35~50℃, atomization The air pressure...

Embodiment 2

[0154] The preparation of embodiment 2 Lansoprazole enteric-coated pellets

[0155] 300.0g lansoprazole, 105.0g magnesium carbonate, 195.0g purifying sucrose and 75.0g low-substituted hydroxypropyl cellulose are evenly mixed to obtain dusting powder for the active ingredient layer; 75.0g purifying sucrose, 48.8g titanium dioxide and 18.8g of low-substituted hydroxypropyl cellulose is evenly mixed to obtain the dusting powder for the middle layer; 9.4g of hydroxypropyl cellulose is dissolved in 469.0g of purified water to prepare a hydroxypropyl cellulose solution; 375.0g of sucrose-starch Fill the microspheres into a fluidized bed granulator and coater, and while spraying the hydroxypropyl cellulose solution, use the above-mentioned dusting bag for the active ingredient layer and the dusting bag for the middle layer to coat the sucrose-starch microspheres coating, the obtained pellets coated with the drug-loaded layer solution; set the material temperature at 40°C, fluidize an...

Embodiment 3

[0164] The preparation of embodiment 3 esomeprazole magnesium enteric-coated pellets

[0165] Take 61.0g of HPMC and add it into 500.0g of purified water at 25°C, stir and swell until clear and ready for use; weigh 11.5g of disodium hydrogen phosphate and 11.5g of sodium phosphate and dissolve them in 50.0g of purified water, and add the above-mentioned ones in turn while stirring the HPMC solution. Disodium hydrogen phosphate solution and sodium phosphate solution; add 8.0 g of Tween 80 and 14.0 g of silicon dioxide while stirring; add 162.0 g of esomeprazole magnesium (equivalent to 145.7 g of esomeprazole), Stir well to obtain a suspension. Pass the above suspension through an 80-mesh sieve, rinse it with 100.0 g of purified water, add 223.0 g of purified water, and stir evenly to obtain a drug-loaded layer solution. Fill 700.0g of sucrose-starch microspheres (particle size 0.6~0.8mm) into the fluidized bed granulation coating machine, fan frequency 20~40Hz, air inlet temp...

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Abstract

The invention relates to the field of medicines, especially to a proton pump inhibitor enteric coated pellet and a preparation and a preparation method thereof. The proton pump inhibitor enteric coated pellet is composed of a blank pellet core, a drug loaded layer, a protective layer, a separating layer, a waterproof layer and an enteric coating, wherein the waterproof layer is made from zein, the drug loaded layer is composed of a proton pump inhibitor, a first binder, a first stabilizing agent, a first antiadherent and a solubilizer or of the proton pump inhibitor, the first binder, the first stabilizing agent, a filler, a disintegrating agent and a first opacifier, the protective layer is composed of a second binder, a second stabilizing agent, a plasticizer, a second opacifier and an antifoaming agent, the separating layer is made of a coating material, and the enteric coating is composed of an enteric material, a plasticiser and a second antiadherent. The proton pump inhibitor enteric coated pellet and the preparation thereof in the invention have stable properties, reliable quality and high bioavailability and can avoid burst effects and moisture absorption.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a proton pump inhibitor enteric-coated pellet and its preparation and preparation method. Background technique [0002] Peptic ulcer mainly refers to chronic ulcers that occur in the stomach and duodenum, and can also occur in the lower esophagus, around the gastrojejunostomy, and Meckel's diverticulum with ectopic gastric mucosa. The formation of these ulcers is related to gastric acid and pepsin. It is related to the digestion of gastric ulcer, so it is called peptic ulcer, mainly including gastric ulcer and duodenal ulcer. In recent years, studies have found that the formation of peptic ulcer is related to the existence of Helicobacter pylori. The on-site manifestations are chronic, periodic, and rhythmic mid-upper abdominal pain. Gastric ulcers are often located under the xiphoid process or to the left, and occur 1 to 2 hours after eating. It lasts for 1 to 2 hours and is relieved a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K45/00A61K31/4439A61K47/42A61P1/04
Inventor 谢斌
Owner KANGBOSHI PHARMA LIAONING
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