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Preparation method of tiny proton pump inhibitor enteric-coated pellet

A proton pump inhibitor and small intestine technology, which is applied in the field of preparation of proton pump inhibitor extremely small enteric-coated pellets, can solve the problems of high production cost, complicated preparation process, narrow application range, etc., and achieve enhanced roundness and simple operation , the effect of saving manpower

Active Publication Date: 2016-03-30
SHOUGUANG FUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most of the proton pump inhibitor preparations on the market have complex preparation processes, high production costs and narrow application ranges. Therefore, there is an urgent need for a preparation product that is simple in process, cheap and can serve all people

Method used

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  • Preparation method of tiny proton pump inhibitor enteric-coated pellet
  • Preparation method of tiny proton pump inhibitor enteric-coated pellet
  • Preparation method of tiny proton pump inhibitor enteric-coated pellet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Take esomeprazole magnesium enteric-coated pellets as an example

[0036] (1) Preparation of active pellet core: take 120 grams of micronized esomeprazole magnesium, 30 grams of hypromellose, 24 grams of microcrystalline cellulose, 3 grams of simethicone, 4 grams of disodium hydrogen phosphate, 806 grams of polysorbate and 900 grams of purified water are formulated into a drug layer coating solution; 100 grams of microcrystalline cellulose blank pellet core (particle size 180 ~ 250 μm) is used as the master pellet and sprayed on the bottom of a German Glatt fluidized bed The active pill core is prepared by medicine technology, and the particle diameter of the prepared active pill core is 180-425 μm.

[0037] (2) Coating of the isolation layer: take 15 grams of hypromellose, 9 grams of Kollicoat IR, 2 grams of propylene glycol, 4 grams of titanium dioxide, and 400 grams of 95% ethanol to prepare a coating solution for the isolation layer; take the drug layer active pellet cor...

Embodiment 2

[0041] Take esomeprazole magnesium enteric-coated pellets as an example

[0042] (1) Preparation of active pellet core: take 120 grams of micronized esomeprazole magnesium, 30 grams of hypromellose, 24 grams of microcrystalline cellulose, 3 grams of simethicone, 4 grams of disodium hydrogen phosphate, 806 grams of polysorbate and 900 grams of purified water are formulated into a drug layer coating solution; 100 grams of microcrystalline cellulose blank pellet core (particle size 180 ~ 250 μm) is used as the master pellet and sprayed on the bottom of a German Glatt fluidized bed The active pill core is prepared by medicine technology, and the particle diameter of the prepared active pill core is 180-425 μm.

[0043] (2) Isolation layer coating: take 15 grams of hypromellose, 2 grams of propylene glycol, 4 grams of titanium dioxide, and 400 grams of 95% ethanol to prepare the isolation layer coating solution; take the drug layer active pellet core as the master pellet German Glatt f...

Embodiment 3

[0054] Take esomeprazole magnesium enteric-coated pellets as an example

[0055] (1) Preparation of active pellet core: take 100 grams of micronized esomeprazole magnesium, 25 grams of hypromellose, 20 grams of microcrystalline cellulose, 1 gram of simethicone, 2 grams of disodium hydrogen phosphate, 803 grams of polysorbate and 750 grams of purified water were prepared as a coating solution for the drug layer; 80 grams of microcrystalline cellulose blank pellet core (particle size 180 ~ 250 μm) was used as the master pellet and sprayed on the bottom of a German Glatt fluidized bed The active pill core is prepared by medicine technology, and the particle diameter of the prepared active pill core is 180-425 μm.

[0056] (2) Coating of the isolation layer: take 15 grams of hypromellose, 9 grams of Kollicoat IR, 2 grams of propylene glycol, 4 grams of titanium dioxide, and 400 grams of 95% ethanol to prepare a coating solution for the isolation layer; take the drug layer active pellet...

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Abstract

The invention discloses a tiny proton pump inhibitor enteric-coated pellet and a preparation method thereof. The method comprises preparation of an active pellet core, coating an isolating layer and coating an enteric layer; the particle size of the proton pump inhibitor enteric-coated pellet prepared by the method reaches 250-600 microns; and the proton pump inhibitor enteric-coated pellet can be taken through a stomach tube, has good acid tolerance and stability and high bioavailability, and is simple in preparation technology and low in contamination risk.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a preparation method of proton pump inhibitor very small enteric-coated pellets. Background technique [0002] Proton pump inhibitors are currently the most advanced class of drugs for the treatment of peptic ulcers. They have been widely used in clinical practice and have the best curative effect in the past ten years. They can effectively and rapidly inhibit gastric acid secretion and eliminate Helicobacter pylori to achieve rapid healing of ulcers. purpose. [0003] At present, proton pump inhibitors mainly include omeprazole, lansoprazole, pantoprazole, rabeprazole and their corresponding salts (such as omeprazole magnesium, etc.) and monorotating isomers (Such as esomeprazole magnesium, etc.) and other products, with a large number of products, complete varieties, strong pertinence, and a wide range of treatments. [0004] Proton pump inhibitors are unstable un...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/38A61K45/06A61K31/4439A61P1/04
CPCA61K9/5042A61K31/4439A61K45/06
Inventor 宋成刚王中华赵瑞勇宋伟国李洪程王伟李金艳郝冠华杨磊
Owner SHOUGUANG FUKANG PHARMA
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