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Mesalazine enteric-coated sustained-release pellet and preparation method thereof

A technology of mesalazine and sustained-release pellets, which can be applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems such as the inability to obtain a uniform sustained-release film and the like

Active Publication Date: 2015-09-23
广东暨大基因药物工程研究中心有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention provides another solution for the preparation of mesalazine enteric-coated sustained-release pellets to solve the problem that the domestic prior art cannot obtain a uniform sustained-release film for pellets

Method used

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  • Mesalazine enteric-coated sustained-release pellet and preparation method thereof
  • Mesalazine enteric-coated sustained-release pellet and preparation method thereof
  • Mesalazine enteric-coated sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] 1) Sustained release pill core

[0055]

[0056] Mix mesalamine with microcrystalline cellulose, glyceryl behenate, silicon dioxide, and polyethylene glycol evenly, add water to moisten evenly, extrude into 1mm strip soft material with an extrusion spheronizer, and spheroidize to about 1mm spherical wet pills. The wet pellets were dried at about 60°C. After drying, sieve the sustained-release pellet cores with sieves with apertures of 0.5 mm and 1 mm.

[0057] 2) Enteric coating

[0058]

Embodiment 2

[0061] 1) Sustained release pill core

[0062]

[0063] Mix mesalazine with microcrystalline cellulose, glyceryl behenate, and polymerized sugar evenly, add water to moisten evenly, use an extrusion spheronizer to extrude into a strip-shaped soft material of 1mm, and spheroidize into a spherical wet pellet of about 1mm. The wet pellets were dried at about 60°C. After drying, sieve the sustained-release pellet cores with sieves with apertures of 0.5 mm and 1 mm.

[0064] 2) Isolation coating

[0065] Easy-release premix with film coating TM The sustained-release ball core is coated with an isolation coat, and the weight of the coating is increased by 5%.

[0066] 3) Enteric coating

[0067]

[0068] Eudragit L100 and S100 were dissolved in 1500g 80% ethanol solution, and then talcum powder and triethyl citrate were dispersed into the solution; the above-mentioned enteric coating solution was sprayed in the fluidized bed (bottom spray) coating equipment On gown beads....

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Abstract

The invention provides a mesalazine enteric-coated sustained-release pellet, which consists of a slow-release pellet core and an enteric-coated dressing. The slow-release pellet core contains 40-45 wt.% of mesalazine, 45-50 wt.% of a matrix sustained-release composite, 5-10% of a chaotropic agent and 0-5 wt.% of other additives; the matrix sustained-release composite consists of glyceryl behenate and microcrystalline cellulose in the weight ratio of 2-4:1. The invention also provides a preparation method of the mesalazine enteric-coated sustained-release pellet. The method provided by the invention employs a skeleton controlled-release technology to control drug release, reaches ideal drug release rate and good inter-batch reproducibility in preparation, does not have high requirement on equipment, and is in favor of ndustrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an enteric-coated sustained-release pellet containing 5-aminosalicylic acid (also known as mesalazine) as an active ingredient for relieving ulcerative colitis. The application also provides the A preparation method of enteric-coated sustained-release pellets. Background technique [0002] Mesalazine is an anti-inflammatory drug used to treat inflammatory bowel diseases such as ulcerative colitis, Crohn's disease. The preparations currently on the market in China include enteric-coated tablets, sustained-release granules, sustained-release tablets, and suppositories. [0003] Mesalazine has an anti-inflammatory effect on the intestinal tract by inhibiting the synthesis of prostaglandins that cause inflammation and the formation of inflammatory mediators leukotrienes. Mesalamine is very easy to be absorbed and metabolized in the human body, and mesalamine can only play a...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/606A61K47/38A61P29/00A61P1/00
Inventor 陈波罗厚旺夏红英
Owner 广东暨大基因药物工程研究中心有限公司
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