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Nimesulide sustained-release tablet and preparation method thereof

A technology for sustained-release tablets and matrix sustained-release materials, which is used in pharmaceutical formulations, drug delivery, amide active ingredients, etc., to achieve the effects of reducing surface tension, good process reproducibility, and reducing the number of times of taking

Active Publication Date: 2009-05-06
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The nimesulide sustained-release preparation achieves a slow-release effect, but the stability and sustained-release effect need to be further improved

Method used

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  • Nimesulide sustained-release tablet and preparation method thereof
  • Nimesulide sustained-release tablet and preparation method thereof
  • Nimesulide sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] 1000 Nimesulide Sustained Release Tablets, each containing Nimesulide 200mg.

[0022] Nimesulide 200g,

[0023] Hypromellose 60RT50 100g,

[0024] Compressible starch 100g,

[0025] Magnesium Stearate 5g,

[0026] 2.5% ethyl cellulose 95% ethanol solution 140ml.

[0027] Preparation method: mix nimesulide, hypromellose, compressible starch, etc. uniformly according to the method of equal amount addition, and use 140ml of 2.5% ethylcellulose and 95% ethanol solution to make the powder after mixing uniformly Material, pass through 16 mesh sieve to granulate, ventilate and dry at 55~60℃, control water content <3%, after granulation with 14 mesh sieve, add magnesium stearate in prescribed amount, mix well, compress into tablets, control tablet The hardness is between 6.5 and 7.5kg.

Embodiment 2

[0029] 1000 Nimesulide Sustained Release Tablets, each containing Nimesulide 200mg.

[0030] Nimesulide 200g,

[0031] High viscosity hypromellose 90g,

[0032] Low viscosity hypromellose 10g,

[0033] Compressible starch 100g,

[0034] Magnesium Stearate 5g,

[0035] 2.5% ethyl cellulose 95% ethanol solution 140ml.

[0036] Preparation method: mix high-viscosity hypromellose and low-viscosity hypromellose to form hypromellose with a viscosity of 4000 milliPascal seconds, and add nimesulide and hypromellose to , compressible starch, etc., mix well, use 140ml of 2.5% ethyl cellulose and 95% ethanol solution to make the above mixed powder into a soft material, pass through a 16-mesh sieve to granulate, and ventilate and dry at 55-60°C to control the content of The amount of water is less than 3%. After the granules are sized with a 14-mesh sieve, the prescribed amount of magnesium stearate is added, mixed evenly, and compressed into tablets. The hardness of the tablets is c...

Embodiment 3

[0038]1000 Nimesulide Sustained Release Tablets, each containing Nimesulide 200mg.

[0039] Nimesulide 200g,

[0040] High viscosity hypromellose 65g,

[0041] Low viscosity hypromellose 35g,

[0042] Compressible starch 100g,

[0043] Magnesium Stearate 5g,

[0044] 4.5% polyvinylpyrrolidone 95% ethanol solution 120ml.

[0045] The preparation method is the same as in Example 2, wherein the high viscosity hypromellose and the low viscosity hypromellose are mixed to form the hypromellose with a viscosity range of 2000 milliPascals.

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Abstract

The invention provides a Nimesulide sustained-release tablet and a preparation method thereof. The Nimesulide sustained-release tablet is prepared by Nimesulide, skeleton sustained-release material, a bond and a lubricant. The invention is characterized in that the skeleton sustained-release material is a mixture of compressible starch and hydroxypropyl methylcellulose with the weight ratio of 1 : 1; moreover, the weight ratio of the Nimesulide : the compressible starch : the hydroxypropyl methylcellulose is 2 : 1 : 1; wherein, the preferable viscidity range of the hydroxypropyl methylcellulose is 20 to 4000 mpa.s. The Nimesulide sustained-release tablet can be slowly released to maintain more stable blood medicine concentration and longer action time; the Nimesulide sustained-release tablet taken before sleeping can appear peaking effect in the morning, achieve the best clinic treatment target and have better medicament economy advantage.

Description

technical field [0001] The invention relates to a nimesulide slow-release tablet, which is prepared by combining appropriate pharmaceutical auxiliary materials and nimesulide to make a slow-release pharmaceutical preparation. Background technique [0002] Nimesulide, Latin name: Nimesulide, has a wide range of anti-inflammatory and analgesic effects, can quickly relieve toothache, menstrual pain, post-operative pain and other pains, and can effectively improve osteoarthritis or rheumatoid arthritis, pelvic inflammatory disease, It is a new generation of highly selective, powerful and safe non-steroidal anti-inflammatory painkillers for otitis, laryngitis and other related symptoms. The half-life is 2-3 hours. The current commercially available product specification is 100mg per tablet (or per capsule), 100mg once a day twice a day. For this drug, patients sometimes require an extended-release dosage form that can be taken infrequently and delivered smoothly. For symptoms ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/18A61P29/00
Inventor 洪江游洪丽萍陈云飞王稳奇
Owner HAINAN HONZ PHARMA
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