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Nimesulide sustained-release tablet and preparation method thereof

A sustained-release tablet and compressibility technology, applied in the field of nimesulide sustained-release tablets, to achieve the effects of reducing surface tension, good process reproducibility, and reducing the number of times of taking

Active Publication Date: 2011-04-06
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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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/18A61K47/36A61K47/38A61P29/00
Inventor 洪江游洪丽萍陈云飞王稳奇
Owner HAINAN HONZ PHARMA
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