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Loxoprofen sodium composition

A technology of loxoprofen sodium and a composition is applied in the field of phenylpropionic acid non-steroidal anti-inflammatory drugs, and can solve the problems of poor dispersion uniformity of loxoprofen sodium and the like

Active Publication Date: 2012-09-19
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved in the present invention is: solve the technical problem that loxoprofen sodium dispersion uniformity is not good, provide a kind of loxoprofen sodium dispersion composition that meets Pharmacopoeia regulation, and this composition property is stable

Method used

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  • Loxoprofen sodium composition
  • Loxoprofen sodium composition
  • Loxoprofen sodium composition

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Features of Example 1: Addition of silicon dioxide.

[0028] Loxoprofen sodium 2H 2 O 68.00g, microcrystalline cellulose 199.0g, crospovidone (XL-10) 15.00g, silicon dioxide 15.00g, magnesium stearate 3.00g, an appropriate amount of 95% ethanol solution. Made: 1000 tablets.

[0029] The preparation method of the composition of the present invention is

[0030] The first step takes loxoprofen sodium and auxiliary materials and passes through a 100-mesh sieve.

[0031] The second step weighs loxoprofen sodium dihydrate, microcrystalline cellulose, silicon dioxide, and crospovidone (XL-10) in the prescription amount in a wet mixing granulator, and dry mixes for 5 minutes to mix evenly , to get a mixture.

[0032] The third step is to add 95% ethanol (about 75g / 1000 tablets) to the mixture to make soft materials.

[0033] The fourth step is to granulate through a 24-mesh sieve.

[0034] The fifth step is to air-dry the wet granules at 60°C until the weight loss is les...

Embodiment 2

[0039] Features of Example 2: Addition of silicon dioxide.

[0040] Loxoprofen sodium 2H 2 O 68.00g, microcrystalline cellulose 199.0g, crospovidone (XL-10) 15.00g, silicon dioxide 9.00g, magnesium stearate 3.00g, an appropriate amount of 95% ethanol solution. Make 1000 pieces by the method for embodiment 1.

Embodiment 3

[0041] Features of Example 3: silicon dioxide internally added.

[0042] Loxoprofen sodium 2H 2 O 68.00g, microcrystalline cellulose 199.0g, crospovidone (XL-10) 15.00g, silicon dioxide 12.00g, magnesium stearate 3.00g, an appropriate amount of 95% ethanol solution. Make 1000 pieces by the method for embodiment 1.

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Abstract

The invention relates to a loxoprofen sodium composition. Due to the high viscosity of loxoprofen sodium, on one hand, the dispersible tablet of the loxoprofen sodium is easy to clot after being disintegrated, so that the dispersible tablet cannot completely pass through a 2# sieve easily; and on the other hand, the dispersible tablet is easy to absorb moisture, and after the moisture absorption, the tablet is fluffy, the content of the main medicament is decreased, and particularly, the dissolution rate is decreased obviously. According to the loxoprofen sodium composition, a preparation process is changed, and silicon dioxide in the formula is added by an interior addition, so that the composition with high dispersible uniformity and stability is obtained.

Description

[0001] Technical Field The present invention relates to a loxoprofen sodium composition. Background technique [0002] Loxoprofen sodium, chemical name: sodium 2-[4-(2-oxocyclopentylmethyl)phenyl]propionate dihydrate. Belongs to phenylpropionic acid non-steroidal anti-inflammatory drugs. [0003] Loxoprofen sodium was developed by Japan Sankyo Co., Ltd. Compared with similar clinical drugs, loxoprofen sodium has the following characteristics: good clinical effect and small side effects. The other feature is that it has a wide range of indications, and it can be widely used clinically for anti-inflammatory and analgesic treatment of rheumatoid arthritis, low back pain, frozen shoulder, neck, shoulder and wrist syndrome, etc., as well as analgesic and anti-inflammatory treatment after surgery, trauma and tooth extraction And antipyretic and analgesic for acute upper respiratory tract inflammation. Loxoprofen Sodium Dispersible Tablets belong to Category B medical insurance pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/192A61K47/02A61P29/00
Inventor 梁巧余许蕾龙连清
Owner DISHA PHARMA GRP
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