Dextral ibuprofen amino acid salt tablets and preparation method thereof

An amino acid salt tablet, amino acid salt technology, applied in the directions of anti-inflammatory agents, pill delivery, pharmaceutical formulations, etc., can solve the problems of difficulty in the development of solution preparations, affecting the bioavailability of drugs, etc., to improve medication compliance and reduce adverse effects. Response, the effect of rational drug use

Inactive Publication Date: 2011-02-23
AEROSPACE CENT HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, dextrobuprofen is almost insoluble in water like ibuprofen, which not only brings difficulties to the development of solution formulations, but more importantly, may affect the bioavailability of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1 (common sheet, adopts wet granulation method)

[0016] prescription:

[0017] Dexibuprofen Arginine Salt 138.3g (calculated as Dexibuprofen 75g)

[0018] Starch 80g

[0019] Dextrin 40g

[0020] Microcrystalline Cellulose 60g

[0021] 10% starch slurry appropriate amount

[0022] Magnesium Stearate 1.5g (0.5%)

[0023]

[0024] Made into 1000 tablets (each tablet contains 75mg of Dexibuprofen)

[0025] Preparation: pass dextrobuprofen arginine salt through 80 mesh sieve, mix with starch, dextrin and microcrystalline cellulose, add starch slurry to make soft material, granulate with 20 mesh sieve, put wet granules in 50 Dry at ℃, control the water content at 2% to 3%, granulate into 14 meshes, add magnesium stearate, mix evenly, and compress into tablets to obtain the product.

Embodiment 2

[0026] Example 2 (chewable tablet, soluble tablet, orally dissolving tablet or orally rapidly disintegrating tablet)

[0027] prescription:

[0028] Dexibuprofen lysine salt 256.3g (150g based on Dexibuprofen)

[0029] Sucrose 40g

[0030] Mannitol 40g

[0031] Sorbitol 20g

[0032] 5% hydroxypropyl methylcellulose (HPMC) solution appropriate amount

[0033] Magnesium stearate 1.9g (0.5%)

[0034]

[0035] Make 1000 tablets (each tablet contains 150mg of Dexibuprofen)

[0036] Preparation: Pass ibuprofen arginine salt through a 80-mesh sieve, sucrose and mannitol through a 100-mesh sieve, mix the three, add 5% HPMC solution to make a soft material, granulate with a 20-mesh sieve, The wet granules are dried at 50°C, the water content is controlled at 2% to 3%, granulated into 14 mesh, added with magnesium stearate, mixed evenly, and then compressed into tablets.

Embodiment 3

[0037] Embodiment 3 (effervescent tablet)

[0038] prescription:

[0039] Dexibuprofen arginine salt 553.3g (300g based on Dexibuprofen)

[0040] Lactose 120g

[0041] Citric acid 24g

[0042] Sodium bicarbonate 40g

[0043] Sodium Carboxymethyl Starch (CMS-Na) 20g

[0044] 5% povidone (PVP) absolute ethanol solution appropriate amount

[0045] Magnesium Stearate 3.7g (0.5%)

[0046]

[0047] Made into 1000 tablets (each tablet contains 300mg of Dexibuprofen)

[0048] Preparation: Mix the raw and auxiliary materials through a 100-mesh sieve, and after mixing evenly, add 5% PVP anhydrous ethanol solution to make a soft material. After granulating with a 20-mesh sieve, dry the wet granules at 50°C, and control the water content at 2% to 3 %, 14-mesh whole grain, add magnesium stearate, mix well, and then compress into tablets.

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PUM

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Abstract

The invention discloses dextral ibuprofen amino acid salt tablets and a preparation method thereof. The tablets are prepared from the following raw materials in part by weight: 1 part of dextral ibuprofen amino acid salt, 0.2 to 20 parts of diluent (or filler), 0.01 to 1 part of adhesive, 0.01 to 1 part of disintegrating agent, 0.01 to 1 part of flavoring agent and 0.001 to 0.1 part of lubricating agent. Wet granulation, dry granulation and tabletting or direct powder tabletting and tablet coating are adopted in the preparation process of the tablets. Based on the dextral ibuprofen, the specification of the tablets can be 30 to 300 milligrams, preferably 37.5 milligrams or integral multiple of 37.5 milligrams. The dextral ibuprofen amino acid salt serving as an effective ingredient of the tablets has the advantages of quick response, accurate dose, low side effect and small individual difference. The tablets can be prepared into common tablets, chewable tablets, effervescent tablets, soluble tablets, oral fast dissolving tablets, sugar coated tablets, film coated tablets and the like.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a Dexibuprofen amino acid salt tablet and a preparation method thereof. Background technique [0002] Ibuprofen (Ibuprofen), 2-(4-isobutylphenyl) propionic acid, also known as ibuprofen, molecular formula C 13 h 18 o 2 , the molecular weight is 206.28. Ibuprofen has strong anti-inflammatory, analgesic, and antipyretic effects, and has little irritation to the gastrointestinal tract, few adverse reactions, and good tolerance. It is currently a commonly used antipyretic and analgesic drug in clinical practice. [0003] Ibuprofen has optical activity, and the activity of dextro ibuprofen is 160 times that of its levorotatory form, and 1.6 times that of the racemic form. The racemic form is commonly used clinically at present. Studies have shown that after racemic ibuprofen enters the human body, part of the L-body will be transformed into a D-body, and the conversion r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/195A61P29/00A61K31/198A61K31/192A61K9/20A61K31/4172A61K9/28
Inventor 韩静王振龙强桂芬郑天雷王晓琳王涛刘会臣
Owner AEROSPACE CENT HOSPITAL
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