Ibuprofen diphenhydramine orally disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and diphenhydramine hydrochloride, which is applied in the field of pharmacy, can solve the problems of no products on the market, no research reports on ibuprofen and diphenhydramine orally disintegrating tablets, and achieve reasonable prescription design, Good application prospect, suitable hardness effect

Active Publication Date: 2012-06-13
SOUTHWEST UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But so far, there are no research reports on ibuprofen and diphenhydramine orally disintegrating tablets at home and abroad, and no related products are on the market.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] prescription:

[0031] components mass (g) Mass percentage (%) ibuprofen 200 40 diphenhydramine citrate 38 7.6 microcrystalline cellulose 120 24 Mannitol 70 14 Crospovidone 40 8 hypromellose 7.5 1.5 Sodium dodecyl sulfate 10 2 stearic acid 5 1 Colloidal silica 1.5 0.3 aspartame 6.5 1.3 mint flavor 1.5 0.3 gross weight 500 100

[0032] Preparation:

[0033] a. Grinding each component of the raw and auxiliary materials into a fine powder passing through a 100-mesh sieve; dissolving the prescribed amount of sodium lauryl sulfate in water to make a solution as a wetting agent;

[0034] b. Take the prescribed amount of ibuprofen, microcrystalline cellulose, mannitol and hypromellose, 3 / 4 of the prescribed amount of crospovidone and 2 / 3 of the prescribed amount of aspartame, mix well, add Soft material made of wetting agent, granulated with 24 mesh sieve, dried at 60±5°C, g...

Embodiment 2

[0040] prescription:

[0041] components mass (g) Mass percentage (%) ibuprofen 200 40 Diphenhydramine hydrochloride 25 5 microcrystalline cellulose 125 25 Mannitol 62.5 12.5 Crospovidone 30 6 citric acid 15 3 sodium bicarbonate 10 2 hypromellose 5 1 Sodium dodecyl sulfate 7.5 1.5 Magnesium stearate 6 1.2 Colloidal silica 1 0.2 aspartame 7.5 1.5 stevia 3.5 0.7 lemon zest 2 0.4 gross weight 500 100

[0042] Preparation:

[0043] a. Grinding each component of the raw and auxiliary materials into a fine powder passing through a 100-mesh sieve; dissolving the prescribed amount of sodium lauryl sulfate in water to make a solution as a wetting agent;

[0044] b. Take the prescribed amount of ibuprofen, microcrystalline cellulose, mannitol, sodium bicarbonate, and hypromellose, three-quarters the prescribed amount of crospovidone, and one-half the prescribed amo...

Embodiment 3

[0050] prescription:

[0051] components mass (g) Mass percentage (%) ibuprofen 200 40 diphenhydramine citrate 38 7.6 microcrystalline cellulose 105 21 Mannitol 87 17.4 Croscarmellose Sodium 42 8.4 Hypromellose 5.5 1.1 Sodium dodecyl sulfate 12.5 2.5 Magnesium stearate 5 1.0 Colloidal silica 1 0.2 aspartame 4 0.8 gross weight 500 100

[0052] Preparation:

[0053] a. Grinding each component of the raw and auxiliary materials into a fine powder passing through a 100-mesh sieve; dissolving the prescribed amount of sodium lauryl sulfate in water to make a solution as a wetting agent;

[0054] b. Take the prescribed amount of ibuprofen, microcrystalline cellulose, mannitol, hypromellose, and sodium lauryl sulfate, three-quarters the prescription amount of crospovidone, and one-half the prescription amount of Aspartame, mix evenly, add wetting agent to make soft material, granulate with...

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Abstract

The invention provides an ibuprofen diphenhydramine orally disintegrating tablet, comprising the following ingredients, by weight: 40% of ibuprofen, 5% of diphenhydramine hydrochloride or 7.6% of diphenhydramine citrate, 35-40% of filler, 6-12% of disintegrating agent, 0-5% of effervescent disintegrant, 1-2% of adhesive, 1-2.5% of surfactant, 1-1.5% of lubricant, 0.7-2.5% of sweetener and 0-0.5% of perfume. The filler is at least two from microcrystalline cellulose, mannitol and pregelatinized starch; the disintegrating agent is at least one from crospovidone, cross linked sodium carboxymethyl cellulose and sodium carboxymethyl starch; the effervescent disintegrant comprises citric acid and sodium bicarbonate in a mass ratio of 1-2:1; the adhesive is hydroxypropyl methylcellulose; the surfactant is sodium dodecyl sulfate; the lubricant is eleaostearic acid or magnesium stearate and colloid silica; the sweetener is aspartame and / or steviosin; and the perfume is medicinal essence. Theinvention also provides a preparation method of the orally disintegrating tablet and is simply operated, at low cost and suitable for industrialized production; and the obtained product satisfies quality requirement of an orally disintegrating tablet and has beautiful appearance, good mouthfeel and stable quality.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a pharmaceutical preparation and a preparation method of the preparation. Background technique [0002] Pain is a symptom associated with many diseases, and it is also a disease with multiple characteristics such as physiology, psychology and society. Pain can be caused by many reasons, and usually it is mainly caused by noxious stimuli that cause tissue damage, such as mechanical stimuli such as knife cutting and stick hitting, as well as noxious stimuli caused by electric current, strong acid, and strong alkali. Pain can be further divided into sharp pain and dull pain. Sharp pain has a stronger sense of pain and a shorter duration, such as tingling pain, cramping pain, burning pain and electric shock-like pain, etc. It is more common in trauma, surgery, inflammation, visceral injury and malignant tumors. Dull pain is milder and lasts longer, such as distending pain, dull pain, soreness ...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K31/135A61K9/20A61K47/38A61K47/26A61K47/36A61K47/20A61K47/18A61P29/00A61P25/20
Inventor 罗永煌罗玲艳戈振凯张玉洁其他发明人请求不公开姓名
Owner SOUTHWEST UNIVERSITY
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