Composition of fexofenadine hydrochloride and microcrystalline cellulose and preparation method thereof

A technology of fexofenadine hydrochloride and microcrystalline cellulose is applied in the field of fexofenadine hydrochloride and microcrystalline cellulose composition and preparation thereof, and achieves good clinical effect, good fluidity and compressibility, good Effects of disintegration and compressibility

Active Publication Date: 2011-07-27
西安万隆制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, for the excellent formulation of the combined pharmaceutical preparation related to fexofenadine hydrochloride and the fluidity and disintegration problems of the clinical medicine, there is still a problem of optimizing the components of the combined drug and cannot be limited to the limitations of known technologies

Method used

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  • Composition of fexofenadine hydrochloride and microcrystalline cellulose and preparation method thereof
  • Composition of fexofenadine hydrochloride and microcrystalline cellulose and preparation method thereof
  • Composition of fexofenadine hydrochloride and microcrystalline cellulose and preparation method thereof

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Embodiment Construction

[0024] Referring to accompanying drawing, the present invention relates to a kind of combination medicine of fexofenadine hydrochloride and microcrystalline cellulose, it is characterized in that, described medicine has by making 1000 cores altogether:

[0025] 60g of fexofenadine hydrochloride, 66g of microcrystalline cellulose, 34g of starch, 10g of sodium carmellose, appropriate amount of 5% ethanol solution of povidone, 0.8g of magnesium stearate;

[0026] Pack 1000 film coats in total: hypromellose 0.67g, propylene glycol 0.33ml, polysorbate 800.33ml, titanium dioxide 0.67g, 95% ethanol 26.7ml, purified water 6.67ml.

[0027] Preferably, the medicine has 50 tablet cores: fexofenadine hydrochloride 3.00g, microcrystalline cellulose 4.75g, carmellose sodium 0.44g, magnesium stearate 0.04g, 5% povidone Appropriate amount of ethanol solution.

[0028] Preferably, the medicine has 50 cores made in total: 3.00 g of fexofenadine hydrochloride, 4.45 g of microcrystalline cellulo...

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Abstract

The invention relates to a composition of fexofenadine hydrochloride and microcrystalline cellulose. On the basis of totally manufacturing 1000 chips, the composition comprises the following components: 60 grams of the fexofenadine hydrochloride, 66 grams of the microcrystalline cellulose, 34 grams of starch, 10 grams of sodium carboxymethyl cellulose, proper quantity of 5-pecent povidone ethanolsolution, and 0.8 gram of magnesium stearate; and on the basis of totally coating 1000 film coats, the composition comprises the following components: 0.67 gram of hydroxypropyl methylcellulose, 0.33milliliter of propylene glycol, 800.33 milliliters of polysorbate, 0.67 gram of titanium dioxide, 26.7 milliliters of 95-percent ethanol and 6.67 milliliters of purified water. The method for preparing the composition comprises staged production steps. As both the microcrystalline cellulose and the starch have high fluidity and compressibility and can accelerate disintegration of tablets, the microcrystalline cellulose and the starch are selected and used on the basis of determining the used amount of the fexofenadine hydrochloride; and the sodium carboxymethyl cellulose is selected as a disintegrating agent, has higher disintegration and higher compressibility, and is an excellent disintegrating agent for the tablets.

Description

technical field [0001] The invention relates to a composition of fexofenadine hydrochloride and microcrystalline cellulose in the field of medicine and a preparation method thereof. Background technique [0002] Fexofenadine hydrochloride is a white crystalline powder, easily soluble in methanol, soluble in ethanol, almost insoluble in acetone, very slightly soluble in purified water, and the fluidity of the raw material drug is poor. When the fexofenadine hydrochloride tablet is a film-coated tablet, the foreign manufacturer is Aventis Company of the United States, the trade name is Allegra, and the FDA-approved marketing specifications are 30 mg, 60 mg and 180 mg. In addition to the main drug, its tablet components also contain microcrystalline cellulose, starch, carmellose sodium and magnesium stearate, and the film and coating contain hypromellose, iron oxide mixture, silicon dioxide, titanium dioxide , povidone and polyethylene glycol. Chinese patent literature CN1016...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/445A61P11/00A61K47/38A61K47/36A61P11/02A61P37/08A61P17/00
Inventor 郑方晔刘护鱼周小园於长权
Owner 西安万隆制药股份有限公司
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