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A kind of fexofenadine hydrochloride tablet and preparation method thereof

A fexofenadine hydrochloride tablet technology, which is applied in the field of medicine, can solve the problems of high production cost and strict storage conditions, and achieve the effects of good one-sidedness, reduced disintegrant dosage, and simple preparation process

Active Publication Date: 2015-08-12
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In the prior art, fexofenadine hydrochloride is generally prepared into orally disintegrating tablets. Although orally disintegrating tablets can be taken conveniently, a large amount of disintegrating agents need to be added. At the same time, in order to prevent the tablets from absorbing moisture, the storage conditions must be strict, so the production The cost is relatively expensive compared to ordinary tablets

Method used

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  • A kind of fexofenadine hydrochloride tablet and preparation method thereof
  • A kind of fexofenadine hydrochloride tablet and preparation method thereof
  • A kind of fexofenadine hydrochloride tablet and preparation method thereof

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Effect test

Embodiment 1

[0020] Embodiment 1 fexofenadine hydrochloride tablet and preparation method thereof

[0021]

[0022] Preparation process: Dissolve fexofenadine hydrochloride and citric acid in ethanol, dry under reduced pressure at 40°C to remove ethanol, pass the dried product through a 80-mesh sieve, and pass through a 100-mesh sieve with lactose, microcrystalline cellulose, Sodium carboxymethyl starch is mixed evenly, then mixed with magnesium stearate, and compressed into tablets.

Embodiment 2

[0023] Embodiment 2 fexofenadine hydrochloride tablet and preparation method thereof

[0024]

[0025] Preparation process: Dissolve fexofenadine hydrochloride and citric acid in ethanol, dry under reduced pressure at 50°C to remove ethanol, pass the dried product through a 80-mesh sieve, and pass through a 100-mesh sieve with the prescribed amount of microcrystalline cellulose, cross-linked The povidone is mixed evenly, then mixed with magnesium stearate, and compressed into tablets.

Embodiment 3

[0026] Embodiment 3 fexofenadine hydrochloride tablet and preparation method thereof

[0027]

[0028] Preparation process: Dissolve fexofenadine hydrochloride and citric acid in ethanol, dry under reduced pressure at 55°C to remove ethanol, pass the dried product through a 80-mesh sieve, and pass through a 100-mesh sieve with the prescribed amount of microcrystalline cellulose and carboxymethyl Sodium starch glycolate is mixed evenly, then mixed with magnesium stearate, and compressed into tablets.

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PUM

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Abstract

The invention discloses a fexofenadine hydrochloride tablet and a preparation method thereof. The preparation is prepared from solid dispersion and pharmaceutical acceptable auxiliary materials by the procedures of evenly mixing and directly tabletting, wherein the solid dispersion is obtained by dissolving fexofenadine hydrochloride and citric acid into ethanol, drying and removing ethanol. According to the tablet disclosed by the invention, the dosage of a disintegrating agent is reduced under the premise of ensuring that the drug is rapidly dissolved out; the production cost is reduced; meanwhile, the fexofenadine hydrochloride tablet is simple in preparation technology, and good in surface after accelerated inspection.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a fexofenadine hydrochloride tablet and a preparation method thereof. Background technique [0002] Fexofenadine hydrochloride is a second-generation H1 receptor antagonist, which can selectively block H1 receptors, has good antihistamine effect, has no anticholinergic and antiadrenaline effects, so it has no sedative effect and others It acts on the central nervous system and cannot pass through the blood-brain barrier. Fexofenadine hydrochloride can also inhibit the release of inflammatory substances from human nasal epithelial cells, and also inhibit the expression of ICAM-1 in epithelial cells. It is suitable for the treatment of seasonal allergic rhinitis, chronic idiopathic urticaria and other diseases. Its chemical name is α,α-dimethyl-4-[1-hydroxy-4-[4-(hydroxybenzhydryl)-1-piperidinyl]-butyl]-phenylacetic acid hydrochloride. At present, fexofenadine hydr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/445A61K47/12A61P37/08A61P11/02A61P17/00
Inventor 不公告发明人
Owner 南京易亨制药有限公司
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