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Preparation method for fexofenadine hydrochloride-containing medicinal composition

A technology of fexofenadine hydrochloride and fexofenadine, which is applied in the direction of drug combinations, active ingredients of heterocyclic compounds, sugar-coated pills, etc., can solve the problem of relatively low utilization rate of equipment, inconvenience for patients to carry and use, inactive Problems such as large amount of ingredients are used to achieve the effect of high relative equipment utilization, good response, and reduced energy consumption and cost

Inactive Publication Date: 2010-11-17
ZHEJIANG WAN SHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0058] Its main disadvantages are: the amount of inactive components is large. On the one hand, it is difficult to mix the active component fexofenadine hydrochloride evenly, which increases energy consumption and cost, and the relative utilization rate of equipment is not high. On the other hand, it is not convenient to Patient portability and ease of use

Method used

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  • Preparation method for fexofenadine hydrochloride-containing medicinal composition
  • Preparation method for fexofenadine hydrochloride-containing medicinal composition

Examples

Experimental program
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Effect test

Embodiment 1

[0110] The preparation of embodiment one 30mg / fexofenadine hydrochloride tablet

[0111] Get 300 grams of fexofenadine hydrochloride, 480 grams of lactose, 300 grams of starch and 60 grams of hydroxypropyl cellulose (the materials are all passed through a 100 mesh sieve) and put in the fast stirring granulator, after fast stirring and mixing for 10 minutes, use 80% ~85% ethanol (v / v) into polyvinylpyrrolidone (k30) 5% (g / l) solution 276 grams. Quickly stir and mix for two minutes, take it out, use a 14-mesh nylon screen to make granules, then dry at 60-65°C, add 60 grams of crospovidone, 8 grams of magnesium stearate, and granulate with a 14-mesh stainless steel mesh. well mixed. After the detection of the intermediate, it is compressed into tablets, coated with 8% Opadry ethanol suspension prepared with 80% to 85% ethanol (v / v), and obtained after packaging.

[0112] The finished product can meet the requirements of the State Food and Drug Administration standard YBH02552...

Embodiment 2

[0113] The preparation of embodiment two 60mg / fexofenadine hydrochloride tablet

[0114] Get 600 grams of fexofenadine hydrochloride, 720 grams of lactose, 480 grams of starch and 80 grams of hydroxypropyl cellulose (materials are all passed through a 100 mesh sieve) and put in the fast stirring granulator, after fast stirring and mixing for 10 minutes, use 80% ~85% ethanol (v / v) into polyvinylpyrrolidone (k30) 5% (g / l) solution 356 grams. Quickly stir and mix for two minutes, take it out, use a 14-mesh nylon screen to make granules, then dry at 60-65°C, add 80 grams of crospovidone, 16 grams of magnesium stearate, and granulate with a 14-mesh stainless steel mesh. well mixed. After the detection of the intermediate, it is compressed into tablets, coated with 8% Opadry ethanol suspension prepared with 80% to 85% ethanol (v / v), and obtained after packaging.

[0115] The finished product can meet the requirements of the State Food and Drug Administration standard YBH02552006...

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Abstract

The invention relates to a preparation method for a fexofenadine hydrochloride-containing medicinal composition. The method is characterized by comprising the following steps of: (1), respectively sieving a main medicament, namely fexofenadine hydrochloride, and auxiliary materials, namely lactose, starch, hydroxypropylcellulose, cross-linked povidone and magnesium stearate for later use; (2), preparing 5 percent (g / l) solution by dissolving polyvinylpyrrolidone (k30) into ethanol solution; (3), uniformly mixing fexofenadine hydrochloride, and the auxiliary materials, namely lactose, starch and hydroxypropylcellulose; (4), uniformly mixing appropriate amount of (2) and (3), and making the mixture into granules with a 14-mesh nylon sieve, drying the granules at 60 to 65 DEG C; (5), mixing the cross-linked povidone and the magnesium stearate with (4), modifying the grains by using a 14-mesh stainless steel net, and uniformly mixing; and (6), detecting an intermediate, and tabletting and coating. The use amount of an inactive component is small; the mixing difficulty of fexofenadine hydrochloride is low so that the energy consumption and production cost are lowered and the utilization rate of equipment is comparatively high on the one hand; and tablets are small enough to be carried and used conveniently by patients on the other hand.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical composition containing fexofenadine hydrochloride, in particular to the treatment and improvement of details in the in vitro release of the drug and the production process. Background technique [0002] Fexofenadine is an active metabolite of the antihistamine Terfenadine in the human body, and it selectively acts on peripheral H 1 - acceptor, usually its hydrochloride is used. The drug was first launched in the United States in 1997 under the trade name Allegra, and its indication is seasonal allergic rhinitis: the first indication of fexofenadine hydrochloride is to relieve seasonal allergic rhinitis in adults and children over 6 years old Related symptoms; the second indication is chronic idiopathic urticaria with isolated manifestations in adults and children over 6 years of age. [0003] Its chemical name is 4-[1-hydroxy-4-[4-(hydroxybenzhydryl)-1-piperidinyl]-butyl]-α,α-dimethylp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/445A61P11/02A61P37/08A61P17/00
Inventor 黄法张正青杨丽珍张松林王莹莹
Owner ZHEJIANG WAN SHENG PHARMA CO LTD
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