Rapidly released fexofenadine pills and preparation method thereof

Abstract

The invention discloses rapidly released fexofenadine pills and a preparation method thereof. The rapidly released fexofenadine pills take water as a solvent, are high in concentration of effective drugs, are simple in process, have an environment-friendly effect, are suitable for industrial production, can be applied fast, stably and efficiently and allow fexofenadine to be rapidly released in a human body. According to the technical essentials disclosed by the invention, the pills are prepared by covering a fexofenadine mixed suspension solution on the surfaces of pseudo ephedrine sustained-release pellets, wherein each 100ml of fexofenadine mixed suspension solution contains 5.0g-35.0g of fexofenadine; the preparation process comprises the following steps: adding a disintegrating agent and a bonding agent into purified water; then adding the fexofenadine; when the mixed suspension solution starts to become sticky, stopping adding the fexofenadine, and adding an anti-sticking agent; repeating the operations until the fexofenadine and the anti-sticking agent of the prescribed doses are added; then treating the mixed suspension solution by a colloid mill; placing the pseudo ephedrine sustained-release pellets into a multifunctional coating machine and spraying the fexofenadine mixed suspension solution; and drying and sieving to obtain the rapidly released fexofenadine pills. The rapidly-released fexofenadine pills and the preparation method thereof belong to the technical field of medicines.

Description

technical field [0001] The invention discloses a fexofenadine pellet and a preparation method thereof, in particular to a fast-release fexofenadine pellet and a preparation method thereof, and belongs to the technical field of medicine. Background technique [0002] Fexofenadine is the active metabolite of the antihistamine drug terfenadine in the human body, which selectively acts on peripheral H1-receptors, and its hydrochloride is usually used. It has good curative effect, rapid onset, no central nervous system and cardiovascular reactions, and high safety. It can treat seasonal allergic rhinitis, skin allergies, urticaria, and allergic asthma and other diseases, and the above-mentioned patients account for the total population of the world. Fexofenadine has become a best-selling drug in the world. [0003] The administration method of fexofenadine is usually oral administration, which has rapid absorption, and the plasma concentration reaches the peak about 1 to 3 hours...

AI Technical Summary

Problems solved by technology

Both of the above two patents use organic solvents to prepare fexofenadine, and its manufacturing process is neither environmentally friendly nor dangerous

And the preparation of fexofenadine solution by organic solvent will easily lead to the abnormal increase of the relevant impurities of fexofenadine, increase the side effect of medicine, and reduce the safety of medication

[0006] Chinese patent CN102512389A discloses a kind of fexofenadine hydrochloride orally disintegrating pharmaceutical composition, and its principal ingredient fexofenadine is prepared with povidone and purified water; Chinese patent CN101919853A discloses pharmaceutical composition, Its preparation method and its use, its main drug fexofenadine is prepared with hypromellose and purified water; the fexofenadine of the above two patents all only use conventional adhesives, and the prescription Without a disintegrant, its main drug, fexofena, is difficult to release quickly

If the concentration of fexofenadine suspension is too low, the amount (weight) of fexofenadine suspension will be very large, and the operation process of the whole fexofenadine pellets will become Very long, not conducive to industrial production

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