A kind of azelnidipine composition

Abstract

The invention relates to an azelnidipine composition and a preparation method thereof, and belongs to the technical field of pharmacy. According to the technical scheme, the azelnidipine composition is prepared from, per unit dose, 6-12 mg of azelnidipine, 50-100 mg of mannitol, 20-40 mg of low substituted hydroxyl propul cellulose, 3-8 mg of meglumine, 15-30 mg of polysorbate 80, 26-35 mg of superfine silica powder and 1.6 mg of magnesium stearate. According to the technical scheme, various raw and auxiliary materials are reasonably compatible; particularly, due to introduction of polysorbate80, the stability of an azelnidipine preparation is achieved, and the problem that the dissolution rate does not reach the standard is solved; the safe, stable and effective product is provided clinically.

Description

technical field [0001] The invention relates to an azeldipine composition composition and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] Azedipine belongs to the dihydropyridine (DHP) class of calcium channel blockers (CCBs). CCBs are used as first-line hypertension treatment drugs and are widely used due to their reliable antihypertensive effect. Azedipine was developed with the goal of "an ideal CCB antihypertensive drug with mild and long-lasting antihypertensive effect and less stimulation to the heart". The antihypertensive effect of the drug is very similar to the third-generation DHP CCB drug amlodipine, and the effect lasts for a long time and the effect is mild. Studies have shown that Azedipine has diuretic effect, cardioprotective effect, renal protective effect and anti-arteriosclerosis effect. Azedipine with these characteristics has epoch-making significance as an ideal channel blocking drug for the t...

AI Technical Summary

Problems solved by technology

Excessive use of alkaline ingredients will firstly affect the hardness of the tablet, and secondly, excessive alkalinity will have certain side effects on the stomach

[0004] Chinese patent 201310211425.2 discloses a kind of Azeldipine tablet, and this patent technology contains acrylic resin E and tromethamine, and the weight ratio of Azeldipine and acrylic resin E and tromethamine is 1:2-6: 0.3-2.5, solves the problem of slow dissolution rate and unstable preparation, but the side effects of tromethamine include: strong irritation, when it is intravenously dripped as an injection, if it leaks outside the blood vessel, it can cause tissue necrosis, and It can cause thrombosis or phlebitis; when a large amount of rapid instillation, it will cause depression of the respiratory center and even stop breathing; use with caution in patients with renal insufficiency

In view of these side effects of trometamol, it is not suitable to be used as an excipient. If it is used as an excipient, it will cause huge safety hazards to patients

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