Benzenesulfonate amlodipine dispersible tablet and preparation method thereof

Abstract

The invention discloses a benzenesulfonate amlodipine dispersible tablet, which is prepared from the following ingredients in percentage by mass: 3.5% of benzenesulfonate amlodipine, 42-82% of microcrystalline cellulose SH102, 12.5-45% of dicalcium phosphate anhydrous, 1.0-6.0% of carboxymethyl starch sodium and 1.0-3.0% of magnesium stearate. The preparation method comprises the following steps:firstly, adding benzenesulfonate amlodipine, carboxymethyl starch sodium and 1 / 3 of microcrystalline cellulose of a prescription dosage to be mixed for 8-15 minutes, sieving by a sieve of 40 meshes, and adding a residual quantity of microcrystalline cellulose to be mixed for 8-15 minutes; then, adding the dicalcium phosphate anhydrous of the prescription dosage to be mixed for 15-25 minutes, finally, mixing with magnesium stearate for 2-5 minutes, and tableting. The benzenesulfonate amlodipine dispersible tablet provided by the invention has the advantages of the tablet and liquid preparation,is convenient in taking, is quick in disintegration, is quick in absorption and higher in blood pressure reduction effect and is high in bioavailability, blood pressure is more effectively controlled, and the adverse reaction of the medicine can be lowered. A 5-min dissolution rate is as high as 97.8%, and therefore, the benzenesulfonate amlodipine dispersible tablet has the advantages of high accumulated dissolution rate, high bioavailability, good stability, simple preparation technology and the like and is suitable for industrialized production and the like.

Description

technical field [0001] The invention relates to amlodipine besylate dispersible tablets and a preparation method thereof. Background technique [0002] Amlodipine besylate is the third-generation long-acting dihydropyridine calcium channel antagonist, which mainly inhibits the calcium storage capacity of myocardial and vascular smooth muscle cell membranes and the ability to combine with calcium ions, allowing extracellular calcium ions to enter through slow channels. The reduction of flow muscle cells directly relaxes vascular smooth muscle, expands vascular arterioles, reduces peripheral resistance, and achieves the effect of lowering blood pressure. It has long half-life, high bioavailability, mild, slow and long-lasting action, few side effects, remarkable curative effect, easy to use, does not affect blood lipid and blood sugar metabolism, and has no damage to liver and kidney functions. [0003] Amlodipine besylate has poor stability to humidity, heat and light, and i...

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Problems solved by technology

[0004] The technical problem to be solved in the present invention is to overcome the poor stability of the amlodipine besylate dispersible tablet in the prior art, and the defect that the dissolution rate is low, provide a kind of amlodipine besylate dispersible tablet with high dissolution rate and preparation method thereof

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