Lacidipine dispersible tablets and preparation method thereof

Abstract

The invention provides Lacidipine dispersible tablets, which are medicines for treating hypertension, and a preparation method thereof. The Lacidipine dispersible tablets contain an effective amount of Lacidipine and pharmaceutical auxiliary materials. The auxiliary materials comprise polyethylene glycol, a diluent, a disintegrating agent, a lubricant and a flow aid. In the preparation process ofthe Lacidipine dispersible tablets, the polyethylene glycol is introduced as a medicine dispersion medium, the Lacidipine is formed into solid dispersion first and then mixed uniformly with other auxiliary materials, and the mixture is tabletted to form the disperse tablets. Compared with the common tablets, the Lacidipine dispersible tablets have the advantages of optimal dispersion state, shortdisintegrating time, quick medicine dissolution and the like. The Lacidipine dispersible tablets can be taken conveniently, the preparation process of the Lacidipine dispersible tablets is simple, special requirements on materials and equipment are avoided, and the industrial production can be realized easily.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a lacidipine dispersible tablet and a preparation method thereof. Background technique [0002] Lacidipine, the English name is Lacidipine, the chemical name is (E)-4-[2-[3-(carboxy-tert-butyl)-3-oxo-1-propenyl]phenyl]-1,4-di Diethyl hydrogen-2,6-dimethyl-3,5-pyridine-dicarboxylate, molecular formula C 26 h 33 NO 6 ; The molecular weight is 455.59. [0003] [0004] Lacidipine is a new type of dihydropyridine calcium antagonist, which acts highly selectively on smooth muscle calcium channels, mainly expands peripheral arteries, reduces peripheral resistance, and has a strong and long-lasting antihypertensive effect. It has no significant effect on the cardiac conduction system and myocardial systolic function. And can improve the diastolic function of the damaged hypertrophic left ventricle, and anti-atherosclerosis. It can increase renal blood flow without...

AI Technical Summary

Problems solved by technology

However, there are still many problems in the industrial production of these methods: preparation equipment is generally not explosion-proof, and if wet granulation with organic solvents is used, there are special explosion-proof requirements for equipment and workshops, and the solvent is not easy to recycle, and the solvent will not volatilize during the production process. It is beneficial to the labor protection and environmental protection of workers. After wet granulation, it needs to be dried again, which consumes a lot of energy. To micronize raw materials, special ultra-fine pulverization equipment is required, which increases the process and has higher requirements on the particle size of raw materials.

[0010] However, the dissolution rate of dispersible tablets has a lot to do with the pharmaceutical excipients, ratio and preparation process used. If the selection is improper, the disintegration speed may not reach the expected effect.

Changing the drug variety into a dispersible tablet dosage form requires a breakthrough in the formulation and preparation process, and industrial production is more difficult

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