Preparation method of amlodipine besylate tablets

Abstract

The invention provides a preparation method of amlodipine besylate tablets. The preparation method comprises the following steps of: employing wet granulation and tabletting, filtering each component in a formula through an 80-mesh sieve, and then drying the filtered components at 50 DEG C for future use; evenly mixing amlodipine besylate, microcrystalline cellulose and crospovidone together, forming a soft material from the mixture by using 5% starch slurry, granulating through an 18-mesh sieve, drying at 50 DEG C, and then shaping the granules through the 18-mesh sieve, thereby obtaining granules I; next, evenly mixing starch with dextrin, forming a soft material from the mixture by using 5% starch slurry, granulating through the 18-mesh sieve and drying at 50 DEG C, and then shaping the granules through the 18-mesh sieve, thereby obtaining granules II; finally, mixing the granules I with the granules II, adding magnesium stearate and evenly mixing all the materials, and then tableting the mixture, thus obtaining the amlodipine besylate tablets. According to the invention, the major component amlodipine besylate tablets are white crystalline powder which is good in fluidity; the prepared granules are excellent in both compressibility and fluidity. The disintegration time of the tablets is appropriate, and the content of the tablets, the content uniformity and the dissolution rate all meet the requirements; therefore, the tablets have high clinical application value. The method provided by the invention is simple and suitable for industrial production.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a preparation method of amlodipine besylate tablets. Background technique [0002] Amlodipine besylate is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker). The contraction of cardiac and smooth muscles depends on the entry of extracellular calcium ions into the cells through specific ion channels. Amlodipine besylate selectively inhibits calcium ion transmembrane entry into smooth muscle cells and cardiomyocytes, and its effect on smooth muscle is greater than that on cardiac muscle. Its interaction with the calcium channel is determined by the progressive rate of its binding and dissociation to the receptor site, so the pharmacological effect occurs gradually. It is a peripheral artery dilator, acting directly on vascular smooth muscle, reducing peripheral vascular resistance, thereby lowering blood pressure. Patients with mild to moderate hy...

AI Technical Summary

Problems solved by technology

The existing preparation method is to granulate and compress all the raw and auxiliary materials in the prescription together. Since amlodipine besylate is slightly soluble in water, the tablet amlodipine thus prepared has poor dissolution

At the same time, due to mixing and granulating together, it is easy to cause unstable product quality

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