Amlodipine besylate tablet and preparation method thereof

Abstract

The invention provides an amlodipine besylate tablet and a preparation method thereof. The amlodipine besylate tablet comprises the following components in parts by weight: 1-5 parts of amlodipine besylate, 0.3-0.6 part of aerosil, 30-70 parts of microcrystalline celluloses, 20-50 parts of calcium phosphate dibasic, 1-3 parts of magnesium stearate and 0.4-0.6 part of sodium carboxymethyl starch. The method comprises the following specific steps: mixing the amlodipine besylate with the aerosil at first to obtain a mixed material A; dissolving the microcrystalline celluloses and the calcium phosphate dibasic in an organic solvent, and drying to obtain a mixed material B; then placing the mixed material A, the mixed material B and the magnesium stearate in an efficient wet-process mixing granulator to obtain a mixed material C; granulating the mixed material C by a dry process to obtain particles I; and uniformly mixing the particles I, the magnesium stearate and the sodium carboxymethylstarch to obtain particles II, and carrying out tabletting to obtain the amlodipine besylate tablet. The amlodipine besylate tablet prepared by the method has high dissolution rate and good stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an amlodipine besylate tablet and a preparation method thereof. Background technique [0002] Amlodipine besylate is a dihydropyridine calcium antagonist, which mainly inhibits the calcium storage capacity of the myocardial and vascular smooth muscle cell membranes and the ability to combine with calcium ions, and achieves the antihypertensive effect by dilating vascular arterioles and reducing peripheral resistance. [0003] During the preparation process of amlodipine besylate tablets, due to the contact and collision between the material and the wall of the device, electrostatic effects are likely to occur. On the one hand, the particles are urged to aggregate and block the sieve holes, resulting in slow and difficult sieving; Particles adhere to the inner wall of the device, resulting in low yield and high cost. Simultaneously, because of its easy generation of ...

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Problems solved by technology

[0003] During the preparation process of amlodipine besylate tablets, due to the contact and collision between the material and the wall of the device, electrostatic effects are likely to occur. On the one hand, the particles are urged to aggregate and block the sieve holes, resulting in slow and difficult sieving; Particles adhere to the inner wall of the device, resulting in low yield and high cost

At the same time, because it is prone to electrostatic interaction, the main drug amlodipine besylate is easy to accumulate into agglomerates during the mixing process with other excipients, which affects the dissolution and content uniformity of the main drug.

[0004] Because amlodipine besylate is unstable to light, humidity and heat, the preparation obtained by the general preparation method is prone to degradation under the action of high temperature, high humidity and strong light, thereby affecting the stability of the drug

[0005] At present, the commonly used excipients for the preparation of amlodipine besylate tablets include anhydrous calcium hydrogen phosphate and microcrystalline cellulose, but anhydrous calcium hydrogen phosphate has a heavy texture, while microcrystalline cellulose has a light texture, which makes it difficult for the material to be uniform Mixing will affect the dissolution rate of the product and reduce the efficacy of the drug

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