Composition containing amlodipine besylate and preparation method of composition

Abstract

The invention relates to the technical field of medicine preparation, in particular to a composition containing amlodipine besylate and a preparation method of the composition. The composition consists of the following components in parts by weight: 5 parts of amlodipine besylate, 90-195 parts of a filling agent, 0.4-2.7 parts of a disintegrating agent and 1.1-3.1 parts of a lubricating agent; and the method for preparing the composition containing the amlodipine besylate comprises the following steps: preparing materials, adding 3/4 of the filling agent to the amlodipine besylate and premixing for the first time, sieving, premixing for the second time, adding the rest 1/4 of the filling agent, premixing for the third time, adding the disintegrating agent to a material 4 and premixing for the fourth time, adding the lubricating agent and premixing for the fifth, and tabletting. According to the preparation method disclosed by the invention, the uniformly mixed powder is directly compressed into a tablet core by virtue of a tablet press; and compared with an existing wet-process granulation process, the tablet prepared by the method disclosed by the invention is dissolved out more thoroughly, simple in production process, simple in equipment, low in production cost and stable in product property, and the hardness of the tablet core is enhanced and weight difference is significantly improved.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a composition containing amlodipine besylate and a preparation method thereof. Background technique [0002] Amlodipine besylate chemical name 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl Base-3,5-pyridinedicarboxylate benzenesulfonate, white crystal powder, soluble in methanol, slightly soluble in water. Amlodipine besylate is a commonly used drug for the treatment of hypertension and angina pectoris. It directly acts on vascular smooth muscle to reduce peripheral vascular resistance, thereby lowering blood pressure; by dilating peripheral arterioles, peripheral resistance is reduced, thereby reducing myocardial oxygen consumption, and in addition, coronary arteries and coronary arteries in normal and ischemic areas are expanded to make In patients with coronary artery spasm, the myocardial oxygen supply is increased to relieve ...

AI Technical Summary

Problems solved by technology

The tablets produced by the dry granulation and tableting process disintegrate slowly, which is not conducive to the dissolution of the drug; the usual process of the tablet process is to granulate, and the granulation process is to solve the problem of improving the fluidity of the material and making the tableting process Tablet weight difference becomes smaller

Wet granulation is generally adopted. This process is traditional, classic and reliable, but this method has many equipments, long process route and high cost. Dry granulation is to directly compress the material into solids with high pressure and break them, and sieve them into granules, which is better than wet granulation. The process is simple, but the equipment is expensive

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