Valsartan amlodipine tablet and preparation method thereof

Abstract

The invention discloses a valsartan amlodipine tablet. The valsartan amlodipine tablet comprises a tablet core and a coating layer outside the tablet core, wherein the tablet core comprises the following components in parts by weight: 8-12 parts of valsartan; 0.8-1 part of amlodipine besylate; 8-12 parts of microcrystalline cellulose; 0.4-0.6 parts of cross-linked povidone; and 0.1-0.2 parts of aflow aid; The coating layer comprises the following components in parts by weight: 0.2-0.4 parts of crospovidone; 0.1-0.2 parts of the flow aid; and 0.4-0.6 parts of magnesium stearate. The present invention also provides a method of preparing the valsartan amlodipine tablet. The valsartan amlodipine tablet of the invention has good dispersion uniformity and high yield. In addition, the process ofthe invention is simple and easy to operate, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a valsartan medicament and a preparation method thereof. Background technique [0002] Valsartan and amlodipine tablets are the world's first angiotensin Ⅱ receptor antagonist / long-acting calcium channel blocker single-chip compound preparation developed by Novartis. It was approved by the Supervision and Administration Bureau as the first-line antihypertensive drug, and it went on the market in China in September 2009. Its main component, valsartan, is an angiotensin Ⅱ receptor blocker, and amlodipine besylate is a new type of dihydropyridine calcium channel blocker, both of which are ideal long-acting antihypertensive drugs, suitable for For patients whose blood pressure cannot be controlled with a single drug, the compound preparation has good curative effect and strong selectivity to blood vessels, can relax coronary blood vessels and systemic blood vessels, increase coron...

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Problems solved by technology

[0003] The absolute oral availability of valsartan is about 25%. It has a solubility dependent on pH. It is slightly soluble in acidic environment and soluble in the neutral environment of gastrointestinal tract. At the same time, both amlodipine besylate and valsartan It has physical and chemical properties such as light texture, low bulk density, and electrostatic effect during production. These special physical and chemical properties lead to poor dissolution, poor content uniformity, and poor yield of valsartan and amlodipine tablets prepared according to conventional preparation processes. Low

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