Dispersible tablets containing valsartan and amlodipine besylate and preparation method thereof

A technology of amlodipine besylate and dispersible tablets, applied in the direction of medical preparations containing active ingredients, organic active ingredients, active ingredients of heterocyclic compounds, etc., can solve the problems of low oral bioavailability, slow disintegration and dissolution, Complicated preparation process and other issues, to achieve the effect of reducing investment in equipment and workshops, good preparation stability, and simple process

Inactive Publication Date: 2010-09-29
包丽昕
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to solve the problem that existing medicines containing amlodipine besylate and valsartan have poor stability, slow disintegration and dissol

Method used

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Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment approach 1

[0015] Specific embodiment one: present embodiment contains the dispersible tablet of valsartan and amlodipine besylate by weight and number ratio by the valsartan of 80~160 parts, the amlodipine besylate of 3.47~6.94 parts, 2 ~50 parts of disintegrant, 10~200 parts of diluent, 30~170 parts of binder, 0.5~25 parts of lubricant, 0.2~20 parts of glidant, 0.1~2.5 parts of surfactant It is made with 0-2 parts of flavoring agent; the disintegrating agent is sodium carboxymethyl cellulose, crospovidone, compressible starch, low-substituted hydroxypropyl cellulose, croscarmellose one or more of sodium; the diluent is one or more of compressible starch, dextrin, lactose, microcrystalline cellulose, and mannitol; the binder is polystyrene with a mass concentration of 2-10%. Povidone K30 aqueous solution, povidone K30 alcohol solution with a mass concentration of 2 to 10%, starch slurry with a mass concentration of 5 to 15%, and hydroxypropyl methylcellulose aqueous solution with a mass...

specific Embodiment approach 2

[0019] Specific embodiment two: what this embodiment is different from specific embodiment one is that the dispersible tablet that contains valsartan and amlodipine besylate is by the valsartan of 80 parts, the ammonium besylate of 3.47 parts by weight ratio Clodipine, 2 parts of disintegrant, 10 parts of diluent, 30 parts of binder, 0.5 part of lubricant, 0.2 part of glidant and 0.1 part of surfactant. Others are the same as in the first embodiment.

specific Embodiment approach 3

[0020]Specific embodiment three: what this embodiment is different from specific embodiment one is that the dispersible tablet containing valsartan and amlodipine besylate is made up of 160 parts of valsartan, 6.94 parts of amlodipine besylate by weight and number Clodipine, 50 parts of disintegrant, 200 parts of diluent, 170 parts of adhesive, 25 parts of lubricant, 20 parts of glidant, 2.5 parts of surfactant and 2 parts of flavoring agent become. Others are the same as in the first embodiment.

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Abstract

The invention discloses to dispersible tablets containing valsartan and amlodipine besylate and a preparation method thereof, and relates to medicament dispersible tablets and the preparation method thereof, solving the problem of poor stability, slow disintegration and dissolution, low oral bioavailability and high cost existing in the traditional medicine containing valsartan and amlodipine besylate. The dispersible tablets are prepared from valsartan, amlodipine besylate, disintegrant, diluent, adhesive, lubricant, fluidizer, surfactant and flavoring agent. The method comprises the following steps of: weighting and screening materials; mixing the valsartan, disintegrant and diluent to obtain mixed powder A; mixing amlodipine besylate and the mixed powder A to obtain mixed powder B; mixing the adhesive, surfactant and the mixed powder B to prepare soft material; screening, granulating and drying the soft material; mixing and screening and the dried granules with the fluidizer, lubricant, disintegrant and flavoring agent; and finally carrying out size stabilization and tabletting. The medicine prepared by the method has good stability, fast disintegration and dissolution, high oral bioavailability and low cost.

Description

technical field [0001] The invention relates to a dispersible tablet of medicine and a preparation method thereof. Background technique [0002] Hypertension is the most common cardiovascular disease in the world, and it is also one of the largest epidemics. It often causes complications in the heart, brain, kidney and other organs, seriously endangering human health, and this rising trend is still continuing . With the increase of blood pressure, the risk of stroke and coronary artery events increases. Hypertension is the main pathogenic factor of coronary heart disease, cerebrovascular disease, and renal vascular disease, and is also the main cause of adult death and disability. [0003] Amlodipine (amlodipine) or its salts, such as amlodipine besylate is a new generation of dihydropyridine calcium channel blockers (CCB); and valsartan (valsartan) is an angiotensin receptor blocker Both have antihypertensive and vasodilation effects, and can be used to prevent and treat ...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/41A61K9/20A61P9/12
Inventor 包丽昕
Owner 包丽昕
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