Compound valsartan benzenesulfonic acid amlodipine medicament composition and new preparation method thereof

Abstract

The invention relates to a compound valsartan benzenesulfonic acid amlodipine medicament composition and a new preparation method thereof. The compound valsartan benzenesulfonic acid amlodipine medicament composition is in a capsule type and is prepared by adopting the preparation method of a solid dispersion technique so that the dissolution of a medicament and the adsorption of the medicament in gastrointestinal tracts can be obviously promoted. The preparation method overcomes the defects of poor dissolution outside benzenesulfonic acid amlodipine and low bioavailability, greatly improve the quality of a preparation product and can realize industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a valsartan amlodipine besylate pharmaceutical composition and a new preparation method thereof. Background technique [0002] Valsartan / amlodipine besylate is a combination of calcium channel antagonist amlodipine besylate and angiotensin receptor inhibitor valsartan. Amlodipine besylate and valsartan are all leading varieties in their respective therapeutic fields, wherein, valsartan (trade name: substitute ) sales in 2006 exceeded 6 billion US dollars, while amlodipine besylate (trade name: Luohuo) whose patent expired in 2007 ), with a sales volume of 5 billion US dollars in 2006, which is in a period of growth in my country. [0003] Amlodipine valsartan besylate tablets are consistent with the recommendations of the current US treatment guidelines, that is, combined medication should be used for the initial treatment of suitable patients. Studies ha...

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Problems solved by technology

[0007] US6858228, US6485745, WO2005082329, EP1410797, WO9749394, WO2007022113 and other patents all adopt dry granulation process, all of which use expensive auxiliary materials, and the cost is high

[0008] Regardless of the rolling method or the dry method, it is easy to cause uneven particle size, which may lead to poor fluidity, large differences in tablet weight or loading capacity, and normal industrialization cannot be realized.

[0009] Due to the two main physical and chemical properties of valsartan and amlodipine besylate, the use of conventional preparation techniques may easily cause many shortcomings such as slow dissolution of amlodipine besylate, low bioavailability, and unstable product quality.

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