Compound valsartan amlodipine besylate pharmaceutical composition and preparation method thereof

A technology of valsartan amlodipine besylate capsule and amlodipine besylate solid, applied in the valsartan amlodipine besylate pharmaceutical composition and its new preparation field, can solve the problem of amlodipine besylate amlodipine besylate Problems such as slow dissolution of clodipine, unstable product quality, and low bioavailability

Active Publication Date: 2011-12-14
天津汉嘉医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[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.

Method used

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  • Compound valsartan amlodipine besylate pharmaceutical composition and preparation method thereof
  • Compound valsartan amlodipine besylate pharmaceutical composition and preparation method thereof
  • Compound valsartan amlodipine besylate pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] The composition of the capsule prescription is as follows per 1000 capsules:

[0076] Valsartan 80g

[0077] Microcrystalline Cellulose 30g

[0078] Croscarmellose Sodium 10g

[0079] Appropriate amount of water

[0080] Amlodipine besylate solid dispersion 45.161g

[0081] Lactose 64.839g

[0082] Carboxymethyl Starch Sodium 10g

[0083] Appropriate amount of water

[0084] Magnesium Stearate 1g

[0085] Composition of amlodipine besylate solid dispersion

[0086] Amlodipine besylate 6.944g

[0087] Povidone K30 34.72g

[0088] Polyoxyethylene castor oil 3.497g

[0089] 1) Preparation of amlodipine besylate solid dispersion: Weigh amlodipine besylate, povidone K30 and polyoxyethylene castor oil respectively, add absolute ethanol, stir to dissolve, evaporate under reduced pressure to remove absolute ethanol , evacuated, dried overnight, ground through a 100-mesh sieve, and set aside.

[0090] 2) Preparation of amlodipine besylate granules: Weigh the amlodipi...

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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. Both amlodipine besylate and valsartan are leading varieties in their respective therapeutic fields, among which, valsartan (trade name: Diovan ) sales in 2006 exceeded 6 billion US dollars, while amlodipine besylate (trade name: Norvasc) 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 ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/32A61K31/41A61P9/12A61K9/48A61K47/34A61K31/4422A61K47/44
Inventor 严洁黄欣
Owner 天津汉嘉医药科技有限公司
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