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Valsartan medicine composition and preparation method thereof

A composition and technology of valsartan, applied in the field of valsartan pharmaceutical composition and its preparation, can solve the problems of incomplete drug release and decreased release rate during storage, and achieve high release rate in vitro and good quality stability Effect

Active Publication Date: 2014-05-28
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the problems of drug burst release in the above valsartan preparation, incomplete drug release in the later stage and decrease in release rate during storage, the present invention provides a drug granule prepared by wet granulation with high release rate and good stability

Method used

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  • Valsartan medicine composition and preparation method thereof
  • Valsartan medicine composition and preparation method thereof
  • Valsartan medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] The preparation of embodiment 1 valsartan capsule

[0057] A preparation of drug-containing granules

[0058] Add 54g of PVP K30 into 2000g of purified water, stir until clarified, add sodium lauryl sulfate while stirring, stir until dissolved and set aside; weigh the raw and auxiliary materials according to the prescription in Table 4, pass through an 80-mesh sieve, and mix the processed raw and auxiliary materials Put it into a wet granulator (G6 experimental multifunctional wet mixing granulator, Shenzhen Xinyite Technology), dry mix for 5-10 minutes, slowly add the prepared binder solution, and stir at a speed of 3-5r / min , Cutting speed 3-5r / min, wet mixing 3-6min, discharging, put in a swing granulator (YK160A swing granulator, Jiangsu Changzhou Shuangdong Pharmaceutical Machinery Factory) 18 mesh granules. Put the wet granules in a drying oven at 55°C (JC101 electric blast drying oven, Shanghai Chengshun Instrument Co., Ltd.), and dry for 5-7 hours until the moi...

Embodiment 2

[0067] The preparation of embodiment 2 valsartan tablets

[0068] A preparation of drug-containing granules

[0069] Add 54.0g of PVP K30 into 2000g of purified water, stir until clarified, add sodium lauryl sulfate while stirring, stir until dissolved and set aside; weigh the raw and auxiliary materials according to the prescription in Table 6, pass through an 80-mesh sieve, and process the raw Put the auxiliary materials into the wet granulator (G6 experimental multifunctional wet mixing granulator, Shenzhen Xinyite Technology), dry mix for 5-10 minutes, slowly add the prepared binder solution, and stir at a speed of 3-5r / min, cutting speed 3-5r / min, wet mixing for 3-6min, discharge, put in a swing granulator (YK160A swing granulator, Jiangsu Changzhou Shuangdong Pharmaceutical Machinery Factory) to make 20 mesh granules. Put the wet granules in a drying oven at 55°C (JC101 electric blast drying oven, Shanghai Chengshun Instrument Co., Ltd.), and dry for 5-7 hours until th...

Embodiment 3

[0082] The preparation of embodiment 3 valsartan tablets

[0083] A preparation of drug-containing granules

[0084] Take 54.0g of PVP K30 and add it into 2000g of purified water, stir until clarified, add sodium lauryl sulfate while stirring, stir until dissolved and set aside; weigh the raw and auxiliary materials according to the prescription in Table 9, pass through an 80-mesh sieve, and process the raw Put the auxiliary materials into the wet granulator (G6 experimental multifunctional wet mixing granulator, Shenzhen Xinyite Technology), dry mix for 5-10 minutes, slowly add the prepared binder solution, and stir at a speed of 3-5r / min, cutting speed 3-5r / min, wet mixing for 3-6min, discharge, put in a swing granulator (YK160A swing granulator, Jiangsu Changzhou Shuangdong Pharmaceutical Machinery Factory) to make 20 mesh granules. Put the wet granules in a drying oven at 55°C (JC101 electric blast drying oven, Shanghai Chengshun Instrument Co., Ltd.), and dry for 5-7 ho...

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Abstract

The invention relates to a medicine composition, and particularly relates to a valsartan medicine composition and a preparation method thereof. The medicine composition disclosed by the invention comprises the following components: valsartan, an adhesive, filler, a disintegrating agent, a solubilizer and a solvent.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a valsartan pharmaceutical composition and a preparation method thereof. Background technique [0002] Valsartan is an orally effective specific angiotensin II (AT1) receptor antagonist, which selectively acts on AT1 receptor subtypes, blocking the binding of Ang II to AT1 receptors (its The effect of specifically antagonizing the AT1 receptor is about 20,000 times greater than that of the AT2 receptor), thereby inhibiting vasoconstriction and the release of aldosterone, resulting in a hypotensive effect. So far, valsartan single preparations and compound preparations that have been listed abroad include Diovan (valsartan capsules, valsartan tablets), Fudaowen (valsartan hydrochlorothiazide tablets), Bebot (valsartan ammonia Clodipine tablets), etc., the above-mentioned preparations have been imported domestically. [0003] Valsartan is an antihypertensive drug. In order to achie...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/28A61K31/41A61K31/549A61K31/4422A61K47/38A61K47/32A61K47/26A61P9/12
Inventor 陈茵茵吴杰文朱俊杰谢斌周爱新陈新民
Owner 珠海润都制药股份有限公司
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