Sustained-release preparation containing felodipine and preparation method thereof

A technology for sustained-release preparations and sustained-release excipients, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and pharmaceutical formulas, which can solve the problems of slow release and incomplete release, and achieve complete and Guarantee the effect of continuous release and solve the release problem

Active Publication Date: 2008-01-16
HAINAN SHENGKE LIFE SCI RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the purpose of improving drug release can be achieved, the phenomeno

Method used

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  • Sustained-release preparation containing felodipine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation Process:

[0020] Hypromellose K100M CR was crushed through a 160-mesh sieve, felodipine was crushed through a 100-mesh sieve, microcrystalline cellulose PH102 and lactose were respectively passed through a 80-mesh sieve, and magnesium stearate was passed through a 60-mesh sieve. Mix felodipine, hypromellose K100M CR, microcrystalline cellulose PH102 and lactose evenly, and then use the aqueous solution of hypromellose K4M CR to make a soft material. After granulation, drying and sizing, finally add magnesium stearate and mix well, 7mm shallow concave punched tablets (141mg / tablet), and use Opadry for film coating.

Embodiment 2

[0023] Preparation Process:

[0024] Hypromellose K100M CR is crushed through a 160-mesh sieve, felodipine is crushed through a 100-mesh sieve, microcrystalline cellulose PH102 and lactose are respectively passed through a 80-mesh sieve, magnesium stearate is passed through a 60-mesh sieve, and silicon dioxide is passed through a 40-mesh sieve screen. Mix felodipine, hypromellose K100MCR, microcrystalline cellulose PH102 and lactose evenly, and then use 50% ethanol aqueous solution as a wetting agent to make a soft material. After granulation, drying and sizing, finally add silicon dioxide and magnesium stearate and mix evenly, 7mm shallow concave punched tablets (145mg / tablet), and use Opadry for film coating.

Embodiment 3

[0027] Preparation Process:

[0028] Hypromellose K100M CR and Hypromellose K4M CR were crushed through a 160-mesh sieve, microcrystalline cellulose PH102 and lactose were respectively passed through a 80-mesh sieve, and magnesium stearate was passed through a 60-mesh sieve. Felodipine and povidone K30 were dissolved in absolute ethanol solution. Mix hypromellose K100M CR, hypromellose K4M CR, microcrystalline cellulose PH102 and lactose evenly, then stir with the mixed solution of raw and auxiliary materials to make soft material. If the soft material is too dry, add 50 % ethanol aqueous solution. After granulation, drying and sizing, finally add magnesium stearate and mix well, 7mm shallow concave punched tablets (145mg / tablet), and use Opadry for film coating.

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Abstract

The invention provides a preparation method of a sustained-release preparation containing felodipine. The invention is characterized in that the felodipine and bond are dissolved in ethanol absolute solution or water solution containing more than 60 percent ethanol, then are fixed with matrix sustained-release necessities and filling agent and finally are moistened and granulated by the ethanol absolute solution or the water solution of ethanol. The invention also provides the sustained-release preparation prepared by the method and usage in preparation of medicine for treating hypertension.

Description

technical field [0001] The invention relates to an antihypertensive drug, in particular to a sustained-release preparation with felodipine as an active substance. technical background [0002] An ideal antihypertensive drug should control blood pressure in a balanced manner, not affect lipid and glucose metabolism, and improve existing target organ damage, while having no or minimal adverse reactions. It is well known that calcium antagonists are used in the treatment of hypertension, coronary heart disease and angina pectoris. As a third-generation calcium antagonist, felodipine has a structural formula of 2,6-dimethyl-4-(2,3-dichlorophenyl)-1,4-dihydro-3,5-pyridinedicarboxylic acid Methyl Ethyl Ester: [0003] [0004] Since it came out in 1988, a large number of studies have proved that it can uniquely expand the arteries selectively without affecting the veins, and there is no negative myocardial contractility effect of other calcium antagonists, so that the hypertr...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4422A61K47/34A61K47/38A61P9/12A61P9/10A61K47/32
Inventor 任意
Owner HAINAN SHENGKE LIFE SCI RES INST
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