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Sustained release tablet for treating cardiovascular diseases and preparation method thereof

A sustained-release tablet and cardiovascular technology, which is applied in the field of sustained-release tablets for the treatment of cardiovascular diseases and its preparation, can solve the problems of not containing immediate-release ingredients, consuming large energy, and harming patients, so as to avoid production equipment and production processes , Conducive to environmental protection, to avoid the effect of potential harm

Active Publication Date: 2014-06-11
YABAO PHARMA BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current clinical application of nifedipine sustained-release tablets has the following disadvantages: the prescription does not contain immediate-release ingredients, and the effective blood drug concentration cannot be quickly reached; the drug is completely released in about 6 hours; expensive tablet presses are needed in the production process; Dichloromethane is used in the preparation of release granules, which pollutes the environment and is easy to endanger human health, and there may be residual drugs, which may cause potential harm to patients; the preparation method is complicated, and vacuum drying equipment must be used, which consumes a lot of energy, etc.

Method used

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  • Sustained release tablet for treating cardiovascular diseases and preparation method thereof
  • Sustained release tablet for treating cardiovascular diseases and preparation method thereof
  • Sustained release tablet for treating cardiovascular diseases and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0122] Embodiment 1: Nifedipine sustained release tablet

[0123] Immediate Release Granules:

[0124]

[0125] Slow-release granules:

[0126]

[0127] Additional accessories:

[0128] Magnesium stearate 0.6g

[0129] Microcrystalline Cellulose PH102 12g

[0130] Weigh nifedipine, lactose, microcrystalline cellulose PH101 and starch according to the prescription, place them in the granulator, turn on the main paddle at 200r / m, and the cutter at 1500r / m, stir for 4 minutes, and mix well; weigh the starch for slurry , add purified water, stir evenly, add polysorbate 80, stir evenly, heat and stir, and prepare 13% starch slurry as an adhesive; add the adhesive to the uniformly mixed material, turn on the main paddle 200r / m. Cutter 1500r / m, stir for 30 seconds, stop the machine to clean the pot wall, continue stirring for 1 minute, and discharge; the soft material is granulated through a 20-mesh sieve, dried at 60°C, granulated with a 20-mesh sieve, and the instant-rel...

Embodiment 2

[0131] Embodiment 2: Nifedipine sustained release tablet

[0132] Immediate Release Granules:

[0133]

[0134]

[0135] Slow-release granules:

[0136]

[0137] Additional accessories:

[0138] Magnesium Stearate 1.0g

[0139] Microcrystalline Cellulose PH102 9.6g

[0140] Weigh nifedipine, lactose, microcrystalline cellulose PH101 and starch according to the prescription, place them in the granulator, turn on the main paddle at 100r / m, and the cutter at 2500r / m, stir for 8 minutes, and mix well; weigh the starch for pulp , add purified water, stir evenly, add polysorbate 80, stir evenly, heat and stir, and prepare 6% starch slurry as an adhesive; add adhesive to the uniformly mixed material, turn on the main paddle 100r / m. Cutter 3000r / m, stir for 80 seconds, stop the machine to clean the pot wall, continue to stir for 0.6 minutes, and discharge; the soft material is granulated through a 12-mesh sieve, dried at 70°C, and granulated with a 30-mesh sieve to obtai...

Embodiment 3

[0141] Embodiment 3: Nifedipine sustained release tablet

[0142] Immediate Release Granules:

[0143]

[0144] Slow-release granules:

[0145]

[0146] Additional accessories:

[0147] Magnesium stearate 0.4g

[0148] Microcrystalline Cellulose PH102 14.4g

[0149] Weigh nifedipine, lactose, microcrystalline cellulose PH101 and starch according to the prescription, place them in the granulator, turn on the main paddle at 250r / m, and the cutter at 600r / m, stir for 3 minutes, and mix well; weigh the starch for pulp , add purified water, stir evenly, add polysorbate 80, stir evenly, heat and stir, and prepare a 15% starch slurry as an adhesive; add the adhesive to the uniformly mixed material, turn on the main paddle 250r / m. Cutter 600r / m, stir for 20 seconds, stop the machine to clean the pot wall, continue stirring for 4 minutes, and discharge; the soft material is granulated through a 30-mesh sieve, dried at 50°C, granulated with a 12-mesh sieve, and the instant-re...

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PUM

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Abstract

The invention discloses a nifedipine sustained release tablet for treating cardiovascular diseases and a preparation method thereof. Sustained release granules are prepared by adopting low-melting-point sustained release materials including glyceryl behenate, polyethylene glycol 4000 and nifedipine; use of an organic solvent is avoided; the nifedipine sustained release tablet disclosed by the invention is good for the environmental protection; potential hurt to patients caused by residual organic solvents is also avoided; the sustained release materials and active medicines form granules similar to solid dispersoid, so that sustained release of nifedipine is kept for a long time, and furthermore, rapid release of medicines in rapid release granules is not influenced. The nifedipine sustained release tablet disclosed by the invention is prepared by adopting the conventional granulating process; the complex production equipment and the production process are avoided; energy is saved; the production efficiency is greatly increased.

Description

field of invention [0001] The invention relates to a sustained-release tablet for treating cardiovascular diseases and a preparation method thereof, in particular to a nifedipine sustained-release tablet and a preparation method thereof. Background technique [0002] Nifedipine is a 1,4 dihydropyridine calcium ion antagonist and is currently the main drug for the treatment of cardiovascular and cerebrovascular diseases. By improving the dosage form of calcium antagonists, the common dosage form is transformed into a sustained-release type, which changes its The release rate in the body maintains the steady-state blood drug concentration, prolongs the half-life, reduces the number of administrations, and correspondingly reduces adverse reactions. The current clinical application of nifedipine sustained-release tablets has the following disadvantages: the prescription does not contain immediate-release ingredients, and the effective blood drug concentration cannot be reached q...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4422A61K47/38A61P9/00
Inventor 吴协迪禹玉洪任武贤肖璇
Owner YABAO PHARMA BEIJING
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