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Nitrendipine sustained-release preparation and preparation method thereof

A technology of nitrendipine and nitren, applied in the field of sustained-release pharmaceutical compositions

Inactive Publication Date: 2010-03-31
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Nitrendipine is a second-generation dihydropyridine calcium antagonist that inhibits transmembrane calcium ion influx in vascular smooth muscle and myocardium, but it mainly acts on blood vessels, so it has strong vascular selectivity

Method used

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  • Nitrendipine sustained-release preparation and preparation method thereof
  • Nitrendipine sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

1000 pieces

[0036] Preparation process

[0037] 1 Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 5% (w / w) adhesive solution for subsequent use;

[0038] 2 Granulation Mix nitrendipine, lactose, and ethyl cellulose evenly, add a binder for wet granulation, take out the granules and use a 20-mesh sieve for wet granulation. After drying, pass through a 20-mesh sieve for granulation and set aside.

[0039] 3. Tablet preparation. After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test the content to determine the tablet weight, and press into tablets to obtain.

Embodiment 2

[0042] Preparation process

[0043] 1 Preparation process of plain tablets

[0044] 1.1 Preparation of dispersion Take the prescribed amount of nitrendipine and copovidone and dissolve them in ethanol to make a 5% (w / w) copovidone ethanol dispersion for subsequent use;

[0045] 1.2 Granulation Put hypromellose, starch, sucrose, and micropowder silica gel into a mixing granulator, mix them, and add copovidone ethanol dispersion for wet granulation after uniformity, take out the granules and use a 12-mesh sieve for wet sizing Granules, the granules are ventilated and dried below 50°C. The dry granules are tested for water content, and after the test is qualified (the water content of the granules is 2.0-4.0%), the granules are sized with a 12-mesh sieve and set aside.

[0046]1.3 Tablet compression: After mixing the prepared granules with stearic acid in the prescribed amount evenly, test the content to determine the tablet weight, and then press into tablets to obtain ...

Embodiment 3

Appropriate amount

[0055] Makes 1000 pieces

[0056] Preparation process

[0057] 1 Preparation process of plain tablets

[0058] 1.1 Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 6% (w / w) adhesive for subsequent use;

[0059] 1.2 Granulation Put nitrendipine, alginic acid, lactose, and mannitol together into a mixing granulator, mix them, and add a binder to carry out wet granulation after uniformity. Take out the granules and use a 16-mesh sieve for wet granulation. After drying, pass through a 16-mesh sieve for granulation and set aside.

[0060] 1.3 Compression: After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test the content to determine the tablet weight, and then compress the tablet.

[0061] 2 coating process

[0062] Take cellulose acetate, add 800ml of acetone, stir to dissolve; take another polyethylene glycol, put it in a 100ml measuring bottle, add water to di...

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PUM

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Abstract

The invention discloses a sustained-release drug composite containing nitrendipine, which is composed of nitrendipine with effective dose and accessories accepted physiologically; the nitrendipine sustained-release drug composite can release the nitrendipine in a sustained way, the food effect is reduced and the bioavailability is increased.

Description

technical field [0001] The invention relates to a sustained-release pharmaceutical composition, in particular to an antihypertensive drug nitrendipine sustained-release pharmaceutical composition and a preparation method thereof. Background technique [0002] Nitrendipine is a second-generation dihydropyridine calcium antagonist that inhibits transmembrane calcium ion influx in vascular smooth muscle and myocardium, but it mainly acts on blood vessels, so its vascular selectivity is strong. Nitrendipine can cause expansion of systemic blood vessels such as coronary arteries and renal arterioles, and its main effect is to reduce diastolic blood pressure. It can also reduce myocardial oxygen consumption and has a protective effect on ischemic myocardium. Nitrendipine is clinically used for the treatment of hypertension. It is a first-line antihypertensive drug, especially suitable for hypertension complicated with ischemic heart disease, and has good curative effect. It is th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/435A61K9/00A61P9/12
Inventor 林鹏郑顺利李育巧
Owner COSCI MED TECH CO LTD
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