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Preparation method of pharmaceutical composition capable of increasing dissolution rate of indissolvable drug isradipine

A technology for insoluble drugs, isradipine, applied in the direction of drug combinations, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve problems such as difficulty in dissolution and impact on bioavailability, and achieve increased specific surface area and improved bioavailability. Utilization, effect of improving wettability

Inactive Publication Date: 2015-07-22
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because it is insoluble in water, isradipine has difficulty in dissolution, which seriously affects the bioavailability of this product

Method used

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  • Preparation method of pharmaceutical composition capable of increasing dissolution rate of indissolvable drug isradipine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] (1) Pass the isradipine through a 200-mesh sieve, dry the lactose through a 200-mesh sieve, and set aside;

[0013] (2) Mix isradipine 2g and 18g lactose evenly;

[0014] (3) Utilize the mortar to thoroughly grind the material after mixing uniformly for more than 1 hour, and cross a 200-mesh sieve to obtain the isradipine solid dispersion;

[0015] (4) Get isradipine solid dispersion powder 10g, 6g microcrystalline cellulose, 0.5g carboxymethyl starch sodium, with 5%PVPK 30 The aqueous solution is granulated, and after drying at 40°C for granulation, 0.05 g of magnesium stearate is added as a glidant, mixed evenly, and filled into No. 3 capsules (200 capsules).

Embodiment 2

[0017] (1) Isradipine is passed through a 200-mesh sieve, and the mannitol is dried through a 200-mesh sieve for subsequent use;

[0018] (2) Isradipine 2g and 18g mannitol are mixed homogeneously;

[0019] (3) Utilize the mortar to thoroughly grind the material after mixing uniformly for more than 1 hour, and cross a 200-mesh sieve to obtain the isradipine solid dispersion;

[0020] (4) Get isradipine solid dispersion powder 10g, 6g lactose, 0.35g carboxymethyl starch sodium, with 10%PVPK 30 The aqueous solution is granulated, and after drying at 40°C for granulation, 0.05 g of magnesium stearate is added as a glidant, mixed evenly, and filled into No. 3 capsules (200 capsules).

Embodiment 3

[0022] (1) Isradipine is passed through a 200-mesh sieve, and the sucrose is dried through a 200-mesh sieve for subsequent use;

[0023] (2) mix isradipine 2g and 18g sucrose;

[0024] (3) Utilize the mortar to thoroughly grind the material after mixing uniformly for more than 1 hour, and cross a 200-mesh sieve to obtain the isradipine solid dispersion;

[0025] (4) Get isradipine solid dispersion powder 10g, 6g microcrystalline cellulose, 0.5g carboxymethyl starch sodium, with 3%PVPK 30 The aqueous solution is granulated, and after drying at 40°C for granulation, add 0.05 g of micropowder silica gel as a glidant, mix evenly, and press into tablets (200 pieces) with a punch of Ф=5 mm.

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Abstract

The invention relates to a pharmaceutical composition capable of increasing a dissolution rate of an indissolvable drug isradipine. The pharmaceutical composition can effectively increase the dissolution rate of isradipine. An isradipine solid preparation, such as a tablet, is prepared by a solid dispersion technology and a micronization technology and prepared from a pharmaceutically acceptable diluent or carrier, so that the indissolvable isradipine can be released quickly from the preparation. The product is stable in quality, high in dissolution rate, beneficial to increase absorption of isradipine in a human body, capable of effectively improving the bioavailability, and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical composition for improving the bioavailability of insoluble drug isradipine by using solid dispersion technology and micronization technology. Background technique [0002] Isradipine is a novel dihydropyridine calcium channel blocker. Isradipine was developed by the Swiss company Sandoz and was first introduced to the market by the British company Ciba-Geigy in February 1989. Isradipine achieves the purpose of lowering blood pressure by dilating blood vessels, reducing peripheral vascular resistance, increasing coronary blood flow, and improving myocardial oxygen supply. Isradipine has a strong vasodilator effect, but no heart inhibitory effect, and almost does not cause reflex tachycardia. Clinical and animal experiments have proved that the drug has obvious antihypertensive and anti-atherosclerotic effects. By maintaining or restoring the bl...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/32A61K47/34A61K47/26A61P9/12A61P9/10
Inventor 何勇杨贤龙冯栓张亮亮高永好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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