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Isradipine controlled-release tablets and preparation method thereof

A technology of isradipine and controlled-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc.

Active Publication Date: 2012-02-15
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no controlled-release preparation of isradipine on the market in China.

Method used

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  • Isradipine controlled-release tablets and preparation method thereof
  • Isradipine controlled-release tablets and preparation method thereof
  • Isradipine controlled-release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] (1) Drug-containing layer

[0037]

[0038] (2) booster layer

[0039]

[0040] (3) Semi-permeable membrane

[0041] Cellulose acetate 40g

[0042] Polyethylene glycol 4.5g

[0043] Acetone 2000ml

[0044] A total of 1000 pieces were made

[0045] Preparation Process:

[0046] Preparation of drug-containing layer granules: operate in the dark, first pass the main drug and auxiliary materials through a 100-mesh sieve, weigh the prescribed amount of isradipine, polyoxyethylene, hydroxypropyl methylcellulose, and iron oxide yellow, mix them evenly, and prepare them with ethanol. Soft material, wet granules with 40-mesh sieve, dry at 40°C for 4 hours, granulate, add magnesium stearate, mix evenly, and obtain drug-containing layer granules.

[0047] Preparation of booster layer granules: First pass the auxiliary materials through a 100-mesh sieve, weigh the prescribed amount of polyoxyethylene, sodium chloride, sodium carboxymethyl cellulose, and iron oxide red a...

Embodiment 2

[0052] (1) Drug-containing layer

[0053]

[0054] (2) booster layer

[0055]

[0056] (3) Semi-permeable membrane

[0057] Cellulose acetate 40g

[0058] Polyethylene glycol 4.5g

[0059] Acetone 2000ml

[0060] A total of 1000 pieces were made

[0061] Preparation Process:

[0062]Preparation of drug-containing layer granules: avoid light, first pass the main drug and auxiliary materials through a 100-mesh sieve, weigh the prescribed amount of isradipine, polyoxyethylene, sodium alginate, and iron oxide yellow, mix evenly, and use ethanol to make a soft material. Prepare wet granules through a 40-mesh sieve, dry at 40°C for 4 hours, size the granules, add magnesium stearate, and mix evenly to obtain drug-containing layer granules.

[0063] Preparation of booster layer granules: first pass the auxiliary materials through a 100-mesh sieve, weigh the prescribed amount of polyoxyethylene, potassium chloride, polyvinylpyrrolidone, and iron oxide red and mix evenly, us...

Embodiment 3

[0068] (1) Drug-containing layer

[0069]

[0070] (2) booster layer

[0071]

[0072] (3) Semi-permeable membrane

[0073] Cellulose acetate 40g

[0074] Polyethylene glycol 4.5g

[0075] Acetone 2000ml

[0076] A total of 1000 pieces were made

[0077] Preparation Process:

[0078] Preparation of drug-containing layer granules: avoid light, first pass the main drug and auxiliary materials through a 100-mesh sieve, weigh the prescribed amount of isradipine, polyoxyethylene, and iron oxide yellow and mix evenly, use ethanol as a soft material, and make a 40-mesh sieve The wet granules are dried at 40°C for 4 hours, sized, added with magnesium stearate, and mixed evenly to obtain drug-containing layer granules.

[0079] Preparation of booster layer granules: First pass the auxiliary materials through a 100-mesh sieve, weigh the prescribed amount of polyoxyethylene, sodium chloride, polyvinylpyrrolidone, and iron oxide red and mix evenly, use ethanol solution to make...

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Abstract

The invention provides a method for preparing isradipine controlled-release tablets. The isradipine controlled-release tablets comprise a double-layer tablet core composed of a medicament-containing layer and a promoting layer, a semi-permeable membrane, a drug-releasing small hole and a moistureproof coating layer, wherein the medicament-containing layer comprises active ingredients as isradipine and pharmaceutically acceptable excipients; the promoting layer at least comprises macromolecular osmoactive substances, water-insoluble polymer, penetration enhancer, colouring agent and others; and the semi-permeable membrane is composed of a film-forming material, a plasticizer and a porogenic agent.

Description

1. Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a single-chamber double-layer osmotic pump type drug delivery preparation containing isradipine as an active ingredient and a preparation method thereof. way to release the drug. 2. Technical background [0002] Isradipine (Isradipine) is a dihydropyridine calcium antagonist with high selectivity to blood vessels, can relax peripheral blood vessels, coronary blood vessels and cerebrovascular vessels, has little effect on the heart, and only inhibits the spontaneous activity of the sinoatrial node. It can lower blood pressure, take effect slowly (2 to 4 weeks), and last for a long time. It is well absorbed after oral administration, and the peak plasma concentration time is 2 hours after oral administration. The binding rate to protein in plasma is 95%, and it is metabolized in liver. t 1 / 2 About 9 hours. For hypertension, coronary heart disease and angina pectori...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K31/4439A61K47/32A61K47/36A61K47/38A61P9/04A61P9/10A61P9/12
Inventor 吴宗好高宇
Owner HEFEI HUAFANG PHARMA SCI & TECH
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