Felodipine sustained-release preparation and preparation method thereof

A felodipine, slow-release preparation technology, applied in the field of medicine, can solve the problem of no negative inotropic effect found

Inactive Publication Date: 2010-01-20
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In clinical trials in hypertensive patients without left ventricular dysfunction, no clear negative inotropic effects were found

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] prescription:

[0068] Plain Tablet Prescription:

[0069] Felodipine 5g

[0070] Copovidone 20g

[0071] Microcrystalline Cellulose 41

[0072] Sucrose 82g

[0073] Hypromellose 50g

[0074] Magnesium Stearate 2g

[0075] Proper amount of ethanol

[0076] Coating Solution Prescription:

[0077] Opadry 30g

[0078] Appropriate amount of water

[0079] Makes 1000 pieces

[0080] Preparation process:

[0081] 1 Preparation process of plain tablets

[0082] 1.1 Preparation of the main agent-containing adhesive

[0083] Take 5 g of felodipine and add 60 g of ethanol and stir to dissolve, then add 20 g of copovidone and stir to dissolve, and place it away from light for later use.

[0084] 1.2 Granulation

[0085] Crush the sucrose, pass it through a 80-mesh sieve, and put it into a wet mixing granulator together with microcrystalline cellulose and hypromellose, stir to mix evenly, and then add the binder containing the main ingredient to granulate , Rinse the...

Embodiment 2

[0094] prescription:

[0095] Plain Tablet Prescription:

[0096] Felodipine 5g

[0097] Povidone 20g

[0098] Microcrystalline Cellulose 40g

[0099] Sucrose 40g

[0100] Hypromellose 40g

[0101] Starch 40g

[0102] Magnesium Stearate 2g

[0103] Proper amount of ethanol

[0104] Coating Solution Prescription:

[0105] Opadry 20g

[0106] Appropriate amount of water

[0107] Makes 1000 pieces

[0108] Preparation process:

[0109] 1 Preparation process of plain tablets

[0110] 1.1 Preparation of the main agent-containing adhesive

[0111] Take 5g of felodipine and add 70g of ethanol and stir to dissolve, then add 20g of povidone and stir to dissolve, and place it away from light for later use.

[0112] 1.2 Granulation

[0113] Crush the sucrose, pass it through a 80-mesh sieve, and put it into a wet mixing granulator together with microcrystalline cellulose, hypromellose, and starch, stir to mix evenly, and add the binder containing the main ingredient after mi...

Embodiment 3

[0122] prescription:

[0123] Plain Tablet Prescription:

[0124] Felodipine 5g

[0125] Copovidone 20g

[0126] Starch 40g

[0127] Sucrose 52g

[0128] Hypromellose 75g

[0129] Micronized silica gel 5g

[0130] Stearic acid 2g

[0131] Proper amount of ethanol

[0132] Coating Solution Prescription:

[0133] Opadry 20g

[0134] Appropriate amount of water

[0135] Makes 1000 pieces

[0136] Preparation process:

[0137] 1 Preparation process of plain tablets

[0138] 1.1 Preparation of the main agent-containing adhesive

[0139] Take 5 g of felodipine and add 53 g of ethanol and stir to dissolve, then add 20 g of copovidone and stir to dissolve, and place it away from light for later use.

[0140] 1.2 Granulation

[0141] The sucrose is crushed and passed through an 80-mesh sieve for later use. Take the prescribed amount of sucrose powder and micropowder silica gel to pre-mix through a 40-mesh sieve, and then put them into a wet mixing granulator together wi...

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PUM

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Abstract

The invention discloses a felodipine-containing sustained-release preparation, which comprises a tablet core and a thin film, wherein the inside of the tablet core contains an effective curative dose of felodipine and a physiologically acceptable pharmaceutic adjuvant. The sustained-release preparation is characterized by consisting of the felodipine, a sustained-release material, a bulking agent, an adhesive, a coloring agent, a lubricant, a wetting agent and a film-forming material. The sustained-release preparation prepared can control drug release effectively to achieve ideal treatment effect, enable human bodies to obtain stable treated blood concentration and optimize the curative effect dose.

Description

technical field [0001] The invention relates to a sustained-release preparation with felodipine as an active substance and a preparation method thereof. It can effectively control the drug release to achieve the ideal therapeutic effect, so that the human body can obtain a stable therapeutic blood drug concentration and optimize the curative dose. The invention belongs to the field of medicine. Background technique [0002] Felodipine is a dihydropyridine calcium channel blocker that reversibly competes with nitrendipine and / or other calcium channel blockers for the dihydropyridine binding site, and can block vascular smooth muscle and artificially cultured rabbit atrial cells The voltage dependence of Ca 2+ current, and blocks the K + Induced murine portal vein contracture. [0003] In vitro studies have shown that felodipine has a selective inhibitory effect on vascular smooth muscle rather than on the myocardium; negative inotropic effects can be detected in vitro, bu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K31/4422A61P9/10
Inventor 李育巧林鹏郑顺利
Owner COSCI MED TECH CO LTD
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