Fenofibrate nanometer suspension and preparation method thereof

A nanosuspension and fenofibrate technology, which is applied in the field of fenofibrate nanosuspension and its freeze-dried powder, can solve the problems of difficult to solve the influence of medication, bioavailability cannot reach 100%, and the like, Achieve the effect of low cost, easy to scale up industrial production, and avoid toxic and side effects

Inactive Publication Date: 2008-10-15
NANJING UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these methods still have certain defects, and the bioavailability cannot reach 100%, and the influence of diet on medication is also difficult to solve.

Method used

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  • Fenofibrate nanometer suspension and preparation method thereof
  • Fenofibrate nanometer suspension and preparation method thereof
  • Fenofibrate nanometer suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Weigh 500 mg of poloxamer 188, add 250 mg of polyvinylpyrrolidone into 50 ml of three-distilled water, heat at a slight temperature to dissolve completely, add 250 mg of fenofibrate raw material, and then heat in a water bath at 85-90 ° C until the drug becomes molten; 10000 rpm Shear pre-emulsification for 3 minutes; high-pressure homogenization of the primary suspension under the conditions of 3 cycles at 300 bar, 3 cycles at 500 bar, and 12 cycles at 800 bar. During the homogenization process, keep the temperature above the melting point of fenofibrate, and then quickly freeze After cooling in the bath, a milky white nanosuspension was obtained, the measured particle diameter was 365nm, and the zeta potential was -38.54mv.

Embodiment 2

[0038] Weigh 1000mg of Poloxamer 188, add 500mg of polyvinylpyrrolidone into 50ml of three-distilled water, heat at a slight temperature to dissolve completely, add 250mg of fenofibrate raw material, and then heat in a water bath at 85-90℃ until the drug becomes molten; 10000rpm high Shear pre-emulsification for 3 minutes; high-pressure homogenization of the primary suspension under the conditions of 3 cycles at 300 bar, 3 cycles at 500 bar, and 12 cycles at 1500 bar. During the homogenization process, the temperature was maintained above the melting point of fenofibrate, and then quickly iced. After cooling in the bath, a milky white nanosuspension was obtained, with a measured particle diameter of 190 nm and a zeta potential of -34.61 mv.

Embodiment 3

[0040] Weigh 1000mg of poloxamer 188, add 1000mg of polyvinylpyrrolidone into 50ml of three-distilled water, heat at a slight temperature to dissolve completely, add 500mg of fenofibrate raw material, and then heat in a water bath at 85-90℃ until the drug becomes molten; 10000rpm high Shear pre-emulsification for 3 minutes; high-pressure homogenization of the primary suspension under the conditions of 3 cycles at 300 bar, 3 cycles at 500 bar, and 12 cycles at 1200 bar. During the homogenization process, the temperature was maintained above the melting point of fenofibrate, and then quickly iced. After cooling in a bath, a milky white nanosuspension was obtained, the measured particle diameter was 287nm, and the zeta potential was -34.57mv.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a fenofibrate nanosuspension and a lyophilized powder thereof. The fenofibrate nanosuspension is characterized in that poloxamer 188 and polyvinylpyrrolidone (PVP), with a weight ratio of (1-3):1, are used as surfactant. The fenofibrate nanosuspension has stable quality and particle diameter of about 190-380nm. The invention further discloses a preparation method thereof.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to nano-suspensions of fenofibrate and freeze-dried powder thereof, and the invention also discloses a preparation method thereof. Background technique [0002] Fenofibrate (molecular formula: C 20 h 21 ClO 4 , molecular weight: 360.84, chemical name: 2-methyl-2-[4-(4-chlorobenzoyl)phenoxy]isopropyl propionate) belongs to the third generation of clofibrate ester hypolipidemic drugs, clinical It can be used to treat hypertriglyceridemia, high cholesterol and mixed hyperlipidemia. It is mainly used for the treatment of type II, III, and IV hyperlipoproteinemia. It is of great significance to the treatment and prevention of atherosclerotic heart disease and cardiovascular and cerebrovascular diseases in the elderly. It is effective for hyperlipidemia in type II diabetes, and does not affect blood sugar and urine sugar results during treatment. Fenofibrate is generally a...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K9/19A61K47/34A61K31/216A61P3/06A61K47/10A61K47/32
Inventor 李学明顾立徐元龙
Owner NANJING UNIV OF TECH
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