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Fenofibrate pellet and method for preparing the same

A technology of fenofibrate and pellets, which is applied in the field of fenofibrate solid dispersion pellets, can solve the problems of low dissolution rate and achieve the effects of good reproducibility, high yield, and simple and reliable method

Active Publication Date: 2008-03-05
ANHUI PROV INST OF BIOLOGICAL MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, micronization and solid dispersion technology are commonly used to solve the problem of low dissolution rate

Method used

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  • Fenofibrate pellet and method for preparing the same
  • Fenofibrate pellet and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 Preparation of fenofibrate pellets

[0026] Fenofibrate 2.5g, acrylic resin Euragit 5.0g, micro-powder silica gel 2.5g.

[0027]Put fenofibrate (2.5g) and Eu RS (5.0g) in a 50ml beaker, add 5-30ml of ethanol or methanol and 5-30ml of chloroform or dichloromethane, and stir to dissolve in a quick mixer. After dissolving completely Then add micro-powder silica gel and suspend evenly to make a "drug solution". Place 100-200ml of distilled water in a column-shaped reactor, control the temperature at 20-25°C, and slowly add the "medicine solution" under the stirring of a propeller stirring paddle (300-800rpm) to form O / W half-emulsion droplets. Stir for 20 minutes, add 100-200ml of distilled water, and continue to stir for 40-60 minutes. Under the action of stirring, ethanol or methanol will continue to diffuse into the water, and the drugs and polymer materials in the emulsion will precipitate and deposit on the inner and outer surfaces of the micro-powder silica gel....

Embodiment 2

[0029] Example 2 Preparation of fenofibrate sustained-release pellets

[0030] Fenofibrate 3.0g, acrylic resin Euragit 6.0g, micro-powder silica gel 3.0g.

[0031] Put fenofibrate (3.0g) and Eu RL (6.0g) in a 50ml beaker, add 2.5-15ml of ethanol or methanol and 2.5-15ml of chloroform or dichloromethane, and stir to dissolve in a quick mixer. After it is completely dissolved Then add micro-powder silica gel and suspend evenly to make a "drug solution". Place 100-200ml of distilled water in a column-shaped reactor, control the temperature at 20-25°C, and slowly add the "medicine solution" under the stirring of a propeller stirring paddle (300-800rpm) to form O / W half-emulsion droplets. Stir for 20 minutes, add 100-200ml distilled water containing 0.5% sodium lauryl sulfate as a surfactant, and continue to stir for 40-60 minutes. Under stirring, ethanol or methanol will continue to diffuse into the water and the drug in the emulsion It precipitates with polymer materials and deposits...

Embodiment 3

[0033] Example 3 Preparation of fenofibrate sustained-release pellets

[0034] Fenofibrate 2.0g, ethyl cellulose 4.0g, micro-powder silica gel 2.0g.

[0035] Put 2.0g of fenofibrate and 4.0g of ethyl cellulose in a 50ml beaker, add 2.5-15ml of ethanol or methanol and 2.5-15ml of chloroform or dichloromethane, stir to dissolve in a quick mixer, and add micropowder after it is completely dissolved Silica gel is uniformly suspended to make a "drug solution". Place 120-200ml of distilled water in a cylindrical reactor (with a baffle inside). The temperature is controlled at 20-25℃. Under the stirring of a propeller stirring paddle (300 ~800rpm) Slowly add the "drug solution".

[0036] Place 100-200ml of distilled water in a column-shaped reactor, control the temperature at 20-25°C, and slowly add the "medicine solution" under the stirring of a propeller stirring paddle (300-800rpm) to form O / W half-emulsion droplets. Stir for 20 minutes, add 100-200ml distilled water containing 0.5% T...

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Abstract

The present invention relates to a new method for making insoluble medicine fenofibrate be prepared into micropills in liquid phase. Said method includes the following steps: making the fenofibrate and macromolecular material be dissolved in solvent to form medicine-macromolecular material solution; then making insoluble material be uniformly mixed and suspended in the medicine-macromolecular material solution, adding poor solvent, using medicine-macromolecular material solution as inner phase and using poor solvent as outer phase to form metastable emulsion; along with the continuous diffusion of good solvent in emulsion drop the medicine and macromolecular material in said emulsion drop can be simultaneously separated out and precipitated on the internal and external surfaces of diffusion agent, under the bridge-forming action of liquid bridge-forming agent and stirring action the spherical granules can be obtained.

Description

Technical field [0001] The present invention relates to fenofibrate solid dispersion pellets. To be precise, it is a new method and new process for making fenofibrate solid dispersion pellets and using spherical agglomeration technology to make the insoluble drug fenofibrate pellets . Background technique [0002] Atherosclerosis is an important risk factor for cardiovascular disease, and increased blood lipids are the main cause of atherosclerosis. Hyperlipidemia can promote atherosclerosis by damaging the vascular intima, changing the function of macrophages, promoting platelet aggregation, lipid deposition and foam cell formation. Lowering blood lipids is of great significance for preventing the occurrence of coronary heart disease and reducing the mortality of cardiovascular and cerebrovascular diseases. Fibrates have a clear effect on lowering serum cholesterol and triglycerides. It is an ideal lipid-lowering drug. Fenofibrate can be used as a first-line lipid-lowering drug ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/20A61K9/48A61K31/216A61K47/34A61K47/38A61P9/10A61K47/32
Inventor 胡容峰陈光亮王琳琳梅康康李师谢君
Owner ANHUI PROV INST OF BIOLOGICAL MEDICINE
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