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Solid lipid nanoparticles of finasteride and preparation method thereof

A technology of solid lipid nanometer and finasteride, applied in the field of medicine, can solve the problems of low bioavailability and poor oral absorption, and achieve the effects of good reproducibility, poor absorption improvement and simple operation

Active Publication Date: 2009-10-21
江苏黄河药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is to provide a solid lipid nanoparticle of finasteride to improve poor oral absorption and low bioavailability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The components are as follows:

[0032] Finasteride: 1 part,

[0033] Solid lipid material: stearic acid (melting point 70°C), 100 parts,

[0034] Phospholipids: Lecithin, 120 parts,

[0035] Emulsifier: polyethylene glycol, 50 parts.

[0036] The production method is as follows:

[0037] (1) Under the condition of about 85°C, melt the solid lipid material;

[0038] (2) Maintaining the temperature condition of step (1), under stirring condition (800rpm), evenly disperse finasteride in the molten liquid of solid lipid material;

[0039] (3) lecithin and polyethylene glycol are dissolved in water, and the weight of water is 2 times of the total weight of phospholipid and emulsifier;

[0040] (4) Maintain the temperature condition of step (1), under stirring conditions (600rpm), add the aqueous solution obtained in step (3) into the molten liquid obtained in step (2), and mix evenly to obtain an emulsion;

[0041] (5) step (4) is obtained the emulsification of high-p...

Embodiment 2

[0044] The components are as follows:

[0045] Finasteride: 5 parts,

[0046] Solid lipid material: cetyl palmitate (melting point 55°C), 3 parts,

[0047] Phospholipids: soybean lecithin, 10 parts,

[0048] Emulsifier: Poloxamer 188, 10 parts.

[0049] The production method is as follows:

[0050] (1) Under the condition of about 60°C, melt the solid lipid material;

[0051] (2) Maintaining the temperature conditions of step (1), under stirring conditions (1000rpm), evenly disperse finasteride in the molten liquid of the solid lipid material;

[0052] (3) dissolving soybean lecithin and poloxamer 188 in water, the weight of water is 2.5 times of the total weight of lecithin and emulsifier;

[0053] (4) Maintain the temperature condition of step (1), under stirring conditions (500rpm), add the aqueous solution obtained in step (3) into the molten liquid obtained in step (2), and mix evenly to obtain an emulsion;

[0054] (5) step (4) is obtained the emulsification of hig...

Embodiment 3

[0057] The components are as follows:

[0058] Finasteride: 10 parts,

[0059] Solid lipid material: a mixture of monoglyceride behenate, diglyceride behenate and triglyceride behenate in a weight ratio of 2:3:1 (melting point 65°C), 100 parts,

[0060] Phospholipids: cephalin, 50 parts,

[0061] Emulsifier: Poloxamer 188, 50 parts.

[0062] The production method is as follows:

[0063] (1) Melt the solid lipid material at about 75°C;

[0064] (2) Maintaining the temperature condition of step (1), under stirring condition (900rpm), evenly disperse finasteride in the molten liquid of solid lipid material;

[0065] (3) phospholipid and emulsifier are dissolved in water, and the weight of water is 3 times of the total weight of phospholipid and emulsifier;

[0066] (4) Maintain the temperature condition of step (1), under stirring conditions (600rpm), add the aqueous solution obtained in step (3) into the molten liquid obtained in step (2), and mix evenly to obtain an emulsion...

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Abstract

The invention relates to the technical field of medicines, disclosing solid lipid nanoparticles of finasteride, which comprise the ingredients according to parts by weight as follows: 1 to 10 parts of finasteride, 3 to 500 parts of solid lipid materials, 10 to 200 parts of phospholipid and 10 to 100 parts of emulsifiers. The invention also discloses a preparation method of the above solid lipid nanoparticles of finasteride. The solid lipid nanoparticles of finasteride primely solve the problems of slightly solubility, low dissolution rate and low bioavailability of the finasteride, being advantageous to fabrication of medicinal preparation and quality improvement.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a solid lipid nanoparticle of finasteride and a preparation method thereof. Background technique [0002] Finasteride is a tetraazesteroid compound that competitively and selectively inhibits the activity of 5-alpha reductase, thereby inhibiting the conversion of testosterone into dihydrotestosterone (DHT) and reducing prostate swelling. This product is clinically used to treat male hair loss, benign prostatic hyperplasia, shrink the enlarged prostate, improve urine flow and improve the symptoms of benign prostatic hyperplasia. [0003] Finasteride was developed by Merck Company of the United States. my country approved the import of this drug in 1994. The main dosage forms are tablets and capsules. Since finasteride is insoluble in water and the preparation is small in size, the difficulty in the process of its conventional preparation tablets and capsules is mainl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/14A61K31/58A61K47/34A61P13/08A61P17/14A61K47/10A61K47/14A61K47/24A61K47/26
Inventor 葛海涛唐俊陶元明王党国
Owner 江苏黄河药业股份有限公司
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