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Ketoconazole nanometer suspension freeze-dried powder and preparation method thereof

A technology of ketoconazole nanometer and freeze-dried powder, which is applied in freeze-dried transportation, powder transportation, antifungal agents, etc., and can solve the problems of low dissolution and utilization of ketoconazole dosage forms

Inactive Publication Date: 2011-06-29
HUAZHONG NORMAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The object of the invention provides a kind of ketoconazole nano-suspension freeze-dried powder and preparation method thereof

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Take 10L of a mixed solvent of dichloromethane and acetone with a volume ratio of 2:8, add 100 g of the original drug of ketoconazole, dissolve and filter with suction to remove a small amount of undissolved particles. Weigh 300 g of sodium dodecyl sulfonate and add it into 5 L of water and stir to dissolve. The ketoconazole solution is added into the water in which the sodium dodecylsulfonate is dissolved, and stirred until clear to prepare the ketoconazole nano-suspension. Add 150 g of sucrose to the suspension, dissolve it, place it in a refrigerator below -20°C for 12 hours, and then freeze-dry it for more than 48 hours to obtain a freeze-dried powder. The freeze-dried powder can be dispersed into a clear liquid within half a minute in water, and the measured dispersion average particle size is 290nm. The lyophilized powder was analyzed by headspace gas chromatography and no residual solvent was detected (the minimum detection limit of dichloromethane was 0.027ppm,...

Embodiment 2

[0018] Take 10L of a mixed solvent of dichloromethane and acetone with a volume ratio of 2:8, add 100 g of the original drug of ketoconazole, dissolve and filter with suction to remove a small amount of undissolved particles. Weigh 120 g of cetyltrimethylammonium bromide and add it into 5 L of water and stir to dissolve. The ketoconazole solution is added into the water in which cetyltrimethylammonium bromide is dissolved, and stirred until clear to prepare the ketoconazole nano-suspension. Add 50 g of sucrose to the suspension, dissolve it, place it in a refrigerator below -20°C for 12 hours, and then freeze-dry it for more than 48 hours to obtain a freeze-dried powder. The freeze-dried powder can be dispersed into a clear liquid within half a minute in water, and the measured dispersion average particle size is 360nm. The lyophilized powder was analyzed by headspace gas chromatography and no residual solvent was detected (the minimum detection limit of dichloromethane was 0...

Embodiment 3

[0020] Take a mixed solvent of dichloromethane and acetone with a volume ratio of 2:8, add 100 g of the original drug of ketoconazole, dissolve and filter with suction to remove a small amount of undissolved particles. Weigh Tween 80 100g into 5L water and stir to dissolve. The ketoconazole solution is added into the water in which Tween 80 is dissolved, and stirred until clear to prepare the ketoconazole nano-suspension. Add 200 g of sucrose to the suspension, dissolve it, place it in a refrigerator below -20°C for 12 hours, and then freeze-dry it for more than 48 hours to obtain a freeze-dried powder. The freeze-dried powder can be dispersed into a clear liquid within half a minute in water, and the measured dispersion average particle size is 360nm. The lyophilized powder was analyzed by headspace gas chromatography and no residual solvent was detected (the minimum detection limit of dichloromethane was 0.032ppm, and the minimum detection limit of acetone was 124.8ppm). A...

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Abstract

The invention discloses ketoconazole nanometer suspension freeze-dried powder and a preparation method thereof. The ketoconazole nanometer suspension freeze-dried powder is prepared from the following components in part by mass: 1 part of ketoconazole medicinal powder, 1.5 to 4 parts of surfactant and 0.5 to 2 parts of freeze-dried auxiliary material. The preparation method comprises the following steps of: dissolving ketoconazole in mixed solvent of organic solvent and water-soluble organic solvent, adding water in which the surfactant is dissolved, stirring until the mixture is clarified, adding the freeze-dried auxiliary material, stirring until the mixture is clarified, putting into a refrigerator at the temperature of below 20 DEG C, and freeze drying for over 48 hours to prepare the ketoconazole nanometer suspension freeze-dried powder. In the ketoconazole nanometer suspension freeze-dried powder, ketoconazole medicinal granules are reduced to a nanoscale, so the dissolution rate of the ketoconazole in the water is improved greatly, and the antifungal effect of the ketoconazole is fully played. The freeze-dried powder can be applied to the preparation of freeze-dried powder injection, soft capsules, oral liquid, tablets, gel, emulsifiable paste and other liquid and solid formulations which are used for treating superficial and deep fungal infection.

Description

technical field [0001] The invention relates to a ketoconazole nano-suspension freeze-dried powder. The freeze-dried powder has the application of preparing other dosage forms for treating superficial and deep fungal infections. Background technique [0002] Ketoconazole is an imidazole antifungal drug. At present, the main dosage forms of ketoconazole are tablets, capsules, ointments, gels, creams, tinctures, suppositories, hair lotions, etc., which can be used orally or externally. However, due to the poor solubility of ketoconazole, the dissolution rate and bioavailability of the existing dosage forms are limited. Contents of the invention [0003] The purpose of the present invention is to provide a ketoconazole nanosuspension freeze-dried powder and a preparation method thereof in order to solve the disadvantages of the existing ketoconazole dosage form of low dissolution and utilization. The freeze-dried powder can improve the solubility and dissolution rate of keto...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K31/4174A61K47/26A61P31/10
Inventor 程靖吴艳林李晓燕
Owner HUAZHONG NORMAL UNIV
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