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Fenofibrate lipid cubic liquid crystal solid powder and preparation method thereof

A technology of fenofibrate and solid powder, which is applied in the field of fenofibrate lipid cubic liquid crystal solid powder and its preparation, can solve the problems of unfavorable mass production, difficulty, long reaction time, etc., and achieve the improvement of bioavailability, particle size The effect of uniform diameter and easy transportation

Inactive Publication Date: 2015-04-22
GUANGDONG PHARMA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method has the following disadvantages: 1. Because the large cubic gel particles of the intermediate product are very viscous, it is difficult to nanosize it, and a large amount of energy needs to be input, which will reduce the self-assembly ability of the cubic lipid-water system , and too much energy input will destroy the internal structure of the cubic liquid crystal phase; 2. The reaction time is too long, which is not conducive to mass production
However, the ability of these dosage forms to increase the bioavailability of fenofibrate remains limited

Method used

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  • Fenofibrate lipid cubic liquid crystal solid powder and preparation method thereof
  • Fenofibrate lipid cubic liquid crystal solid powder and preparation method thereof
  • Fenofibrate lipid cubic liquid crystal solid powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 Preparation of fenofibrate lipid cubic liquid crystal

[0041] Take 20g of glycerol monooleate, 2.0g of emulsifier poloxamer 407 (F-127), melt in a water bath at 60°C, add 1g of fenofibrate to form an oil phase, add 177ml of deionized water to the oil phase, After ultrasonic dissolution, put it into an autoclave, heat to 100°C, let it cool for 3-5 minutes, then cover the vent hole, heat up to 121°C, and continue the heat treatment for 15 minutes. Lipid Cubic Liquid Crystals of Fenofibrate.

[0042]

Embodiment 2

[0043] Example 2 Preparation of fenofibrate lipid cubic liquid crystal spray-dried powder

[0044] S1. Take glycerol monooleate (GMO), poloxamer 407 (F-127) and fenofibrate respectively, and melt them in a water bath at 60°C; add 45 mL of deionized water for ultrasonic dissolution and put them in an autoclave , heat up to 100°C, let cool air for 4 minutes, then cover the vent hole, heat up to 121°C, and continue heating treatment for 15 minutes;

[0045] S2. Add maltodextrin, dilute to a certain concentration with 55mL of deionized water, and spray dry with a spray dryer; the spraying conditions are: the inlet air temperature is 130°C, the actual outlet temperature is 97-90°C, and the wind speed is 90L / min , the feed rate was 35 mL / min. As a result, fenofibrate lipid cubic liquid crystal spray-dried powder was obtained.

[0046]

Embodiment 3

[0047] Example 3 Preparation of fenofibrate lipid cubic liquid crystal freeze-dried powder

[0048] S1. Take 20g of glycerol monooleate, 2.0g of emulsifier poloxamer 407 (F-127), melt in a water bath at 60°C, add 1.0g of fenofibrate, according to the oil phase: add 177ml of distilled water, and dissolve by ultrasonic Then put it into an autoclave, heat it to 100°C, let it cool for 3 to 5 minutes, cover the back cover with a vent hole, heat it up to 121°C, and continue heating treatment for 15 minutes to obtain fenofibrate lipid cubic liquid crystal;

[0049] S2. After adding 20g of lyophilized excipient respectively to the fenofibrate lipid cubic liquid crystal obtained in S1, carry out cooling

[0050] Drying; Freeze-drying conditions: pre-freeze in a freeze dryer at -45°C for 6 hours, and then start to heat up and dry, the program is: -35°C 1h; -30°C 8h; -25°C 8h; -20°C 5h; -10 2h at 0°C; 2h at 0°C; 1h at 10°C; 3h at 20°C.

[0051]

[0052] Screening of lyophilize...

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Abstract

The invention relates to the technical field of pharmaceutic preparations, and provides fenofibrate lipid cubic liquid crystal solid powder and a preparation method thereof. The fenofibrate lipid cubic liquid crystal solid powder is prepared by adding an appropriate amount of maltodextrin in fenofibrate lipid cubic crystal and spraying and drying the fenofibrate lipid cubic crystal; or adding a freeze-drying excipient in fenofibrate lipid cubic crystal and spraying and drying the fenofibrate lipid cubic crystal. The fenofibrate lipid cubic liquid crystal solid powder has the advantages of convenience in transportation and storage, high stability and high drug loading capacity and bioavailability of medicine.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, more specifically, to a fenofibrate lipid cubic liquid crystal solid powder and a preparation method thereof. Background technique [0002] Lipid cubic liquid crystal particles (cubosomes) means that a certain concentration of amphiphilic lipids will spontaneously form a thermodynamically stable lipid bilayer in water, and then form a space-filling cubic liquid crystal system by twisting. The cubic liquid crystal has double continuous but non-intersecting water channels, that is, in the three-dimensional direction, with the minimum surface principle, the water region and the lipid region are periodically arranged to form a "honeycomb" structure. Because of its unique double channel structure, it has a variety of encapsulation properties. It can not only enclose water-soluble drugs such as timolol maleate, tetracycline, cefazolin, doxorubicin, etc., but also enclose fat-soluble drugs. S...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K9/19A61K9/10A61K31/216A61K47/36A61K47/34A61K47/14A61K47/26A61P3/06
Inventor 高崇凯李宁任晶波卫世杰易军郭波红
Owner GUANGDONG PHARMA UNIV