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Compound clobetasol propionate nano-emulsion and preparation method thereof

A technology of compound chlorine propionate and nanoemulsion, which can be applied in the directions of pharmaceutical formulation, emulsion delivery, medical preparations containing active ingredients, etc., can solve the problems of restriction, lack of solubility and stability of compound clobetasol propionate, etc., To achieve the effect of stable quality, good antibacterial effect and simple process

Inactive Publication Date: 2018-01-09
CHENGDU LINGXI SHANGPIN TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the solubility and stability of compound clobetasol propionate are lacking, which is greatly restricted in clinical application.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The compound clobetasol propionate nanoemulsion of this example, in terms of mass fraction: w (clobetasol propionate) = 0.05%, w (Amitraz) = 0.05%, w (terbinafine) = 1 %, w (RH-40) = 23%, w (ethyl acetate) = 15.4%, w (distilled water) = 54.6%.

[0025] Its preparation method comprises the following steps:

[0026] (1) Add RH-40, clobetasol propionate, terbinafine and amitraz into a four-necked flask, and stir to mix evenly;

[0027] (2) Fix the four-necked flask under the condition of water bath, keep the water temperature at 40~60℃, after the raw materials are fully melted, start the stirrer, and the stirring speed is 150~200rpm;

[0028] (3) After the temperature of the raw materials in the four-neck flask reaches 40~60°C, stop stirring, add ethyl acetate, and continue stirring for 30 minutes;

[0029] (4) Stop stirring, add hot distilled water at 40~60°C dropwise with a rubber dropper, after 3~8h of dropping, keep warm at 40~60°C for 1h;

[0030] (5) Turn off the ...

Embodiment 2

[0035] In order to better realize the preparation of nanoemulsions in this example, it is further limited that the stirrers used in the preparation process are all magnetic stirrers. Other parts of this embodiment are the same as those of the foregoing embodiment, and will not be repeated here.

Embodiment 3

[0037] In order to better realize the preparation of nanoemulsions in this embodiment, it is further limited that in the step (4), the distilled water is dripped with a glue-tipped dropper. Other parts of this embodiment are the same as those of the foregoing embodiment, and will not be repeated here.

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PUM

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Abstract

The invention discloses a compound clobetasol propionate nano-emulsion. The compound clobetasol propionate nano-emulsion is mainly prepared from the following components in parts by weight: 20 to 30 parts of RH-40, 10 to 20 parts of ethyl acetate, 0.5 to 2 parts of terbinafine, 0.01 to 0.1 part of amitraz, 0.01 to 0.1 part of clobetasol propionate and plenty of distilled water. A preparation method of the compound clobetasol propionate nano-emulsion comprises the following steps: (1) uniformly mixing the terbinafine, the amitraz, the clobetasol propionate and the RH-40; (2) after the terbinafine, the amitraz, the clobetasol propionate and the RH-40 are fully fused, starting a stirrer, wherein the stirring speed is 150 to 200 rpm; (3) after the temperature reaches 40 to 60 DEG C, stopping stirring, adding the ethyl acetate, and continuing stirring for 30 minutes; (4) stopping stirring, adding hot distilled water at 40 to 60 DEG C dropwise, and after the hot distilled water is added dropwise, keeping the temperature for one hour; (5) cooling, adding a sterilizing agent, and continuing stirring; (6) cooling to filtering out a material. The nano-emulsion prepared by the preparation method does not have an acute toxicity reaction, does not have irritation and does not have an anaphylactic reaction, and is an externally applied medicament which is stable in quality and safe to use; the method for preparing the compound clobetasol propionate nano-emulsion is simple in process and controllable in quality; the compound clobetasol propionate nano-emulsion has a good antibacterial effect and is expected to be applied to clinical practice.

Description

technical field [0001] The invention relates to the field of nanoemulsion preparation, in particular to a compound clobetasol propionate nanoemulsion and a preparation method thereof. Background technique [0002] Nanoemulsion (nanoemulsion), also known as microemulsion (microemulsion), is formed spontaneously by water, oil, EL-40 and 1,2-propanediol, etc., with a particle size of 1-100nm, thermodynamically stable, isotropic, transparent or translucent In general, nanoemulsions are divided into three types, namely, oil-in-water nanoemulsion (O / W), water-in-oil type nanoemulsion (W / O and bicontinuous nanoemulsion (B.C) , This dispersion system was first discovered and reported by Hoar and Schulman in 1943. It was not until 1959 that Schulman proposed the concept of "microemulsion". Since then, the theory and application research of nanoemulsion has developed rapidly. At present, nanoemulsion The technology has penetrated into the fields of daily chemical industry, fine chemi...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/573A61K31/137A61K31/155A61P33/14A61P31/10A61P17/00A61P17/06
Inventor 姜迪蛟
Owner CHENGDU LINGXI SHANGPIN TECH CO LTD
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