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External applied gel with butenafine hydrochloride as principal ingredient

A technology of butenafine hydrochloride and gel for external use, applied in the field of medicine, can solve problems such as toxic effect, inhibited growth of fungi, death of fungi, etc., and achieve the effects of less side effects, good curative effect, and difficulty in recurrence.

Inactive Publication Date: 2007-11-28
凌沛学
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Butenafine hydrochloride belongs to the third-generation allylamine antifungal drug, which has unique dual functions of inhibiting fungi and killing fungi. It can inhibit the activity of fungal squalene epoxidase at a lower concentration, causing fungal Insufficient squalene accumulation and ergosterol synthesis in the body: (1) squalene has a direct toxic effect on fungal cells, can cause rapid fungal death, and exhibits bactericidal activity; (2) ergosterol is necessary for the formation of fungal cell membranes Component whose insufficient synthesis inhibits fungal growth
[0005] At present, there are creams and sprays of butenafine hydrochloride developed and listed both at home and abroad, but there is no public report on the gel

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Prescription: Butenafine Hydrochloride 10g, Carbomer 940 10g, Triethanolamine 12g, Glycerin 50g, Ethanol 400ml, Polyoxyethylene Hydrogenated Castor Oil 60g, Sodium Bisulfite 1g, Disodium EDTA 0.5g, transparent 10g of sodium hyaluronate, 536.5g of distilled water.

[0016] Preparation method: Dissolve sodium bisulfite, disodium edetate, and sodium hyaluronate in an appropriate amount of water, add carbomer under stirring, and continue stirring until the swelling is uniform; stir and dissolve butenafine hydrochloride in ethanol , add glycerin, polyoxyethylene hydrogenated castor oil, add the remaining amount of water, stir to form a uniform solution, add this solution to the carbomer swelling product, stir evenly, add triethanolamine, and stir evenly. The product is a colorless transparent gel.

Embodiment 2

[0018] Prescription: butenafine hydrochloride 10g, hypromellose (viscosity 4Pa.s) 15g, benzalkonium bromide solution (5%) 20g, glycerin 50g, ethanol 300ml, Pingpingjia O-1580g, distilled water 695g.

[0019] Preparation method: Take butenafine hydrochloride, Pingping plus O-15, add ethanol and stir to dissolve, add appropriate amount of water, and stir well; take benzalkonium bromide solution, add remaining water and stir to dissolve, heat to 85°C, add hypromell Cellulose, stirred to make it fully dispersed and hydrated, cooled to 40°C while stirring, added the above-mentioned butenafine hydrochloride solution, stirred evenly, and obtained. The product is a colorless transparent gel.

[0020] Experimental data

[0021] Randomized, double-blind, Controlled, multiple heart clinical trials, with 1% terbinafine gel against fungal infection as the control drug. A total of 285 patients were selected, and the test results showed that the clinical effective rates of butenafine hydr...

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PUM

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Abstract

The present invention provides one kind of externally applied gel preparation with butenafine hydrochloride as the main component and supplementary materials. The externally applied gel preparation is used in treating fungus infection caused tinea manuum, tinea pedis, tinea corporis, tinea cruris and tinea versicolor. It has the advantages of high stability, convenient use, high patient' s compliance, etc. The present invention provides one new preparation form of butenafine hydrochloride for clinical application.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to an external gel mainly composed of butenafine hydrochloride, which is used for treating tinea manus, pedis, jock corporis and / or tinea versicolor caused by fungal infection. Background technique [0002] Superficial fungal infection is very common in the world, is contagious and easy to relapse, and is a common and frequently-occurring disease in clinical practice. According to statistics, the incidence rate is as high as 50% or more in some areas. [0003] Butenafine hydrochloride belongs to the third-generation allylamine antifungal drug, which has unique dual functions of inhibiting fungi and killing fungi. It can inhibit the activity of fungal squalene epoxidase at a lower concentration, causing fungal Insufficient squalene accumulation and ergosterol synthesis in the body: (1) squalene has a direct toxic effect on fungal cells, can cause rapid fungal death, and exhibits bactericidal a...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/137A61P31/10
Inventor 凌沛学王淑华汤漩刘爱华张玲贺艳丽
Owner 凌沛学
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