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Antifungal drug composition for external use

A technology of antifungal drugs and compositions, which is applied in antifungal agents, drug delivery, pharmaceutical formulations, etc., and can solve problems such as inability to use in combination at the same time, and inability to use in combination at the same time

Inactive Publication Date: 2017-06-09
BEIJING ENCHENG KANGTAI BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For the unilateral cream with relatively good curative effect, due to the special administration method of cream and other external preparations, it is impossible to combine two external preparations for treatment at the same time, and the combination ratio of the two has not been scientifically verified. It is also difficult to achieve the best synergistic or cumulative effect with a suitable ratio. For example, although terbinafine hydrochloride ointment and sertaconazole nitrate ointment have been reported in combination to treat tinea pedis, one (sertaconazole nitrate ointment) morning Single use, one (terbinafine hydrochloride ointment) single use of that kind of combined drug at night, because of the particularity of its cream drug method, it is not yet possible to use it in combination at the same time; although oral and external combined drug can also be selected for treatment, oral The systemic treatment of ketoconazole will be accompanied by adverse reactions such as liver and kidney toxicity and gastrointestinal tract. The production and use of ketoconazole oral preparations have been stopped in my country because of serious liver toxicity adverse reactions.

Method used

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  • Antifungal drug composition for external use
  • Antifungal drug composition for external use
  • Antifungal drug composition for external use

Examples

Experimental program
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Effect test

specific Embodiment approach

[0078] The present invention will be further illustrated by specific examples / test examples below, but it should be understood that these examples and test examples are only used for more detailed description, and should not be interpreted as being used for limiting in any form this invention.

[0079] The present invention provides general and / or specific descriptions of the materials and test methods used in the tests. While many of the materials and methods of manipulation which are employed for the purposes of the invention are well known in the art, the invention has been described here in as much detail as possible. It is clear to those skilled in the art that if no specific conditions are specified or indicated in the examples / test examples, the conventional conditions or the conditions suggested by the manufacturer shall be followed. The reagents or instruments used were not indicated by the manufacturer, and they were all commercially available conventional products....

Embodiment 1

[0082] Prepare the antifungal composition ointment for external use according to the following formula (prepared by 10 grams, the following is in g):

[0083]

[0084] The preparation method is as follows:

[0085] Dissolve terbinafine hydrochloride and sertaconazole in propylene glycol for later use; then add sodium lauryl sulfate, glycerin, methyl Nepal, and propyl Nepal into purified water with stirring, and heat to 80-85°C (water phase ); cetearyl alcohol, white petrolatum, liquid paraffin, glyceryl monostearate, and stearic acid are heated to 80-85°C (oil phase); the water phase is added to the oil phase to form a cream, and the drug solution is added to continue emulsification , and stirring constantly, slowly cooled to room temperature.

Embodiment 2

[0087] Prepare the antifungal composition ointment for external use according to the following formula (prepared by 10 grams, the following is in g):

[0088]

[0089] The preparation method is as follows:

[0090] Dissolve terbinafine hydrochloride and sertaconazole in propylene glycol for later use; then add sodium lauryl sulfate, glycerin, methyl Nepal, and propyl Nepal into purified water with stirring, and heat to 80-85°C (water phase ); cetearyl alcohol, white petrolatum, liquid paraffin, glyceryl monostearate, and stearic acid are heated to 80-85°C (oil phase); the water phase is added to the oil phase to form a cream, and the drug solution is added to continue emulsification , and stirring constantly, slowly cooled to room temperature.

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Abstract

The invention provides an antifungal drug composition for external use, and a preparation method of an external preparation, and application of the composition in treating superficial fungal infections, such as tinea manus and pedis, tinea corporis, tinea cruris, tinea unguium, tinea versicolor and oidiomycosis cutis. The drug composition contains terbinafine or pharmaceutical salt thereof, sertaconazole or pharmaceutical salt thereof, and any one or multiple pharmaceutically acceptable excipient. An experimental study shows that the terbinafine or pharmaceutical salt thereof and the sertaconazole or pharmaceutical salt thereof have obvious synergistic effect when the proportion thereof in the drug composition for treating the superficial fungal infections is (1: 10) to (5: 1)(w / w). The antifungal drug composition for treating the superficial fungal infections has the advantages of being good in security, excellent in curative effect, short in treatment course, high in curing rate, low in relapse rate and the like.

Description

technical field [0001] The present invention relates to topical compositions for the treatment of superficial fungal infections. More specifically, the present invention relates to an antifungal composition for external use comprising terbinafine or a pharmaceutically acceptable salt thereof and sertaconazole or a pharmaceutically acceptable salt thereof. Background technique [0002] Superficial fungal infection is an infection caused by pathogenic fungi invading the stratum corneum, hair, and nail plate of the skin. The main pathogen is dermatophyte, and other common pathogens include Malassezia and Candida. Superficial mycoses caused by superficial fungal infections include tinea capitis, tinea corporis, tinea manuum, onychomycosis, tinea versicolor and Malassezia folliculitis, etc. A fungal disease with a high rate. In recent years, due to obesity, the abuse of topical glucocorticoids, the increase in the incidence of diabetes, the increase in the frequency of people ...

Claims

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Application Information

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IPC IPC(8): A61K31/4178A61K9/06A61P31/10A61K31/137
CPCA61K9/0014A61K9/06A61K31/137A61K31/4178A61K47/44A61K2300/00
Inventor 郭云珍欧阳旭王斌孙占国卢建勋
Owner BEIJING ENCHENG KANGTAI BIOLOGICAL TECH
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