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Spray containing butenafine hydrochloride

A technology of butenafine hydrochloride and spray, which is applied in the field of spray containing butenafine hydrochloride, can solve the problems of long treatment course and unfavorable recovery of patients with skin allergies, and achieve the goal of reducing treatment course and improving antifungal activity Effect

Active Publication Date: 2010-11-03
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the general use of butenafine hydrochloride spray has a long course of treatment, and long-term use of external preparations containing a large concentration of ethanol is not conducive to the recovery of patients with skin allergies.

Method used

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  • Spray containing butenafine hydrochloride
  • Spray containing butenafine hydrochloride
  • Spray containing butenafine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 preparation technology:

[0035] Preparation of hydroxypropyl-β-cyclodextrin inclusion compound of butenafine hydrochloride:

[0036] Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, put it in a beaker, add an appropriate amount of water, make a saturated aqueous solution at 45±5°C, keep it warm, and set aside; dissolve butenafine hydrochloride in a small amount of ethanol, Standby; put the saturated aqueous solution of hydroxypropyl-β-cyclodextrin on a magnetic stirrer, slowly add the ethanol solution of butenafine hydrochloride, fully stir for 2 hours, and put it into a rotary evaporator to remove most of the ethanol. Put it into a shallow dish, put it in the freezer of the refrigerator, pre-freeze for 12 hours at -50°C, vacuumize, sublimate and dry for 24 hours to obtain the clathrate.

[0037] Preparation of the spray:

[0038] Dissolve the obtained hydroxypropyl-β-cyclodextrin inclusion complex of butenafine hydrochloride into an appropri...

Embodiment 6

[0042] Embodiment 6 preparation technology:

[0043] Preparation of hydroxypropyl-β-cyclodextrin inclusion compound of butenafine hydrochloride:

[0044] Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, put it in a beaker, add an appropriate amount of water, make a saturated aqueous solution at 45±5°C, keep warm, and set aside; dissolve butenafine hydrochloride in a small amount of ethanol, set aside ; Put the saturated aqueous solution of hydroxypropyl-β-cyclodextrin on a magnetic stirrer, slowly add the ethanol solution of butenafine hydrochloride, fully stir for 2 hours, and put it into a rotary evaporator to remove most of the ethanol. Put it into a shallow dish, put it in the freezer of the refrigerator, pre-freeze for 12 hours at -50°C, vacuumize, sublimate and dry for 24 hours to obtain the clathrate.

[0045] Preparation of the spray:

[0046] Dissolve the obtained hydroxypropyl-β-cyclodextrin inclusion compound of butenafine hydrochloride in a small amou...

Embodiment 11

[0049] Example 11 In vitro antifungal test of hydroxypropyl-β-cyclodextrin inclusion compound of butenafine hydrochloride

[0050] 1. Reagents and strains

[0051] 1.1 Reagent

[0052] Butenafine hydrochloride (analytical purity 99.5%, provided by Lunan Beite Pharmaceutical Co., Ltd.);

[0053] Hydroxypropyl-β-cyclodextrin inclusion compound of butenafine hydrochloride (preparation process is the same as that of Example 3).

[0054] 1.2 Strains

[0055] Trichophyton rubrum, Candida albicans

[0056] 2. Experimental method

[0057] The determination of MIC and MBC value adopts NCCLS M27-A2 scheme microdilution method to determine MIC.

[0058] Preparation of bacterial suspension:

[0059] The strains of Trichophyton rubrum and Candida albicans were respectively activated by SDA culture twice, and their concentration was adjusted to 3×10cfu / ml with a hemocytometer, and then diluted 10 times to make the concentration of bacteria solution 3×10cfu / ml (2 times Final concentrati...

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PUM

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Abstract

The clinical and conventional butenafine hydrochloride spray has adverse reactions, such as local irritation, erythema, burning heat sensation, tingling sensation, contact dermatitis and the like. The invention optimally screens the formulation process of the butenafine hydrochloride spray to reduce the adverse reactions, wherein butenafine hydrochloride forms a clathrate compound with hydroxypropyl-beta-cyclodextrin to increase the solubility and stability of medicament in water, reduce clinical dosage and toxic and side effect of the medicament, and improve the curative effect of the medicament. The butenafine hydrochloride spray provided by the invention is almost nonirritating.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a spray containing butenafine hydrochloride. Background technique [0002] Superficial skin fungal infectious diseases account for a high proportion of skin diseases, are generally easy to relapse, and are difficult to cure, and belong to one of the intractable skin diseases. Clinically common skin fungal infectious diseases include tinea manuum, tinea pedis, jock itch, tinea corporis, tinea capitis, etc. The symptoms are mainly manifested in local skin moist flushing, erosion, maceration and whitish or small blisters, unbearable itching of the skin, erysipelas and lymphangitis often caused by secondary infection after scratching, easy keratosis and desquamation after drying, chapped. The main causes of skin fungal infections are Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton gypsum, Trichophyton violaceum, Phytophthora furfur, Ascosporum, Epidermophyt...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/137A61K47/48A61P17/00A61P31/10A61K47/69
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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