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Preparation method of butenafine hydrochloride liniment

A technology of butenafine hydrochloride and nafine liniment, which is applied in the field of preparation of butenafine hydrochloride liniment, can solve the problems of severe skin irritation, long treatment course, unfavorable recovery of patients with skin allergies, etc., and achieve equipment energy consumption The condition is low, the dosage is reduced, and the effect of reducing irritation

Active Publication Date: 2010-06-23
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Analysis main reason is that contains a large amount of ethanol (weight percentage composition is generally 10%-30%) in the liniment, and ethanol itself has bigger irritant to skin, especially when the patient who is allergic to ethanol uses, appears The odds of the above adverse reactions are higher
In addition, the general use of butenafine hydrochloride liniment takes 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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  • Preparation method of butenafine hydrochloride liniment
  • Preparation method of butenafine hydrochloride liniment
  • Preparation method of butenafine hydrochloride liniment

Examples

Experimental program
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Effect test

Embodiment 1

[0023] Example 1 Preparation of butenafine hydrochloride hydroxypropyl-β-cyclodextrin inclusion compound

[0024] 1. Instruments and reagents

[0025] DSC204 Thermal Analyzer (Netzsch, Germany); UV Spectrophotometer (Beijing Scientific Instrument Factory); Butenafine Hydrochloride Reference Substance (Shanghai Jiachen Chemical Co., Ltd.); Butenafine Hydrochloride API (Shanghai Jiachen Chemical Co., Ltd.) ; Hydroxypropyl-β-cyclodextrin (Zibo Qianhui Fine Chemical Co., Ltd.); other reagents were of analytical grade.

[0026] 2. Methods and Results

[0027] 2.1 Determination method of inclusion drug content

[0028] 2.1.1 Selection of UV detection wavelength

[0029] Accurately weigh butenafine hydrochloride reference substance 10.00mg and place it in a 10ml measuring bottle, dissolve it with methanol, after constant volume, get 1ml in a 10ml measuring bottle, use methanol solution (methanol: water=5:5) to constant volume, with Methanol solution was used as a blank control, a...

Embodiment 2

[0055] Embodiment 2 A kind of preparation method of butenafine hydrochloride liniment

[0056] Butenafine Hydrochloride Hydroxypropyl-β-Cyclodextrin Inclusion Compound 3.5g

[0057] Sodium Hyaluronate 0.2g

[0058] Urea 10g

[0059] Propylene glycol 10g

[0060] water up to 100g

[0061] Preparation:

[0062] Dissolve the clathrate in the prescribed amount in propylene glycol and water, then dissolve sodium hyaluronate and urea with appropriate amount of water respectively, add it to the clathrate solution, add water to a sufficient amount, and stir well to obtain the product.

Embodiment 3

[0064] Butenafine Hydrochloride Hydroxypropyl-β-Cyclodextrin Inclusion Compound 3.5g

[0065] Sodium Hyaluronate 0.2g

[0066] Urea 5g

[0067] Propylene glycol 10g

[0068] Benzalkonium Bromide 0.2

[0069] water up to 100g

[0070] Preparation:

[0071] Dissolve the clathrate in the prescribed amount in propylene glycol and water, then dissolve sodium hyaluronate and urea with appropriate amount of water respectively, add it to the clathrate solution, add water to a sufficient amount, and stir well to obtain the product.

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Abstract

The invention discloses a preparation method of butenafine hydrochloride liniment. Firstly butenafine hydrochloride hydroxypropyl-beta-cyclodextrin clathrate compound is prepared and then the clathrate compound is dissolved to prepare a liniment. In the process of preparing the clathrate compound, the weight ratio of the butenafine hydrochloride and the hydroxypropyl-beta-cyclodextrin, the constant temperature blending time, the blending speed and the temperature are optimally selected. The inclusion of the butenafine hydrochloride by the hydroxypropyl-beta-cyclodextrin enhances the solubility of the butenafine hydrochloride, thereby solving the problem of poor water solubility of the butenafine hydrochloride. Meanwhile, the preparation method significantly reduces the consumption of ethanol, thus reducing the irritation of the liniment to the skin of the user.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a preparation method of butenafine hydrochloride liniment. 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...

Claims

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Application Information

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