Terbinafine hydrochloride emulsifiable paste and preparation method thereof

A technology of terbinafine hydrochloride and naphthene cream, which is applied in the directions of ointment delivery, pharmaceutical formulation, emulsion delivery, etc., can solve the problems of demulsification, unstable cream, rough paste, etc. Good transdermal absorption and little change in consistency

Active Publication Date: 2009-07-01
ZHEJIANG CONBA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The terbinafine hydrochloride cream preparations currently on the market all adopt the traditional cream preparation method, that is, prepare the oil phase and the water phase respectively, form through mixing and emulsification, and make the cream homogeneously, but the traditional emulsifier When encountering acidic, alkaline or high ionic strength drugs, the cream is often unstable or even demulsified, and the paste is also rough

Method used

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  • Terbinafine hydrochloride emulsifiable paste and preparation method thereof

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Effect test

Embodiment 1

[0037] The ingredients and weight proportions of the self-emulsifying terbinafine hydrochloride cream prescription of the present invention are: terbinafine hydrochloride 10g, TEFOSE63 (polyethylene glycol-7 stearate) 140g, Span 8030g, light Liquid paraffin 20g, glyceryl monostearate 20g, purified water 780g.

[0038] Heat the polyethylene glycol-7 stearate, glyceryl monostearate, Span 80, light liquid paraffin and purified water in the above prescription to 75°C-80°C, and wait until the components are completely dissolved Continue to stir rapidly for 30 minutes to 45 minutes, and cool to about 40°C (can be 30°C to 50°C). Keep this temperature, add terbinafine hydrochloride, continue to stir evenly, evacuate, continue to stir and cool to room temperature, and make 1000g of self-emulsified terbinafine hydrochloride cream, and the pH of the cream at this time is about 2-6 .

Embodiment 2

[0040] The ingredients and weight proportions of the self-emulsifying terbinafine hydrochloride cream prescription of the present invention are: terbinafine hydrochloride 30g, TEFOSE63 (polyethylene glycol-7 stearate) 60g, Span 8010g, light Liquid paraffin 10g, glyceryl monostearate 10g, purified water 880g.

[0041] Heat the polyethylene glycol-7 stearate, glyceryl monostearate, Span 80, light liquid paraffin and purified water in the above prescription amount to 65°C-80°C, and wait until the components are completely dissolved Continue to stir rapidly for 10-40 minutes, and cool to about 50°C-60°C. Keep this temperature, add terbinafine hydrochloride, continue to stir evenly, add an appropriate amount of triethanolamine to adjust the pH value between 4-6, vacuumize, continue to stir and cool to room temperature, and make 1000g self-emulsifying terbinafine hydrochloride cream . In the preparation process, triethanolamine is used to adjust the pH value of the preparation, an...

Embodiment 3

[0043] The ingredients and weight proportions of the self-emulsifying terbinafine hydrochloride cream prescription of the present invention are: terbinafine hydrochloride 5g, TEFOSE63 (polyethylene glycol-7 stearate) 180g, Span 8060g, light Liquid paraffin 40g, glyceryl monostearate 50g, purified water 665g.

[0044] Heat the polyethylene glycol-7 stearate, glyceryl monostearate, Span 80, light liquid paraffin and purified water in the above prescription to 75°C-95°C, and wait until the components are completely dissolved Continue to stir rapidly for 40-60 minutes, and cool to 20°C-30°C. Keep this temperature, add terbinafine hydrochloride, continue to stir evenly, add an appropriate amount of triethanolamine to adjust the pH value between 4-6, vacuumize, continue to stir and cool to room temperature, and make 1000g self-emulsifying terbinafine hydrochloride cream . In the preparation process, triethanolamine is used to adjust the pH value of the preparation, and the dosage ...

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Abstract

The invention relates to a self-emulsified terbinafine hydrochloride cream and preparation method thereof, comprising, main medicaments, terbinafine hydrochloride of 0.5-3%, TEFOSE63 (polyethylene glycol-7 stearate) of 6-18%, span 80 of 1-6%, glycerin monostearate of 1-5%, and light liquid petrolatum of 1-4%; the remainder being purified water. Self-emulsifier, surfactant and solvent are heated to 75-80 DEG C, rapidly stirred for 30-45 minutes after complete dissolution, and cooled to around 40 DEG C; maintaining the temperature, the terbinafine hydrochloride is added and stirred continuously; triethanolamine of proper amount is added to regulate the pH value between 4-6, vacuumized, and continuously stirred to the room temperature to obtain the cream with good brightness, good coating ability, less consistency change with the environmental temperature change, good stability and transdermal absorption. Compared with the traditional preparation technology, the preparation method thereof is simple in operation, low in the energy consumption and low in device investment.

Description

technical field [0001] The present invention relates to a new preparation of an external medicament and a preparation method thereof, in particular to a terbinafine hydrochloride cream formulated with a self-emulsifying matrix and a preparation method thereof. The name of the medicine is terbinafine hydrochloride cream. Background technique [0002] Terbinafine hydrochloride, its chemical name is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-carboxamide naphthalene hydrochloric acid. It is an allylamine drug with broad-spectrum antifungal activity. It can specifically interfere with the early biosynthesis of fungal sterols, highly selectively inhibit fungal squalene epoxidase, and hinder the epoxidation reaction of squalene in the process of fungal cell membrane formation, thereby achieving the effect of killing or inhibiting fungi . Applicable to: 1. Consisting of Trichophyton (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucous, Trichophyton cleavu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/135A61P31/10
Inventor 胡林水黄正标汪享惠郑珺柳群山
Owner ZHEJIANG CONBA PHARMA
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