Amoluofen emulsifiable paste

A technology of amorolfine and cream, applied in the field of medicine, can solve the problems of cream damage, uneven particle size distribution of cream, oil-water separation and the like

Active Publication Date: 2009-07-22
CHINA PHARM UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that when using polyoxyl 40 stearate as the cream base to prepare amorolfine cream, there are generally following problems in the preparation process: when the oil and water are mixed, high-speed stirring is required to obtain For a fine and stable emulsion, the resulting cream needs to be homogenized at high speed, otherwise it is difficult to obtain a fine cream with uniform particle size distribution
Unhomogenized creams have uneven particle size distribution, poor stability, and oil-water separation is prone to occur at high temperatures (40 degrees and above)
In addition, in the stability study of amorolfine cream (Loceryl) produced by Galderma, it was found that when placed at high temperature, the Loceryl cream product may produce irreversible oil-water two-phase separation, resulting in the destruction of the cream

Method used

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  • Amoluofen emulsifiable paste
  • Amoluofen emulsifiable paste
  • Amoluofen emulsifiable paste

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Recipe for Cream 1

[0064] Composition of preparation prescription Component content in every 100 grams of cream

[0065] Amorolfine Hydrochloride 278mg

[0066] Macrogol-7 stearate (tefose 63) 22g

[0067] Purified water up to 100g

[0068] making process:

[0069] (a) polyethylene glycol-7 stearate is melted at 60 degrees;

[0070] (b) heating purified water to 60 degrees;

[0071] (c) under continuous stirring at 1000 rpm, transfer the hot purified water into the polyethylene glycol-7 stearate liquid, and stir for 20 minutes;

[0072] (d) Turn the mixture to 30 degrees, stir continuously at 1000 rpm for 15 minutes, add the medicine and stir evenly;

[0073] (e) filling to obtain amorolfine cream.

[0074] The morphology of the obtained cream was observed under an optical microscope, and the cream was placed at 40°C and 60°C for 10 days respectively, and cooled to room temperature after taking it out to investigate the change in properties ...

Embodiment 2

[0076] Recipe for Cream 2

[0077] Composition of preparation prescription Component content in every 100 grams of cream

[0078] Amorolfine Hydrochloride 278 mg

[0079] Macrogol-7 stearate (tefose 63) 18g

[0080] 5.5 grams of liquid paraffin

[0081] Phenoxyethanol 0.45g

[0082] Appropriate amount of sodium hydroxide

[0083] Purified water up to 100g

[0084] making process:

[0085] (a) polyethylene glycol-7 stearate and liquid paraffin are melted at 60 degrees;

[0086] (b) Heat the purified water to 60 degrees, add phenoxyethanol to dissolve;

[0087] (c) under continuous stirring at 1200 rpm, transfer (b) into (a) and stir for 20 minutes;

[0088] (d) Turn the mixture to 35 degrees, stir continuously at 1200 rpm for 15 minutes, add amorolfine hydrochloride and stir evenly, then add sodium hydroxide solution to adjust the pH value to 6.0-7.0;

[0089] (e) filling to obtain amorolfine cream.

[0090] The morphology of the obtained cream wa...

Embodiment 3

[0092] Recipe for Cream 3

[0093] Composition of preparation prescription Component content in every 100 grams of cream

[0094] Amorolfine Hydrochloride 278mg

[0095] PEG-7 Stearate (Tefose 63) 14.5g

[0096] 6 grams liquid paraffin

[0097] Carbopol 980 0.02g

[0098] Phenoxyethanol 0.45g

[0099] Disodium edetate 0.005 g

[0100] Appropriate amount of sodium hydroxide

[0101] Purified water up to 100g

[0102] making process:

[0103] (a) polyethylene glycol-7 stearate and liquid paraffin are melted at 60 degrees;

[0104] (b) Add water to swell carbomer for 6 hours, heat to 60 degrees, add phenoxyethanol and disodium edetate to dissolve;

[0105] (c) under continuous stirring at 1200 rpm, transfer (b) into (a) and stir for 20 minutes;

[0106] (d) Turn the mixture to 35 degrees, stir continuously at 1200 rpm for 15 minutes, add the drug and stir evenly, add sodium hydroxide solution to adjust the pH to 6.5-7.5;

[0107](e) filling to obtai...

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Abstract

The invention relates to amorolfine cream for treating dermatomycosis and cutaneous candidiasis caused by dermatophytes. The amorolfine cream comprises amorolfine or pharmacologically tolerable salt thereof and polyethyleneglycol-7 stearate. The amorolfine cream which is refined, has the particle size meeting the requirements of Chinese pharmacopoeia on cream quality and has good coating performance can be prepared by use of low-speed stir during preparation. The cream has better high-temperature resistant stability, and is not easy to have oil-water separation. Therefore, the amorolfine cream has the advantages of better suitability for industrial production and better stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an amorolfine cream for treating dermatophytosis and cutaneous candidiasis caused by skin fungi. Background technique [0002] The chemical name of amorolfine is cis-4[3-[4-(1,1-dimethyl-propyl)phenyl]-2-methylpropane]-2,6-dimethyl-morpholine Hydrochloride is a broad-spectrum antifungal drug, which can inhibit and kill bacteria by interfering with the biosynthesis of ergosterol in the fungal cell membrane. Current formulations of amorolfine include liniments and creams. The specification of liniment is 50mg / ml, and it is clinically used for the treatment of nail (toe) infection caused by sensitive fungi; the cream specification is 0.25%, and it is clinically used for the treatment of dermatophytosis (tinea pedis, jock itch) caused by dermatophytes. ringworm, tinea corporis) and cutaneous candidiasis. [0003] According to the product manual of amorolfine cream pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/5377A61K47/34A61K47/44A61P17/00A61P31/10A61K47/06A61K47/14
Inventor 张建军高缘舒文娟高丽琼
Owner CHINA PHARM UNIV
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