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Ketoconazole gel and preparation method thereof

A ketoconazole gel and ketoconazole technology are applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., which can solve the problems of easy oxidation and unstable properties, and achieve the effect of improving stability

Active Publication Date: 2012-07-04
BEIJING ACTING PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In addition, ketoconazole is easily oxidized in the air, and its properties are unstable

Method used

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  • Ketoconazole gel and preparation method thereof
  • Ketoconazole gel and preparation method thereof
  • Ketoconazole gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] prescription:

[0070] Ketoconazole 1g Hydroxypropyl-β-cyclodextrin 10g Carbomer 0.3g

[0071] Chitosan 0.1g Poloxamer 407 15g Ethanol 10g

[0072] Distilled water 85g Ethylparaben 0.12g.

[0073] Preparation method: A. Dissolve ketoconazole in ethanol; then dissolve hydroxypropyl-β-cyclodextrin in distilled water at 60°C to obtain hydroxypropyl-β-cyclodextrin solution; then dissolve ketoconazole Slowly add the ethanol solution into the hydroxypropyl-β-cyclodextrin solution, and stir at 35°C for 24 hours to obtain the clathrate solution;

[0074] B. Dissolve chitosan in distilled water, then add poloxamer 407 and carbomer in turn, and mix well to obtain a gel matrix;

[0075] C. Add the clathrate solution obtained in step A to the gel matrix obtained in step B, and stir evenly to obtain.

Embodiment 2

[0077] prescription:

[0078] Ketoconazole 2g Hydroxypropyl-β-cyclodextrin 20g Carbomer 0.8g

[0079] Chitosan 0.4g Poloxamer 188 20g Ethanol 15g

[0080] Distilled water 100g Methylparaben 0.42g.

[0081] Preparation method: A. Dissolve ketoconazole with ethanol; then dissolve hydroxypropyl-β-cyclodextrin in distilled water at 65°C to obtain hydroxypropyl-β-cyclodextrin solution; then dissolve ketoconazole The ethanol solution was slowly added to the hydroxypropyl-β-cyclodextrin solution, and stirred at 37°C for 30 hours to obtain the clathrate solution;

[0082] D. Dissolve chitosan in distilled water, then add poloxamer 188 and carbomer in turn, and mix well to obtain a gel matrix;

[0083] C. Add the clathrate solution obtained in step A to the gel matrix obtained in step B, and stir evenly to obtain.

Embodiment 3

[0085] prescription:

[0086] Ketoconazole 1.5g Hydroxypropyl-β-cyclodextrin 17g Carbomer 0.6g

[0087] Chitosan 0.3g Poloxamer 407 16g Ethanol 13g

[0088] Distilled water 90g Ethylparaben 0.3g.

[0089] Preparation method: A. Dissolve ketoconazole with ethanol; then dissolve hydroxypropyl-β-cyclodextrin in distilled water at 65°C to obtain hydroxypropyl-β-cyclodextrin solution; then dissolve ketoconazole The ethanol solution was slowly added to the hydroxypropyl-β-cyclodextrin solution, and stirred at 40°C for 36 hours to obtain the clathrate solution;

[0090] E. Dissolve chitosan in distilled water, then add poloxamer 407 and carbomer in turn, and mix well to obtain a gel matrix;

[0091] C. Add the clathrate solution obtained in step A to the gel matrix obtained in step B, and stir evenly to obtain.

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Abstract

The invention provides a ketoconazole gel and a preparation method thereof. The ketoconazole gel is used for treating vulval and vaginal infection and vaginal mixed infection which are caused by bacteria, trichomonad and candida albicans. The ketoconazole gel mainly consists of ketoconazole, hydroxypropyl-beta-cyclodextrin, carbomer, chitosan and poloxamer, improves stability of the ketoconazole and quanlity, does not cause drug resistance phenomena, and is high in safety and suitable for treatment of vaginal infection of women in the gestation period. The ketoconazole gel is characterized by having temperature susceptibility and biological adhesion and slowly performing long-acting release so that the ketoconazole gel has the advantages of facilitating use of patients and being high in patient compliance, convenient to take, safe, hygienic and the like. The quality standard is improved comprehensively, pharmacy variety is enriched after dosage form is changed, and the ketoconazole gel and the preparation method have great significant meaning for further meeting and guaranteeing pharmacy requirements of users.

Description

technical field [0001] The invention relates to the field of chemical medicine and pharmacy, in particular to a ketoconazole gel and a preparation method thereof. Background technique [0002] Bacterial vaginosis (BV) and vaginal trichomoniasis are common and frequently-occurring diseases in obstetrics and gynecology. It is reported that about 75% of women of childbearing age have had one episode of BV, and about 5% can recur. There are more than 200 million people infected with Trichomonas, and BV often coexists with Trichomonas vaginitis. It has been reported that 86% of women with positive cultures of Trichomonas have BV. There are also domestic surveys showing that among 227 gynecological outpatients with increased vaginal discharge or peculiar smell, 120 cases were BV patients, accounting for 43.33%, and 19.17% of them were combined with trichomonas infection (23 / 120); 36 cases of trichomonas vaginitis ( 13%), 31 cases (11.1%) of candidal vaginitis. It can be seen tha...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/496A61K47/40A61P15/02A61P31/04A61P33/02
Inventor 程雪翔
Owner BEIJING ACTING PHARMA BIOTECH
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