Ketoconazole foaming agent and preparation method thereof

A technology of foam agent and ketoconazole drug, applied in the field of pharmacy, can solve problems such as difficult control, high cost, strong toxicity, etc., and achieve the effect of avoiding adverse conditions and good foam effect

Active Publication Date: 2010-10-13
北京京卫燕康药物研究所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main performance is that the ethanol used in this product must be modified by some special reagents (such as tert-butanol, strychnine sulfate, etc.), and these modifiers often have strong toxicity and are not easy to control
The product has high and strong danger, the amount of ethanol is as high as 58%, and the propellant used is a mixture of propane and butane, which are extremely flammable and explosive items, which are not good for production safety control, and the cost is high. People's daily use also brings great hidden dangers

Method used

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  • Ketoconazole foaming agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Weigh absolute ethanol and propylene glycol and mix them uniformly as a solvent, keep the temperature at 50-60°C, and set aside.

[0030] Add stearyl alcohol, stir at 60°C to dissolve completely, keep the temperature at 50-60°C, and set aside.

[0031] Weigh ketoconazole and add it to the above solvent to dissolve completely to form the alcohol phase.

[0032] Weigh Tween 60 and citrate buffer solution into the prescribed amount of water to dissolve completely and make the water phase.

[0033] Keep the temperature at 50-60°C, and slowly add the water phase to the alcohol phase.

[0034] Keep the temperature at 50°C, stir for 30 minutes, stop heating, and continue stirring to about 40°C.

[0035] Filling, sealing, capping.

[0036] Fill the propellant.

[0037] Citrate buffer preparation method: take 10% potassium citrate solution and use 10% citric acid solution to adjust the pH value to 7.0.

Embodiment 2

10

[0041] Weigh absolute ethanol and propylene glycol and mix them uniformly as a solvent, keep the temperature at 40°C, and set aside.

[0042] Add octadecyl alcohol, stir at 60°C to dissolve completely, keep the temperature at 40°C, and set aside.

[0043] Weigh ketoconazole and add it to the above solvent to dissolve completely to form the alcohol phase.

[0044] Weigh Tween 60 and citrate buffer solution into the prescribed amount of water to dissolve completely and make the water phase.

[0045] Keeping the temperature at 40°C, the water phase was slowly added to the alcohol phase.

[0046] Keep the temperature at 40°C and stir for 1 hour.

[0047] Filling, sealing, capping.

[0048] Fill the propellant.

[0049] Citrate buffer preparation method: with embodiment 1.

[0050]The state of the sample prepared by the method of Example 2 is not significantly different from that of the sample prepared in Example 1.

Embodiment 3

[0053] Weigh absolute ethanol and propylene glycol and mix them uniformly as a solvent, keep the temperature at 40°C, and set aside.

[0054] Add octadecyl alcohol, stir at 60°C to dissolve completely, keep the temperature at 40°C, and set aside.

[0055] Weigh ketoconazole and add it to the above solvent to dissolve completely to form the alcohol phase.

[0056] Weigh Tween 60 and citrate buffer solution into the prescribed amount of water to dissolve completely and make the water phase.

[0057] Keeping the temperature at 40°C, the water phase was slowly added to the alcohol phase.

[0058] Keep the temperature at 40°C and stir for 1 hour.

[0059] Filling, sealing, capping.

[0060] Fill the propellant.

[0061] Citrate buffer preparation method: with embodiment 1.

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Abstract

The invention provides a ketoconazole foaming agent and a preparation method thereof, which are used for treating fungal infective diseases, such as seborrheic dermatitis and the like.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing ketoconazole, which is used for treating seborrheic dermatitis and local fungal infection, and belongs to the field of pharmacy. Background technique [0002] Foaming agents are widely used in the cosmetics industry. In recent years, foaming agents have been deeply developed in the pharmaceutical industry as a new type of drug carrier. Its main feature is that it is easy to use, low in density, easier to distribute on the epidermis than other external preparations, does not stain, can guarantee the adsorption or action time of the drug, but is easy to wash and has strong compliance. [0003] Ketoconazole is a classic antifungal drug, and its efficacy and safety have been extensively reviewed since it was launched for more than 20 years. Lotions, gels, creams, oral tablets, suppositories, capsules, vaginal tablets, shampoos, etc. have been developed successively at home and abroad. In Jul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/496A61P17/00A61P31/10
Inventor 李鹏飞张彦源冯志媛
Owner 北京京卫燕康药物研究所有限公司
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