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Ketoconazole foaming agent and preparation method thereof

A technology for foaming agent and ketoconazole medicine, applied in the field of pharmacy, can solve the problems of hidden dangers in daily use, difficult to control, and high cost

Active Publication Date: 2013-01-30
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
  • Ketoconazole foaming agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Weigh and mix the absolute ethanol and propylene glycol as the solvent and keep the temperature at 50-60°C for use.

[0030] Add stearyl alcohol and stir at 60°C to complete the dissolution. Keep the temperature at 50-60°C for use.

[0031] Weigh the ketoconazole and add it to the above solvent to make the dissolution complete and make the alcohol phase.

[0032] Weigh Tween 60 and citrate buffer solution into the prescribed amount of water to make the dissolution 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. Filling, sealing, capping.

[0035] Fill with propellant.

[0036] Citrate buffer preparation method: take 10% potassium citrate solution, use 10% citric acid solution, adjust the pH value to 7.0.

Embodiment 2

[0039] Weigh and mix the absolute ethanol and propylene glycol as the solvent and keep the temperature at 40°C for use.

[0040] Add stearyl alcohol, stir at 60°C to make the dissolution complete, keep the temperature at 40°C, and set aside.

[0041] Weigh the ketoconazole and add it to the above solvent to make the dissolution complete and make the alcohol phase.

[0042] Weigh Tween 60 and citrate buffer solution into the prescribed amount of water to make the dissolution complete and prepare the water phase.

[0043] Keep the temperature at 40°C and slowly add the water phase to the alcohol phase.

[0044] Keep the temperature at 40°C and stir for 1 hour.

[0045] Filling, sealing, capping.

[0046] Fill with propellant.

[0047] Citrate buffer preparation method: the same as in Example 1.

[0048] The state of the sample prepared by the method in Example 2 is not significantly different from that of the sample prepared in Example 1.

Embodiment 3

[0051] Weigh and mix the absolute ethanol and propylene glycol as the solvent and keep the temperature at 40°C for use.

[0052] Add stearyl alcohol, stir at 60°C to make the dissolution complete, keep the temperature at 40°C, and set aside.

[0053] Weigh the ketoconazole and add it to the above solvent to make the dissolution complete and make the alcohol phase.

[0054] Weigh Tween 60 and citrate buffer solution into the prescribed amount of water to make the dissolution complete and prepare the water phase.

[0055] Keep the temperature at 40°C and slowly add the water phase to the alcohol phase.

[0056] Keep the temperature at 40°C and stir for 1 hour.

[0057] Filling, sealing, capping.

[0058] Fill with propellant.

[0059] Citrate buffer preparation method: the same as in Example 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 developed in the pharmaceutical industry as a new type of drug carrier. Its characteristics are that it is easy to use, has low density, is easier to distribute on the epidermis than other external preparations, does not stain, can ensure the absorption or action time of the drug, but is easy to wash, and has strong compliance. [0003] Ketoconazole is a classic antifungal drug. Since it has been on the market for more than 20 years, its efficacy and safety have been widely recognized. At home and abroad, lotions, gels, creams, oral tablets, suppositories, capsules, vaginal tablets, shampoos, etc. have been successively developed. In July 2...

Claims

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Application Information

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Patent Type & Authority Patents(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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