Vaginal ointment containing tioconazole and preparation method thereof

A technology of tioconazole and ointment, applied to vaginal ointment containing tioconazole and preparation thereof, in the field of medicine, to achieve the effects of reducing production cost, strong drug effect, and easy implementation of production process

Inactive Publication Date: 2012-05-23
SHANGHAI GOLDEN PHARMATECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And menthol is added to the formula to solve the adverse reactions such as local irritation, itching and burning sensation during the use of the existing tioconazole vaginal ointment preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] formula:

[0023] Tioconazole 300mg

[0024] Menthol 200mg

[0025] Vaseline 5000mg

[0026] Liquid paraffin 500mg

[0027] Ethylparaben 0.1mg

[0028] Preparation:

[0029] The tioconazole is crushed to a powder between 10 μm and 50 μm, mixed with the formulated amount of vaseline, liquid paraffin, and menthol and stirred evenly, and finally ethylparaben is added and stirred evenly.

Embodiment 2

[0031] formula:

[0032] Tioconazole 300mg

[0033] Menthol 100mg

[0034] White petrolatum 3050mg

[0035] Liquid paraffin 300mg

[0036] BHA 0.1mg

[0037] Preparation:

[0038] Grind tioconazole to a powder between 10 μm and 50 μm, mix with white petrolatum, liquid paraffin, and menthol in the formula and mix evenly, and finally add BHA (tert-butyl-4-hydroxyanisole) and mix evenly.

Embodiment 3

[0040] formula:

[0041] Tioconazole 300mg

[0042] Peppermint Oil 50mg

[0043] Vaseline 4650mg

[0044] Ethylparaben 0.1mg

[0045] Preparation:

[0046] The tioconazole is crushed to a powder between 10 μm and 50 μm, mixed with the formulated amount of vaseline and peppermint oil and stirred evenly, and finally ethylparaben is added and stirred evenly.

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Abstract

The invention provides vaginal ointment containing tioconazole, and the vaginal ointment comprises the tioconazole, menthol crystal and pharmaceutical excipients, wherein the weight percentage of the tioconazole in the total weight of the ointment is between 5 percent and 8 percent, the weight percentage of the menthol crystal in the total weight of the ointment is between 1 percent and 6 percent, and the balance is the pharmaceutical excipients; and the tioconazole and the menthol crystal are distributed in the pharmaceutical excipients. A method for preparing the ointment comprises a process of distributing the tioconazole and the menthol crystal into the pharmaceutical excipients, wherein the process comprises the steps of smashing the tioconazole into powdery particles with the diameters between 10mu m and 50mu m, mixing the pharmaceutical excipients with the powdery particles of the tioconazole and the menthol crystal, and adding a preservative into the mixture and then stirring the mixture. The formula and the production technology of the tioconazole ointment provided by the invention are easy to implement, and by adding the menthol crystal to the formula, adverse reactions of local stimulation, pruritus, burning sensation, and the like, which occur in the use process of the existing tioconazole vaginal ointment preparation, are solved. The ointment provided by the invention can be used for treating vaginal fungus infection.

Description

technical field [0001] The invention belongs to the field of medicine and relates to a medicine, in particular to a vaginal ointment containing tioconazole and a preparation method thereof. Background technique [0002] Tioconazole is a new generation of imidazole antifungal drugs with strong efficacy and broad antibacterial spectrum. Its biggest feature is that it is difficult to absorb through the skin or mucous membranes. Therefore, it has almost no systemic effect when used as a local drug, thus avoiding some toxic and side effects. [0003] Tioconazole was first developed by Pfizer, which filed a patent application for tioconazole in the United States in 1975, with the patent number US4062966. And in 1985 applied for the patent of tioconazole composition, the patent number is US717423. The patent covers 100mg oral tablets, 1% and 2% creams, 6.5% ointment and 100mg vaginal tablets. This patent has now expired. [0004] Pfizer's topical tioconazole product was approve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/4178A61K47/10A61K47/44A61K47/46A61P31/10
Inventor 王朝廷隆艳
Owner SHANGHAI GOLDEN PHARMATECH
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