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Butoconazole nitrate vaginal expansion suppository and preparation method and application thereof

A technology of butoconazole nitrate and vaginal expansive suppository, which is applied in suppository delivery, pharmaceutical formula, medical preparations of non-active ingredients, etc., can solve the problems of slow drug effect and unstable quality, and achieve the elimination of vaginal redness, increase The uniformity of dispersion and the effect of enhancing vaginal self-healing ability

Active Publication Date: 2019-12-31
HARBIN OT PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The active ingredient, butoconazole nitrate, is still relatively difficult to form an oily suppository base, and can only be suspended in the melted oily suppository base, with slow efficacy and unstable quality

Method used

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  • Butoconazole nitrate vaginal expansion suppository and preparation method and application thereof
  • Butoconazole nitrate vaginal expansion suppository and preparation method and application thereof
  • Butoconazole nitrate vaginal expansion suppository and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] The present embodiment provides a butoconazole nitrate vaginal expansion suppository, the composition is as follows:

[0078]

[0079]

[0080] The preparation method is as follows:

[0081] (1) Mix the matrix components and melt them under the condition of heating in a water bath at 60°C to obtain a matrix melt;

[0082] (2) Mix the matrix melt obtained in step (1) with butoconazole nitrate at 500 rpm for dispersing and grinding for 2 hours to obtain the drug matrix;

[0083] (3) Put the drug matrix obtained in step (2) into a suppository mold, insert the expansion carrier, and cool to 10° C. to obtain 100 vaginal expansible suppositories, each with a mass of about 2.89 g.

Embodiment 2

[0085] The present embodiment provides a butoconazole nitrate vaginal expansion suppository, the composition is as follows:

[0086]

[0087] The preparation method was the same as in Example 1, and 100 vaginal expansion suppositories were obtained, each weighing about 3.27g.

Embodiment 3

[0089] The present embodiment provides a butoconazole nitrate vaginal expansion suppository, the composition is as follows:

[0090]

[0091]

[0092]The preparation method is the same as in Example 1, and 100 vaginal expansion suppositories are obtained, each with a mass of about 3.28g.

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Abstract

The invention provides a butoconazole nitrate vaginal expansion suppository. The vaginal expansion suppository comprises an expansion carrier and a drug matrix coating the surface of the expansion carrier; and the drug matrix comprises butoconazole nitrate and a matrix. According to the invention, the active components are matched with each other and have a synergistic effect, so that the self-healing capability of vagina is enhanced, and the growth and propagation of pathogenic bacteria are effectively controlled; the medicine effect can also be exerted to the greatest extent, and the bioavailability is improved; and the drug release speed is effectively controlled, the drug dispersion uniformity is improved, the time of the drug acting on an affected part is prolonged, and vaginitis canbe effectively treated.

Description

technical field [0001] The invention belongs to the technical field of vaginal suppositories, and in particular relates to a butoconazole nitrate vaginal expansive suppository, a preparation method and application thereof. Background technique [0002] The causative bacteria of vulvovaginal candidiasis are mainly yeasts such as Candida albicans, and others such as Candida glabrata, Candida tropicalis, and Candida parapsilosis account for a minority. Among its treatment principles, the use of antifungal drugs against pathogenic bacteria is the key to the treatment of this disease. Antifungal therapy includes vaginal and oral medication. For simple vulvovaginal candidiasis, vaginal medication is preferred. Currently commonly used miconazole suppositories, nystatin vaginal effervescent tablets, clotrimazole suppositories and so on. The ubiquitous disadvantage is that the medication cycle is long, generally 7-14 days, and the patient's compliance is low. A considerable proport...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K47/40A61K47/36A61P31/10A61P15/02
CPCA61K9/0034A61K9/02A61K47/40A61K47/36A61P31/10A61P15/02
Inventor 邱明世
Owner HARBIN OT PHARMA
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