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Fenticonazole nitrate vaginal expansive suppository, preparation method and detection method thereof

A technology of fenticonazole nitrate and vaginal expansion suppository, applied in the directions of suppository delivery, pharmaceutical formulation, material inspection, etc., can solve the problems of easily contaminated clothes, insufficient absorption, small contact surface of active ingredients, etc., to avoid secondary Infection, outflow prevention effect

Active Publication Date: 2016-01-13
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The preparations of fenticonazole nitrate include preparations such as ointment, gel and suppository; Among them, in the treatment of vulvovaginitis, fenticonazole nitrate suppository is more widely used because of its easy dose control; clinically, this suppository is mainly used for Vulvovaginal candidiasis; for example, CN102028652 discloses a preparation method of fenticonazole nitrate suppository, which suppository includes 130 parts of fenticonazole nitrate, 90 parts of lanolin and 780 parts of mixed fatty acid glycerides; Conazole and mixed fatty acid glycerides are not well soluble in each other; during the preparation process, the pharmaceutical ingredients often precipitate from the auxiliary materials, resulting in uneven dispersion of fenticonazole nitrate; CN102342930 discloses a suppository for fenticonazole nitrate, which includes nitric acid Fenticonazole, mixed fatty acid glyceride and silicon dioxide; The suppository overcomes the technical problem of uneven dispersion of fenticonazole nitrate, but the stability of the suppository is still unsatisfactory; CN101313904 discloses a kind of fenticonazole nitrate , gelatin, glycerin, polyvinylpyrrolidone, titanium dioxide, ethylparaben sodium, propylparaben sodium and water; the suppository is also unstable for a long time, which further affects the curative effect of the suppository; Clean, easy to contaminate clothes; the active ingredient has a small contact surface with the human body, resulting in insufficient absorption, failure to exert the best curative effect of the formula, effective administration time period and other technical problems

Method used

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  • Fenticonazole nitrate vaginal expansive suppository, preparation method and detection method thereof
  • Fenticonazole nitrate vaginal expansive suppository, preparation method and detection method thereof
  • Fenticonazole nitrate vaginal expansive suppository, preparation method and detection method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0093]

[0094] Preparation:

[0095] 1) Preparation of drug-containing matrix:

[0096] a. heating and melting the semi-synthetic fatty acid glyceride in a water bath to obtain a melt;

[0097]b. adding fenticonazole nitrate to the melt obtained in step a, and mixing uniformly to obtain a drug-containing matrix;

[0098] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 bullet-shaped suppositories, each weighing about 3.5g.

Embodiment 2

[0100]

[0101] Preparation:

[0102] 1) Preparation of drug-containing matrix:

[0103] a. placing semi-synthetic litsea cubeba and cocoa butter in a water bath for heating and melting to obtain a melt;

[0104] b. Put octyldodecanol in a mortar, slowly add fenticonazole nitrate under grinding, continue grinding for 0.5h, the rotation speed is 200rmp, take it out, and pass through a 120 mesh sieve to obtain a solid dispersion;

[0105] c. adding the solid dispersion to the melt obtained in step a, and mixing uniformly to obtain a drug-containing matrix;

[0106] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 oval suppositories, each weighing about 1.8g.

Embodiment 3

[0108]

[0109] Preparation method: make 100 duckbill-shaped suppositories according to the method in Example 2, each weighing about 4.4g.

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Abstract

The invention relates to a fenticonazole nitrate vaginal expansive suppository and a preparation method and a detection method thereof. The expansive suppository comprises a drug-containing matrix and an expansion carrier formed of fenticonazole nitrate and a matrix; Alkanol improves the curative effect of the expansion plug; at the same time, the shell of the expansion plug includes a capsule shell made of polyvinyl alcohol, pullulan and hydrogenated rosin ester, which improves the stability of the expansion plug and reduces the impact of the expansion plug on the vagina. and the provided fenticonazole nitrate vaginal expansion suppository adopts the original seven leading technologies, which have the beneficial effects of preventing the outflow of the drug liquid, lasting drug effect, and preventing secondary infection.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, and in particular relates to a fenticonazole nitrate vaginal expansive suppository, a preparation method and a detection method thereof. Background technique [0002] Fenticonazole nitrate, chemical name 1-[2-(2,4-dichlorophenyl)-2-[[4-(phenylthio)phenyl]methoxy]ethyl]-1H-imidazole Nitrate, which is white crystalline powder, odorless; soluble in water; Fenticonazole nitrate is a topical antifungal drug developed by Italy Rocordati company, used for tinea manus, pedis, pityriasis versicolor and candida Treatment of infections etc. [0003] The preparations of fenticonazole nitrate include preparations such as ointment, gel and suppository; Among them, in the treatment of vulvovaginitis, fenticonazole nitrate suppository is more widely used because of its easy dose control; clinically, this suppository is mainly used for Vulvovaginal candidiasis; for example, CN102028652 discloses a preparati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K31/7056A61K47/34A61K47/44A61P31/10A61P31/02A61P15/02G01N33/15G01N5/04
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司