Fenticonazole nitrate vaginal suppository composition

A technology for fenticonazole nitrate and teconazole suppositories, applied in the directions of suppository delivery, drug combination, antifungal agent, etc., can solve problems such as high cost, complicated process operation, insufficient production line, etc., and achieves repair of diseased tissue and mature technology. , to avoid the effect of gastric acid damage

Inactive Publication Date: 2011-01-05
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The dosage form of vaginal soft capsules marketed abroad, the process is complicated, the domestic production line is insufficient, and the cost is high. However, most of the vaginal soft capsules in China rely on foreign production, and the idea of ​​domestic import and sub-packaging is on the market.

Method used

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  • Fenticonazole nitrate vaginal suppository composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The prescription consists of:

[0025] (a) Fenticonazole Nitrate 200mg / capsule

[0026] (b) Semi-synthetic fatty acid glyceride (type 36) 2300mg / capsule

[0027] Taking the preparation of 1000 fenticonazole nitrate vaginal suppositories as an example, the specific preparation method is to grind and pulverize fenticonazole nitrate with a rotary mill or an air jet ultra-fine grinder. The particle size of the drug particles is not greater than 30 μm. Heat and melt the semi-synthetic fatty acid glyceride (type 36) in the preparation tank to 50°C ± 5°C, maintain the temperature of the melting matrix at 50°C ± 5°C, add the prescribed amount of fenticonazole nitrate into the above preparation tank , mix it well and homogenize to obtain a homogeneous dispersion. Maintaining mixing and maintaining the temperature at 45°C ± 5°C, the drug dispersion is formed into suppositories using an automatic form / fill / seal suppository machine.

Embodiment 2

[0029] The prescription consists of:

[0030] (a) Fenticonazole Nitrate 200mg / capsule

[0031] (b) Semi-synthetic fatty acid glyceride (type 38) 2300mg / capsule

[0032] Taking the preparation of 1000 fenticonazole nitrate vaginal suppositories as an example, the specific preparation method is to grind and pulverize fenticonazole nitrate with a rotary mill or an air jet ultra-fine grinder. The particle size of the drug particles is not greater than 30 μm. Heat and melt the semi-synthetic fatty acid glyceride (type 38) to 50°C±5°C in the preparation tank, and melt the base

[0033] The temperature of the substance was maintained at 50°C ± 5°C, and the prescribed amount of fenticonazole nitrate was added into the above preparation tank, mixed and homogenized to obtain a uniform dispersion. Maintaining mixing and maintaining the temperature at 45°C ± 5°C, the drug dispersion is formed into suppositories using an automatic form / fill / seal suppository machine.

Embodiment 3

[0035] The prescription consists of:

[0036] (a) Fenticonazole Nitrate 200mg / capsule

[0037] (b) Semi-synthetic fatty acid glyceride (type 36) 1800mg / capsule

[0038] Taking the preparation of 1000 fenticonazole nitrate vaginal suppositories as an example, the specific preparation method is to grind and pulverize fenticonazole nitrate with a rotary mill or an air jet ultra-fine grinder. The particle size of the drug particles is not greater than 30 μm. Heat and melt the semi-synthetic fatty acid glyceride (type 36) in the preparation tank to 50°C ± 5°C, maintain the temperature of the melting matrix at 50°C ± 5°C, add the prescribed amount of fenticonazole nitrate into the above preparation tank , mix it well and homogenize to obtain a homogeneous dispersion. Maintaining mixing and maintaining the temperature at 45°C ± 5°C, the drug dispersion is formed into suppositories using an automatic form / fill / seal suppository machine.

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Abstract

The invention discloses a fenticonazole nitrate vaginal suppository composition. By utilizing the high-efficiency antibacterial activity of the fenticonazole nitrate and adopting local vaginal administration, the antibacterial activity is greatly improved, and the toxic or side effect due to oral administration is remarkably reduced. The fenticonazole nitrate vaginal suppository composition is used for locally treating double infection caused by vulvovaginal candidiasis and gram positive bacteria. The invention also relates to a fenticonazole nitrate vaginal suppository composition and a preparation method thereof.

Description

technical field [0001] The invention relates to a vaginal suppository composition of fenticonazole nitrate and a preparation method thereof. Background technique [0002] Fenticonazole nitrate, its chemical name is: 1-[2-(2,4-dichlorophenyl)-2-[[4-(phenylthio)phenyl]methoxy]ethyl]-1H - imidazole nitrate. [0003] Its structural formula is as follows: [0004] [0005] Molecular formula: C 24 h 20 C 12 N 2 oS·HNO 3 [0006] Molecular weight: 518.41 [0007] Fenticonazole nitrate is an imidazole derivative with antibacterial activity. Topical treatment of candidal vulvovaginal disease and double infection caused by Gram-positive bacteria such as: cervicitis, vaginitis, abnormal leucorrhea, etc. Fenticonazole nitrate was developed by the Italian Recordati pharmaceutical company and is listed in Italy, Argentina, Austria, Brazil, France, Germany, the United Kingdom, and Switzerland. The listed dosage forms include cream, solution, aerosol and vaginal soft capsule. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/4174A61K9/44A61P15/02A61P31/02A61P31/10
Inventor 严洁黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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