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Ciclopirox olamine vaginal suppository

A kind of technology of ciclopirox amine and vaginal suppository, applied in the field of medicine

Active Publication Date: 2015-09-02
YANTAI RONGCHANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Specific impurities in existing ciclopirox olamine formulations have been found to increase during prolonged storage of the formulation

Method used

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  • Ciclopirox olamine vaginal suppository
  • Ciclopirox olamine vaginal suppository
  • Ciclopirox olamine vaginal suppository

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Embodiment 1: Preparation of ciclopirox olamine suppository

[0096] formula:

[0097] Ciclopirox olamine 100mg,

[0098] Mixed fatty acid glycerides 2000mg,

[0099] Gallic acid 20mg.

[0100] Preparation method:

[0101] (1) Pre-crushing and sieving the solid material (passing 60 mesh) for subsequent use; mixing ciclopirox olamine and the auxiliary agent uniformly to obtain a mixed powder;

[0102] (2) Mix an appropriate amount of substrate (equivalent to 3 times that of ciclopirox olamine) with the above-mentioned mixed powder, and heat to 75-85°C under stirring until the material melts;

[0103] (3) Heat the remaining matrix to 75-85°C to melt, add it to the material obtained in step (2) under stirring, and stir evenly;

[0104] (4) Lower the temperature of the material to 45-50°C under stirring and maintain this temperature, then pour the material into the cooled bolt mold coated with lubricant under stirring until it slightly overflows the die opening;

[...

Embodiment 2

[0106] Embodiment 2: Preparation of ciclopirox amine suppository

[0107] formula:

[0108] Ciclopirox olamine 100mg,

[0109] Mixed fatty acid glycerides 1000mg,

[0110] Gallic acid 30mg.

[0111] Preparation method:

[0112] (1) Pre-crushing and sieving the solid material (passing 60 mesh) for subsequent use; mixing ciclopirox olamine and the auxiliary agent uniformly to obtain a mixed powder;

[0113] (2) Mix an appropriate amount of substrate (equivalent to 4 times that of ciclopirox olamine) with the above-mentioned mixed powder, and heat to 75-85°C under stirring until the material melts;

[0114] (3) Heat the remaining matrix to 75-85°C to melt, add it to the material obtained in step (2) under stirring, and stir evenly;

[0115] (4) Lower the temperature of the material to 45-50°C under stirring and maintain this temperature, then pour the material into the cooled bolt mold coated with lubricant under stirring until it slightly overflows the die opening;

[01...

Embodiment 3

[0117] Embodiment 3: preparation ciclopirox olamine suppository

[0118] formula:

[0119] Ciclopirox olamine 100mg,

[0120] Mixed fatty acid glycerides 5000mg,

[0121] Gallic acid 10mg.

[0122] Preparation method:

[0123] (1) Pre-crushing and sieving the solid material (passing 60 mesh) for subsequent use; mixing ciclopirox olamine and the auxiliary agent uniformly to obtain a mixed powder;

[0124] (2) Mix an appropriate amount of substrate (equivalent to twice the amount of ciclopirox olamine) with the above-mentioned mixed powder, and heat to 75-85°C under stirring until the material melts;

[0125] (3) Heat the remaining matrix to 75-85°C to melt, add it to the material obtained in step (2) under stirring, and stir evenly;

[0126] (4) Lower the temperature of the material to 45-50°C under stirring and maintain this temperature, then pour the material into the cooled bolt mold coated with lubricant under stirring until it slightly overflows the die opening;

...

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Abstract

The invention relates to a ciclopirox olamine vaginal suppository, which comprises ciclopirox olamine, a substrate and an auxiliary agent, wherein the substrate is selected from an aqueous substrate and an oil substrate; the aqueous substrate is selected from any one or several materials from polyethylene glycol 6000, polyethylene glycol 4000, polyethylene glycol 400, polyoxyethylene-40 stearate, gelatin glycerin, poloxamer 188, polysorbate 61, sodium carboxymethylcellulose, hypromellose, carbopol, alginic acid or sodium alginate; the oil substrate is selected from synthetic fatty acid ester, natural fatty acid ester, lipid granule substrates and the like. The invention also relates to a method for preparing the ciclopirox olamine vaginal suppository and a pharmaceutic purpose of the ciclopirox olamine vaginal suppository. The ciclopirox olamine vaginal suppository has the excellent performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a suppository for vaginal administration, in particular to a ciclopirox olamine vaginal suppository, a preparation method thereof, and an application of the suppository in the preparation of medicines for treating fungal vaginitis. Background technique [0002] Mycotic vaginitis is mainly a kind of vaginal inflammation caused by infection with Candida albicans, Cryptococcus neoformans and other candida. Such fungi can often be isolated from patients with vaginitis who are ineffective or relapse frequently, and clinically, leucorrhea increases. It is like bean curd residue, with itching and burning pain in the genitals as the main manifestations. The susceptibility factors are related to the low cellular immunity of the body. The application of immunosuppressants, long-term application of broad-spectrum antibiotics, adrenal cortex hormones, and antineoplastic drugs can cause the im...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K31/4412A61K47/42A61K47/34A61K47/38A61K47/36A61K47/44A61P15/02A61P31/10A61P31/04
Inventor 熊晓滨张永光柳莉张丽
Owner YANTAI RONGCHANG PHARMA
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