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Ciclopirox olamine vaginal suppository and its preparation method

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

Active Publication Date: 2017-09-26
YANTAI RONGCHANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, it has been found that specific impurities in existing ciclopirox olamine formulations tend to increase during long-term storage of the formulations

Method used

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  • Ciclopirox olamine vaginal suppository and its preparation method
  • Ciclopirox olamine vaginal suppository and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Embodiment 1: Preparation of ciclopirox olamine suppository

[0086] formula:

[0087] Ciclopirox olamine 100mg,

[0088] Mixed fatty acid glycerides 2000mg.

[0089] Preparation method:

[0090] (1) Pre-crushing and sieving the raw and auxiliary materials for subsequent use;

[0091] (2) Mix ciclopirox olamine with part (50% of the formulation amount) of the matrix evenly, and heat to 80-85°C under stirring until the material is completely melted, and the active ingredient is evenly dispersed in the matrix;

[0092] (3) The rest of the matrix powder is placed in the batching tank, and under rapid stirring of the matrix powder, slowly pour the molten material obtained in step (2) into the stirred matrix powder. After mixing, continue stirring Raise the temperature of all materials to 55-60°C and maintain at this temperature for 5 hours;

[0093] (4) Then, under stirring, lower the temperature of the material to 45-50°C and maintain this temperature, pour the mate...

Embodiment 2

[0095] Embodiment 2: Preparation of ciclopirox amine suppository

[0096] formula:

[0097] Ciclopirox olamine 100mg,

[0098] Mixed fatty acid glycerides 1000mg.

[0099] Preparation method:

[0100] (1) Pre-crushing and sieving the raw and auxiliary materials for subsequent use;

[0101] (2) Mix the ciclopirox olamine with part (60% of the formulation amount) of the matrix evenly, and heat to 80-85°C under stirring until the material is completely melted, and the active ingredient is evenly dispersed in the matrix;

[0102] (3) The rest of the matrix powder is placed in the batching tank, and under rapid stirring of the matrix powder, slowly pour the molten material obtained in step (2) into the stirred matrix powder. After mixing, continue stirring Raise the temperature of all materials to 55-60°C and maintain this temperature for 4 hours;

[0103] (4) Then, under stirring, lower the temperature of the material to 45-50°C and maintain this temperature, pour the mater...

Embodiment 3

[0105] Embodiment 3: preparation ciclopirox olamine suppository

[0106] formula:

[0107] Ciclopirox olamine 100mg,

[0108] Mixed fatty acid glycerides 5000mg.

[0109] Preparation method:

[0110] (1) Pre-crushing and sieving the raw and auxiliary materials for subsequent use;

[0111] (2) Mix ciclopirox olamine with part (40% of the formulation amount) of the matrix evenly, and heat to 80-85°C under stirring until the material is completely melted, and the active ingredient is evenly dispersed in the matrix;

[0112] (3) The rest of the matrix powder is placed in the batching tank, and under rapid stirring of the matrix powder, slowly pour the molten material obtained in step (2) into the stirred matrix powder. After mixing, continue stirring Raise the temperature of all materials to 55-60°C and maintain at this temperature for 6 hours;

[0113] (4) Then, under stirring, lower the temperature of the material to 45-50°C and maintain this temperature, pour the materia...

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Abstract

The invention relates to a ciclopirox pessary and a preparation method thereof. The ciclopirox pessary is prepared from ciclopirox and a substrate, wherein the substrate is selected from an aqueous substrate and an oily substrate, the aqueous substrate is selected from any one or several of macrogol 6000, macrogol 4000, macrogol 400, polyoxyethylene-40 stearate, glycogelatin, poloxamer 188, polysorbate 61, carboxymethyl cellulose sodium, hydroxypropyl methylcellulose, carbomer, alginic acid or sodium alginate, and the oily substrate is selected from synthetic fat acid ester, natural fat acid ester, lipoid type substrates and the like. The invention further relates to a method for preparing the ciclopirox pessary and the medical use of the ciclopirox pessary. The ciclopirox pessary disclosed by the invention has excellent properties.

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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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K31/4412A61K47/42A61K47/10A61K47/26A61K47/38A61K47/36A61K47/44A61P15/02A61P31/10
Inventor 熊晓滨张永光柳莉张丽
Owner YANTAI RONGCHANG PHARMA
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