Ciclopirox olamine vaginal dilation suppository as well as preparation method and detection method thereof

A vaginal expansion suppository, ciclopirox amine technology, applied in the directions of suppository delivery, pharmaceutical formulations, material testing products, etc., can solve the problems of affecting application, easy to pollute clothes, poor water solubility, etc., achieve fast drug release speed, avoid The effect of secondary infection and overcoming the peak and valley phenomenon

Active Publication Date: 2014-01-08
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

As CN101116656 and CN101049286 disclose the gel of ciclopirox olamine, and CN102657603 discloses the cream of ciclopirox olamine, because there is a large amount of moisture in the gel, which affects the stability of ciclopirox olamine, which is easy to deteriorate. Special tools are required for smearing, which is very inconvenient and likely to cause secondary infection, which affects its clinical application
[0007] In the treatment of candida vulvovaginal disease, the characteristics of the suppository itself make it accepted by the majority of patients. In order to overcome the technical problems of poor water stability and poor water solubility of ciclopirox olamine in the prior art, CN101579306 discloses a kind of suppository composed of cyclic The ciclopirox olamine vaginal suppos

Method used

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  • Ciclopirox olamine vaginal dilation suppository as well as preparation method and detection method thereof
  • Ciclopirox olamine vaginal dilation suppository as well as preparation method and detection method thereof
  • Ciclopirox olamine vaginal dilation suppository as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102]

[0103] Preparation:

[0104] 1) Preparation of drug-containing matrix:

[0105] a. Carbomer, sodium alginate and glycerol tristearate are placed in a water bath for heating and melting to obtain a melt;

[0106] b. Add ciclopirox olamine into step a under stirring, and mix evenly to obtain a drug-containing matrix; 2) preparation of the expansion plug: pour the drug-containing matrix into the plug mold, insert a cotton sliver, cool and shape, and make 100 A spherical suppository, each weighing about 3.4g.

Embodiment 2

[0108]

[0109] Preparation:

[0110] 1) Preparation of drug-containing matrix:

[0111] a. Glycerin gelatin, poloxamer and fractionated coconut oil are placed in a water bath for heating and melting to obtain a melt;

[0112] b. heating and melting the citric acid to obtain a viscous substance;

[0113] c. Pulverize ciclopirox olamine, pass through a 50-mesh sieve, add to the viscous substance described in step b under stirring, and mix evenly to obtain a solid dispersion;

[0114] d. Mix the solid dispersion and sodium bicarbonate evenly to obtain a drug-containing matrix; 2) preparation of the expansion suppository: pour the drug-containing matrix into a plug mold, insert a tampon, cool and shape, and make 100 rod-shaped suppositories , each weighing about 1.2g.

Embodiment 3

[0116]

[0117] Preparation method: make 100 cylindrical bullet-shaped suppositories according to the method in Example 2, each weighing about 2.1g.

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Abstract

The invention relates to a ciclopirox olamine vaginal dilation suppository as well as a preparation method and a detection method thereof. The dilation suppository comprises a medicine-containing matrix formed by ciclopirox olamine and a matrix, and a dilation carrier. An organic acid and the ciclopirox olamine in the medicine-containing matrix are prepared into a solid dispersion and form a complex salt, so that the absorption of the ciclopirox olamine can be promoted, the bioavailability of the dilation suppository can be improved, and an acidic environment in the vagina can be kept; according to the hollow effervescent vaginal dilation suppository, the peak valley phenomenon generated during medicine release can be overcome, the stability of the dilation suppository is further improved and the curative effect can reach the depth and wrinkles of the vagina. As few types of excipients exist in the dilation suppository, the release of the ciclopirox olamine and the formation of the suppository are facilitated; in addition, the ciclopirox olamine vaginal dilation suppository provided by the invention adopts six unique leading technologies and has the beneficial effects of preventing outflow of medicine liquor and preventing secondary infection, and is high in stability, durable in curative effect and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a ciclopirox olamine vaginal expansion suppository and a preparation method and a detection method thereof. Background technique [0002] Ciclopirox amine, the chemical name is 4-methyl-6-cyclohexyl-1-hydroxy-2(1H)-pyridone-2-aminoethanol salt, its structure is as follows: [0003] [0004] Ciclopirox olamine [0005] Ciclopirox olamine is a white crystalline powder, easily soluble in methanol and ethanol, and slightly soluble in water. It is a new generation of non-imidazole broad-spectrum antifungal drug. Strong antibacterial and bactericidal effects, strong permeability, and certain inhibitory effects on various actinomycetes, gram-positive and gram-negative bacteria, mycoplasma, chlamydia, trichomonas, etc., is currently an ideal topical antibacterial fungal medicine. [0006] Currently, the dosage forms of ciclopirox olamine mainly include cream, gel, suppository a...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K31/4412A61P31/10G01N33/15G01N5/04
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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