Vaginal fenticonazole nitrate soft capsule and preparation method thereof

A technology for fenticonazole nitrate and soft capsules, applied in the field of medicine, can solve problems such as poor dissolution, and achieve the effects of small drug particle size, increased stability, and improved drug absorption

Active Publication Date: 2014-03-26
HAINAN HAILI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Airflow ultrafine pulverization technology is a kind of ultrafine pulverization, which uses the material to obtain huge energy under the action of high-speed airflow, causing high-speed collision and friction between material particles in the pulverization chamber, and at th

Method used

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  • Vaginal fenticonazole nitrate soft capsule and preparation method thereof
  • Vaginal fenticonazole nitrate soft capsule and preparation method thereof
  • Vaginal fenticonazole nitrate soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0040] Example 1

[0041]

[0042] The formulated amount of fenticonazole nitrate is ultra-finely pulverized into 800 mesh (with a particle size of less than 15 microns), and the formulated amount of soybean lecithin and hydrogenated soybean oil are mixed into the colloid mill to dissolve and then added to the formulated amount of In the white petrolatum melted at 40-45°C, the above-mentioned fenticonazole nitrate micropowder is added after mixing uniformly, stirring uniformly, and grinding uniformly through a colloid mill to obtain the contents of soft capsules.

[0043] Set the temperature of the water bath in the gelatinization tank to 80°C, add the formulated amount of purified water and raise the temperature to 60°C, add the formulated amount of gelatin granules and stir for one hour until the gelatin is completely melted, and add the formulated amount of glycerin and p-hydroxybenzoic acid. After the ethyl ester and titanium dioxide are evenly stirred, adjust the temperature t...

Example Embodiment

[0044] Example 2

[0045]

[0046] The formula amount of fenticonazole nitrate is ultra-finely pulverized into 600 mesh (particle size below 20 microns), and the formula amount of saturated fatty acid triglyceride and colloidal silicon dioxide are added to the colloidal mill to grind, and the mixture is evenly mixed before adding The above-mentioned fenticonazole nitrate micropowder is evenly stirred, and evenly ground through a colloid mill to prepare the contents of the soft capsule.

[0047] The gelatin liquid is prepared by setting the temperature of the water bath in the gelatinization tank to 80°C, adding the formulated amount of purified water and heating to 60°C, adding the formulated amount of gelatin particles and stirring for one hour until the gelatin is completely melted, and adding the formulated amount of glycerin, After stirring the ethyl p-hydroxybenzoate and titanium dioxide evenly, adjust the temperature to 55°C, evacuate and de-air bubbles, and then put the cont...

Example Embodiment

[0048] Example 3

[0049]

[0050] The formula amount of fenticonazole nitrate is ultra-finely pulverized into 600 mesh (particle size below 20 microns), and the formula amount of PEG6000, Tween 80 and liquid paraffin are mixed into the colloid mill to dissolve, and then added after mixing. The above-mentioned fenticonazole nitrate micropowder is evenly stirred, and evenly ground through a colloid mill to prepare the contents of the soft capsule.

[0051] Set the temperature of the water bath in the gelatinization tank to 70°C, add the prescription amount of purified water and raise the temperature to 50°C, add the prescription amount of gelatin particles and stir for one hour until the gelatin is completely melted, and add the prescription amount of glycerin and p-hydroxybenzoic acid. After the ethyl ester and titanium dioxide are evenly stirred, adjust the temperature to 55°C, evacuate and de-bubble, and then put the contents of the soft capsule into the hopper of the soft capsul...

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Abstract

The application provides a micronized vaginal fenticonazole nitrate soft capsule and a preparation method thereof. According to the preparation method, an active ingredient-fenticonazole nitrate is subjected to superfine grinding so as to obtain a preparation; a drug is small in particle size and ultra-large in specific surface area, so that the drug easily penetrates tissue space, the drug absorptivity and the bioavailability are improved, and a drug effect can be quickly generated; the active ingredient is uniformly dispersed in a matrix, so that the stability is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a novel fenticonazole nitrate preparation, more specifically, to a micronized fenticonazole nitrate vaginal soft capsule and a preparation method thereof. Background technique [0002] Fenticonazole nitrate is a topical antifungal drug developed by Italy Rocordati Company, which is used for the treatment of tinea pedis, tinea corporis, pityriasis versicolor and candida infection. The trade name of fenticonazole nitrate registered abroad is Lomexin, which was first listed in Italy in 1987, and then listed in the United Kingdom, Germany, Australia, France, South Korea and other countries. Its dosage forms include cream, solution, aerosol and Soft gelatin vaginal suppositories, etc. Fenticonazole nitrate has a broad antibacterial spectrum and is effective against skin fungi, yeasts and other fungi that cause skin mycosis. Fenticonazole nitrate has antibacterial effect at low concen...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/4174A61P31/10A61P15/02A61P15/00
Inventor 宋力余国新杨术发
Owner HAINAN HAILI PHARMACEUTICAL CO LTD
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