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 the same time, the high-speed airflow produces shearing effect on the material, thereby To achieve the purpose of crushing materials, it can process materials into extremely fine powders, which are used to improve the defects of poor dissolution of pharmaceutical preparations

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

Embodiment 1

[0041]

[0042] The formulated amount of fenticonazole nitrate is ultrafinely pulverized into 800 mesh (particle size below 15 microns) micropowder, the formulated amount of soybean lecithin and hydrogenated soybean oil are mixed and added to the colloid mill for grinding and dissolving, and then added to the formulated amount Add the fenticonazole nitrate micropowder to the white vaseline melted at 40-45°C, mix evenly, stir evenly, pass through a colloid mill to grind evenly, and obtain the content of the soft capsule.

[0043] Set the temperature of the water bath in the glue tank to 80°C, add the formulated amount of purified water and raise the temperature to 60°C, add the formulated amount of gelatin particles and stir for one hour until the gelatin is completely melted, then add the formulated amount of glycerin and p-hydroxybenzoic acid After the ethyl ester and titanium dioxide are evenly stirred, adjust the temperature to 55°C, vacuumize and remove air bubbles, and pu...

Embodiment 2

[0045]

[0046] Superfinely pulverize the formulated amount of fenticonazole nitrate into a 600-mesh (particle size below 20 microns) micropowder, add the formulated amount of saturated fatty acid triglyceride and colloidal silicon dioxide into the colloid mill for grinding, mix well and then add The above-mentioned fenticonazole nitrate micropowder is stirred evenly, and ground evenly by a colloid mill to obtain the content of the soft capsule.

[0047] The gelatin solution is prepared by setting the temperature of the water bath in the glue tank to 80°C, adding the formulated amount of purified water and raising the temperature to 60°C, adding the formulated amount of gelatin particles and stirring for one hour until the gelatin is completely dissolved, adding the formulated amount of glycerin, After stirring the ethyl p-hydroxybenzoate and titanium dioxide evenly, adjust the temperature to 55°C, vacuumize and debubble, set aside, add the contents of the above soft capsule...

Embodiment 3

[0049]

[0050] Superfinely pulverize the formulated amount of fenticonazole nitrate into a 600-mesh (particle size below 20 microns) micropowder, mix the formulated amount of PEG6000, Tween 80 and liquid paraffin into a colloid mill for grinding and dissolving, mix well and then add The above-mentioned fenticonazole nitrate micropowder is stirred evenly, and ground evenly by a colloid mill to obtain the content of the soft capsule.

[0051] Set the temperature of the water bath in the glue tank to 70°C, add the prescribed amount of purified water and raise the temperature to 50°C, add the formulated amount of gelatin particles and stir for one hour until the gelatin is completely melted, then add the prescribed amount of glycerin and p-hydroxybenzoic acid After the ethyl ester and titanium dioxide are evenly stirred, adjust the temperature to 55°C, vacuumize and remove air bubbles, and put the contents of the above soft capsules into the hopper of the soft capsule machine, ...

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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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