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Miconazole nitrate-chitosan sustained-release vaginal gel and preparation method thereof

A technology of miconazole nitrate and chitosan nitrate, which is applied in the field of medicine, can solve the problems that it is difficult to achieve the effect, the suppository has a large drug load, and is easy to produce drug resistance, so as to prolong the drug retention time and ensure the curative effect. , the effect of reducing the number of doses

Inactive Publication Date: 2017-08-22
滨州医学院附属医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral preparations of miconazole nitrate are difficult to collect in large quantities in the mucous membrane of the reproductive tract, and must be used in large doses to produce curative effects, thus causing relatively large toxic and side effects. Liniments, creams, and existing gels have long-lasting effects after use Short term, it is difficult to achieve good results, and the suppository has a large drug load, and long-term use is prone to drug resistance

Method used

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  • Miconazole nitrate-chitosan sustained-release vaginal gel and preparation method thereof
  • Miconazole nitrate-chitosan sustained-release vaginal gel and preparation method thereof
  • Miconazole nitrate-chitosan sustained-release vaginal gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 A kind of miconazole nitrate chitosan vaginal sustained-release gel

[0025] The sustained-release gel consists of the following components in parts by weight:

[0026] 2 parts of miconazole nitrate, 0.5 parts of chitosan, 1 part of polycarbophil, 5 parts of glycerin, 2 parts of glyceryl behenate, 0.3 parts of sodium benzoate, 0.2 parts of triethanolamine, 2% acetic acid solution 15 parts, add water for injection to 100 parts.

[0027] The method for preparing miconazole nitrate chitosan vaginal sustained-release gel, the concrete steps are as follows:

[0028] (1) Prepare chitosan acetic acid solution: take chitosan, add in the beaker that fills the acetic acid solution of 2% by mass fraction, stir until dissolving;

[0029] (2) Preparation of polymer phase: Soak polycarbophil with an appropriate amount of water for injection overnight, fully stir until fully swollen into a uniform gel-like polymer, slowly add the chitosan acetate solution prepared in st...

Embodiment 2

[0033] Embodiment 2 A kind of miconazole nitrate chitosan vaginal sustained-release gel

[0034] The sustained-release gel consists of the following components in parts by weight:

[0035] 1.2 parts of miconazole nitrate, 0.3 parts of chitosan, 0.7 parts of polycarbophil, 4.5 parts of glycerin, 1.3 parts of glyceryl behenate, 0.3 parts of sodium benzoate, 0.15 parts of triethanolamine, and an acetic acid solution with a mass fraction of 2%. 13 parts, add water for injection to 100 parts.

[0036] The method for preparing miconazole nitrate chitosan vaginal sustained-release gel, the concrete steps are as follows:

[0037] (1) Prepare chitosan acetic acid solution: take chitosan, add in the beaker that fills the acetic acid solution of 2% by mass fraction, stir until dissolving;

[0038] (2) Preparation of polymer phase: Soak polycarbophil with an appropriate amount of water for injection overnight, fully stir until fully swollen into a uniform gel-like polymer, slowly add th...

Embodiment 3

[0042] Example 3 A miconazole nitrate chitosan vaginal sustained-release gel

[0043] The sustained-release gel consists of the following components in parts by weight:

[0044] 3 parts of miconazole nitrate, 0.7 parts of chitosan, 1.5 parts of polycarbophil, 6.5 parts of glycerin, 2.8 parts of glyceryl behenate, 0.5 parts of sodium benzoate, 0.3 parts of triethanolamine, and an acetic acid solution with a mass fraction of 2%. 16 parts, add water for injection to 100 parts.

[0045] The method for preparing miconazole nitrate chitosan vaginal sustained-release gel, the concrete steps are as follows:

[0046] (1) Prepare chitosan acetic acid solution: take chitosan, add in the beaker that fills the acetic acid solution of 2% by mass fraction, stir until dissolving;

[0047] (2) Preparation of polymer phase: Soak polycarbophil with an appropriate amount of water for injection overnight, fully stir until fully swollen into a uniform gel-like polymer, slowly add the chitosan ace...

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Abstract

The invention relates to a miconazole nitrate-chitosan sustained-release vaginal gel and a preparation method thereof. The miconazole nitrate-chitosan sustained-release vaginal gel comprises miconazole nitrate, chitosan, polycarbophil, glycerin, glyceryl behenate, sodium benzoate, triethanolamine, an acetic acid solution with a mass fraction of 2% and injection water. The method comprises the following steps: preparation of a chitosan-acetic acid sohution; preparation of a polymer phase; preparation of an oil phase; preparation of a water phase; and preparation of a sustained-release capsule. According to the invention, good linear relation is obtained in a range of 0.050 to 0.80 mg / ml; an average recovery rate is 97.91% (wherein RSD is equal to 0.24%); within-day and day-to-day precision tests are carried out, and test results show that within-day precision and day-to-day precision are good; the prepared miconazole nitrate-chitosan sustained-release vaginal gel has accumulative release rates of 35.54%, 56.02% and 93.92% in 1 h, 2 h and 12 h, respecitively; and clinical data shows that the sustained-release vaginal gel has an effective rate of 95.83% in treatment of monilial vaginitis.

Description

technical field [0001] The invention relates to a miconazole nitrate chitosan vaginal sustained-release gel and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Miconazole nitrate is a derivative of 1-phenylethyl imidazole, and its active ingredient is miconazole, which belongs to antifungal drugs, Blastomyces, Histoplasma, Cryptococcus, Candida, Coccidioides, etc. Sensitive to this product, it can be used for vaginal infections caused by gynecological Candida and repeated infections caused by Gram-positive bacteria. Miconazole nitrate can interfere with the activity of fungal cytochrome P450, inhibit the biosynthesis of ergosterol in the fungal cell membrane, change the permeability of the membrane, and cause the leakage of intracellular substances; it can also inhibit the biosynthesis of triacylglycerol and phospholipids in fungi The activity of ethyl oxidase and peroxidase causes the accumulation of intracellular o...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/4174A61K47/32A61K47/36A61P15/02A61P31/10A61P31/04
CPCA61K9/0002A61K9/0034A61K9/06A61K31/4174A61K47/32A61K47/36
Inventor 邢树礼徐燕平汪风芹孙迎东王春伟孙绍伟蔺婷婷
Owner 滨州医学院附属医院
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