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A kind of vaginal contraceptive gel composition and its preparation method and application

A gel composition and vaginal technology, which is applied in the direction of drug combination, medical preparations with non-active ingredients, non-effective ingredients of polymer compounds, etc., can solve the problem of affecting the phase transition temperature and gel state, destroying the vaginal environment, and difficult to commercialize issues such as chemicalization, to achieve the effects of reducing the possibility of infectious transmission, ease of use, and reducing absorption

Inactive Publication Date: 2012-02-08
SHANGHAI INST OF PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to overcome the defects that the existing vaginal gel composition used for contraception or prevention of reproductive system diseases either destroys the vaginal environment, or has high viscosity and is difficult to commercialize, and the existing Adding other additives to the temperature-sensitive vaginal gel composition will affect its phase transition temperature and gel state. The content ratio of the temperature-sensitive components is optimized to provide a method that can avoid the above problems. Vaginal gel composition with phase transition temperature suitable for vaginal use, stable gel state, pH value similar to vaginal environment, and good adhesion, and its preparation method and application

Method used

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  • A kind of vaginal contraceptive gel composition and its preparation method and application
  • A kind of vaginal contraceptive gel composition and its preparation method and application
  • A kind of vaginal contraceptive gel composition and its preparation method and application

Examples

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Effect test

Embodiment 1

[0055] 20% Poloxamer 407, 1% Poloxamer 188, 6% Lactic Acid, 3% Citric Acid, 2% Potassium Bitartrate, 1% Benzoic Acid, Sodium Lactate, Sodium Citrate, Sodium Tartrate, Sodium Potassium Tartrate and Benzene Sodium formate (the content of the above-mentioned salt is the amount that forms a pH3.5 with its corresponding acid), 10% glycerin, 0.8% Carbopol 934, and the water content is to make up 100%.

[0056] Preparation method: Dissolve lactic acid, citric acid, potassium hydrogen tartrate and benzoic acid in water, add 1mol / L sodium hydroxide solution (18ml) under stirring condition to adjust pH to 3.5; increase stirring speed, add poloxamer 407 and Poloxamer 188, stirred evenly, and placed overnight at 4°C; mixed glycerin and Carbopol 934 evenly, added to the above solution, and stirred for 120 minutes to obtain a uniform gel; the detected pH was 3.8.

Embodiment 2

[0058] 20% Poloxamer 407, 3% Poloxamer 188, 4% Lactic Acid, 1% Citric Acid, 0.4% Potassium Bitartrate, 0.2% Benzoic Acid, 8.0% Glycerin, Sodium Lactate, Sodium Citrate, Sodium Tartrate, Tartaric Acid Sodium Potassium and Sodium Benzoate (the content of the above-mentioned salt is the amount that forms a pH3.5 with its corresponding acid), 0.8% Carbopol 934, and the water content is to make up 100%.

[0059] The preparation method is the same as in Example 1, and the measured pH is 3.8.

Embodiment 3

[0061] 20% Poloxamer 407, 9% Poloxamer 188, 1.5% Lactic Acid, 1% Citric Acid, 0.4% Potassium Bitartrate, 0.1% Benzoic Acid, Sodium Lactate, Sodium Citrate, Sodium Tartrate, Sodium Potassium Tartrate and Benzene Sodium formate (the content of the above-mentioned salt is the amount that forms a pH3.5 with its corresponding acid), 5.0% glycerin, 0.5% Carbopol 934, and the water content is to make up 100%.

[0062] The preparation method is the same as in Example 1, and the measured pH is 3.7.

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Abstract

The invention discloses a gel composition for vagina, containing buffering agent, bioadhesive polymer, water, phase transition temperature regulator and one or more poloxamer of poloxamer 237, poloxamer338 and poloxamer407. The weight percentage of the poloxamer is 15-30 percent, the weight percentage of the phase transition temperature regulator is 1.5-6.75 percent; the weight ratio of the poloxamer and the phase transition temperature regulator is 20:1-20:9; and the pH of the composition is 3.0-5.5. The invention also discloses a preparation method of the gel composition and the application of the gel composition in preparing conception control preparation, vagina lubricant, preparation or medicament for preventing sexually transmitted diseases or medicaments for preventing gynecological diseases. The gel composition for vagina is liquid under room temperature and is semi-solid in vagina, is convenient to prepare and use, has the pH value similar to the vagina environment and has better acidic buffering capability and viscosity without damaging the vagina.

Description

technical field [0001] The invention relates to a gel composition and its preparation method and application, in particular to a vaginal contraceptive gel composition and its preparation method and application. Background technique [0002] At present, the most widely used external contraceptive drug at home and abroad is mainly nonoxynol-9, and its traditional preparations include suppositories, gels, films and vaginal tablets. The contraceptive effect of nonoxynol-9 has been fully affirmed clinically, and this drug has played a major role in the family planning cause in the world. Nonoxynol-9 is a powerful nonionic surfactant. Its contraceptive mechanism is to reduce the surface tension of sperm cell membranes and change the osmotic pressure of sperm cells, thereby killing sperm or immobilizing sperm, so as to achieve the purpose of contraception. Nonoxynol-9 is also a strong cytotoxic agent, which can destroy cell membranes without specificity. Clinical studies have con...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K47/32A61K47/36A61K47/34A61K47/42A61K47/38A61P15/02A61P15/00A61P15/18A61K47/10A61K47/12
Inventor 吴莹陈庆华包泳初潘峰瞿挺赵炎龙李坤肖莉莉何雯
Owner SHANGHAI INST OF PHARMA IND CO LTD
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