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Bioadhesive vaginal plug for treating vaginitis and cervicitis as well as preparation method of bioadhesive vaginal plug

A bioadhesion and vaginal suppository technology, which is applied in the directions of medical preparations containing active ingredients, suppository delivery, drug combination, etc. Tissue crusting, repair, regeneration and healing, etc., to achieve the effect of not easily falling off, avoiding the physiological checkpoint effect of the gastrointestinal tract, and avoiding the first-pass effect of the liver

Inactive Publication Date: 2012-07-25
LANZHOU UNIV SECOND HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These freeze-dried powders for external use are inconvenient to use clinically. In order to enhance the convenience and curative effect of the drug, the researchers changed the dosage form of the preparation without changing the route of administration.
However, it does not inhibit the continued development of inflammation and has anti-inflammatory and antibacterial effects, which is not conducive to the scarring, repair, regeneration and healing of wound tissue

Method used

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  • Bioadhesive vaginal plug for treating vaginitis and cervicitis as well as preparation method of bioadhesive vaginal plug
  • Bioadhesive vaginal plug for treating vaginitis and cervicitis as well as preparation method of bioadhesive vaginal plug
  • Bioadhesive vaginal plug for treating vaginitis and cervicitis as well as preparation method of bioadhesive vaginal plug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] (1) Preparation of bioadhesive vaginal suppository matrix solution: Weigh 6.0g of gelatin and add it to 6mL of water for injection to make it fully swell, heat it in a water bath at 60°C, stir to dissolve, and form a gelatin colloidal solution, and then add 4.8g of glycerin, 5.4mL of polyvinyl alcohol-1788 solution with a concentration of 0.1g / mL and 3.0mL of N-succinyl chitosan solution with a concentration of 0.12g / mL were stirred and mixed evenly to obtain a bioadhesive pessary matrix Solution, keep warm at 40-50°C.

[0038] (2) Preparation of bioadhesive vaginal suppository: Take 1 mL of Sophora sophora total alkali solution with a concentration of 2 g / mL and 1 mL of external recombinant human basic fibroblast growth factor solution with a concentration of 100 IU / mL and add them to the matrix solution of bioadhesive vaginal suppository Stir, mix evenly, pour it into a duckbill pessary suppository mold coated with an appropriate amount of liquid paraffin while it is ...

Embodiment 2

[0040] (1) Preparation of bioadhesive vaginal suppository matrix solution: Take 6.6g of gelatin and add it to 5mL of water for injection to make it fully swell, heat it in a water bath at 60°C, stir to dissolve, and form a gelatin colloid solution, and then add 6.0 g of glycerin, 5 mL of polyvinyl alcohol-1788 solution with a concentration of 0.114 g / mL and 3 mL of N-succinyl chitosan solution with a concentration of 0.14 g / mL, stirred, and mixed uniformly to obtain a bioadhesive vaginal suppository matrix solution, 40 ~50°C heat preservation.

[0041] (2) Preparation of bioadhesive vaginal suppository: Take 1 mL of Sophora sophora total alkali solution with a concentration of 2 g / mL and 0.5 mL of external recombinant human basic fibroblast growth factor solution with a concentration of 1000 IU / mL and add them to the matrix of the bioadhesive vaginal suppository solution, stirred, mixed evenly, poured into a duckbill-shaped pessary suppository mold coated with an appropriate a...

Embodiment 3

[0043] (1) Preparation of bioadhesive vaginal suppository matrix solution: Take 5.4g of gelatin and add it to 6mL of water for injection to make it fully swell, heat it in a water bath at 60°C, stir to dissolve, and form a gelatin colloid solution, then add 5.4 g of glycerin, 5 mL of polyvinyl alcohol-1788 solution with a concentration of 0.102 g / mL and 3 mL of N-succinyl chitosan solution with a concentration of 0.10 g / mL, stirred, and mixed uniformly to obtain a bioadhesive vaginal suppository matrix solution, 40 ~50°C heat preservation.

[0044] (2) Preparation of bioadhesive vaginal suppository: Take 1 mL of total alkali solution of Sophora sophorae with a concentration of 1.4 g / mL and 2 mL of external recombinant human basic fibroblast growth factor solution with a concentration of 750 IU / mL and add them to the above-mentioned bioadhesive vaginal suppository matrix solution, stirred, mixed evenly, poured into a duckbill-shaped pessary suppository mold coated with an appro...

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Abstract

The invention discloses a bioadhesive vaginal plug for treating vaginitis and cervicitis as well as a preparation method of the bioadhesive vaginal plug. The bioadhesive vaginal plug for treating vaginitis and cervicitis consists of major medicine and a bioadhesive vaginal plug substrate, wherein major ingredients of each vaginal plug comprise 100 to 300mg of total alkali of sophora alopecuroids and 50 to 150IU of external recombinant human basic fibroblast growth factors, the bioadhesive vaginal plug substrate comprises N-succinyl-chitosan, polyving akohol-1788, glycerol, gelatin and injection water, wherein the mass ratio of N- succinyl-chitosan: polyving akohol-1788: glycerol: gelatin: injection water is (1.7-1.9): (1-1.4): (16-20): (18-22): (54.7-63.3), and the total mass of auxiliary materials is 2.65 to 2.9g.

Description

Technical field: [0001] The invention relates to a new drug preparation or dosage form, in particular to a bioadhesive vaginal suppository for treating vaginitis and cervicitis and a preparation method thereof. Background technique: [0002] Vaginitis is a kind of vaginal inflammation caused by changes in the biochemical properties of vaginal micro-ecological environment flora and secretions, including bacterial vaginitis, fungal vaginitis, trichomonal vaginitis, senile vaginitis, etc. Vaginitis is mainly caused by women's poor hygiene and living habits, abuse of broad-spectrum antibiotics, corticosteroid hormones, estrogen, immunosuppressants, and irregular vaginitis treatment. At present, the treatment of vaginitis is mainly based on oral, topical or injection antibiotics, corticosteroids and estrogen drugs. These drugs are often prone to adverse reactions and complications, resulting in drug resistance, causing vaginal flora imbalance, destroying the normal physiological...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K9/02A61K47/42A61P15/00A61P15/02A61K36/489
Inventor 李平高峻李晓强焦海胜王晓飞周静苏晨魏琴文惠方
Owner LANZHOU UNIV SECOND HOSPITAL
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