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Vagina administration mifepristone prepn and its composition and prepn process

A technology for mifepristone and vaginal administration, which is applied in the field of medicine to achieve the effects of improving bioavailability, good adhesion and avoiding damage

Inactive Publication Date: 2006-10-18
程定超
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the drug is now all oral preparations, and mifepristone is absorbed through the gastrointestinal tract, metabolized by the liver, and has a first-pass effect. Its bioavailability is only 30-40%, and there are gastrointestinal reactions to varying degrees. , such as: nausea, anorexia, vomiting, and discomfort such as dizziness, fatigue, and lower abdominal pain

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Get ethanol 30g, add mifepristone 25g, stir to dissolve. Take 10g of polycarboxyethylene (carbomer) and add 800g of water and stir to fully swell, add 20g of laurocapram, 1.8g of methylparaben, and the above-mentioned dissolved mifepristone solution, mix evenly, and use triethanolamine Adjust the pH value to 4, add water to 1000g, stir evenly, and defoam. Sampling is carried out for quality identification, and after passing the test, it is subpackaged to obtain the gel preparation for vaginal administration of mifepristone.

Embodiment 2

[0032] Get ethanol 50g, add mifepristone 50g, stir to dissolve. Get 15 g of hydroxypropyl methylcellulose, 5 g of polycarboxyethylene (carbomer), add 800 g of water and stir to swell, add 30 g of laurocapram, 1.8 g of methylparaben, and the above-mentioned dissolved mifepristone The solution was uniformly mixed, adjusted with triethanolamine to make the pH value 4, added water to 1000g, stirred evenly, and defoamed. Sampling is carried out for quality identification, and after passing the test, it is subpackaged to obtain the gel preparation for vaginal administration of mifepristone.

Embodiment 3

[0034] Get 30g of ethanol, add mifepristone solid lipid nanoparticles 20g, stir to dissolve. Get polycarboxyethylene (carbomer) 5g, alginic acid 10g, add water 800g and stir to make swelling, add laurocaprone 15g, methylparaben 1.5g, and the above-mentioned dissolved mifepristone solid lipid nanoparticles The solution was uniformly mixed, adjusted with triethanolamine to make the pH value 4, added water to 1000g, stirred evenly, and defoamed. Sampling is carried out for quality identification, and after passing the test, it is subpackaged to obtain the gel preparation for vaginal administration of mifepristone.

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PUM

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Abstract

The vagina administrated mifepristone preparation for birth control and health reproduction consists of mifepristone or nanometer mifepristone liposome particle as main component, excipient, osmosis promoter, pH regulator, preservative, surfactant, solvent, water and other pharmaceutically acceptable components, and may be prepared into gel, film or other preparation forms. The vagina administrated mifepristone preparation is absorbed through vagina mucous membrane into blood circulation, and has high bioavailability, lowered dosage, less toxic side effect and less stimulation.

Description

[0001] Field: [0002] The invention belongs to the technical field of medicine, and relates to a preparation for vaginal administration of mifepristone for family planning and reproductive health, as well as its composition and preparation method. Background technique: [0003] Mifepristone (Mifepristone) was successfully developed in 1982 by the French company Roussel-Uclaf (original code Ru-486), which is an orally absorbed drug through the gastrointestinal tract with anti-progestin and anti-glucocorticoid activity. Mifepristone was initially used clinically as a drug for terminating early pregnancy, and its effectiveness and safety have been confirmed. With the deepening of its understanding, mifepristone is now widely used in family planning and reproductive health, such as: termination of (early, middle, and late) pregnancy, emergency contraception, and treatment of some gynecological diseases, such as: uterus Fibroids, abnormal uterine bleeding, endometriosis, endometr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/565A61K9/02A61P15/00
Inventor 程定超
Owner 程定超
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