Mifepristone shell-type vaginal ring preparation and application

A mifepristone shell-type, mifepristone technology, applied in the field of shell-type vaginal ring preparation, to achieve the effects of stable drug release, avoid gastrointestinal reactions, and avoid the first-pass effect

Inactive Publication Date: 2014-01-15
NAT RES INST FOR FAMILY PLANNING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation of the mifepristone shell-type vaginal ring is detailed in the following process:

Method used

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  • Mifepristone shell-type vaginal ring preparation and application
  • Mifepristone shell-type vaginal ring preparation and application
  • Mifepristone shell-type vaginal ring preparation and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Weigh an appropriate amount of mifepristone, use PVP as the dispersion medium, and prepare mifepristone solid dispersion by solvent method. Blank American Dow Corning Class VI silicone rubber is molded and vulcanized into a support frame; the mifepristone solid dispersion is mixed with a certain amount of Class VI silicone rubber, pressed into a thin skin, and the drug thin skin is coated on the support frame layer, and molded and vulcanized Molding; finally, the Class VI blank silicone rubber was pressed into a thin skin with a thickness of 1.0mm, which was covered with the above-prepared silicone rubber ring, and molded and vulcanized to obtain the mifepristone shell-type vaginal ring.

Embodiment 2

[0031] Weigh an appropriate amount of mifepristone, use PVP as the dispersion medium, and prepare mifepristone solid dispersion by solvent method. The blank American Dow Corning Class VI silicone rubber is molded and vulcanized into a supporting skeleton; the mifepristone solid dispersion is mixed with a certain amount of American Dow Corning Class VI silicone rubber, pressed into a thin skin, and the drug thin skin is coated on the supporting skeleton layer, Molding and vulcanization; finally, the Q7 blank silicone rubber is pressed into a thin skin with a thickness of 1.0mm, which is covered with the above-prepared silicone rubber ring, and molded and vulcanized to obtain a mifepristone shell-shaped vaginal ring.

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Abstract

The invention relates to mifepristone shell-type vaginal ring preparation and application. A miferprisone shell-type vaginal ring comprises, by weight, 1.0-6.0% of mifepristone, 0.5-3.0% of medicine dispersion carriers, 0.3-2.0% of additives and 89.0-98.2% of medical polymer controlled release materials. Firstly, a solid dispersion technology is adopted for improving the solubility in water and release degree in vitro of the mifepristone, then a method of mold pressing vulcanization forming is adopted for preparing the mifepristone shell-type vaginal ring, the inner layer is a vacancy silicon rubber skeleton layer, the middle is a medicated layer, and the outmost layer is a controlled release film. By the implementation of the mifepristone shell-type vaginal ring preparation and application, the vaginal ring can release the mifepristone within 21 days at almost constant speed slowly and continuously for a long time, so that the medicine can be released more stably, the first-pass effect and gastrointestinal reaction caused by oral medication of the mifepriston are avoided, and the biological availability of the medicine and medication compliance of a patient are improved. The vaginal ring can be used for routine contraception and treating gynecological diseases such as the endometriosis and the uterine fibroid.

Description

technical field [0001] The invention relates to a novel vaginal ring, in particular to the preparation and application of a shell-shaped vaginal ring loaded with mifepristone. Background technique [0002] With the rapid development of society and the continuous expansion of the world's population, it is imminent to actively adopt safe and effective contraceptive measures to control the population, improve the quality of the population and the health of the whole people. The accelerated pace of life and increasingly fierce competition have increased the pressure on people, especially professional women, and gynecological diseases have followed one after another, such as uterine fibroids and endometriosis. It can be seen that caring for women's health cannot be ignored. [0003] Mifepristone (Mifepristone, Mifepristone) was originally developed and produced by the French Roussel-Uclaf company in the 1980s. It has strong anti-progestin and anti-glucocorticoid effects, but alm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M31/00A61L31/16A61K31/567A61P15/00A61P15/18
Inventor 段雪艳宁美英王彦坤张莹刘颖
Owner NAT RES INST FOR FAMILY PLANNING
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