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Pessulum preparation containing drospirenone or drospirenone and estrogen

A drospirenone and estrogen technology, applied in the field of vaginal ring preparations containing drospirenone or drospirenone and estrogen, can solve unseen and other problems

Inactive Publication Date: 2013-10-30
NAT RES INST FOR FAMILY PLANNING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, there is no patent report on a vaginal ring containing drospirenone or drospirenone and estrogen for routine contraception

Method used

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  • Pessulum preparation containing drospirenone or drospirenone and estrogen
  • Pessulum preparation containing drospirenone or drospirenone and estrogen
  • Pessulum preparation containing drospirenone or drospirenone and estrogen

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Weigh 1kg of silicone rubber and 60.48g of drospirenone and mix them uniformly to obtain the drug-containing silicone rubber raw material, vulcanize by hot pressing on a flat vulcanizer, and coat a certain thickness of inactive silicone rubber film on the outside of the matrix-type drospirenone vaginal ring. After secondary vulcanization, the coated compound vaginal ring containing drospirenone can be obtained.

Embodiment 2

[0023] Weigh 0.45g ethinyl estradiol and 0.45g PVP solvent method to prepare a solid dispersion, mix with silicone rubber to obtain a mixed silicone rubber raw material, a section of drug-containing core matrix that is hot-pressed and vulcanized by a flat vulcanizer, 60.48g snail Ketone and silicone rubber are mixed, hot-pressed and vulcanized to obtain another drug-containing core matrix, and a certain thickness of inactive silicone rubber film is coated on the outside of the two drug-containing core matrix, and secondary vulcanization is obtained to obtain drospirenone and ethinyl estradiol Alcohol-encapsulated compound vaginal ring.

Embodiment 3

[0025] Weigh 60.48g drospirenone and 181.44g PVP, 0.45g ethinyl estradiol and 0.45g PVP, prepare solid dispersions by solvent method respectively, mix with silicone rubber respectively, obtain the silicone rubber raw material containing medicine, put the above raw materials into Put it into a flat vulcanizer for hot press vulcanization to obtain two sections of drug-containing core matrix, which are coated with a certain thickness of inactive silicone rubber film, and then vulcanized twice to obtain a coated compound vaginal matrix containing drospirenone and ethinyl estradiol. ring.

[0026] In vitro drug release test

[0027] Instrument: 1. UV-visible spectrophotometer Lambda35

[0028] 2. Intelligent dissolution tester ZRS-8G

[0029] process:

[0030] 1. Take a nylon filament and fix the test ring on the stirring paddle of the dissolution apparatus, use 0.3% SDS as the dissolution medium, the volume is 200ml, the set temperature is 37°C, the speed is 50 rpm, every 24 ho...

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PUM

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Abstract

The invention relates to a contraceptive which is a pessulum preparation containing drospirenone or drospirenone and estrogen. The pessulum comprises a controlled release membrane and one or more framework sections; and at least one framework section contains the drospirenone which can slowly release acyeterion at a constant speed within 21 days, so that the zero-order release characteristic is realized. The controlled release medicinal preparation containing the drospirenone or drospirenone and estrogen can overcome the inconvenience caused by an oral contraceptive pill and improve the compliance in taking the medicine.

Description

technical field [0001] The patent of the present invention belongs to the field of new intravaginal drug delivery system, which relates to a vaginal ring preparation containing drospirenone or drospirenone and estrogen. Background technique [0002] With the continuous expansion of the population in my country and the world, it is imminent to actively adopt safe and effective contraceptive measures to control the population, improve the quality of the population and the health level of the whole people. The research on "safe and effective contraception" has become one of the "ten challenges" in the field of reproductive health "one. [0003] Synthetic steroid hormones have been used as contraceptives for 60 years. Initially, oral tablets were mainly used. Because they need to be taken regularly every day, the contraceptive effect of oral contraceptives is often affected by missed doses and vomiting, resulting in unintended pregnancy. In order to overcome the above-mentioned...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/585A61K45/00A61K9/00A61P15/18
Inventor 张莹宁美英李春晓段雪艳刘颖
Owner NAT RES INST FOR FAMILY PLANNING
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