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Preparation method and applications of compound levonorgestrel pessary

A technology of levonorgestrel and vaginal ring, which is applied in the field of pharmacy and can solve problems such as release effects

Inactive Publication Date: 2019-01-22
国家卫生健康委科学技术研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The invention discloses a preparation method and application of a block-type compound levonorgestrel vaginal ring, which solves the problems in the prior art that side effects are easily produced by a single preparation, and the direct mixing of two medicines will have mutual influence on the release

Method used

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  • Preparation method and applications of compound levonorgestrel pessary
  • Preparation method and applications of compound levonorgestrel pessary
  • Preparation method and applications of compound levonorgestrel pessary

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Accurately weigh 8g of liquid silicone rubber MED-6382 matrix, 0.04g of catalyst, mix for 10min to make it evenly mixed, then weigh 0.2g of levonorgestrel, add it to the silicone rubber, continue to stir for 10min to make it evenly mixed, and then add The mixture is injected into a mold and vulcanized at a high temperature of 80°C for 20 minutes to obtain a drug core loaded with levonorgestrel. The drug core has an outer diameter of 50 mm and a cross-sectional diameter of 4 mm. Accurately weigh 8g of liquid silicone rubber MED-6382 matrix, 0.04g of catalyst, mix for 10min to make it evenly mixed, then weigh 0.048g of ethinyl estradiol, add it to the silicone rubber, continue to stir for 10min to make it evenly mixed, and then inject the mixture In the mold, vulcanize at a high temperature of 80°C for 20 minutes to obtain a drug core loaded with ethinyl estradiol. The drug core has an outer diameter of 50 mm and a cross-sectional diameter of 4 mm. Accurately weigh 15g eac...

Embodiment 2

[0031] Accurately weigh 8g of liquid silicone rubber MED-6382 matrix, 0.04g of catalyst, mix for 10min to make it evenly mixed, then weigh 0.2g of levonorgestrel, add it to the silicone rubber, continue to stir for 10min to make it evenly mixed, and then add The mixture is injected into a mold and vulcanized at a high temperature of 80°C for 20 minutes to obtain a drug core loaded with levonorgestrel. The drug core has an outer diameter of 50 mm and a cross-sectional diameter of 4 mm. Accurately weigh 8g of liquid silicone rubber MED-6382 matrix, 0.04g of catalyst, mix for 10min to make it evenly mixed, then weigh 0.048g of ethinyl estradiol, add it to the silicone rubber, continue to stir for 10min to make it evenly mixed, and then inject the mixture In the mold, vulcanize at a high temperature of 80°C for 20 minutes to obtain a drug core loaded with ethinyl estradiol. The drug core has an outer diameter of 50 mm and a cross-sectional diameter of 4 mm. Accurately weigh 15g eac...

Embodiment 3

[0034] Accurately weigh 4g each of the two components of liquid silicone rubber MED-4950A and B, mix for 10 minutes to make it uniform, then weigh 0.2g of levonorgestrel, add it to the silicone rubber, continue to stir for 10 minutes to make it uniform, then The mixture was injected into a mold, and vulcanized at a high temperature of 80°C for 20 minutes to obtain a drug core loaded with levonorgestrel. The drug core had an outer diameter of 50 mm and a cross-sectional diameter of 4 mm. Accurately weigh 4g each of the two components of liquid silicone rubber MED-4950A and B, mix for 10 minutes to make it uniform, then weigh 0.048g of ethinyl estradiol, add it to the silicone rubber, continue to stir for 10 minutes to make it uniform, and then mix the mixture Inject into a mold and vulcanize at a high temperature of 80°C for 20 minutes to obtain a drug core loaded with ethinyl estradiol. The drug core has an outer diameter of 50 mm and a cross-sectional diameter of 4 mm. Accurat...

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Abstract

The invention belongs to the field of pharmaceutics, and in particular relates to preparation and applications of a compound levonorgestrel pessary. The pessary is of a blocked structure, and is composed of one or more sections of medicine cores at the inner layer and controlled-release membranes at the outer layers, wherein each section of medicine core contains at most one of levonorgestrel andethynylestradiol, and each two adjacent sections of medicine-containing medicine cores are partitioned by a blank medicine core containing no medicine. With the pessary, the defects in the existing administration modes of levonorgestrel are overcome, meanwhile, due to the blocked structure, the mutual influences of the two medicines including progestogen and estrogen during the release process areobviously reduced, and the zero-level release of the two medicines can be realized.

Description

Technical field: [0001] The invention belongs to the field of pharmacy and relates to the preparation of a compound levonorgestrel vaginal ring. Background technique: [0002] Approximately 75 million unintended pregnancies occur every year worldwide, of which about 45 million terminate their pregnancy through abortion. From the perspective of my country, there are more than 13 million induced abortions each year, of which 50% are repeated abortions. Repeated abortion may cause a series of gynecological diseases, such as: chronic pelvic inflammatory disease, menstrual abnormalities, endometriosis, blocked fallopian tubes, cervical adhesions, etc. In severe cases, it may lead to infertility. Therefore, from the perspective of reproductive health, contraception is very necessary to protect women's physical and mental health. On the other hand, controlling population growth and achieving sustainable development is an important development goal for my country and the world. Therefor...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/567A61P15/18
CPCA61K9/0036A61K31/567A61K47/34A61K2300/00
Inventor 宁美英刘振齐邱顺晨
Owner 国家卫生健康委科学技术研究所
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