Novel intrauterine sustained control release drug delivery system and preparation method thereof

A drug delivery system and controlled-release drug technology, applied in the field of a new type of intrauterine sustained and controlled-release drug delivery system and its preparation, can solve the problems of uterine injury, copper woman injury, unreasonable shape of the drug delivery system, etc., and restore reproductive function , to avoid bleeding, the effect of high contraceptive effect

Active Publication Date: 2012-10-24
杨立群
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In summary, the intrauterine drug delivery system containing progesterone currently studied is either a stent structure, which will cause certain damage to the uterus of women; or an intrauterine drug delivery system containing copper, and the side effects of copper also c

Method used

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  • Novel intrauterine sustained control release drug delivery system and preparation method thereof
  • Novel intrauterine sustained control release drug delivery system and preparation method thereof
  • Novel intrauterine sustained control release drug delivery system and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] 1. Set the molecular weight to 2×10 4 g / mol polycaprolactone and gestodene crystalline powder (mass ratio: 100:4) were stirred in an internal mixer at 70°C for 5 minutes to form a premix, and then put into the mold of the pressing rod, and the mold was placed On a flat vulcanizing machine, preheat at 80°C for 2 minutes, then pressurize at 5Mpa for 1 minute, take it out, and cold press it for 2 minutes, and finally remove the mold to obtain a gestodene-containing drug core with a diameter of 1.8mm, and make an effective length of gestodene-containing Intrauterine drug delivery system of enone 8mg / 25mm.

[0045] 2. Put the drug core and polypropylene tail wire prepared in step 1 into a silicone rubber slow-release tube with a length of 30 mm, an outer diameter of 3.0 mm, and a wall thickness of 0.5 mm.

[0046] 3. The two ends of the silicone rubber sustained and controlled release tube are sealed with a silicone rubber adhesive to obtain an intrauterine drug delivery sy...

Embodiment 2

[0048] The difference from Example 1 is that the mass ratio of polycaprolactone to gestodene crystalline powder is 100:8, so that the drug core contains gestodene 16mg / 25mm, and the molecular weight of polycaprolactone used is 5.3× 10 4 g / mol, the release amount is 20μg / d, and the service life is at least 2 years.

Embodiment 3

[0050] The difference from Example 1 is that the preparation method of the drug core containing gestodene is extrusion molding, and the molecular weight is 2×10 4 The g / mol polycaprolactone and gestodene crystalline powder (mass ratio is 100:4) were stirred at 70°C for 5 min in an internal mixer to form a premix, and then extruded on a micro precision extruder with a diameter of 1.8mm drug core containing gestodene, the screw speed is 20r / min, the traction speed is 20cm / min, the melt pump speed is 5r / min, and the air flow rate is 10ml / min.

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Abstract

The present invention relates to a female intrauterine drug delivery system, and more particularly to a novel intrauterine sustained control release drug delivery system and a preparation method thereof. The present invention provides a novel intrauterine sustained control release drug delivery system and a preparation method thereof, wherein the system has characteristics of short length, light weight, efficiency, and reversibility. The system comprises a sustained control release pipe, a drug core and a tail filament, wherein the sustained control release pipe is wrapped on the external of the drug core, the tail filament is positioned between the sustained control release pipe and the drug core or is accomodated in the middle of the drug core, the drug core is a rod prepared by blending progesterone or an available intrauterine sustained control release drug and a biodegradable polymer, and the sustained control release pipe is made of a silicon rubber. The system of the present invention has characteristics of no stent, no copper ion, safety, practicality, and simple placement technology.

Description

Technical field: [0001] The invention relates to an intrauterine drug delivery system for women, and more specifically relates to a novel intrauterine sustained and controlled release drug delivery system and a preparation method thereof. Background technique: [0002] At present, the progesterone-containing intrauterine drug delivery system on the market is mainly Mirena, but it has a stent structure and causes certain damage to the uterus of women. Intrauterine drug delivery systems for the treatment of gynecological conditions also commonly come in the form of IUDs. Intrauterine Device (IUD) is a contraceptive device placed in the uterine cavity of a woman. It is a safe, effective, simple, economical and reversible birth control method. According to statistics from the World Health Organization in 2002, more than 156 million women in the world use IUDs, and their usage rate is on the rise. In my country, more than 100 million women use IUDs, accounting for about 2 / 3 of t...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K45/00A61K31/567A61K31/57A61K31/585A61K47/34A61K47/30A61P15/00A61P15/18A61P5/34
Inventor 李建新杨立群杨丹关艳敏
Owner 杨立群
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