Making process of intrauterine medicine releasing device

Abstract

The present invention is making process of intrauterine medicine releasing device. Cylindrical, semi-cylindrical or fanned medicine tablet is first made in a sulfurizing and molding apparatus and then attached to longitudinal arm of IUD plastic rack to coat or soak with silicone or medicinal polymer to form release-controlling layer around the medicine tablet. The said method needs no special molding machine, has simple operation and low cost, and can obtain required long-period medicine releasing curve.

Description

Technical field:

[0001] The invention relates to the field of medical devices, in particular to a method for preparing a drug-containing intrauterine drug release device. Background technique:

[0002] The currently listed LNG-IUD (levonorgestrel intrauterine device) is an intrauterine drug-releasing device produced by Liras Pharmaceuticals in Finland. The blasting shock reduces side effects and enables long-term steady-state release of the effective dosage of the lower limit. The analysis of its many advantages mainly lies in the production of its drug-containing layer, which is also the key to the quality assurance of the product. According to relevant information and actual dissection of the product, it is known that the levonorgestrel intrauterine drug-releasing device is composed of an inner plastic stent, a cylindrical drug-containing silica gel layer and a silica gel controlled release layer. On the longitudinal arm of the IUD, the injection molding vulcanization me...

Examples

Embodiment 1

[0062] Embodiment 1, containing LNG-IUD

[0063] (1) Weigh 20g of LTV (liquid addition forming) silicone rubber, 20g of levonorgestrel, appropriate amount of platinum catalyst and active hydrogen cross-linking agent, put them into a mold and hot press to form a semicircular drug-containing layer valve , hot-pressed and vulcanized into drug-containing layer petals, trimmed, cut to a length of 1.9cm, and a weight of 45-47mg per petal.

[0064] (2) Take the polyethylene IUD plastic bracket and soak it in absolute ethanol for two hours, drain it and set it aside.

[0065] (3) Adhere the drug layer valve that meets the requirements with the IUD stent after slight friction, put the outer silicon rubber controlled release tube into a glass vessel, swell it with chloroform to more than double the original volume, and then Put it into the outer layer of the valve containing the cylindrical drug layer, and after it volatilizes naturally, the outer layer of silicon rubber controlled rel...

Embodiment 2

[0066] Example 2 Gestodene-containing -IUD

[0067] (1) Mix gestodene and medical grade LS-4100 addition type silicone rubber 1:1 uniformly on the rubber mixer, put it into a 1 / 3 semicircular mold, hot press and vulcanize to form a drug-containing layer flap, trim the edge , the interception length is 1.9cm and the weight is 17mg / per petal.

[0068] (2) Gently rubbing and covering the two semicircular drug-containing layer flaps on the longitudinal arm of the IUD stent, and then continuously dipping in 10% EVAC: chloroform controlled-release dipping membrane solution, Volatile, film 4 times. Then put the outer silicone rubber controlled-release tube into a glass container, swell it with chloroform to more than double its original volume, and then put it into the outer layer containing the cylindrical drug layer flap, and wait for it to volatilize naturally , combined into a complex reservoir type and a rate-controlled release membrane multiple controlled drug release system....

Embodiment 3

[0069] Example 3: IUDs containing mifepristone

[0070] (1) Mix mifepristone and medical grade LS-4100 addition type silicone rubber 1:1 uniformly on the rubber mixer, press it into a cylindrical shape through a mold, and vulcanize it by hot pressing to form a drug-containing layer. The drug-containing layer is thick 0.75mm, inner diameter 1.5mm, outer diameter 3mm, then trimmed, and cut out a cylindrical drug-containing layer with a length of 1.9cm and a weight of 92mg.

[0071] (2) Put the cylindrical drug-containing layer on the longitudinal arm of the IUD stent, and then continuously dip in 10% EVAC: chloroform controlled-release impregnation membrane solution for dipping, volatilization, and film formation twice. After the solvent is completely volatilized naturally, it is combined into a dual controlled drug release system of composite storage type and rate controlled release membrane. This embodiment is also applicable to the preparation of some difficult-to-dissolve p...

Technical field:

[0001] The invention relates to the field of medical devices, in particular to a method for preparing a drug-containing intrauterine drug release device. Background technique:

[0002] The currently listed LNG-IUD (levonorgestrel intrauterine device) is an intrauterine drug-releasing device produced by Liras Pharmaceuticals in Finland. The blasting shock reduces side effects and enables long-term steady-state release of the effective dosage of the lower limit. The analysis of its many advantages mainly lies in the production of its drug-containing layer, which is also the key to the quality assurance of the product. According to relevant information and actual dissection of the product, it is known that the levonorgestrel intrauterine drug-releasing device is composed of an inner plastic stent, a cylindrical drug-containing silica gel layer and a silica gel controlled release layer. On the longitudinal arm of the IUD, the injection molding vulcanization me...

Examples

Embodiment 1

[0062] Embodiment 1, containing LNG-IUD

[0063] (1) Weigh 20g of LTV (liquid addition forming) silicone rubber, 20g of levonorgestrel, appropriate amount of platinum catalyst and active hydrogen cross-linking agent, put them into a mold and hot press to form a semicircular drug-containing layer valve , hot-pressed and vulcanized into drug-containing layer petals, trimmed, cut to a length of 1.9cm, and a weight of 45-47mg per petal.

[0064] (2) Take the polyethylene IUD plastic bracket and soak it in absolute ethanol for two hours, drain it and set it aside.

[0065] (3) Adhere the drug layer valve that meets the requirements with the IUD stent after slight friction, put the outer silicon rubber controlled release tube into a glass vessel, swell it with chloroform to more than double the original volume, and then Put it into the outer layer of the valve containing the cylindrical drug layer, and after it volatilizes naturally, the outer layer of silicon rubber controlled rel...

Embodiment 2

[0066] Example 2 Gestodene-containing -IUD

[0067] (1) Mix gestodene and medical grade LS-4100 addition type silicone rubber 1:1 uniformly on the rubber mixer, put it into a 1 / 3 semicircular mold, hot press and vulcanize to form a drug-containing layer flap, trim the edge , the interception length is 1.9cm and the weight is 17mg / per petal.

[0068] (2) Gently rubbing and covering the two semicircular drug-containing layer flaps on the longitudinal arm of the IUD stent, and then continuously dipping in 10% EVAC: chloroform controlled-release dipping membrane solution, Volatile, film 4 times. Then put the outer silicone rubber controlled-release tube into a glass container, swell it with chloroform to more than double its original volume, and then put it into the outer layer containing the cylindrical drug layer flap, and wait for it to volatilize naturally , combined into a complex reservoir type and a rate-controlled release membrane multiple controlled drug release system....

Embodiment 3

[0069] Example 3: IUDs containing mifepristone

[0070] (1) Mix mifepristone and medical grade LS-4100 addition type silicone rubber 1:1 uniformly on the rubber mixer, press it into a cylindrical shape through a mold, and vulcanize it by hot pressing to form a drug-containing layer. The drug-containing layer is thick 0.75mm, inner diameter 1.5mm, outer diameter 3mm, then trimmed, and cut out a cylindrical drug-containing layer with a length of 1.9cm and a weight of 92mg.

[0071] (2) Put the cylindrical drug-containing layer on the longitudinal arm of the IUD stent, and then continuously dip in 10% EVAC: chloroform controlled-release impregnation membrane solution for dipping, volatilization, and film formation twice. After the solvent is completely volatilized naturally, it is combined into a dual controlled drug release system of composite storage type and rate controlled release membrane. This embodiment is also applicable to the preparation of some difficult-to-dissolve p...

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