Paclitaxel-loaded ethylene-vinyl acetate esophageal stent and preparation method thereof

A vinyl acetate esophagus, vinyl acetate technology, applied in the field of medical devices, can solve the problems of ineffective regulation and control of drug release, slow release of 5-fluorouracil, lack of basis for selection of backing layers, etc. The effect of simple and easy measurement method and preparation method

Inactive Publication Date: 2016-01-13
SHANGHAI JIAO TONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] After searching the literature of the prior art, it was found that the Chinese patent publication number is CN2638761Y, the publication date is September 8, 2004, and the patent name is esophageal drug stent, which is a kind of stent implanted into the narrow segment of esophagus tumor by a conveyor. The esophageal drug stent has the disadvantages of insu...

Method used

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  • Paclitaxel-loaded ethylene-vinyl acetate esophageal stent and preparation method thereof
  • Paclitaxel-loaded ethylene-vinyl acetate esophageal stent and preparation method thereof
  • Paclitaxel-loaded ethylene-vinyl acetate esophageal stent and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0040] This embodiment relates to the preparation of the backing layer, and the specific operations are as follows:

[0041] Weigh about 4.0g of EVA and dissolve it in 30ml of dichloromethane solution, place it in a water-bath shaker at 37°C overnight, then take it out, and vortex for about 10min until the EVA is completely dissolved to obtain a backing layer solution.

[0042] Put a braided 3.5cm long, 0.9cm in diameter Ni-Ti alloy bare metal stent with a diameter of 1.1cm in expansion ports at both ends on a glass rod with a diameter of 0.9cm, and slowly immerse in the prepared backing layer polymer solution for 2s~ 10s, take it out and volatilize in the fume hood for 24 hours, take it off the glass rod for use, and get the metal bracket covered with the backing layer.

Embodiment 2

[0044] The present embodiment relates to the preparation of drug film, concrete operation is as follows:

[0045] According to the formula that the ratio of polymer material to paclitaxel is 1:1, feed and mix with the hacker machine. The specific operation steps are: raise the temperature of the feeding chamber of the hacker KAAKEMiniLabII to 85°C, add EVA, start the hacker machine, and rotate to clean Feeding chamber. The above steps can be repeated many times to ensure that the feeding chamber is clean. After fully cleaning the Hack machine, add the prescription ingredients corresponding to the prescription numbers in the table, and mix for 30 minutes. After mixing, put a polyester film of a certain size under the feeding chamber, then open the feeding chamber, and scrape the mixture while it is hot. .

Embodiment 3

[0047] This embodiment relates to the pressing and orientation of the drug film, and the specific operations are as follows:

[0048] (1) The carrier material is EVA42 / 60, and the drug film with a drug loading capacity of 50% is pressed under a film press at 100°C to about 340 μm and 320 μm, with an initial length of 2.5 cm, and at a constant temperature of 80°C, at a speed of 2.5min / r Stretch on the orientation machine, stretch orientation 2.4 times and 2.35 times, about 6.0cm and 5.8cm long. When it reaches about 180 μm, cool at room temperature for 30 minutes, remove it from the orientation machine, and cut it for later use.

[0049] (2) The carrier material is EVA32 / 43, and the drug film with a drug loading capacity of 50% is pressed under a film press at 100°C for about 1.5 hours to about 350 μm, with an initial length of 2.5 cm. Cut into two parts, one part was pressed at 100°C for about 2 hours to reach a thickness of about 180 μm, cooled at room temperature for 30 min...

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Abstract

The invention pertains to the field of medical instruments and discloses a paclitaxel-loaded ethylene-vinyl acetate esophageal stent and a preparation method thereof. The stent is composed of a bare metal stent and a covering film covering the bare metal stent. The covering film comprises an ethylene-vinyl acetate esophageal backing layer and a paclitaxel medicine film layer. The inside of the ethylene-vinyl acetate esophageal backing layer is closely adhered to the bare metal stent. The outside of the ethylene-vinyl acetate esophageal backing layer is adhered to the paclitaxel medicine film layer. The stent is 50% in the theoretical drug-loading amount ranges from 48.26% -50.81% in the measured drug-loading amount. Within 80d, paclitaxel ranges from 615.274-1101.368 [mu]m/cm2 in the accumulative releasing amount and ranges from 57.93-108359 [mu]m/cm2 and also ranges from 57.93-108359 [mu]m/cm2 in the infiltration amount from the backing layer. The paclitaxel-loaded ethylene-vinyl acetate esophageal stent and the preparation method thereof have following beneficial effects: the preparation method is easily and conveniently applied; the good mechanical property is obtained; the slow release function can be fulfilled for a long time; and the stent has good functions of mechanical support and prevention against growth inside of tumors.

Description

technical field [0001] The invention relates to a drug-loaded polymer film-covered stent in the field of medical devices, in particular to an ethylene-vinyl acetate esophageal stent loaded with paclitaxel and a preparation method thereof, which are applied to the treatment of esophageal lumen strictures. Background technique [0002] Stents are an ideal drug delivery system. Traditional stents do not have a positive therapeutic effect, but only play a palliative role in mechanical support and short-term maintenance of cavity opening. Compared with ordinary bare metal stents, drug-loaded stents add two parts, one is drugs, which can inhibit intimal hyperplasia and prevent restenosis; the other is drug carriers, which are often synthetic polymers with good biocompatibility . Drug release from the drug-loaded layer must be controlled and predictable. To achieve this goal, it is necessary to select a suitable drug-loading material. In the non-vascular field, there is no drug...

Claims

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Application Information

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IPC IPC(8): A61F2/04A61L31/10A61L31/16
Inventor 郭圣荣李静沈园园刘洁颖
Owner SHANGHAI JIAO TONG UNIV
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