Polyelectrolyte-containing drug coating and preparation method thereof

A drug coating, polyelectrolyte technology, applied in the field of medical devices, can solve problems such as uncontrollable and slow drug release

Active Publication Date: 2014-06-04
SHANGHAI VASOLUTIONS MEDTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The advantage of the drug coating is that it can ensure to a certain extent that the drug is adsorbed to a specific part after using the medical device, but the disadvantage is that the drug release is slow and uncontrollable

Method used

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  • Polyelectrolyte-containing drug coating and preparation method thereof
  • Polyelectrolyte-containing drug coating and preparation method thereof
  • Polyelectrolyte-containing drug coating and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Prepare polyethyleneimine aqueous solution with a concentration of 0.2g / ml (solution A), 0.2g / ml type A gelatin NaOH aqueous solution (pH=9, solution B), and paclitaxel dichloromethane solution with a concentration of 50mg / ml ( Solution C), 30% PVP (molecular weight 10,000) in isopropanol IPA solution (solution D). Immerse the balloon in solution A for 1min, after drying, immerse it in solution C for 10min, and dry it, then immerse it in solution B for 1min, and rinse it with double distilled water for 3 times, after drying, immerse it in solution C for 10min, repeat the above coating operation 5 times, fold the coated balloon and dip it into 30% PVP (molecular weight: 10,000) isopropanol IPA solution, then dry and sterilize with ethylene oxide to obtain the drug balloon.

Embodiment 2

[0030] Prepare chitosan solution with a concentration of 0.2g / ml (solution A), 0.2g / ml type A gelatin NaOH aqueous solution (pH=9, solution B), and paclitaxel ethanol solution with a concentration of 50mg / ml (solution C) , 30% PVP (molecular weight 10,000) in isopropanol IPA solution (solution D). Immerse the balloon in solution A for 1min, after drying, immerse it in solution C for 10min, and dry it, then immerse it in solution B for 1min, and rinse it with double distilled water for 3 times, after drying, immerse it in solution C for 10min, repeat the above coating operation 5 times, fold the coated balloon and dip it into 30% PVP (molecular weight: 10,000) isopropanol IPA solution, then dry and sterilize with ethylene oxide to obtain the drug balloon.

Embodiment 3

[0032] In vitro release test

[0033] Take a section of 6F catheter and immerse it in pH 7.4 phosphate buffer solution, keep it at a constant temperature of 37°C, pass the drug balloon through the catheter in the folded state and keep it for 1 min, take out the drug balloon, measure the drug residue by HPLC, and calculate the drug during delivery loss rate.

[0034] Take another balloon, repeat the above operation, expand the balloon, keep the expanded state for 2 minutes, take out the drug balloon, measure the drug residue by HPLC, and calculate the drug release during the expansion process.

[0035] tissue absorption test

[0036] Take an isolated porcine arterial segment that is about 20% larger than the diameter of the balloon, and immediately immerse it in pig blood added with anticoagulant, keep a constant temperature of 37°C, pass the drug balloon through the 6F catheter in the folded state and keep it for 1min, and then the balloon enters The lumen of the blood vesse...

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Abstract

The invention belongs to the field of medical equipment, and particularly relates to a polyelectrolyte-containing drug coating and a preparation method thereof. The drug coating provided by the invention is formed by alternately coating at least one material with positive charges and at least one bipolar polyelectrolyte; preferably, the drug coating also comprises a top layer above the drug coating. When the saccule reaches the lesion, two polyelectrolytes with the same charges are quickly released (a quick release effect) due to the repulsive interaction of the charges; one end of the polyelectrolyte with positive charges is connected with drug microparticles through a hydrogen bond, and the other end is adsorbed on a cell membrane with negative charges so as to realize a long-acting effect. Moreover, the top layer on the drug coating guarantees the compliance of the operation process and avoids the release of the drug before reaching the lesion.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to a drug coating containing polyelectrolyte and a preparation method thereof. Background technique [0002] Drug-coated balloon is a new method for endovascular treatment that has emerged in recent years. Compared with drug stents, it avoids the endothelialization barrier caused by continuous contact with drugs. Drug-coated balloons or drug-coated balls based on it Capsular-associated bare-metal stents show promise. However, the current drug balloon products still do not solve the following problems well: [0003] (1) Controlled release performance, maintaining the adhesion of the drug to the medical device until it reaches the target site, and then delivering the drug to the target tissue with the required release and absorption kinetics. If the drug is released from the device very easily, it may be lost during device delivery before it is placed at the target site, o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/10A61L31/08
Inventor 张鹏张琳琳郭芳赵林立桂流峰
Owner SHANGHAI VASOLUTIONS MEDTECH CO LTD
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