Novel drug-eluting balloon catheter and preparation method thereof

A technology for balloon catheters and drugs, applied in catheters, pharmaceutical formulations, drug delivery, etc., can solve the problems of difficult reprinting of drugs, strong adhesion between hydrophobic coating and balloon surface, etc., to facilitate industrial operation and improve Bioavailability, effect with small batch-to-batch variation

Inactive Publication Date: 2020-06-09
SHANDONG RIENTECH MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the adhesion between the hydrophobic coating and the surface of the balloon is relatively large, and the drug is not easily transferred to the tissue during the contact process between the balloon and the target lesion tissue

Method used

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  • Novel drug-eluting balloon catheter and preparation method thereof
  • Novel drug-eluting balloon catheter and preparation method thereof
  • Novel drug-eluting balloon catheter and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042]Weigh 10mg of rapamycin, disperse it in 20ml of water, add this solution dropwise to 50ml of PVA solution with a mass fraction of 3%, and use ultrasonic emulsification at 4°C for 40 minutes, then stir the emulsion overnight at a speed of 1000rpm. The overnight emulsion was centrifuged at 3500rpm, and the supernatant was taken to obtain a suspension of rapamycin microspheres. The suspension was centrifuged at 12000rpm for 30 minutes, then the supernatant was discarded, and 5 % Span 85 emulsifier solution 2ml, repeat this centrifugation step 2 times and adopt nano particle size analyzer to test the size and distribution of solid microsphere particles, the particle size range is 0.3nm-3nm, the result is as follows figure 1 .

Embodiment 2

[0044] Weigh 10mg of rapamycin, dissolve it in 10ml of acetone, add this solution dropwise to 50ml of PVA solution with a mass fraction of 1%, use ultrasonic emulsification at 4°C for 40 minutes, then stir the emulsion overnight at a speed of 1000rpm, The overnight emulsion was centrifuged at 2000 rpm, and the supernatant was taken to obtain a suspension of rapamycin microspheres (also referred to as a suspension, the same below). Centrifuge the suspension at 10,000rpm for 30 minutes, then pour off the supernatant, add 2ml of 1% cetyl alcohol emulsifier solution, repeat this centrifugation step 3 times, and use a nanometer (Zetasizer Nano ZS90) to test the solid microspheres The size and distribution of particles, the particle size range is 10nm-90nm, the results are as follows figure 2 .

Embodiment 3

[0046] Weigh 10 mg of rapamycin, disperse it in 10 ml of water, add this solution dropwise to 50 ml of polysorbate 20 solution with a mass fraction of 3%, and use ultrasonic emulsification at 4°C for 40 minutes, then stir the emulsion overnight, at a speed of centrifuge the overnight emulsion at 3500rpm, and take the supernatant to obtain a suspension of rapamycin microspheres, centrifuge the suspension at 12000rpm for 30 minutes, then pour off the supernatant , add 2ml of 5% Span 80 emulsifier solution, repeat this centrifugation step twice and use a nanometer to test the size and distribution of solid microsphere particles, the particle size range is 200nm-600nm.

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Abstract

The invention discloses a novel drug-eluting balloon catheter and a preparation method thereof. The drug-eluting balloon catheter consists of a catheter and a drug coating, wherein the drug coating consists of drug particles, an amphiphilic emulsifier and an excipient, and the drug particles wrapped by the amphiphilic emulsifier are uniformly dispersed in the excipient. The drug-eluting balloon catheter has effects of quickly releasing the drug, improving efficiency of transferring the drug into the blood vessel wall in a short time and improving the bioavailability, and has a good applicationprospect in interventional science.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a novel drug-eluting balloon catheter for angioplasty and a preparation method thereof. Background technique [0002] Cardiovascular and cerebrovascular diseases are the number one killer of health in modern society. The number of people who die from cardiovascular and cerebrovascular diseases in the world is as high as 15 million every year, ranking first among various causes of death. Since Gruntzig's first clinical application of percutaneous coronary intervention (PCI) in 1977, intravascular restenosis has been a major focus of therapeutic debate. The application of drug-eluting stents has effectively solved this problem, reducing the target vessel restenosis rate to less than 3%. However, in-stent restenosis caused by drug-eluting stents is extremely difficult to treat. If drug-eluting stents are inserted again, the probability of secondary restenosis is as high as 43%, and p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/08A61L29/16A61L29/14
CPCA61L29/08A61L29/14A61L29/16A61L2300/416A61L2300/602A61L2300/606A61L2300/62
Inventor 张海军宋彩霞周超张军伟冯相蓺
Owner SHANDONG RIENTECH MEDICAL TECH
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