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Drug-loaded medical device and preparation method thereof

A medical device and drug-loading technology, which is applied in the field of drug-loaded medical devices and its preparation, can solve problems such as difficult preparation of macrolide crystals, poor drug transfer effect, weak interaction force, etc., to improve adhesion performance , extend the concentration, improve the effect of transfer speed

Active Publication Date: 2021-06-08
SHANGHAI MICROPORT MEDICAL (GROUP) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is difficult to prepare macrocyclic lactone crystals by traditional methods such as ultrasonic spraying and dripping, and what is obtained is amorphous
Even if the crystallization is promoted by adjusting the supersaturation of macrolide drugs, the morphology of the formed crystal particles is rhombohedral and spheroidal, and the interaction between these round drug crystals and the blood vessel wall Weak force, poor drug transfer effect
Therefore, it is extremely challenging to prepare long columnar crystalline macrolide drug particles with sharp morphology.

Method used

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  • Drug-loaded medical device and preparation method thereof
  • Drug-loaded medical device and preparation method thereof
  • Drug-loaded medical device and preparation method thereof

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preparation example Construction

[0055] The present invention also relates to a method for preparing a drug-loaded medical device, characterized in that the method comprises:

[0056] 1) preparing macrolide drug crystal powder, dispersing the powder in a solvent, adding rigid microspheres for shaking, filtering and removing the rigid microspheres to obtain a suspension;

[0057] 2) Take a medical device body with a solid surface, apply the suspension on the solid surface, and dry to obtain a medical device intermediate;

[0058] 3) Applying the supersaturated solution of the macrolide drug on the surface of the medical device intermediate and drying.

[0059] In some embodiments, the suspension contains crystalline microparticles of macrolide drugs with a particle size of 100 nm to 1000 nm.

[0060] In some embodiments, the particle size of the crystalline microparticles can also be 200nm, 300nm, 400nm, 500nm, 600nm, 700nm, 800nm, 900nm. Further 200nm~500nm.

[0061] In some embodiments, the purity of the ...

Embodiment 1

[0075] Take 1 g of rapamycin raw material and disperse it in 50 mL of n-heptane, add a stirrer, stir overnight at room temperature and avoid light, the stirring speed is 300 rpm, then filter to obtain a filter cake, and vacuum dry to obtain crystalline rapamycin , Use infrared spectroscopy or powder X-ray diffraction to measure the crystallinity, and determine that the crystallinity is above 90%.

[0076] Take 7 mg of the above crystalline rapamycin in a brown bottle, add 10 mL of n-heptane to disperse the rapamycin, then add 2.5 g of zirconia beads (Φ0.2-0.3 mm), seal it, and fix it in a vortex to mix On the instrument, shake for 10 minutes, and the shaking speed is 2500rpm. After oscillating, put it into a water-bath ultrasonic bath for 3 min, and then filter it with a 40 μm nylon filter to remove the zirconia beads and obtain the filtrate. Use a microsampler to draw 20 μL and evenly coat the surface of the balloon, and let it dry naturally for 2 hours in the dark.

[0077...

Embodiment 2

[0080] Take 1 g of everolimus raw material and disperse it in 50 mL of n-heptane, add a stirrer, stir overnight at room temperature and avoid light at a stirring speed of 300 rpm, then filter to obtain a filter cake, and vacuum-dry to obtain crystalline everolimus , Use infrared spectroscopy or powder X-ray diffraction to measure the crystallinity, and determine that the crystallinity is above 90%.

[0081] Take 7 mg of the above crystalline everolimus in a brown bottle, add 10 mL of n-heptane to disperse the everolimus, then add 2.5 g of zirconia beads (Φ0.2-0.3 mm), seal it, and fix it in a vortex to mix On the instrument, shake for 10 minutes, and the shaking speed is 2500rpm. After oscillating, put it into a water-bath ultrasonic bath for 3 min, and then filter it with a 40 μm nylon filter to remove the zirconia beads and obtain the filtrate. Use a microsampler to draw 20 μL and evenly coat it on the surface of the balloon, and let it dry naturally for 2 hours in the dark...

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Abstract

The present invention relates to the field of medicine technology, in particular to a drug-loaded medical device, comprising a medical device body and at least one drug coating, the drug coating is attached to at least one side of the surface of the medical device body, and The main components of the drug coating include macrolide drugs, the drug coating includes long columnar crystals with more than three ribs, and / or the drug coating includes long columnar crystals with more than three ribs Crystal clusters formed by crystals, the aspect ratio of the long columnar crystals is (1-40):1. The drug-loaded medical device can effectively improve the transfer of the drug to the blood vessel wall and prolong the concentration of the drug in the tissue.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a drug-loaded medical device and a preparation method thereof. Background technique [0002] In recent years, a variety of interventional or implantable medical devices containing drug coatings have been developed for various mechanisms of intravascular restenosis. Drug-coated balloons and drug-eluting stents are essentially derived from the concept of a catheter-based local drug delivery device, which inhibits intimal hyperplasia by carrying drugs, but the way of carrying the drug and the local drug action time are different. The concept of "intervention without implantation" of drug-coated balloons has attracted more and more attention. A number of clinical trials have confirmed that it has satisfactory efficacy and safety in various coronary artery stenosis lesions, small vessel lesions, and bifurcation lesions. The surface of the drug-coated balloon is uniformly coa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61M31/00
CPCA61M31/002A61M2210/12A61M2210/005A61F2/82A61M2025/0057A61L29/16A61L31/16A61L2300/416A61L2300/63A61L2420/02A61L2300/606A61F2250/0067A61K9/0024A61K31/436A61K31/7048
Inventor 李猛杜其然李俊菲
Owner SHANGHAI MICROPORT MEDICAL (GROUP) CO LTD
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