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Interventional or implantable medical instrument drug coating and preparation method thereof

A technology for implanting medical devices and drug coatings, applied in the direction of coatings, catheters, etc., can solve the problems of poor coating homogeneity, complex coating process, easy to fall off, etc., achieve uniformity and stability enhancement, and reduce entry Blood circulation, effect of reducing drug loss

Pending Publication Date: 2020-08-28
LIAONING YINYI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug coating on the surface of the balloon prepared by this method is uneven, the particles are large, easy to fall off, and the drug is not easily absorbed by the tissue
[0010] The invention patent of authorized notification number CN103736154B uses organic acid salts and polyols to mix drugs to prepare drug-coated balloons, which also has the disadvantage of not being able to effectively promote the absorption of drugs by tissues and cells
[0011] It can be seen that the prior art basically requires modification or surface treatment of the balloon, and the coating process is complicated, which may easily cause uneven coating
The existing technologies all use water-soluble substrates, excipients, emulsifiers and / or plasticizers to mix with drugs or combine with weak forces such as hydrogen bonds to make drug coatings, but due to the polarity, molecular weight and solubility of each substance The difference in properties, such as poor coating homogeneity, easy to fall off to produce larger particles, unable to release drugs in a short time, and unable to efficiently absorb drugs by tissues and cells

Method used

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  • Interventional or implantable medical instrument drug coating and preparation method thereof

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preparation example Construction

[0052] In an embodiment of the present invention, the method for preparing a drug coating for an interventional or implanted medical device comprises the following steps:

[0053] Dissolve the hydrophilic matrix, add catalyst, react for 10min, 120min or 240min, add active drug, react for 6h, 27h or 48h. The grafted drug copolymer is obtained after purification.

[0054] In other embodiments of the present invention, the method for preparing a drug coating for an interventional or implanted medical device comprises the following steps:

[0055] Dissolve the active drug, add the catalyst, react for 10min, 120min or 240min, add the hydrophilic matrix, react for 6h, 27h or 48h, and purify to obtain the grafted drug copolymer.

[0056] In an embodiment of the present invention, the catalyst is dicyclohexylcarbodiimide, 4-dimethylaminopyridine, N -Hydroxysuccinimide, N -Hydroxysulfosuccinimide, 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide, 1-(3-dimethylaminopropyl)-3-ethylcarbod...

Embodiment 1

[0076] Weigh 1g of polyglutamic acid (molecular weight 1,000,000 Daltons), 0.1g of dicyclohexylcarbodiimide and 0.1g of 4-dimethylaminopyridine, put them in a flask, add dichloromethane, and stir for 30 minutes. Add 0.1 g of paclitaxel, react at room temperature for 12 hours, dialyze (molecular weight cut-off 14,000 Daltons) until no paclitaxel can be detected in the dialysis medium, and freeze-dry to obtain paclitaxel-polyglutamic acid graft copolymer.

Embodiment 2

[0078] Weigh 1g of polyglutamic acid (molecular weight 20,000 Daltons), 0.25g of dicyclohexylcarbodiimide and 0.25g of 4-dimethylaminopyridine, put them in a flask, add dichloromethane, and stir for 30 minutes. Add 0.1 g of paclitaxel, react at room temperature for 12 hours, dialyze (molecular weight cut-off 14,000 Daltons) until no paclitaxel can be detected in the dialysis medium, and freeze-dry to obtain paclitaxel-polyglutamic acid graft copolymer.

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Abstract

The invention relates to an interventional or implantable medical instrument drug coating and a preparation method thereof. The core of the interventional or implantable medical instrument drug coating is a grafted drug copolymer. The preparation method comprises the following steps: under the action of a catalyst, an active drug is covalently connected with a hydrophilic matrix to prepare the grafted drug copolymer, the grafted drug copolymer is dissolved and dispersed in a solvent, and then covered on the surface of an interventional or implantable medical instrument, and drying is performed. The covalent linkage manner can enhance the homogeneity of the drug and the matrix coating, improve the hydrophilicity and hydrophobicity balance of the drug and the adhesion-release balance of thedrug coating and the surface of the medical instrument, and enhance the efficiency that the drug is absorbed by tissues, penetrates through tissue stroma, and is taken in by cells. The homogeneity, uniformity and stability of the medical instrument drug coating are enhanced, the drug loading capacity is reduced, the drug loss is reduced, the drug entering blood circulation is reduced, and the absorption of the drug in target tissues and cells is increased, so that the toxicity is reduced, and the drug efficacy is improved.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to a drug coating for intervention or implantation of medical devices and a preparation method thereof. Background technique [0002] Coronary atherosclerotic heart disease is a heart disease caused by atherosclerotic lesions in the coronary arteries, causing stenosis or blockage of the vessel lumen, resulting in myocardial ischemia, hypoxia or necrosis. It is often called "coronary heart disease". The main means of treating coronary heart disease is percutaneous coronary intervention (PCI), that is, to open the blocked lumen and achieve revascularization. [0003] In the 1970s, percutaneous transluminal coronary angioplasty (PTCA) was performed for the first time in human beings, creating a precedent for interventional treatment of coronary heart disease with simple balloon dilation of coronary artery stenosis. Although PTCA can immediately eliminate vascular stenosis, s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/08A61L29/16A61L29/14
CPCA61L29/08A61L29/085A61L29/14A61L29/16A61L2300/216A61L2300/406A61L2300/416A61L2300/602A61L2300/606C08L5/08C08L77/04C08L71/02C08L67/04
Inventor 董何彦胡义平丁涵滢张秀兰
Owner LIAONING YINYI BIOTECH CO LTD
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