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Composite anti-restenosis drug and its controlled release system of coronary drug-eluting stent

A technology for eluting stents and restenosis, applied in drug combination, drug delivery, cardiovascular system diseases, etc., can solve problems such as thrombosis, reduce the incidence of thrombus, prevent thrombosis, and have excellent anti-restenosis effects

Active Publication Date: 2021-12-17
XINXIN MEDICAL TECH SHANGHAI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, how to solve the problem that anti-restenosis drugs inhibit the growth and repair of vascular endothelial cells and cause thrombosis is still an important challenge to be faced in the development of stent interventional therapy

Method used

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  • Composite anti-restenosis drug and its controlled release system of coronary drug-eluting stent
  • Composite anti-restenosis drug and its controlled release system of coronary drug-eluting stent
  • Composite anti-restenosis drug and its controlled release system of coronary drug-eluting stent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1. In vitro experiment on the effect of arsenic trioxide on porcine coronary vascular smooth muscle cells and endothelial cells

[0043] figure 1 with figure 2 It shows the effect of arsenic trioxide on porcine coronary vascular smooth muscle primary cells and endothelial primary cells in vitro. The vertical axis in the figure represents the total number of cells in the wells of the culture plate, and the horizontal axis represents the concentration of the arsenic trioxide solution. Each curve represents the effect of different concentrations of arsenic trioxide on cell apoptosis (decrease in the total number of cells) at a certain time. From the figure ( figure 2 ) It can be clearly seen that the effect of arsenic trioxide on endothelial cells (within the concentration of 12 μM) is weak or even promotes the proliferation of endothelial cells to a certain extent ( figure 2 ). But for smooth muscle cells from the 2nd day, even at a low concentration (3μM), the ce...

Embodiment 2

[0049] In this example, two implementation methods are listed to realize the controlled release of the drug by changing the structure (single layer or multi-layer) of the drug release system (drug coating) and the ratio of the drug and the polymer material in each layer .

Embodiment approach 1

[0050] Implementation method 1: composite drug monolayer structure release system

[0051] The drug-mixed single-layer structure release system contains arsenic trioxide, rapamycin and polymer material PLGA. By adjusting the ratio between drugs and between drugs and polymer materials, the shape of the drug release curve can be changed to achieve the purpose of controlled drug release.

[0052] As long as there is no harmful interaction between the mixed drugs, in theory, multiple anti-restenotic drugs such as arsenic trioxide, rapamycin or paclitaxel can be selected for drug mixing. In consideration of clinical and manufacturing optimization, two drugs, arsenic trioxide and rapamycin, can be selected to be mixed. For further optimization considerations, in the formulation of the mixed drug, the dosage of arsenic trioxide is 4-8 μg / mm, and the dosage of rapamycin is 1-5 μg / mm. This amount is used to open a stent with an outer diameter of 3.0 mm, and the amount of drug used fo...

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Abstract

The invention provides a composite anti-restenosis drug and a controlled release system for coronary drug-eluting stents. The composite drug for coronary drug-eluting stent of the present invention comprises arsenic trioxide (As 2 o 3 ) and rapamycin (Sirolimus) two anti-restenotic drugs. It can inhibit the proliferation of smooth muscle cells and promote the recovery of endothelial cells. It can achieve excellent in-stent anti-restenosis effect after stent implantation, and reduce the incidence of intravascular thrombosis. The compound drug controlled release system for the coronary drug-eluting stent of the present invention can release the compound drug according to an optimal curve, so as to achieve the best therapeutic effect of controlling restenosis and preventing thrombus formation.

Description

technical field [0001] The invention relates to a composite anti-restenosis drug and a controlled release system for coronary drug-eluting stents. Background technique [0002] Coronary stent, as an interventional medical device, is mainly used to treat ischemic heart disease caused by coronary artery stenosis or occlusion, such as myocardial infarction (Heart Attack). Due to the inevitable damage to the coronary vessels during the expansion process of the stent, the excessive proliferation of vascular smooth muscle cells is caused, resulting in postoperative in-stent restenosis (ISR, In Stent Restenosis). Early coronary stents are made of stainless steel, and the restenosis rate of bare stents made of stainless steel is as high as 20%. [0003] With the development of stent treatment technology, some anti-restenosis drugs are coated on the stent to form a drug-eluting stent, also known as a drug-releasing stent, which mainly carries drugs through the polymer coated on the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K33/36A61L31/10A61L31/16A61P9/10A61P7/02A61K31/436
CPCA61L31/10A61L31/16A61K9/0002A61K31/436A61K33/36A61L2300/204A61L2300/102A61L2300/604A61L2300/606A61L2300/422A61L2300/416A61L2420/06A61K2300/00A61K31/285A61L31/06A61L31/124A61L31/148A61L2300/216A61L2420/04A61L2420/08
Inventor 何福桂马晓意
Owner XINXIN MEDICAL TECH SHANGHAI CO LTD
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