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Beta-elemene controlled-release eluting stent for preventing and treating coronary artery in-stent restenosis

A technology for eluting stents and elemene, which is applied in the field of biomedicine and medical materials, to achieve good tissue compatibility and safety, reduce the degree, and prevent restenosis

Inactive Publication Date: 2016-12-21
SHANGHAI FIRST PEOPLES HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there are no relevant reports at home and abroad

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Take the dried rhizome of Curcuma officinalis (origin: Ruian, Zhejiang), crush it into a coarse powder, weigh 100g, add it to a 1000ml flask, add 8 times the amount of water, and extract it with a volatile oil extractor for 6 hours (extraction conditions were optimized by orthogonal experiments). Obtain an oily substance with a special smell, that is, zedoary oil, with a content of 2%. Distill the zedoary oil under reduced pressure, collect the elemene fraction at 50°C-80°C / 40Pa, and then carry out vacuum distillation on this fraction The fractions at 70°C-72°C / 40Pa were collected, separated by silica gel column chromatography, and eluted with petroleum ether to obtain the product: a single β-elemene.

Embodiment 2

[0019] Example 2 Preparation of β-elemene controlled-release elution stent

[0020] Using stainless steel stents, polybutyl methacrylate / nano-silicon dioxide composite material as drug controlled release coating, first prepare 1% tetrahydrofuran solution of polybutyl methacrylate, which contains 20% to 25% polymer Nano-silica, adding the β-elemene drug into the solution, making the weight ratio of the drug to polybutylmethacrylate 1:1, stirring to suspend the drug in the solution, and spraying the suspension evenly Spray on the stent, dry at 40°C, weigh accurately, and calculate the drug content per square millimeter of the stent surface; the coating thickness is 10-35 μm, and the drug content on the stent surface is 7.1 μg-28.4 μg / mm 2 , install the drug-eluting stent on the balloon, and sterilize it with ethylene oxide for use;

[0021] The in vitro controlled release test of the β-elemene controlled release elution stent showed that the drug was released rapidly in the ini...

Embodiment 3

[0022] Embodiment 3 animal experiments

[0023] Animal experiments were conducted to test the effect of β-elemene controlled-release eluting stent on intimal hyperplasia after stenting in experimental animals, and to evaluate the safety and efficacy of β-elemene controlled-release-eluting stent in preventing restenosis after stenting:

[0024] Healthy Chinese miniature pigs were randomly divided into 2 groups: according to the ratio of stent diameter and coronary artery diameter of 1.2 to 1.3:1, the simple coating stent and the β-elemene controlled-release eluting stent of Example 1 were respectively used. The coating thickness 10μm, the drug content on the surface of the stent is 7.1μg / mm 2 Randomly implant suitable vascular segments of the circumflex branch and anterior descending branch, including coating group and β-elemene group, 12 rats in each group, taking aspirin 250mg 2 days before the operation and stopping after the operation, 1 month and 6 rats Six animals were s...

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Abstract

The invention belongs to the technical field of biomedicine and medical materials, and relates to a beta-elemene controlled-release eluting stent for preventing and treating coronary artery in-stent restenosis. The medicine stent takes a stent as a medicine carrying tool, the effective medicine ingredient beta-elemene achieves controlled releasing through a coating, and the in-stent restenosis is prevented and treated by inhibiting smooth muscle cell proliferation and inducing cell apoptosis; meanwhile, in-stent late thrombosis is prevented by protecting endothelial cells against damage and inhibiting the thrombosis effect. According to the medicine controlled-release eluting stent, in-vitro controlled-release test results show that more than half of the medicine is still not released after six months, the releasing time is significantly prolonged compared with a homologous pure polymer, and the sustained action of the medicine is guaranteed; animal experiments prove that the beta-elemene controlled-release eluting stent can effectively prevent and control the coronary artery in-stent restenosis and thrombosis and has the safety and feasibility.

Description

technical field [0001] The invention belongs to the technical field of biomedicine and medical materials, and relates to a stent for preventing and treating coronary restenosis, in particular to a β-elemene controlled-release eluting stent for preventing restenosis in a coronary stent. Background technique [0002] It is reported that stent implantation has replaced most balloon dilatation and has become the main method of coronary interventional therapy (PCI). However, medical practice shows that the success of in-stent restenosis after bare metal stenting has seriously hindered the further development of this technology. At present, drug-eluting stents have become the best way to solve restenosis after stent implantation. Studies have shown that, The restenosis rate can be reduced from 15% to 30% to less than 10%. However, even the rapamycin-eluting stent and the paclitaxel-eluting stent, which are the most widely used and most effective at present, still cause 1.2% of la...

Claims

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Application Information

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IPC IPC(8): A61M31/00A61F2/82
Inventor 赵军礼
Owner SHANGHAI FIRST PEOPLES HOSPITAL
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