Preparation method for paclitaxel coating on surface of drug balloon

The technology of paclitaxel and balloon is applied in the field of preparation of paclitaxel coating on the surface of drug balloon, which can solve the problem that the lipophilic site of vascular tissue cannot be fully adhered and combined, the binding force of drug coating and balloon is weak, and the drug and blood vessel wall can be solved. Uneven contact and other problems, to achieve the effect of increasing adhesion performance, low cost and strong bonding force

Inactive Publication Date: 2015-10-21
XIANGTAN UNIV
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0005] Paclitaxel-coated balloons were manually coated in the initial stage of development, but the coating drug was unevenly distributed on the surface of the balloon, which made the drug contact with the blood vessel wall unevenly, the drug could not fully contact the target vascular tissue, and the lipophilic site of the vascular tissue The dots cannot be fully adhered and combined, the amount is small, and the binding force between the drug coating and the balloon is weak, when the drug is easily washed away by the blood when the balloon enters the target site or even during delivery; after continuous innovation research, and developed a volume quantitative automatic spraying technology, but the cost of equipment required is relatively high

Method used

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  • Preparation method for paclitaxel coating on surface of drug balloon
  • Preparation method for paclitaxel coating on surface of drug balloon
  • Preparation method for paclitaxel coating on surface of drug balloon

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preparation example Construction

[0026] The invention provides a method for preparing a paclitaxel coating on the surface of a drug balloon, the preparation method comprising the following steps:

[0027] (1) Pretreating the balloon; soaking the balloon in the first organic solvent to obtain a modified balloon;

[0028] (2) Immerse the modified balloon in the paclitaxel coating solution, put it in a low-temperature device and let it stand for a certain period of time, and obtain the paclitaxel-coated balloon after drying;

[0029] (3) Repeat step (2).

[0030] Preferably, the first organic solvent is selected from ethyltrimethoxysilane, aminopropyltriethoxysilane, glycidyloxypropyltrimethoxysilane, vinyltrimethoxysilane, γ-ureidopropyl - One or more of trimethoxysilane, vinyltrichlorosilane and γ-glycidylpropyl-trimethoxysilane;

[0031] Preferably, the paclitaxel coating solution comprises paclitaxel and medical grade carrier dissolved in the second organic solvent according to the weight percentage, where...

Embodiment 1

[0037] (1) Pre-treat the surface of the balloon; soak the balloon in a mixed solution of vinyltrimethoxysilane and methanol (v:v=1:10), and then dry it in a constant temperature drying oven;

[0038] (2) Dissolve paclitaxel and urea (w:w=7:10) in ethanol solution, put it into a low-temperature device, and let it stand at -50°C for 20 hours;

[0039] (3) Take out the balloon and dry it in a constant temperature drying oven to obtain the drug balloon;

[0040] After determination, the content of paclitaxel on the surface of the drug balloon prepared in Example 1 was 531 μg, and the content of paclitaxel per unit area on the surface of the balloon was calculated to be 2.6 μg / mm 2 ;

[0041] The formula for calculating the content of paclitaxel per unit area on the surface of the balloon is: ρ=m / S; where,

[0042] m: the total amount of paclitaxel on the surface of the balloon, in μg;

[0043] S: Balloon surface area, in mm 2 ;

[0044] figure 1 It is the surface topography...

Embodiment 2

[0050] (1) Pretreat the surface of the balloon; immerse the balloon in a mixed solution of vinyltrichlorosilane and methanol (V:V=1:30), take it out after soaking, and put it in a constant temperature drying oven to dry;

[0051] (2) Dissolve paclitaxel and urea (w:w=3:5) in ethanol solution, put it into a low-temperature device, and let it stand at -45°C for 24 hours;

[0052] (3) Take out the balloon and dry it in a constant temperature drying oven to obtain the drug balloon;

[0053]After determination, the content of paclitaxel on the surface of the drug balloon prepared in Example 2 was 572 μg, and the content of paclitaxel per unit area on the surface of the balloon was calculated to be 2.42 μg / mm 2 .

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Abstract

The invention relates to a preparation method for paclitaxel coating on the surface of a drug balloon. The preparation method comprises the steps that a hydrophilic balloon surface is pretreated; the balloon surface is coated with a first organic solution to obtain a modified balloon, wherein the first organic solution contains both a hydrophilic group and a lipophilic group; and the modified balloon is immersed into a paclitaxel coating solution, placed into a low-temperature device to be frozen for a period of time and then is dried, and the crystallization process is repeatedly executed. The preparation method for the paclitaxel coating solution comprises the step of dissolving paclitaxel and a carrier into a second organic solution according to the certain mass percentage, wherein the carrier has the effect of increasing the paclitaxel dissolvability. The preparation technology is simple and reliable, and is low in cost. The preparation method allows precise control of the drug loading capacity of the paclitaxel coating on the surface of the drug balloon and is beneficial to mass production.

Description

technical field [0001] The invention belongs to the field of biomedical devices, in particular to a method for preparing a paclitaxel coating on the surface of a drug balloon. 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. [0003] Interventional therapy is currently the main means of clinical treatment of coronary atherosclerotic heart disease. During the development and evolution of interventional therapy, there are mainly three revolutionary innovations in technology. They are simple balloon dilatation (PTCA), bare metal stent (BMS), and drug-eluting stent (DES). The main defect of PTCA is early vascular elastic recoil and restenosis of the target vessel lumen due to cell proliferation, the incidence rate of which is as ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/08A61L31/16
Inventor 林建国成正辉曹明芳张效凯彭晴张德闯
Owner XIANGTAN UNIV
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