Preparation method of drug balloon

A drug and balloon technology, applied in the field of preparation of drug balloons, can solve the problem of short adhesion time between drugs and target vascular tissue lipophilic sites, insufficient adhesion and binding of vascular tissue lipophilic sites, and inability to play biological roles. Availability and other issues, to achieve the effect of improving long-term release efficacy, improving bioavailability, and enhancing binding capacity

Active Publication Date: 2015-10-28
LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] If the binding force between the drug on the surface of the balloon and the balloon is weak, the drug is easily washed away by the blood when the balloon enters the target site or even during delivery; The lipophilic site of the tissue cannot fully adhere and bind, and the amount is small; the adhesion time of the drug to the lipophilic site of the target vascular tissue is too short; the above factors can cause the drug to be difficult to be absorbed by the tissue cells, that is, it cannot play a good biological role. Availability

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  • Preparation method of drug balloon
  • Preparation method of drug balloon

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preparation example Construction

[0031] The present invention provides a preparation method of a drug balloon. The preparation method includes the following steps:

[0032] Hydrophilic pretreatment of the balloon surface;

[0033] The first water-soluble additive solution is attached to the surface of the balloon to obtain a modified balloon. The first water-soluble additive contains at least one of a hydroxyl group, an amino group, and a carboxyl group. The large van der Waals force can increase the adhesion between the drug and the balloon surface;

[0034] Brush the drug crystals on the surface of the modified balloon, or roll the modified balloon on the drug crystals until the drug crystals attached to the surface of the modified balloon reach the required weight, and the drug is obtained after drying A balloon; the preparation method of the drug crystal includes: adding a second water-soluble additive to a mixed solution of the drug, an organic solvent and water, stirring and dissolving, standing, filtering, a...

Embodiment 1

[0047] A nylon balloon is used to prepare a drug balloon for treating vascular stenosis.

[0048] (1) Pre-treat the surface of the nylon balloon; use low-temperature plasma treatment, select the model GDR-200PR plasma cleaner produced by Yantai Golden Eagle Technology Co., Ltd., select nitrogen, temperature -40°C, output power 500W, frequency 50MHz , The processing time is 15 minutes, and the air pressure is 100Pa;

[0049] (2) Dissolve PEG2000 in ethanol / water (volume ratio 99:1) to obtain a 40mg / ml solution, inflate the balloon obtained in step (1) to 8 atm to expand, immerse in the above solution for 1 minute, and dry naturally to obtain Modified balloon

[0050] (3) Dissolve paclitaxel in a mixed solution of methanol / water (85:15 by volume) to prepare a paclitaxel solution of 40mg / ml, add 250mg of sodium benzoate to 10ml of the paclitaxel solution and stir to dissolve at 10 rpm, at room temperature Let it stand for 24 hours, filter to obtain the solid, and dry naturally to obta...

Embodiment 2

[0064] A nylon balloon is used to prepare a drug balloon for treating vascular stenosis.

[0065] (1) Pre-treat the surface of the nylon balloon; adopt low-temperature plasma treatment, select oxygen, temperature -20℃, output power is 1000W, frequency is 10MHz, treatment time is 10 minutes, and air pressure is 50Pa;

[0066] (2) Dissolve poloxamer 407 in water to obtain a 20mg / ml solution, inflate the balloon obtained in step (1) to 6 atm expansion, immerse it in the above solution for 2 minutes, and heat it with air blowing at 50°C for 30 minutes to dryness. Modified balloon

[0067] (3) Dissolve paclitaxel in a mixed solution of tetrahydrofuran / water (99:1 by volume) to prepare a 20mg / ml paclitaxel solution, add 350mg of acetamide to 10ml of the paclitaxel solution and stir to dissolve at 50 rpm, then- Let stand at 30°C for 5 hours, filter to obtain the solid, and blast dry at room temperature to obtain drug crystals, which are regular in the shape of long sticks, with a particle ...

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Abstract

The invention relates to a drug balloon preparation method. The method includes performing hydrophilic pretreatment on the surface of a balloon; adhering a first water-soluble additive solution on the surface of the balloon to obtain a modified balloon, wherein the first water-soluble additive solution contains at least one of hydroxy, amino and carboxyl; brushing drug crystals on the surface of the modified balloon, or rolling the modified balloon on the drug crystals until the drug crystals adhered on the surface of the modified balloon reach needed weight, and obtaining the drug balloon after drying, wherein a preparation method of the drug crystals include adding a second water-soluble additive in a mixed solution of a drug, an organic solvent and water, stirring for dissolving, standing, filtering, and drying to obtain the drug crystals, and the second water-soluble additive contains at least one of hydroxy, carboxyl and amino and has effect of dispersing, plastifying and improving cellular affinity. The drug balloon preparation method is simple, efficient, stable, simple and convenient in operation and quick.

Description

Technical field [0001] The invention relates to a method for preparing medical devices, in particular to a method for preparing a drug balloon. Background technique [0002] Coronary heart disease is one of the most common heart diseases. It refers to myocardial dysfunction or organic disease caused by coronary artery stenosis and insufficient blood supply, so it is also called ischemic cardiomyopathy. The cause of this disease is heart disease caused by atherosclerotic plaques formed on the walls of the coronary arteries that supply the heart itself. [0003] At present, there are three treatment options for coronary heart disease: drug therapy, interventional therapy, and cardiac surgery bypass surgery. Medication is the most basic treatment. Once a patient is diagnosed, medication must be maintained for life. However, when the drug treatment is not effective or ineffective, coronary angiography should be done as soon as possible to make a detailed evaluation of the coronary ar...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61M29/02A61M31/00A61L31/08A61L31/16
Inventor 谢琦宗卢金华
Owner LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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