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
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[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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