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Method for preparing drug balloon

A balloon and drug technology, applied in catheters, coatings, etc., can solve the problems of affecting the treatment effect, blocking the ultrasonic nozzle, uneven coating, etc., and achieve the effects of improving the prevention of restenosis, reducing the production cost, and increasing the specific surface area.

Active Publication Date: 2018-07-10
LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of this method is that the drug crystals and the smooth surface of the balloon are adsorbed on the surface of the balloon by physical interaction, and the drug in the form of crystals precipitated from the solution will block the nozzle, resulting in failure to spray or block the ultrasonic nozzle, resulting in uneven coating. , thereby affecting its therapeutic effect

Method used

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  • Method for preparing drug balloon

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preparation example Construction

[0033] The invention provides a method for preparing a drug balloon, comprising the following steps:

[0034] S110, uniformly coating the mixed solution containing medicine, polymer and solvent on the surface of the balloon;

[0035] S120, subjecting the coated balloon to low-temperature freezing treatment, so that the mixed solution forms a layer of crystalline film on the surface of the balloon;

[0036] S130. Vacuum-drying the balloon after the low-temperature freezing treatment to obtain a drug balloon;

[0037] Wherein, the temperature of the cryogenic freezing treatment is not higher than the freezing point of the solvent, and the temperature of the vacuum drying treatment is lower than the freezing point of the solvent and lower than the glass transition temperature of the polymer.

[0038] In the preparation method of the above drug balloon, the mixed solution containing the drug is first coated on the surface of the balloon, and then the coated balloon is subjected t...

Embodiment 1

[0054] Step 1, paclitaxel solution: Weigh 50mg of paclitaxel and 10mg of PLA, put them into a 10mL volumetric flask, add 10mL of water / dioxane 1:1 (V:V) mixed solution into the volumetric flask, and The drug was completely dissolved after shaking for 5 minutes to form a homogeneous mixed solution.

[0055] Step 2: Spray the mixed solution onto the surface of the polyester balloon behind the flaps with a spraying device in a class 100 clean environment, so that the drug concentration on the surface of the balloon reaches 3 μg / mm 2 .

[0056] In step 3, the balloon is put into a vacuum box for cryogenic freezing treatment for 2 hours at a temperature of -90°C.

[0057] In step 4, the cryogenically frozen balloon is placed in a vacuum drying oven for 2 hours to be vacuum-dried at a temperature of -95°C.

Embodiment 2

[0059] Step 1, paclitaxel solution: Weigh 75mg of paclitaxel and 25mg of PDLLA, put them into a 10mL volumetric flask, add 10mL of water / chloroform 2:1 (V:V) mixed solution into the volumetric flask, and vibrate for 3min by ultrasonic Then the drug is completely dissolved to form a homogeneous mixed solution.

[0060] Step 2: Apply the mixed solution on the surface of the balloon with a precision syringe in a class 100 clean environment, so that the drug concentration on the surface of the balloon reaches 3 μg / mm 2 .

[0061] In the third step, the balloon is put into a vacuum box for low-temperature freezing treatment, the time is 0.5h, and the temperature is -100°C.

[0062] In step 4, the cryogenically frozen balloon was dried in a vacuum drying oven for 12 hours at a drying temperature of -90°C.

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Abstract

The invention relates to a method for preparing a drug balloon. The method comprises the steps of uniformly applying a mixed solution containing a drug, a polymer and a solvent onto the surface of a balloon; conducting low-temperature freezing treatment on the coated balloon; conducting vacuum drying treatment on the balloon after the low-temperature freezing treatment to obtain the drug balloon;the temperature of the low-temperature freezing treatment is not higher than a freezing point of the solvent, and the temperature of the vacuum drying treatment is lower than the freezing point of thesolvent, and is lower than glass state temperature of the polymer. According to the method for preparing the drug balloon, a uniform porous structure is formed on the surface of the balloon, the drugis uniformly distributed in the porous structure, so that the specific surface area of drug particles can be increased, and the drug can fully contact sites of target cells when the balloon is expanded, and is uniformly released to lesions and absorbed by the cells, thereby improving the therapeutic effect of preventing restenosis and endometrial hyperplasia of the drug balloon.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a preparation method of a drug balloon. Background technique [0002] In recent years, drug-eluting stents have achieved great success in the treatment of vascular stenosis. However, the results of long-term clinical trials have shown that drug-coated stents will cause side effects caused by the metal framework and polymer carriers and the risk of late intravascular thrombosis in the human body. In-stent restenosis after surgery has also become another thorny issue. The problem. In the subsequent research on new devices and treatment technologies, Drug Coated Balloon (hereinafter referred to as "DCB" or "Drug Balloon") has become an emerging means of treating in-stent restenosis. has been widely used. [0003] The mechanism of action of DCB is to evenly coat the anti-cell proliferation drug on the surface of the balloon, and after delivering it to the vascular lesion s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/14A61L29/16
CPCA61L29/14A61L29/146A61L29/16A61L2300/216A61L2300/606A61L2420/02
Inventor 谢琦宗曹明芳宋精忠
Owner LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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