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Medicine coating composition as well as preparation method thereof and an implanting or intervention medical apparatus made thereof

A drug coating and medical device technology, applied in the field of medical devices, can solve problems such as unavoidable impurities, poor drug coating stability, and affecting drug distribution uniformity

Inactive Publication Date: 2014-12-03
杭州瑞维特医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, since drug balloons are cardiovascular interventional materials, the choice of materials is even more limited.
[0009] 2. Selection of coating process. After selecting the formula, a suitable process is required to coat the drug-loading solution on the surface of the balloon. This coating process will directly affect the uniformity of drug distribution on the surface of the balloon. The shape of the balloon surface will eventually affect the release of the drug and the particles released by the drug. Therefore, even with a mature formula, the desired drug coating cannot be obtained without a suitable coating process
But the disadvantage is that shellac is very brittle, and after combining with water-insoluble paclitaxel, the stability of the entire drug coating is not good
At the same time, since shellac is a natural product, impurities are still unavoidable after purification

Method used

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  • Medicine coating composition as well as preparation method thereof and an implanting or intervention medical apparatus made thereof
  • Medicine coating composition as well as preparation method thereof and an implanting or intervention medical apparatus made thereof
  • Medicine coating composition as well as preparation method thereof and an implanting or intervention medical apparatus made thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1A

[0052] Example 1A: Preparation method of inorganic salt-containing drug balloon

[0053] Configuration of polyvinylpyrrolidone (PVP) ethanol solution: Weigh 4g of PVP (Povidone K30) with a balance with a precision of 0.0001g, add it to a 25ml sample bottle, and use a pipette to draw 20ml of ethanol into the sample bottle. Tighten the bottle stopper, shake and stir, and store in a 45°C oven until the PVP is completely dissolved.

[0054] Preparation of paclitaxel ethanol solution: Weigh about 0.15g of paclitaxel and add it to a 25ml glass bottle; add 1ml of ethanol to the glass bottle; keep warm in an oven at 45°C until the paclitaxel is completely dissolved.

[0055] Prepare sodium iodide solution: Add about 0.4g NaI into a 25ml sample bottle; use a pipette to draw 8ml of PVP ethanol solution into the sample bottle;

[0056] Prepare the drug coating composition: add about 1-2ml of sodium iodide solution and a small amount (0.262ml) of distilled water to the paclitaxel ethanol...

Embodiment 1B

[0061] Example 1B: Preparation method of inorganic salt-containing drug balloon

[0062] Configuration of polyvinylpyrrolidone (PVP) methanol solution: Weigh 4g of PVP (Povidone K30) with a balance with a precision of 0.0001g, add it to a 25ml sample bottle, and use a pipette to draw 20ml of methanol into the sample bottle. Tighten the bottle stopper, shake and stir, and store in a 45°C oven until the PVP is completely dissolved.

[0063] Preparation of paclitaxel methanol solution: Weigh about 0.15g of paclitaxel and add it into a 25ml glass bottle; add 1ml of methanol into the glass bottle; keep warm in an oven at 45°C until the paclitaxel is completely dissolved.

[0064] Prepare sodium iodide solution: Add about 0.4g NaI into a 25ml sample bottle; use a pipette to draw 8ml of PVP methanol solution into the sample bottle;

[0065] Prepare the drug coating composition: add about 1-2ml of sodium iodide solution and a small amount (0.262ml) of distilled water to the paclitaxe...

Embodiment 2

[0070] Example 2: Preparation method of drug balloon containing small molecule adjuvant:

[0071] Configuration of PVP ethanol solution: Weigh 4g of PVP (Povidone K30) with a balance with a precision of 0.0001g, and add it to a 25ml sample bottle; use a pipette to draw 20ml of ethanol into the sample bottle. Tighten the bottle stopper, shake and stir, and store in a 45°C oven until the PVP is completely dissolved.

[0072] Preparation of paclitaxel ethanol solution: Weigh about 0.15g of paclitaxel and add it to a 25ml glass bottle; add 1ml of ethanol to the glass bottle; keep warm in an oven at 45°C until the paclitaxel is completely dissolved.

[0073] Prepare nicotinamide solution: Add about 0.2g of nicotinamide into a 25ml sample bottle; use a pipette to draw 8ml of PVP ethanol solution into the sample bottle;

[0074] Preparation of the drug coating composition: add about 1-2ml of nicotinamide solution and a small amount (0.262ml) of distilled water to the paclitaxel etha...

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Abstract

The invention belongs to the technical field of medical appliances, and particularly relates to a medicine coating composition as well as a preparation method thereof and an implanting or intervention medical apparatus made thereof. The medicine coating composition for being coated on the surface of an implanting or intervention medical apparatus comprises the following components: a hydrophilic polymer as the first component, a medicine for treating blood vessel hyperplasia as the second component, an inorganic substance as the third component which is one or more than two compositions selected from inorganic simple substances, water soluble inorganic salts or amphiphilic small molecule compounds, and a solvent system as the fourth component, and the solvent system comprises corresponding solvents for the first component, the second component and the third component. The medicine balloon coating made of the medicine coating composition has good compatibility with balloons and little coating falling rate when folded, and does not form large medicine crystal particles while quickly disintegrating after immersing blood or distilled water, thereby avoiding the occurrence of thrombosis and angiemphraxis.

Description

technical field [0001] The invention belongs to the technical field of medical devices, and in particular relates to a drug coating composition, a preparation method thereof and an implanted or interventional medical device made using the same. Background technique [0002] Drug-coated balloons and drug-eluting stents (DES) are essentially derived from the concept of a catheter-based local drug delivery device, which inhibits intimal hyperplasia by carrying drugs, but the way of carrying drugs and the local drug action time are different. Traditionally, it is believed that the maintenance of local vascular drug effects is the basis for exerting its anti-proliferative effects. However, with the development of isolated cells, animal experiments and human studies, it has been found that this is not the case. Initially, the possibility of inhibiting restenosis was explored by using the contrast agent to carry the drug in short-term contact with the blood vessel wall. The study f...

Claims

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Application Information

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IPC IPC(8): A61L31/10A61L31/08A61L31/16
CPCA61M25/1029A61M2025/1031A61M2025/105
Inventor 赵中
Owner 杭州瑞维特医疗科技有限公司
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