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Drug coating solution used for drug-coated balloon and drug-coated balloon

A technology of drug coating and coating solution, applied in the direction of coating, balloon catheter, catheter, etc., can solve the problems of paclitaxel drug release, disadvantage of rapid release, and influence of blood vessel wall

Active Publication Date: 2020-09-25
CAPITAL UNIVERSITY OF MEDICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the most fatal problem is that, as an excipient, shellac is slightly inferior in the critical step of quick release
During the short time when the balloon is in contact with the vessel wall, shellac cannot release a significant percentage of paclitaxel to the diseased vessel wall, but after the balloon is withdrawn, paclitaxel is wrapped in the blood flow and reaches the rest of the body to completely After the drug is released, it will not only reduce the absorption of the drug at the effective site, but also cause a certain systemic reaction of the drug, which will have a certain impact on the intact blood vessel wall

Method used

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  • Drug coating solution used for drug-coated balloon and drug-coated balloon
  • Drug coating solution used for drug-coated balloon and drug-coated balloon
  • Drug coating solution used for drug-coated balloon and drug-coated balloon

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] Preparation of paclitaxel stock solution:

[0082] Weigh 6mg paclitaxel in a 1.5mL EP tube, add 400μL of absolute ethanol to dissolve it, vortex and sonic until it is completely dissolved and clear to obtain a paclitaxel stock solution with a concentration of 15mg / mL, seal it with para film and store it in a refrigerator at 4°C.

[0083] Preparation of pectin colloid dispersion system:

[0084] Weigh 1.9mg of powdered pectin with a balance for use; take a 50mL eggplant bottle, in an oil bath at 40℃, under manual stirring, add the powdered pectin while adding water, the total volume of water added is 30mL, and finally added 72μL glycerol, and adjust the pH value to 7-7.5 with 2mol / L NaOH, and stir it to form a light brown uniform liquid.

[0085] Pectin-RGDS-OCH 2 (CH 2 ) 6 CH 3 Preparation of colloidal dispersion system:

[0086] Add 19mg of RGDS-OCH to the pectin colloid dispersion system 2 (CH 2 ) 6 CH 3 Mix well to form a light brown uniform liquid.

[0087] Pectin-RGDS-OCH 2 ...

Embodiment 2

[0195] Preparation of paclitaxel stock solution:

[0196] Weigh 6mg paclitaxel in a 1.5mL EP tube, add 400μL of absolute ethanol to dissolve it, vortex and sonic until it is completely dissolved and clear to obtain a paclitaxel stock solution with a concentration of 15mg / mL, seal it with para film and store it in a refrigerator at 4°C.

[0197] Preparation of pectin colloid dispersion system:

[0198] Weigh 1.9mg of powdered pectin with a balance for use; take a 50mL eggplant bottle, in an oil bath at 40℃, under manual stirring, add the powdered pectin while adding water, the total volume of water added is 30mL, and finally added 72μL glycerol, and adjust the pH value to 7-7.5 with 2mol / L NaOH, and stir it to form a light brown uniform liquid.

[0199] Pectin-RGDS-OCH 2 (CH 2 ) 6 CH 3 Preparation of colloidal dispersion system:

[0200] Add 19mg of RGDS-OCH to the pectin colloid dispersion system 2 (CH 2 ) 6 CH 3 Mix well to form a light brown uniform liquid.

[0201] Pectin-RGDS-OCH 2 ...

Embodiment 3

[0206] Preparation of docetaxel stock solution:

[0207] Using a 1.5mL EP tube, weigh 6mg of docetaxel, add 400μL of absolute ethanol to dissolve it, vortex and sonic until it is completely dissolved and clear to obtain a stock solution of docetaxel with a concentration of 15mg / mL, seal it with para film and place it in a refrigerator at 4℃ Save in.

[0208] Preparation of pectin colloid dispersion system:

[0209] Weigh 1.9mg of powdered pectin with a balance for use; take a 50mL eggplant bottle, in an oil bath at 40℃, under manual stirring, add the powdered pectin while adding water, the total volume of water added is 30mL, and finally added 72μL glycerol, and adjust the pH value to 7-7.5 with 2mol / L NaOH, and stir it to form a light brown uniform liquid.

[0210] Pectin-RGDS-OCH 2 (CH 2 ) 6 CH 3 Preparation of colloidal dispersion system:

[0211] Add 19mg of RGDS-OCH to the pectin colloid dispersion system 2 (CH 2 ) 6 CH 3 Mix well to form a light brown uniform liquid.

[0212] Pec...

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Abstract

The invention provides a drug coating solution used for a drug-coated balloon and the drug-coated balloon, and belongs to the technical field of pharmacy. The drug coating solution provided by the invention takes pectin as an excipient of the drug-coated balloon, and is conducive to adhesion of the drug coating solution and an empty balloon after being mixed with an active drug (paclitaxel or docetaxel). When the drug-coated balloon reaches a damaged site, the pectin is conducive to quick release of the active drug from the coating surface of the balloon, and the active drug deposits on the surface of a blood vessel wall to reach effective drug concentration. An arginine-glycine-aspartic acid (RGD) peptide is a structural recognition motif of cell surface integrin, including alpha-nu-beta3 and alpha-5-beta-1, and is associated with the process of anchoring an extracellular matrix. RGDS-OCH2(CH2)6CH3 is added into the drug coating solution provided by the invention, can be used as integrin on targeting vascular endothelial cells, enhances absorption of the active drug, and meanwhile, reduces the loss of the active drug during delivery.

Description

Technical field [0001] The invention relates to the technical field of pharmacy, in particular to a drug coating liquid for a drug coating balloon, and a drug coating balloon. Background technique [0002] With the increasing application of percutaneous transluminal coronary angioplasty (PTCA), many supporting equipment and technologies have also been continuously improved. Compared with stent implantation and second-generation drug elution The stent that has attracted much attention in recent years is the drug-coated balloon (DCB). DCB is an angioplasty balloon directly coated with anti-proliferative active drugs and excipients (drug base or carrier). The excipients play a role in promoting the transfer of drugs to the lesion. The drug-coated balloon is delivered to the narrow part of the blood vessel through a catheter. After inflation, the balloon expands, and the drug coated on the surface of the balloon is quickly released within a certain period of time. Paclitaxel cell c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/08A61L29/16A61M25/10
CPCA61L29/08A61L29/085A61L29/16A61L2300/216A61L2300/416A61L2300/602A61M25/10A61M2025/105C08L5/06
Inventor 王玉记张启迪王彦明彭紫东阿依江冯琦琦
Owner CAPITAL UNIVERSITY OF MEDICAL SCIENCES
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