Method for preparing medicine sustained-releasing bracket

A drug and slow-release technology, applied in stents, medical science, dilators, etc., to achieve the effect of uniform coating, stable drug coating properties, and firm adsorption

Active Publication Date: 2008-05-28
上海赢生医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, none of these methods can prevent the release and decomposition of the drug carried on the stent from the source.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Add 0.5 g of ethylene acid polymer and acrylic acid polymer, 0.1 g of Sirolimus (rapamycin) and 0.01 g of BHT into 10 ml of tetrahydrofuran, mix and stir to form a uniform solution. Spray the solution onto the surface of the prepared stent, and control the number of times of spraying so that the drug loading of the stent reaches 40ug / cm2, then put the stent into a vacuum drying oven, and dry it at 35°C for 24 hours.

[0026] Polymer can also choose fluoropolymer, polyurethane, polyolefin, glycolide, lactide, glycolide / lactide copolymer, polyglycolide, polylactide, methyl lactate, ethyl lactate, Isopropyl Lactate, Propyl Lactate, Butyl Lactate, Octyl Lactate, Lactitol, Lactitol Mixture, Aluminum Lactate, Iron Lactate, Magnesium Lactate, Manganese Lactate, Zinc Lactate, Polyamino Acid, Polyphosphate, Biological Phosphorus Stone, heparinized polymer, heparin and polylactic acid (PLA), or a mixture of two or more of them.

[0027]Drugs can also choose heparin sodium, snake...

Embodiment 2

[0040] A method for preparing a drug slow-release stent, comprising adding 0.4 g of polylactic acid (PLA), 0.07 g of paclitaxel (Paclitaxel) and 0.01 g of ascorbic acid (vitamin C) into 7 ml of glycerol, mixing and stirring to form a uniform solution. Spray the solution onto the surface of the prepared stent, and control the number of times of spraying so that the drug loading of the stent reaches 100ug / cm2, then put the stent into a vacuum drying oven, and dry it for 24 hours at 60°C.

[0041] The drug stent of the patent invention is carried out in vitro release test:

[0042] The bracket is placed on the special mold of the drug release testing machine, and 20ml of bovine serum albumin phosphate slow-release solution is put into the slow-release tube. Set the operating temperature of the equipment at 37.5°C, and set the operating time as 1 hour, 6 hours, 1 day, 2 days, 7 days, 14 days, and 28 days.

[0043] The stent drug sustained-release solution in the corresponding tim...

Embodiment 3

[0059] 0.01~0.1, 0.002~0.02 and 0.0005~0.01;

[0060] A method for preparing a drug slow-release stent, comprising adding 0.6 g of glycolide / lactide copolymer, 0.13 g of paclitaxel (Paclitaxel) and 0.06 g of vitamin E into 13 ml of isopropanol, mixing and stirring to form a uniform solution. Spray the solution onto the surface of the prepared stent, and control the number of sprays so that the drug loading of the stent reaches 280ug / cm 2 , and then put the stent into a vacuum drying oven, and dry it for 24 hours under the condition of 80°C.

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PUM

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Abstract

A preparation method of a drug sustained-release stent includes a preparation stent, a drug sustained-release stent constituted by drug coating on the stent, and the drug coating of the stent is composed of the following steps sequentially: (1) the preparation of a sustained-release drug coating layer; (2) the coating of the sustained-release drug coating layer; (3) drying. The dosages of the drug components on the sustained-release drug stent of the invention are in line with the designed dosages, and the drug can be released according to the stipulated dosages in the stipulated time of the design requirements completely in vitro tests. The invention has good biocompatibility, low cost of spraying process, high yield, controllable thickness of the coating layer, and slow and stable drug release rate.

Description

technical field [0001] The invention belongs to the field of drugs and medical devices (interventional medical devices), and relates to a drug-eluting stent capable of reducing neointima proliferation and treating vascular restenosis, in particular to an anti-oxidative drug slow-release stent and a preparation method thereof . Background technique [0002] With the improvement of living standards, the number of patients with coronary heart disease is increasing. At present, Percutaneous Coronary Intervention (PCI) has become one of the conventional treatment methods for coronary heart disease, and the success rate can reach more than 95%. However, 25-50% of patients will develop restenosis 3-6 months after surgery, which limits the long-term efficacy of PCI. [0003] The mechanism of restenosis after stenting is: the expansion of human blood vessels by stents or other implanted devices causes damage to endothelial cells and smooth muscle cells in the blood vessel wall, whic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/16A61L31/12A61F2/82A61M29/00
Inventor 陈毅生胡铁锋
Owner 上海赢生医疗科技有限公司
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