Method for preparing medicine sustained-releasing bracket

A drug and sustained-release technology, applied in stents, medical science, dilators, etc., to achieve the effects of firm adsorption, uniform coating, and high yield

Active Publication Date: 2010-06-02
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 polymer, 0.1 g of Sirolimus (rapamycin) and 0.01 g of BHT to 10 ml of tetrahydrofuran, mix and stir to form a uniform solution. Spray the solution on the surface of the prepared stent, control the number of spraying, so that the drug loading of the stent reaches 40ug / cm2, and then put the stent in a vacuum drying oven, and dry it at 35°C for 24 hours.

[0026] The polymer can also choose fluoropolymer, polyurethane, polyolefin, glycolide, lactide, glycolide / lactide copolymer, polyglycolide, polylactide, methyl lactide, ethyl lactide, 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 apatite One or a mixture of two or more of stone, heparinized polymer, heparin, and polylactic acid (PLA).

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

Embodiment 2

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

[0041] The drug stent of the invention is tested in vitro:

[0042] Place the stent on the special mold of the drug release testing machine, and put 20ml of bovine serum protein phosphate sustained-release solution in the sustained-release tube. Set the operating temperature of the equipment to 37.5°C, and set the operating time to 1 hour, 6 hours, 1 day, 2 days, 7 days, 14 days, and 28 days.

[0043] The stent drug sustained-release solution was taken out for the corresponding time period, and the content of paclitaxel ...

Embodiment 3

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

[0060] A method for preparing a drug sustained-release stent is to add 0.6 g of glycolide / lactide copolymer, 0.13 g of paclitaxel and 0.06 g of vitamin E to 13 ml of isopropanol, and mix and stir to form a uniform solution. Spray the solution on the surface of the prepared stent and control the number of spraying so that the drug loading of the stent reaches 280ug / cm 2 , Then put the stent into a vacuum drying oven, and dry it for 24 hours at 80°C.

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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 drugcomponents 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 medicines and medical devices (interventional medical devices), relates to a drug-eluting stent that can reduce neointimal proliferation and treat vascular restenosis, and in particular relates to a drug sustained-release stent with antioxidant properties 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, with a success rate of over 95%. However, 3-6 months after surgery, 25-50% of patients will have restenosis, which limits the long-term efficacy of PCI. [0003] The mechanism of restenosis after stent is: the expansion of human blood vessels by stents or other implanted devices causes damage to the endothelial cells and smooth muscle cells of the blood vessel wall, wh...

Claims

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Application Information

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Patent Type & Authority Patents(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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