CN102657899B - Medicament coating stent capable of preventing blood vessel restenosis and preparation method thereof - Google Patents
Medicament coating stent capable of preventing blood vessel restenosis and preparation method thereof Download PDFInfo
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- CN102657899B CN102657899B CN2012101590609A CN201210159060A CN102657899B CN 102657899 B CN102657899 B CN 102657899B CN 2012101590609 A CN2012101590609 A CN 2012101590609A CN 201210159060 A CN201210159060 A CN 201210159060A CN 102657899 B CN102657899 B CN 102657899B
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Abstract
The invention provides a medicament coating stent capable of preventing blood vessel restenosis and a preparation method thereof. The stent is coated with a PLGA (polylactic acid-glycollic acid) nano particle coating which comprises a medicament carrier and a medicament material; the medicament carrier is PLGA; and the medicament material is one or two of rapamycin or paclitaxel. The preparation method comprises the following steps of: dissolving PLGA with dichloromethane, adding the medicament material, dissolving fully, and performing ultrasonic emulsification by use of an ultrasonic cell disruptor under an ice bath condition so as to prepare a suspension; slowly adding a 2% PVA (Polyvinyl Alcohol) water solution into the suspension while performing magnetic stirring, and emulsifying the suspension again so as to prepare an emulsion; performing rotary evaporation on the emulsion under reduced pressure so as to enable dichloromethane to volatilize completely, so that a nano particular colloidal dispersion system is obtained; adding a 1% coupling agent into the system, and then soaking the stent into the system for 5 minutes, so as to prepare the coating stent; and freeze-drying the coating stent for 10 hours, and preserving the freeze-dried stent at the temperature of 4 DEG C.
Description
Technical field
The present invention relates to the drug stent in medical material field, particularly relate to a kind of coating stent of medicine that prevents vascular restenosis and preparation method thereof.
Background technology
Atherosclerosis is to cause that luminal stenosis or obstruction are the main causes that causes ischemic heart desease.Percutaneous intracavity arterioplasty adopts sacculus full with inaccessible or narrow vasodilation, makes blood supply recover normally to be accepted widely and be applied to treat coronary heart disease.Although clinical effectiveness is satisfactory for arterioplasty in bellows, its Acute vessel closure and postoperative blood vessel have limited its development to a certain extent narrow.
In order to solve this difficult problem of arterioplasty postoperative restenosis in bellows, the domestic and international continuous Innovation Exploring of medical circle, research worker is selected the polymer of those good biocompatibilities as medium, with medicament mixed therein, be coated in rack surface, successful exploitation bracket for eluting medicament.Rack surface with medicine can slowly discharge and in the pathological changes part, keep effective treatment concentration of long period after support implants.So far, bracket for eluting medicament is established in the effect of control in-stent restenosis.
Traditional bracket for eluting medicament after its implant into body, the release medicine that the medicament controlled-release coating by surface slowly continues in stenosis, still, medicine is easily by the direct metabolism of blood vessel, utilization ratio of drug is low, and the blood medicine Css persistent period is undesirable.In addition, the destruction of medication coat easily occurs in support in conveying and process of expansion, in case and the medication coat failure very likely causes the coating bulk to come off.Although present bracket for eluting medicament can significantly reduce in bellows restenosis after artery angioplasty, late period, the thrombus in stents incidence rate raise, and had increased relevant acute myocardial infarction and dead the generation.
Summary of the invention
Based on this, be necessary the problem for the shortcoming of prior art, a kind of coating stent of medicine that prevents vascular restenosis and preparation method thereof is provided, has improved the adhesion of medication coat and rack surface, reduced medication coat comes off in support is carried and expanded problem; The Nanoparticle Size of coating medicine material has improved the holdup time of medicine at diseased region.
A kind of coating stent of medicine that prevents vascular restenosis and preparation method thereof, be covered with nanoparticle coating on described support, described nanoparticle coating comprises pharmaceutical carrier and drug material, described pharmaceutical carrier is polylactic acid-glycollic acid PLGA, described drug material is one or both the mixing in rapamycin or paclitaxel, and the mass ratio of described drug material and pharmaceutical carrier is 1:3～10;
The preparation method of described coating stent of medicine comprises following step:
1., at first adopt water cutter engraving mode that described support is engraved as reticulate pattern hollow out tubular body;
2., after support engraving is completed, by dichloromethane, described polylactic acid-glycollic acid PLGA is dissolved and forms the PLGA dichloromethane solution;
3., add described drug material in the PLGA dichloromethane solution, and fully dissolve in the PLGA dichloromethane solution, after described drug material dissolves, the PLGA dichloromethane solution that is dissolved with drug material is placed under condition of ice bath, then adopts Ultrasonic Cell Disruptor emulsifying 8～12 min to make suspension;
4., after suspension preparation completes, slowly add 1.5～2.5% PVAC polyvinylalcohol aqueous solutions in described suspension, by magnetic agitation, the speed of magnetic agitation is 300 r/min when adding the PVA aqueous solution; And then adopt Ultrasonic Cell Disruptor emulsifying 8～12 min, make emulsion;
5., after emulsion preparation completes, at 35～45 ℃ of temperature, with emulsion decompression and the rotary evaporation that makes, make in emulsion the dichloromethane volatilization fully, and then make the nanometer colloid dispersion;
6., add 0.8～1.2% coupling agent in described nanometer colloid dispersion, the support of engraving be impregnated in 4～6 min in the nanometer colloid dispersion that adds coupling agent, make coating stent of medicine, then 10～12 h are processed in prepared coating stent of medicine lyophilization, after finishing dealing with, in 4 ℃ of preservations.
In embodiment, described polylactic acid-glycollic acid PLGA comprises PLA and PGA, molar ratio 75～85:15 of described PLA and PGA～25 therein.
In embodiment, the optimum molar ratio of described PLA and PGA is 80:20 therein, and when the optimum molar ratio of described PLA and PGA, described polylactic acid-glycollic acid PLGA molecular weight is 35000～55000.
Therein in embodiment, described coupling agent is a kind of in silanes, titanate ester and aluminic acid compound.
In embodiment, described support is the cochrome support therein.
In embodiment, described rapamycin and paclitaxel mixed proportion are 1:1 therein.
Above-mentioned coating stent of medicine that prevents vascular restenosis and preparation method thereof, described medication coat Chinese medicine material is the mixture of any or two kinds in rapamycin (RPM) and paclitaxel, described pharmaceutical carrier is polylactic acid-glycollic acid (PLGA), PLGA is prepared to Nanoparticle Size, the PLGA Nanoparticle Size is even, particle size distribution range is narrow, concentrates and is distributed in 100 ~ 200 nm.After the PLGA nanoparticle arrives target cell, with the target cell surface receptor, interact, by modes such as endocytosis, be transported to cell, the degraded by PLGA discharges medicine gradually, has improved the ability of medicine penetrate tissue.PLGA has good biological degradability and the compatibility, and degradation speed is controlled, has improved the bioavailability of medication coat, has significantly improved drug material in the endovascular holdup time, keeps medicine long-time steady plasma-drug concentration in vivo.
Described coupling agent can improve the adhesion of medication coat and support, avoids described medication coat to come off.Described coupling agent reacts at described rack surface, not only can improve the adhesive force of medication coat, also can improve the corrosion resistance of described support.
The specific embodiment
Embodiment one, a kind of coating stent of medicine that prevents vascular restenosis and preparation method thereof, described support is cochrome, and support is covered with nanoparticle coating on being, described nanoparticle coating is rapamycin polylactic acid-glycollic acid (RPM-PLGA) nanoparticle coating.Described nanoparticle coating comprises pharmaceutical carrier and drug material, and described pharmaceutical carrier is polylactic acid-glycollic acid (PLGA), and described drug material is rapamycin (RPM), and the mass ratio of wherein said rapamycin and PLGA is 1:5.
Described PLGA comprises PLA and PGA, and the molar ratio 80:20 of described PLA and PGA, the molecular weight of described PLGA are 40000.
The preparation method of described rapamycin polylactic acid-glycollic acid (RPM-PLGA) nanoparticle coating, comprise the steps:
1., at first adopt water cutter engraving mode that described support is engraved as reticulate pattern hollow out tubular body.
2., after support engraving is completed, by dichloromethane, described PLGA is dissolved and forms the PLGA dichloromethane solution.
3., add rapamycin in the PLGA dichloromethane solution, and fully dissolve in the PLGA dichloromethane solution, after rapamycin dissolves, the PLGA dichloromethane solution that is dissolved with rapamycin is placed under condition of ice bath, then adopts Ultrasonic Cell Disruptor emulsifying 10 min to make suspension.
4., after suspension preparation completes, add 2% polyvinyl alcohol (PVA) aqueous solution in described suspension, by magnetic agitation, the speed of magnetic agitation is 300 r/min when adding the PVA aqueous solution; And then adopt Ultrasonic Cell Disruptor emulsifying 10 min, make emulsion;
5., after emulsion preparation completes, at 40 ℃ of temperature, with emulsion decompression and the rotary evaporation that makes, make in emulsion the dichloromethane volatilization fully, and then make the nanometer colloid dispersion;
6., add 1% coupling agent in described nanometer colloid dispersion, the support of engraving be impregnated in 5 min in the nanometer colloid dispersion that adds coupling agent, make described coating stent of medicine, prepared coating stent of medicine is freezing and dried 10 h then, and in 4 ℃ of preservations.
Wherein, described coupling agent is silanes.
Described drug material and pharmaceutical carrier exist with two kinds of forms simultaneously: a kind of is that described pharmaceutical carrier wraps up rapamycin in it, and another kind is that described pharmaceutical carrier does not wrap up rapamycin.This kind medicine carrying mode makes the rapamycin rate of release have selectivity and controllability, thereby brings into play better Drug therapy efficiency.
Embodiment two, and a kind of coating stent of medicine that prevents vascular restenosis and preparation method thereof, described support are cochrome, and support is covered with nanoparticle coating on being, described nanoparticle coating is paclitaxel polylactic acid-glycollic acid nanoparticle coating.Described nanoparticle coating comprises pharmaceutical carrier and drug material, and described pharmaceutical carrier is polylactic acid-glycollic acid (PLGA), and described drug material is paclitaxel, and wherein the mass ratio of paclitaxel and PLGA is 1:6.
Described PLGA comprises PLA and PGA, and the molar ratio 80:20 of described PLA and PGA, the molecular weight of described PLGA are 40000.
The preparation method of described paclitaxel polylactic acid-glycollic acid nanoparticle coating, comprise the steps:
1., at first adopt water cutter engraving mode that described support is engraved as reticulate pattern hollow out tubular body.
2., after support engraving is completed, by dichloromethane, described PLGA is dissolved and forms the PLGA dichloromethane solution.
3., add paclitaxel in the PLGA dichloromethane solution, and fully dissolve in the PLGA dichloromethane solution, after paclitaxel dissolves, the PLGA dichloromethane solution that is dissolved with paclitaxel is placed under condition of ice bath, then adopts Ultrasonic Cell Disruptor emulsifying 10 min to make suspension.
4., after suspension preparation completes, add 2% polyvinyl alcohol (PVA) aqueous solution in described suspension, by magnetic agitation, the speed of magnetic agitation is 300 r/min when adding the PVA aqueous solution; And then adopt Ultrasonic Cell Disruptor emulsifying 10 min, make emulsion;
5., after emulsion preparation completes, at 40 ℃ of temperature, with emulsion decompression and the rotary evaporation that makes, make in emulsion the dichloromethane volatilization fully, and then make the nanometer colloid dispersion;
6., add 1% coupling agent in described nanometer colloid dispersion, the support of engraving be impregnated in 5 min in the nanometer colloid dispersion that adds coupling agent, make described coating stent of medicine, prepared coating stent of medicine is freezing and dried 10 h then, and in 4 ℃ of preservations.
Wherein, described coupling agent is any in silanes, titanate ester and aluminic acid compound.
Described drug material and pharmaceutical carrier exist with two kinds of forms simultaneously: a kind of is that described pharmaceutical carrier wraps up paclitaxel in it, and another kind is that described pharmaceutical carrier does not wrap up paclitaxel.This kind medicine carrying mode makes the paclitaxel rate of release have selectivity and controllability, thereby brings into play better Drug therapy efficiency.
Embodiment three, and a kind of coating stent of medicine that prevents vascular restenosis and preparation method thereof, described support are cochrome, and support is covered with nanoparticle coating on being.Described nanoparticle coating comprises pharmaceutical carrier and drug material, and described pharmaceutical carrier is polylactic acid-glycollic acid (PLGA), and described drug material is the mixture of rapamycin and paclitaxel, and wherein, the mixed proportion of rapamycin and paclitaxel is 1:1.Described drug material and pharmaceutical carrier mass ratio be 1:6.Described PLGA comprises PLA and PGA, and the molar ratio 80:20 of described PLA and PGA, the molecular weight of described PLGA are 40000.
The preparation method of described nanoparticle coating, comprise the steps:
1., at first adopt water cutter engraving mode that described support is engraved as reticulate pattern hollow out tubular body.
2., after support engraving is completed, by dichloromethane, described PLGA is dissolved and forms the PLGA dichloromethane solution.
3., add rapamycin and paclitaxel in the PLGA dichloromethane solution, and fully dissolve in the PLGA dichloromethane solution, after rapamycin and paclitaxel dissolving, the PLGA dichloromethane solution that is dissolved with rapamycin and paclitaxel is placed under condition of ice bath, then adopts Ultrasonic Cell Disruptor emulsifying 10 min to make suspension.
4., after suspension preparation completes, add 2% polyvinyl alcohol (PVA) aqueous solution in described suspension, by magnetic agitation, the speed of magnetic agitation is 300 r/min when adding the PVA aqueous solution; And then adopt Ultrasonic Cell Disruptor emulsifying 10 min, make emulsion;
5., after emulsion preparation completes, at 40 ℃ of temperature, with emulsion decompression and the rotary evaporation that makes, make in emulsion the dichloromethane volatilization fully, and then make the nanometer colloid dispersion;
6., add 1% coupling agent in described nanometer colloid dispersion, the support of engraving be impregnated in 5 min in the nanometer colloid dispersion that adds coupling agent, make described coating stent of medicine, prepared coating stent of medicine is freezing and dried 10 h then, and in 4 ℃ of preservations.
Wherein, described coupling agent is any in silanes, titanate ester and aluminic acid compound.
Described drug material and pharmaceutical carrier exist with two kinds of forms simultaneously: a kind of is that described pharmaceutical carrier wraps up drug material in it, and another kind is not packaging medicine material of described pharmaceutical carrier.This kind medicine carrying mode makes the drug material rate of release have selectivity and controllability, thereby brings into play better Drug therapy efficiency.
Using when of the present invention, at first described coating stent of medicine be enclosed within on the brief little sacculus of conduit, conduit is inserted that the patient has blocked or the Serious Stenosis blood vessel in.Start the pressurized expansion sacculus, when balloon expandable, described coating stent of medicine, with softened, is attached on the blood vessel wall at obstruction place, to keep vessel expansion.Described support is degraded gradually by the pharmaceutical carrier in its surperficial nanoparticle coating, makes the described drug material release medicine slow and lasting at the angiostenosis place, thereby reduces the probability of vascular restenosis.
In sum, a kind of coating stent of medicine that prevents vascular restenosis and preparation method thereof, described medication coat Chinese medicine material are one or both mixing in rapamycin or paclitaxel.Described pharmaceutical carrier is PLGA, and PLGA is a kind of good biocompatibility, biodegradable polyesters macromolecule, and its degradation in vivo becomes lactic acid and hydroxyacetic acid, finally is metabolized to water and carbon dioxide, avirulence and non-immunogenicity.
PLGA is prepared to Nanoparticle Size, the PLGA Nanoparticle Size is even, particle size distribution range is narrow, concentrate and be distributed in 100 ~ 200 nm, have good biological degradability and the compatibility, and degradation speed is controlled, has improved the bioavailability of medication coat, significantly improve drug material in the endovascular holdup time, kept medicine long-time steady plasma-drug concentration in vivo.
Described coupling agent can improve the adhesion of medication coat and support, avoids described medication coat to come off, and delays simultaneously the degradation process of pharmaceutical carrier.Described coupling agent reacts at described rack surface, not only can improve the adhesive force of medication coat, also can improve the corrosion resistance of described support.
The above embodiment has only expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but can not therefore be interpreted as the restriction to the scope of the claims of the present invention.Should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.
Claims (6)
1. preparation method that prevents the coating stent of medicine of vascular restenosis, it is characterized in that: be covered with nanoparticle coating on described support, described nanoparticle coating comprises pharmaceutical carrier and drug material, described pharmaceutical carrier is polylactic acid-glycollic acid PLGA, described drug material is one or both in rapamycin RPM or paclitaxel, and the mass ratio of described drug material and pharmaceutical carrier is 1:3～10;
The preparation method of described coating stent of medicine comprises following step:
1., at first adopt water cutter engraving mode that described support is engraved as reticulate pattern hollow out tubular body;
2., after support engraving is completed, by dichloromethane, described polylactic acid-glycollic acid PLGA is dissolved and forms the PLGA dichloromethane solution;
3., add described drug material in the PLGA dichloromethane solution, and fully dissolve in the PLGA dichloromethane solution, after described drug material dissolves, the PLGA dichloromethane solution that is dissolved with drug material is placed under condition of ice bath, then adopts Ultrasonic Cell Disruptor emulsifying 8～12 min to make suspension;
4., after suspension preparation completes, slowly add 1.5～2.5% PVAC polyvinylalcohol aqueous solutions in described suspension, by magnetic agitation, the speed of magnetic agitation is 300 r/min when adding the PVA aqueous solution; And then adopt Ultrasonic Cell Disruptor emulsifying 8～12 min, make emulsion;
5., after emulsion preparation completes, at 35～45 ℃ of temperature, with emulsion decompression and the rotary evaporation that makes, make in emulsion the dichloromethane volatilization fully, and then make the nanometer colloid dispersion;
6., add 0.8～1.2% coupling agent in described nanometer colloid dispersion, the support of engraving be impregnated in 4～6 min in the nanometer colloid dispersion that adds coupling agent, make coating stent of medicine, then 10～12 h are processed in prepared coating stent of medicine lyophilization, after finishing dealing with, in 4 ℃ of preservations.
2. the preparation method that prevents the coating stent of medicine of vascular restenosis according to claim 1, it is characterized in that: described polylactic acid-glycollic acid PLGA comprises PLA and PGA, molar ratio 75～85:15 of described PLA and PGA～25.
3. the preparation method that prevents the coating stent of medicine of vascular restenosis according to claim 2, it is characterized in that: the optimum molar ratio of described PLA and PGA is 80:20, when the optimum molar ratio of described PLA and PGA, described polylactic acid-glycollic acid PLGA molecular weight is 35000～55000.
4. the preparation method that prevents the coating stent of medicine of vascular restenosis according to claim 1 is characterized in that: described coupling agent is a kind of in silanes, titanate ester and aluminic acid compound.
5. the preparation method that prevents the coating stent of medicine of vascular restenosis according to claim 1, it is characterized in that: described support is the cochrome support.
6. the preparation method that prevents the coating stent of medicine of vascular restenosis according to claim 1, it is characterized in that: described rapamycin and paclitaxel mixed proportion are 1:1.
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| CN104189963B (en) * | 2014-05-13 | 2017-01-04 | 江苏沣沅医疗器械有限公司 | Reduction can the preparation method of surface coating of degradable magnesium alloy blood vessel rack degradation rate |
| CN105709279B (en) * | 2016-01-19 | 2019-03-05 | 中国医科大学附属第一医院 | The preparation method of PLGA-S1P nano material and PLGA-S1P nano coating bracket |
| CN106512083B (en) * | 2016-10-14 | 2019-09-24 | 湖北大学 | A kind of preparation method of medical titanium alloy |
| CN107335100A (en) * | 2017-07-31 | 2017-11-10 | 首都医科大学附属北京安贞医院 | A kind of CABG prevents bridge reangiostenosis system |
| CN108096583B (en) * | 2017-12-17 | 2021-02-19 | 宋振川 | Preparation method of tumor targeting nanoparticle carrier co-loaded with breast cancer chemotherapeutic drug MTDH siRNA |
| CN108744233A (en) * | 2018-06-28 | 2018-11-06 | 山东吉威医疗制品有限公司 | A kind of medicine balloon dilating catheter and its technique |
| CN109718459A (en) * | 2019-01-03 | 2019-05-07 | 苏州优医港科技有限公司 | Medicinal balloon catheter and preparation method thereof |
| CN115006605A (en) * | 2022-07-20 | 2022-09-06 | 苏州中天医疗器械科技有限公司 | Drug coating balloon and preparation method and application thereof |
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| CN101091806A (en) * | 2006-06-20 | 2007-12-26 | 天津市凯迪亚医疗器械有限公司 | Slow release coating layer of degradable medication for bracket of coronary artery |
| WO2010021883A2 (en) * | 2008-08-20 | 2010-02-25 | Abbott Cardiovascular Systems Inc. | Biosoluble coating with linear over time mass loss |
| CN101869723A (en) * | 2009-04-27 | 2010-10-27 | 赵菁 | Composite medicament stent for inhibiting cardiovascular restenosis and preparation method |
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| US8414909B2 (en) * | 2006-11-20 | 2013-04-09 | Lutonix, Inc. | Drug releasing coatings for medical devices |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101091806A (en) * | 2006-06-20 | 2007-12-26 | 天津市凯迪亚医疗器械有限公司 | Slow release coating layer of degradable medication for bracket of coronary artery |
| WO2010021883A2 (en) * | 2008-08-20 | 2010-02-25 | Abbott Cardiovascular Systems Inc. | Biosoluble coating with linear over time mass loss |
| CN101869723A (en) * | 2009-04-27 | 2010-10-27 | 赵菁 | Composite medicament stent for inhibiting cardiovascular restenosis and preparation method |
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