CN100346850C - Medicine coating rack - Google Patents
Medicine coating rack Download PDFInfo
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- CN100346850C CN100346850C CNB031289061A CN03128906A CN100346850C CN 100346850 C CN100346850 C CN 100346850C CN B031289061 A CNB031289061 A CN B031289061A CN 03128906 A CN03128906 A CN 03128906A CN 100346850 C CN100346850 C CN 100346850C
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- medicine
- paclitaxel
- stent
- coating stent
- bracket
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Abstract
The present invention discloses a novel medicine coating layer bracket which comprises a bracket and a medicine coating layer coated on the bracket, wherein the medicine coating layer is a polymer which comprises paclitaxel or derivatives thereof, antiplatelet medicine and anti-inflammatory reaction medicine. Animal experiments indicate that the present invention can continuously reduce the formation of neonatal tunica intimae and prevent restenosis. The paclitaxel medicine as cytotoxin causes cells contacted with the paclitaxel medicine to be withered and endothelial cells and smooth muscle cells are no exception, but the tolerance extent of various cells to paclitaxel is not entirely identical, and the smooth muscle cells are more responsive than the endothelial cells to the paclitaxel. Animal experiments indicate that compared with a medicine bracket without compact control release layer, the medicine bracket of the present invention can continuously reduce the formation of neonatal tunica intimae, prevents restenosis, does not influence the ordinary endothelialization process, and avoids risks of tardive thrombus.
Description
Technical field
The present invention relates to a kind of support that is provided with medication coat, relate to a kind of coating stent of medicine that is used for neointimal hyperplasia behind the preventing/treating intervene operation specifically.In bracket coating, contain effectively formation and the propagation of smooth muscle cell (SMC) and taxol drug (paclitaxel) or derivatives thereof of migration of angiogenesis inhibiting inner membrance, in the vascular lesion position, reach the purpose that prevents restenosis by slow release medicine.
Background technology
Atherosclerosis causes that luminal stenosis or obstruction are the main causes that causes ischemic heart desease (coronary heart disease), cause 500,000～600,000 people's death every year.Percutaneous transluminal angio plasty (PTA) adopts full inaccessible or narrow blood vessel is expanded of sacculus to open, and makes blood supply recover normal.Wherein percutaneous transluminal coronary angioplasty (PTCA) has been widely used in treating coronary heart disease at present.Through 20 years of development, the PTA technology is obtaining the achievement that attracts people's attention aspect raising success rate and the reduction acute complications.But the PTA postoperative had 30%～50% patient the coronary artery generation restenosis of being expanded, the life and health that seriously jeopardizes people can occur in 3～6 months approximately.(referring to Popma, J.J.et al., Circulation, 84,1426～1436 (1991); AndGruentzig, A.R.et al., N Engl J Med, 316,1127～1132 (1987)).
Endovascular stent can be controlled the restenosis that the PTA elastical retraction is caused effectively, acute or subacute ischemia complication in the time of can significantly reducing interventional therapy, but inserting of support can not improve because PTA and release support process to the damage that the local vascular inner membrance causes, stimulate the hypertrophy of tunica intima hamartoplasia and smooth muscle cell on the contrary and cause restenosis.The restenosis incidence rate is about 20% in the coronary artery bracket at present, and the restenosis in the intracranial vessel support is up to more than 40%.Therefore, in-stent restenosis has become subject matter and the deadly defect that influences the PTA curative effect.
Restenosis is a kind of reparation reaction after the local vascular damage, and it forms mechanism and be mainly SMC propagation that causes after blood vessel endothelium and smooth muscle cell (SMC) damage and the result who divides a word with a hyphen at the end of a line to inner membrance under multiple biological factor effects such as the attached wall of platelet, factors stimulated growth.
Using coating stent of medicine is prevention that receives much concern recently and the method for the treatment of the PTA postoperative restenosis.Coating stent of medicine is slowly to discharge at diseased region by the support carrying medicament to prevent and reduce restenosis.The coating stent of medicine of at present common prevention of restenosis mainly is the coating stent of medicine that contains rapamycin (Rapamycin).
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of newtype drug coating bracket, with the performance of further raising support, satisfy people's needs.
Technical conceive of the present invention is such: paclitaxel (paclitaxel) is a kind of broad-spectrum anti-cancer drug that International Union of Counter Cancer generally acknowledges, is to extract from the bark of Ramulus et folium taxi cuspidatae or carry out semi-synthetic acquisition (precursor still need extract) from its precursor.Paclitaxel and derivant thereof have very strong inhibition cell proliferation, the effect of moving and having certain anti-inflammatory, can suppress the formation of new intima and the migration and the propagation of smooth muscle cell effectively.The unique effect mechanism of paclitaxel is that it can combine with microtubular protein, forms stable microtubule fasolculus, and makes it can not depolymerization, and cell is stopped at G2 late period or M phase, suppresses cell migration and duplicates, and stops its propagation.Because paclitaxel has multiple action mechanism and the new intima forming process is had selective effect, this medicine can effectively suppress the generation of vascular restenosis in the support.(referring to Drachman D.et al.Journal of the American College of Cardiology, 2000,36 (7)).
Employing includes the composition of medicine coating of paclitaxel or derivatives thereof and anti-platelet drug and anti-inflammatory response medicine, act on the different phase of restenosis process respectively, slowly discharge medicine in the vascular lesion position, come to prevent more effectively/treat restenosis.
Coating stent of medicine of the present invention comprises support and the medication coat that is coated on the support, said medication coat is for containing paclitaxel or derivatives thereof and anti-platelet drug (as: cilostazol (Cilostazol), ticlopidine (Ticlopidine) etc.) and anti-inflammatory response medicine (as: Triptolide (Triptolide), the polymer of composition of medicine dexamethasone (Desamethasone) etc.), described polymer comprises lactide, Acetic acid, hydroxy-, bimol. cyclic ester, the homopolymer of 6-caprolactone and between the two or three's copolymer, cellulose family, polyvidon, polyvinyl alcohol, arabic gum, sodium alginate, gelatin, polymethyl methacrylate, poly-methyl-prop diluted acid butyl ester, in ethylene-vinyl alcohol copolymer or the ethylene-vinyl acetate copolymer one or more, preferred drug loading is 20～400 μ g/cm
2
35 cyclic nucleotide phosphodiesterases of Cilostazol in can selective exclusion cyclic adenosine monophosphate (PDE) family, make cAMP concentration rise, thereby have following effect: 1) anticoagulant, the platelet of having assembled there is dissociation, therefore have very strong anti-thrombosis function; 2) can distend the blood vessels, and increase the blood flow of tip tremulous pulse; 3) retardance VSMC propagation and then suppress endotheliosis and new life effectively.Participated in multiple inhibition restenosis mechanism of action.Triptolide is a kind of anti-inflammatory response medicine, also has strong immunologic rejection reagentia, can suppress smooth muscle cell, lymphocytic propagation.Therefore, insert and be loaded with above-mentioned support and have following advantage: 1) suppress the formation of new intima and the migration and the propagation of smooth muscle cell with multiple anti-restenosis mechanism of action medicine; 2) prevent platelet aggregation, suppress the formation of thrombosis, reduced stimulation, further prevented restenosis behind the support smooth muscle cell; 3) reduce organ rejection episodes, suppressed inflammatory reaction; 4) can significantly reduce postoperative complication.
Said support comprises conventional support, as rustless steel self expandable support.
The burst release phenomenon of drug stent initial period can influence the endothelialization process of (delaying) blood vessel.For preventing the burst release of medicine at initial period, more effective sustained release speed is provided with the sustained release layer of one deck densification again outside medication coat.This coating is made up of the non-degradable material: the Parylene (trade name of Parylene, Parylene) or derivatives thereof, polytetrafluoroethylene (PTFE) etc., simultaneously for improving the thrombus source of apparatus, also comprise an amount of antithrombotic reagent in the sustained release layer: cough up thunder etc. as cilostazol, ticlopidine or chlorine ratio, its THICKNESS CONTROL is between 0.01～20 micron.
The preparation method of coating stent of medicine of the present invention comprises the steps:
Stainless steel stent is cleaned with isopropyl alcohol, dry;
The polymer dispersion liquid that will be coated with said medicine then is coated on rack surface equably; Support with coating is put in the vacuum drying oven again, solidifies in 0.5～72 hour 20～100 ℃ of dryings; Support can repeatedly repeat said process or the different dispersion liquids of forming of repetitive coatings.
According to the present invention, after applying, adopt medication coat the method repaste of USP 6471980 disclosed vapour depositions to cover the sustained release layer of one deck densification, and its THICKNESS CONTROL is between 0.01～20 micron, and the sustained release layer of densification is the Parylene or derivatives thereof
The solvent of being addressed that polymer dispersion liquid adopted, its effect is dispersion soln or the emulsion that polymer, active component and additive is separated into homogeneous, can preferably adopt in trichloroethane, chloroform, oxolane or the dimethyl acetylamide one or more.
The objective of the invention is to reduce the incidence rate of the restenosis after the intravascular stent plastys such as coronary artery bracket, intracranial stent, the complication that can reduce patient significantly takes place, and improves patient's survival rate and quality of life; From economic angle, because the reduction of restenosis incidence rate has reduced the expense that patient's secondary is treated.
The taxanes medicine is as cytotoxin, can make the apoptosis of contact with it, endotheliocyte and smooth muscle cell are no exception, but various cells are not quite similar to the tolerance degree of paclitaxel: than the endotheliocyte sensitivity, animal experiment shows smooth muscle cell, compares with the drug stent that does not have fine and close sustained release layer to paclitaxel, drug stent of the present invention can continue to reduce new intima and form, prevent restenosis, do not influence normal endothelialization process simultaneously, avoided the risk of tardy property thrombosis.
The specific embodiment
Embodiment 1
0.20g polybutyl methacrylate and 0.20g ethylene-vinyl acetate copolymer are joined in the 10ml trichloroethane, and mixing is uniformly dispersed, and adds the 0.10g paclitaxel again, is uniformly dispersed under the room temperature condition, is sprayed at rack surface then.Air set 60min.Repeat aforesaid operations and reach 50 μ g/cm up to drug loading
2To prop up again and be placed on drying in the vacuum drying oven.Apply the mixture of Parylene and cilostazol by vapour deposition in the outside of drug-loaded layer, thickness is 1 μ m.
Embodiment 2
(for example 0.10g) polylactic acid (PLA) and 0.10g polycaprolactone (PCL) join in the 10ml trichloroethane in right amount, and mixing is uniformly dispersed, and adds the 0.10g paclitaxel again, is uniformly dispersed under the room temperature condition, is sprayed at rack surface then.Air set 60min.Repeat aforesaid operations and reach 400 μ g/cm up to drug loading
2To prop up again and be placed on drying in the vacuum drying oven.Apply the mixture of Parylene and ticlopidine by vapour deposition in the outside of drug-loaded layer, THICKNESS CONTROL is at 0.01 μ m.
Embodiment 3
With for example 0.20g polybutyl methacrylate and 0.20g ethylene-vinyl acetate copolymer join in the 10ml trichloroethane in right amount, mixing is uniformly dispersed, add 0.075g Cilostazol and 0.10g paclitaxel again, be uniformly dispersed under the room temperature condition, be sprayed at rack surface then.Air set 30min.Repeat aforesaid operations and reach 200 μ g/cm up to drug-loaded layer weight
2To prop up again and be placed in 30 ℃ of vacuum drying ovens evacuation 24 hours.For preventing the adhesion between medication coat and the sacculus, can be coated with last layer Parylene or derivatives thereof in the method for rack surface by vapour deposition, its thickness is 10 microns.
Embodiment 4
Will be in right amount for example 0.10g polylactic acid (PLA) and 0.10g polycaprolactone (PCL) join in the 10ml trichloroethane, mixing is uniformly dispersed, and adds 0.075g Cilostazol and 0.10g paclitaxel again, is uniformly dispersed under the room temperature condition, is sprayed at rack surface then.Air set 60min.Repeat aforesaid operations and reach 100 μ g/cm up to drug-loaded layer weight
2To prop up again and be placed in 30 ℃ of vacuum drying ovens evacuation 24 hours.For preventing the adhesion between medication coat and the sacculus, can be coated with last layer Parylene or derivatives thereof in the method for rack surface by vapour deposition, its THICKNESS CONTROL is at 1 micron.
Embodiment 5
With for example 0.10g polybutyl methacrylate and 0.10g ethylene-vinyl acetate copolymer join in the 10ml oxolane in right amount, mixing is uniformly dispersed, add 0.075gCilostazole, 0.05g Triptolid and 0.10g paclitaxel again, be uniformly dispersed under the room temperature condition, be sprayed at rack surface then.Air set 60min.Repeat aforesaid operations and reach 300 μ g/cm up to drug-loaded layer weight
2To prop up again and be placed in 30 ℃ of vacuum drying ovens evacuation 24 hours.
Embodiment 6
The dispersion liquid shown in spraying one deck example 1 on stainless steel stent, medicament contg 20g/cm
2, and then spray one deck dispersion liquid as follows, about 150 μ g/cm
2
Polybutyl methacrylate 15mg/ml
Paclitaxel 7.5mg/ml
Cilostazol 7.5mg/ml
Trichloroethane 10ml
For preventing the adhesion between medication coat and the sacculus, be coated with last layer Parylene or derivatives thereof in the method for rack surface by vapour deposition, its THICKNESS CONTROL is between 5 microns.
Embodiment 7
The dispersion liquid shown in spraying one deck example 1 on stainless steel stent, the about 50 μ g/cm of medicament contg
2, and then spray one deck dispersion liquid as follows, about 100 μ g/cm
2
Polylactic acid (PLA) 15mg/ml
Polycaprolactone (PCL) 15mg/ml
Cilostazol 7.5mg/ml
Paclitaxel 7.5mg/ml
Triptolide 7.5mg/ml
Trichloroethane 10ml
Embodiment 8
The dispersion liquid shown in spraying one deck example 1 on stainless steel stent, the about 80 μ g/cm of medicament contg
2, and then spray one deck dispersion liquid as follows, about 100 μ g/cm
2
Polylactic acid (PLA) 15mg/ml
Polyoxyethylene 20mg/ml
Cilostazol 10mg/ml
Paclitaxel 10mg/ml
Acetone 10ml
Embodiment 9
This example provides drug stent study on the efficiency method.
The study on the efficiency that the present invention promptly contains the coating stent of medicine of taxol drug is to carry out excessively pulling on the coronary artery model of pig.The main terminal point of research is the change that is recorded the control of neointima area by tissue morphology.
In the porcine coronary model, compare with the support of no medication coat, contain composition of medicine (Cilostazol/Paclitaxel) coating bracket and insert back 30 days neointima areas at support and obviously reduce.As seen, the support that has the combination drug coating in pig model can continue to reduce new intima and form, and prevents restenosis.
Embodiment 10
Drug stent release in vitro of the present invention is measured:
To prop up and be placed in the extracorporeal circulation apparatus, and add the 4% bSA phosphate buffer (0.1mol/l PH=7.4) of a certain amount of (such as 220ml), keeping temperature is 37 ± 0.5 ℃.Change release medium weekly one time.
At 6h, 1 day, 2 days, 7 days, 28 days, 30 days taking-up drug stents, analyze the residual volume of medicine in coating bracket respectively.
With the drug stent that takes out, use the acetone eluting, the methanol extraction polymer is got supernatant, measures medicament contg with HPLC, calculates the percentage rate that the medicine that discharges accounts for original drug loading.
The experiment condition of high performance liquid chromatography is as follows:
Mobile phase: methanol/second eyeball/water=25: 35: 40, flow velocity: 1.4ml/min detects wavelength 227nm, column temperature: room temperature.
Claims (8)
1. a coating stent of medicine comprises support and the medication coat that is coated on the support, it is characterized in that said medication coat is the polymer that contains paclitaxel or derivatives thereof and anti-platelet drug; Anti-platelet drug is selected from cilostazol or Ticlopidine.
2. coating stent of medicine according to claim 1 is characterized in that, also contains the anti-inflammatory response medicine in the said medication coat, and the anti-inflammatory response medicine is selected from Triptolide or dexamethasone.
3. coating stent of medicine according to claim 1, it is characterized in that polymer is selected from the homopolymer of lactide, Acetic acid, hydroxy-, bimol. cyclic ester, 6-caprolactone and between the two or in three's copolymer, cellulose family, polyvidon, polyvinyl alcohol, arabic gum, sodium alginate, gelatin, polymethyl methacrylate, poly-methyl-prop diluted acid butyl ester, ethylene-vinyl alcohol copolymer or the ethylene-vinyl acetate copolymer one or more.
4. coating stent of medicine according to claim 1 is characterized in that, drug loading is 20～400 μ g/cm
2
5. according to each described coating stent of medicine of claim 1～4, it is characterized in that, the sustained release layer of the densification of one deck Parylene and derivant thereof or politef formation is set outside medication coat.
6. coating stent of medicine according to claim 5 is characterized in that, also comprises an amount of antithrombotic reagent in the sustained release layer.
7. according to the preparation method of each described coating stent of medicine of claim 1～6, it is characterized in that, comprise the steps: that the polymer dispersion liquid that will be coated with said medicine is coated on rack surface equably; With the support vacuum drying of coating, solidify again, promptly obtain support of the present invention.
8. the preparation method of coating stent of medicine according to claim 7 is characterized in that, the solvent that polymer dispersion liquid adopted comprises one or more in trichloroethane, chloroform, oxolane or the dimethyl acetylamide.
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031289061A CN100346850C (en) | 2003-05-28 | 2003-05-28 | Medicine coating rack |
| PCT/CN2003/000489 WO2004002367A1 (en) | 2002-06-27 | 2003-06-25 | Drug eluting stent |
| EP03739968A EP1516597A4 (en) | 2002-06-27 | 2003-06-25 | Drug eluting stent |
| AU2003280437A AU2003280437A1 (en) | 2002-06-27 | 2003-06-25 | Drug eluting stent |
| JP2004548875A JP2005531391A (en) | 2002-06-27 | 2003-06-25 | Drug release stent |
| US10/943,633 US20050033414A1 (en) | 2002-06-27 | 2004-09-17 | Drug-eluting stent with multi-layer coatings |
| US10/943,636 US20050043788A1 (en) | 2002-06-27 | 2004-09-17 | Drug-eluting stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031289061A CN100346850C (en) | 2003-05-28 | 2003-05-28 | Medicine coating rack |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1552474A CN1552474A (en) | 2004-12-08 |
| CN100346850C true CN100346850C (en) | 2007-11-07 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB031289061A Expired - Lifetime CN100346850C (en) | 2002-06-27 | 2003-05-28 | Medicine coating rack |
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| Country | Link |
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| CN (1) | CN100346850C (en) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100847123B1 (en) * | 2006-11-22 | 2008-07-18 | 주식회사 스텐다드싸이텍 | Stent |
| EP2243501A1 (en) * | 2009-04-24 | 2010-10-27 | Eurocor Gmbh | Shellac and paclitaxel coated catheter balloons |
| CN101879102B (en) * | 2009-05-07 | 2014-07-09 | 上海微创医疗器械（集团）有限公司 | Groove carrying-type coating decomposable drug eluting stent |
| CN102363052A (en) * | 2011-11-03 | 2012-02-29 | 陆培华 | Drug-eluting stent carrying short-chain ceramide |
| CN102872484A (en) * | 2012-10-16 | 2013-01-16 | 天津市第三中心医院 | Preparation method of dexamethasone sodium phosphate composite sustained-release coating and application thereof |
| CN102861364A (en) * | 2012-10-16 | 2013-01-09 | 天津市第三中心医院 | Preparation method and application of dexamethasone sodium phosphate-sodium alga acid composite slow-release coating |
| TWI697337B (en) * | 2013-08-07 | 2020-07-01 | 學校法人近畿大學 | Process for produing nano particle or nano-particle composition, and process for manufacturing stent or balloon catheter |
| CN105597163B (en) * | 2015-12-29 | 2019-05-31 | 先健科技(深圳)有限公司 | Ferrous alloy implanted medical device and preparation method thereof |
| CN107308501A (en) * | 2017-07-20 | 2017-11-03 | 南开大学 | A kind of method that biological activity protein is loaded on hydrophobic scaffold material and application thereof |
| CN108452392A (en) * | 2018-03-28 | 2018-08-28 | 周胜华 | A kind of newtype drug coating bracket and preparation method thereof |
| CN113289074A (en) * | 2020-02-24 | 2021-08-24 | 张建强 | Novel drug-coated stent and preparation method thereof |
| CN113289073A (en) * | 2020-02-24 | 2021-08-24 | 张建强 | Degradable drug stent for preventing or treating intimal hyperplasia after interventional operation and preparation method thereof |
| CN112137758A (en) * | 2020-03-05 | 2020-12-29 | 上海宏派医疗科技有限公司 | Double-layer drug-coated blood vessel covered stent |
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|---|---|---|---|---|
| CN1130866A (en) * | 1993-07-19 | 1996-09-11 | 盎格尼塞斯技术公司 | Anti-angiogenic compositions and method of use |
| US5886026A (en) * | 1993-07-19 | 1999-03-23 | Angiotech Pharmaceuticals Inc. | Anti-angiogenic compositions and methods of use |
| CN1355005A (en) * | 2001-12-13 | 2002-06-26 | 华东理工大学 | Medicine eluted cardiovascular frame and its preparing process |
| CN1367023A (en) * | 2002-03-08 | 2002-09-04 | 清华大学 | Preparation method of biodegradable medicine composite macromolecular scaffold material |
| US6471980B2 (en) * | 2000-12-22 | 2002-10-29 | Avantec Vascular Corporation | Intravascular delivery of mycophenolic acid |
-
2003
- 2003-05-28 CN CNB031289061A patent/CN100346850C/en not_active Expired - Lifetime
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1130866A (en) * | 1993-07-19 | 1996-09-11 | 盎格尼塞斯技术公司 | Anti-angiogenic compositions and method of use |
| US5886026A (en) * | 1993-07-19 | 1999-03-23 | Angiotech Pharmaceuticals Inc. | Anti-angiogenic compositions and methods of use |
| US6471980B2 (en) * | 2000-12-22 | 2002-10-29 | Avantec Vascular Corporation | Intravascular delivery of mycophenolic acid |
| CN1355005A (en) * | 2001-12-13 | 2002-06-26 | 华东理工大学 | Medicine eluted cardiovascular frame and its preparing process |
| CN1367023A (en) * | 2002-03-08 | 2002-09-04 | 清华大学 | Preparation method of biodegradable medicine composite macromolecular scaffold material |
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| CN1552474A (en) | 2004-12-08 |
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