CN103948975B - A kind of targeted drug release gets involved class medical apparatus and instruments and preparation method thereof - Google Patents
A kind of targeted drug release gets involved class medical apparatus and instruments and preparation method thereof Download PDFInfo
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- CN103948975B CN103948975B CN201410209648.XA CN201410209648A CN103948975B CN 103948975 B CN103948975 B CN 103948975B CN 201410209648 A CN201410209648 A CN 201410209648A CN 103948975 B CN103948975 B CN 103948975B
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Abstract
A kind of targeted drug release gets involved class medical apparatus and instruments and preparation method thereof, it is characterized in that: the release of described targeted drug gets involved class medical apparatus and instruments by getting involved class medical apparatus and instruments and slow releasing pharmaceutical coating forms, and slow releasing pharmaceutical coating is on the surface of described intervention class medical apparatus and instruments; Preparation method is included in get involved on class medical apparatus and instruments and applies through medicine, form targeted drug release and get involved class medical apparatus and instruments, the medicine coating getting involved class medical apparatus and instruments is made up of successively the following step: slow releasing pharmaceutical coating is made up of drug material, drug carrier material, antioxidant and binding agent; (1) preparation of slow releasing pharmaceutical coating; (2) coating of slow releasing pharmaceutical coating; (3) dry.Slow releasing pharmaceutical coating of the present invention is high with intervention class medical apparatus surface adhesion strength, and in following process process, drug material can not have loss, and the medication effect that targeted drug release gets involved class medical apparatus and instruments is good.
Description
Technical field
The present invention relates to medical instruments field, be specifically related to can the administration of targeting fixed point, realize intracavitary therapy apparatus that medicine designs at the integral structure of targeting lesion region slow release and preparation method thereof.
Background technology
Along with the extensive use of medicine slow release stent system and the development of new technique, people are more deep to medicine slow release stent systematic research.Find in operation, when stenter to implant Ink vessel transfusing, because the expansion of the support of metal or nonmetal structure supports, inevitably blood vessel is swiped, thus cause damage.After surgery, needs of patients takes anticoagulation medicine to avoid the formation of thrombosis.Relative to the bare bracket not having medication coat, in 30 days, vascular endothelial cell can heal automatically, and patient need not take anticoagulation medicine again, but the probability that restenosis occurs is 25 ~ 50%.And medicine (comprising rapamycin and derivant, paclitaxel and derivant thereof) is although slow release stent effectively inhibits vascellum endometrial hyperplasia, be delayed the healing of vascular endothelial cell due to the slow releasing of medicine.Cause stenter to implant and late period the lethal potential danger of acute thrombus occurs.According to relevant data display, medicine slow release stent still has the case that acute thrombus occurs to occur at implantable intravascular after 2 years.Therefore the implantation rate of some national drug slow release stent systems (DES) of west drops to current 70% from 90% of the first two years.
So new apparatus and therapeutic strategy continue to bring out and be intended to capture this difficult problem in recent years, drug release sacculus (DEB) is wherein one of more promising technology.Medicament elution sacculus be traditional balloon angioplasty and advanced drug delivery technologies in conjunction with product.In theory, sacculus is the ideal carrier of anti-proliferative drugs, medicine in process of expansion by rapid, extrude and be released into local vessel wall and the effect playing prevention of restenosis uniformity, the high local concentrations persistent period needed for antiproliferative effect is shorter, so be conducive to carrying out fast of blood vessel wall endothelialization, thus avoid the generation of thrombosis.One as stenting is effectively supplemented card and is demonstrated its superiority gradually.
But get involved in class medical device product at the drug release of listing at present, a lot of product occurs that medication coat peels off serious phenomenon in process of expansion in vitro, this can cause medicine in vivo in course of conveying, drug loss is serious, the targeting target bit dose having influence on coating is further unstable, thus affects therapeutic effect.This is the imperfection due to coating formula and coating process, causes existing product in the sequential folds course of processing, and drug loss is serious, have impact on the drug targeting treatment in operation.The medicine for the treatment of in current coating is fat-soluble medicine (paclitaxel, rapamycin and derivant thereof etc.) substantially, and be water soluble drug (iodixanol, Iopromide, carbamide, polyvinyl alcohol etc.) as the carrier material of promotion drug release, the bond strength of medicine and carrier is low, thus it is low to result in binding strength of coating, following process difficulty.
Summary of the invention
The object of the invention is to provide the release of a kind of targeted drug and gets involved class medical apparatus and instruments and preparation method thereof, solves ubiquity medication coat under current technique low with intervention class medical apparatus surface adhesion strength, thus affects a difficult problem for apparatus medication effect.
For achieving the above object, the technical scheme that a kind of targeted drug release that the present invention adopts gets involved class medical apparatus and instruments is: described targeted drug release gets involved class medical apparatus and instruments by getting involved class medical apparatus and instruments and slow releasing pharmaceutical coating forms, and slow releasing pharmaceutical coating is on the surface of described intervention class medical apparatus and instruments; Described slow releasing pharmaceutical coating is made up of drug material, drug carrier material, antioxidant and binding agent;
Described drug material selects the mixture of any one or at least two kinds in llowing group of materials: heparin sodium, batroxobin, Ahylysantinfarctase, aspirin, hirudin, colchicine, rapamycin, Everolimus, Biolimus, Zotarolimus, Tracrolimus, atorvastatin, pravastatin, ciclosporin, Anti-CD34, dexamethasone, bleomycin, plicamycin, ametycin, actinomycin D, paclitaxel, tripterine, methotrexate;
Described drug carrier material selects the mixture of any one or at least two kinds in llowing group of materials: poly phosphate, biological species apatite, Heparinized Polymers, heparin, polylactic acid, iodixanol, Iopromide, carbamide, polyvinyl alcohol, lac, chitin;
The mixture of any one or at least two kinds in llowing group of materials selected by described antioxidant: Butylated hydroxyanisole, dibenzylatiooluene, calcium ascorbate, phospholipid, ascorbic acid, sodium ascorbate, vitamin E, Herba Rosmarini Officinalis extract and AOB;
Described binding agent selects the mixture of any one or at least two kinds in llowing group of materials: polymethyl methacrylate and derivant, polybutyl methacrylate and derivant thereof, polyisobutyl methacrylate and derivant thereof.
Related content in technique scheme is explained as follows:
1, in such scheme, preferably scheme is described intervention class medical apparatus and instruments is that blood vessel gets involved class medical apparatus and instruments and Non-vascularized iliac bone medical apparatus and instruments; It is arteria coronaria sacculus dilating catheter and support or peripheral vascular balloon dilatation catheter and support that wherein said blood vessel gets involved class medical apparatus and instruments; Described Non-vascularized iliac bone class medical apparatus and instruments is urethral dilatation support, dilatation of ureter support, biliary tract expansion support or esophagectasia support.Targeted drug release intracavity of the present invention is got involved class medical apparatus and instruments and is particularly suitable for the body cavity class diseases such as treatment coronary artery, peripheral blood vessel, esophagus, biliary tract, urethra.
For achieving the above object, the technical scheme of the preparation method of a kind of targeted drug release intervention class medical apparatus and instruments that the present invention adopts is: this preparation method is included in get involved on class medical apparatus and instruments and forms targeted drug release intervention class medical apparatus and instruments through medicine coating, and the medicine coating of described intervention class medical apparatus and instruments is made up of successively the following step:
(1), the preparation of slow releasing pharmaceutical coating
A, preparation slow releasing pharmaceutical coating material, described slow releasing pharmaceutical coating material is made up of drug material, drug carrier material, antioxidant and binding agent;
1., described drug carrier material selects any one or at least two kinds in llowing group of materials with the mixture of arbitrary proportion: poly phosphate, biological species apatite, Heparinized Polymers, heparin, polylactic acid, iodixanol, Iopromide, carbamide, polyvinyl alcohol, lac, chitin;
2., described drug material selects the mixture of any one or at least two kinds in llowing group of materials: heparin sodium, batroxobin, Ahylysantinfarctase, aspirin, hirudin, colchicine, rapamycin, Everolimus, Biolimus, Zotarolimus, Tracrolimus, atorvastatin, pravastatin, ciclosporin, Anti-CD34, dexamethasone, bleomycin, plicamycin, ametycin, actinomycin D, paclitaxel, tripterine, methotrexate;
3., described antioxidant selects any one or at least two kinds in llowing group of materials with the mixture of arbitrary proportion: Butylated hydroxyanisole, dibenzylatiooluene, calcium ascorbate, phospholipid, ascorbic acid, sodium ascorbate, vitamin E, Herba Rosmarini Officinalis extract and AOB;
4., described binding agent selects the mixture of any one or at least two kinds in llowing group of materials: polymethyl methacrylate and derivant, polybutyl methacrylate and derivant thereof, polyisobutyl methacrylate and derivant thereof;
B, preparation solvent, described solvent select in any one or at least two kinds with the mixture of arbitrary proportion: formic acid, acetic acid, glycerol, ethanol, isopropyl alcohol, acetone, butanone, Ketohexamethylene, ethyl acetate, butyl acetate, oxolane, dichloromethane and normal hexane;
C, slow releasing pharmaceutical coating material is added in solvent, stir after mixing, wherein, described drug carrier material, antioxidant, drug material and binding agent are 0.001 ~ 0.35,0.00002 ~ 0.0020,0.0005 ~ 0.20 and 0.00002 ~ 0.20 with the mass ratio of solvent respectively;
(2), the coating of slow releasing pharmaceutical coating
The slow releasing pharmaceutical coating being dissolved with drug material, drug carrier material, antioxidant and binding agent is coated on the surface of getting involved class medical apparatus and instruments by following process:
Ultrasonic spraying, imbibition coating, injection coating, gas help spraying, electrostatic spraying, piezoelectricity spraying, electrostatic spinning or dip-coating method be coated to the surface of getting involved class medical apparatus and instruments, intervention class medical apparatus surface medicament contg is 0.1 ~ 10 μ g/mm2;
(3), dry
The intervention class medical apparatus and instruments being coated with slow releasing pharmaceutical coating is moved into temperature be less than or equal to 90 DEG C, be more than or equal in the vacuum drying oven of 15 DEG C and carry out drying.
Related content in technique scheme is explained as follows:
1, in such scheme, preferably scheme is described intervention class medical apparatus and instruments is that blood vessel gets involved class medical apparatus and instruments and Non-vascularized iliac bone medical apparatus and instruments; It is arteria coronaria sacculus dilating catheter and support or peripheral vascular balloon dilatation catheter and support that wherein said blood vessel gets involved class medical apparatus and instruments; Described Non-vascularized iliac bone class medical apparatus and instruments is urethral dilatation support, dilatation of ureter support, biliary tract expansion support or esophagectasia support etc.
Design principle of the present invention and beneficial effect are: present invention adds antioxidant materials, can guarantee that intracavity is got involved class medical apparatus and instruments and stored in link in circulation on the one hand, medicine can not produce the phenomenon of degraded, decomposition, dissolving because of the unstability of environmental condition, thus affects therapeutic effect; Secondly, the use of adhesive material enhances the adhesion between coating solution and apparatus, make the sacculus after coating in follow-up folding processing, and in external augmentation test, obvious slight crack can not be produced and come off, ensure that the drug dose scope of targeting lesion in body, thus reach therapeutic effect.It is high that slow releasing pharmaceutical coating on targeted drug release intervention class medical apparatus and instruments of the present invention and intracavity get involved class medical apparatus surface adhesion strength, in following process process, drug material can not have loss, and the medication effect that targeted drug release gets involved class medical apparatus and instruments is good.
Accompanying drawing explanation
Accompanying drawing 1 is the medication coat SEM picture before the sacculus dilating catheter of the embodiment of the present invention one folds.
Accompanying drawing 2 is the medication coat SEM picture after the sacculus dilating catheter of the embodiment of the present invention one folds.
Detailed description of the invention
Below in conjunction with drawings and Examples, the invention will be further described:
Embodiment one: a kind of targeted drug release gets involved class medical apparatus and instruments and preparation method thereof
Intervention class medical apparatus and instruments used is arteria coronaria sacculus dilating catheter.By the polylactic acid of the paclitaxel of 100mg, 30mg, the polymethyl methacrylate of 5mg, be dissolved in the solution (volume ratio is acetone: formic acid: vitamin E=8: 1:1) of 2ml acetone and formic acid and vitamin E, ultrasonic 10min, obtains finely dispersed medication coat storing solution.Be the balloon surface of 3.0 × 20mm by above-mentioned solution spraying in dimensions, make drug loading reach 3 μ g/mm
2left and right, dry, folding, namely obtain medicinal balloon, accompanying drawing 1 is its folding prodrug coating surface SEM picture, and from figure, we can find out that balloon surface is smooth, flawless, to produce without fragment, accompanying drawing 2 is folding rear medication coat surface SEM picture, from figure, we can find out that coating does not lack, and fragment etc. still maintain intact coating structure.
Embodiment two: a kind of targeted drug release gets involved class medical apparatus and instruments and preparation method thereof
Intervention class medical apparatus and instruments used is peripheral vascular balloon dilatation catheter.By the chitin of the paclitaxel of 200mg, 50mg, the polybutyl methacrylate of 18mg, be dissolved in the solution (volume ratio is ethanol: acetic acid: vitamin E=7: 2:1) of 10ml ethanol, acetic acid and vitamin E, ultrasonic 10min, forms finely dispersed medication coat storing solution.Be the balloon surface of 4.0x100mm by above-mentioned solution dip-coating in dimensions, make drug loading reach 2 μ g/mm
2left and right, dries, folding, namely obtains medicinal balloon.
Embodiment three: a kind of targeted drug release gets involved class medical apparatus and instruments and preparation method thereof
Intervention class medical apparatus and instruments used is urethral dilatation support.By the iodixanol of the plicamycin of 400mg, 700mg, the polyisobutyl methacrylate of 400mg, be dissolved in the solution (volume ratio is glycerol: acetone: Butylated hydroxyanisole=3: 6:1) of 2ml glycerol, acetone and Butylated hydroxyanisole, ultrasonic 10min, forms finely dispersed medication coat storing solution.Biliary tract expansion rack surface is coated in above-mentioned solution imbibition, makes drug loading reach 9 μ g/mm
2left and right, dries, namely obtains medicament slow release urethral dilatation support.
Embodiment four: a kind of targeted drug release gets involved class medical apparatus and instruments and preparation method thereof
Intervention class medical apparatus and instruments used is biliary tract expansion support.By the carbamide of the tripterine of 0.1mg, 2mg, the polybutyl methacrylate of 0.04mg, be dissolved in the solution (oxolane: ethanol: ascorbic acid=45: 54:1) of 2ml oxolane, ethanol and ascorbic acid, ultrasonic 10min, forms finely dispersed medication coat storing solution.By above-mentioned solution electrostatic spraying in biliary tract expansion rack surface, drug loading is made to reach 1 μ g/mm
2left and right, dries, folding, namely obtains medicament slow release biliary tract expansion support.
In above embodiment, drug material used can also select heparin sodium, the acceptable extract of reptilase pharmacy (as batroxobin), Ahylysantinfarctase, aspirin, hirudin, colchicine, rapamycin, Everolimus, Biolimus, Zotarolimus, Tracrolimus, atorvastatin, pravastatin, ciclosporin, Anti-CD34, dexamethasone, bleomycin, ametycin, actinomycin D, methotrexate; Drug carrier material used can also select poly phosphate, biological species apatite, heparin, polylactic acid, Iopromide, carbamide, polyvinyl alcohol, lac, chitin; Antioxidant used can also select dibenzylatiooluene, calcium ascorbate, phospholipid, sodium ascorbate, Herba Rosmarini Officinalis extract or AOB; Described binding agent can also select the derivant of the derivant of polymethyl methacrylate, the derivant of polybutyl methacrylate or polyisobutyl methacrylate; Solvent used all right formic acid, isopropyl alcohol, butanone, Ketohexamethylene, ethyl acetate, butyl acetate, dichloromethane or normal hexane.Intervention class medical apparatus and instruments used can also be that the intracavity well known to those skilled in the art that coronary dilation support, periphery expandable stent, urethral dilatation support, esophagectasia support, dilatation of ureter support or biliary tract expansion support etc. are conventional gets involved class medical apparatus and instruments.
Above-described embodiment, only for technical conceive of the present invention and feature are described, its object is to person skilled in the art can be understood content of the present invention and implement according to this, can not limit the scope of the invention with this.All equivalences done according to spirit of the present invention change or modify, and all should be encompassed within protection scope of the present invention.
Claims (2)
1. the preparation method of a targeted drug release intervention class medical apparatus and instruments, be included in get involved on class medical apparatus and instruments and form targeted drug release intervention class medical apparatus and instruments through medicine coating, it is characterized in that: the release of described targeted drug gets involved class medical apparatus and instruments by getting involved class medical apparatus and instruments and slow releasing pharmaceutical coating forms, and slow releasing pharmaceutical coating is on the surface of described intervention class medical apparatus and instruments; Described slow releasing pharmaceutical coating is made up of drug material, drug carrier material, antioxidant and binding agent;
Described drug material selects the mixture of any one or at least two kinds in llowing group of materials: heparin sodium, batroxobin, Ahylysantinfarctase, aspirin, hirudin, colchicine, rapamycin, Everolimus, Biolimus, Zotarolimus, Tracrolimus, atorvastatin, pravastatin, ciclosporin, Anti-CD34, dexamethasone, bleomycin, plicamycin, ametycin, actinomycin D, paclitaxel, tripterine, methotrexate;
Described drug carrier material selects the mixture of any one or at least two kinds in llowing group of materials: poly phosphate, biological species apatite, Heparinized Polymers, heparin, polylactic acid, iodixanol, Iopromide, carbamide, polyvinyl alcohol, lac, chitin;
Vitamin E selected by described antioxidant;
Described binding agent selects polymethyl methacrylate;
The medicine coating of described intervention class medical apparatus and instruments is made up of successively the following step:
(1), the preparation of slow releasing pharmaceutical coating
A, preparation slow releasing pharmaceutical coating material, described slow releasing pharmaceutical coating material is made up of drug material, drug carrier material, antioxidant and binding agent;
1., described drug carrier material selects any one or at least two kinds in llowing group of materials with the mixture of arbitrary proportion: poly phosphate, biological species apatite, Heparinized Polymers, heparin, polylactic acid, iodixanol, Iopromide, carbamide, polyvinyl alcohol, lac, chitin;
2., described drug material selects the mixture of any one or at least two kinds in llowing group of materials: heparin sodium, batroxobin, Ahylysantinfarctase, aspirin, hirudin, colchicine, rapamycin, Everolimus, Biolimus, Zotarolimus, Tracrolimus, atorvastatin, pravastatin, ciclosporin, Anti-CD34, dexamethasone, bleomycin, plicamycin, ametycin, actinomycin D, paclitaxel, tripterine, methotrexate;
3., vitamin E selected by described antioxidant;
4., described binding agent selects polymethyl methacrylate;
B, preparation solvent, the mixture of described solvent formic acid and acetone, the volume ratio of formic acid and acetone is 1:8;
C, slow releasing pharmaceutical coating material is added in solvent, stir after mixing, wherein, described drug carrier material, antioxidant, drug material and binding agent are 0.001 ~ 0.35,0.00002 ~ 0.0020,0.0005 ~ 0.20 and 0.00002 ~ 0.20 with the mass ratio of solvent respectively;
(2), the coating of slow releasing pharmaceutical coating
The slow releasing pharmaceutical coating being dissolved with drug material, drug carrier material, antioxidant and binding agent is coated on the surface of getting involved class medical apparatus and instruments by following process:
Ultrasonic spraying, imbibition coating, injection coating, gas help spraying, electrostatic spraying, piezoelectricity spraying, electrostatic spinning or dip-coating method be coated to the surface of getting involved class medical apparatus and instruments, intervention class medical apparatus surface medicament contg is 0.1 ~ 10 μ g/mm2;
(3), dry
The intervention class medical apparatus and instruments being coated with slow releasing pharmaceutical coating is moved into temperature be less than or equal to 90 DEG C, be more than or equal in the vacuum drying oven of 15 DEG C and carry out drying.
2. a kind of targeted drug release intracavity according to claim 1 gets involved the preparation method of class medical apparatus and instruments, it is characterized in that: described intervention class medical apparatus and instruments is that blood vessel gets involved class medical apparatus and instruments and Non-vascularized iliac bone medical apparatus and instruments; It is arteria coronaria sacculus dilating catheter and support or peripheral vascular balloon dilatation catheter and support that wherein said blood vessel gets involved class medical apparatus and instruments; Described Non-vascularized iliac bone class medical apparatus and instruments is urethral dilatation support, dilatation of ureter support, biliary tract expansion support or esophagectasia support.
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| CN105031741A (en) * | 2015-03-03 | 2015-11-11 | 江苏海泽医疗科技发展有限公司 | Medical catheter with anti-infective drug coating and drug slowly-releasing function and preparing method thereof |
| CN106512188A (en) * | 2016-12-13 | 2017-03-22 | 天津飞捷科技有限公司 | Mechanical and electrical integrated targeted drug release intervention medical instrument and preparation method thereof |
| JP7315658B2 (en) * | 2018-08-01 | 2023-07-26 | ボストン サイエンティフィック サイムド，インコーポレイテッド | Drug release coating composition |
| CN109288832B (en) * | 2018-10-31 | 2021-01-29 | 浦易（上海）生物技术有限公司 | Medicinal coating composition for ureteral stent and preparation method and application thereof |
| CN112023125B (en) * | 2019-06-03 | 2023-03-21 | 上海微创医疗器械（集团）有限公司 | Crystalline coating and preparation method thereof, drug-loaded implant medical device and preparation method thereof |
| CN110384854B (en) * | 2019-08-02 | 2020-12-01 | 上海心玮医疗科技有限公司 | A kind of drug balloon with controllable drug metabolism and preparation method thereof |
| CN110675717B (en) * | 2019-10-10 | 2021-09-14 | 吉林大学 | Bionic equipment for simulating vascular stenosis and thrombus |
| CN110665072A (en) * | 2019-11-23 | 2020-01-10 | 吉林省蔚来生物科技有限公司 | Targeted drug release interventional medical instrument and preparation method thereof |
| CN114146231A (en) * | 2020-09-07 | 2022-03-08 | 上海鸿脉医疗科技有限公司 | Drug balloon and preparation method thereof |
| CN113893447A (en) * | 2021-10-13 | 2022-01-07 | 成都理工大学 | Drug coating balloon and preparation method thereof |
| CN115300675A (en) * | 2022-03-21 | 2022-11-08 | 上海以心医疗器械有限公司 | Medical device with drug coating and preparation method and application thereof, drug coating and application thereof |
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