CN103655015A - Medicine-carrying nanofiber membrane biliary stent and preparation method thereof - Google Patents
Medicine-carrying nanofiber membrane biliary stent and preparation method thereof Download PDFInfo
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- CN103655015A CN103655015A CN201310728629.3A CN201310728629A CN103655015A CN 103655015 A CN103655015 A CN 103655015A CN 201310728629 A CN201310728629 A CN 201310728629A CN 103655015 A CN103655015 A CN 103655015A
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Abstract
The invention discloses a medicine-carrying nanofiber membrane biliary stent and a preparation method thereof. The medicine-carrying nanofiber membrane biliary stent comprises one part of nanofiber inner layers, the other part of nanofiber inner layers, a metal support and a medicine-carrying degraded fiber outer layer from inside to outside, wherein one part of nanofiber inner layers are arrayed in the pipe diameter direction, and the other part of nanofiber inner layers are arrayed disorderly. The nanofiber inner layers arrayed in the pipe diameter direction and the nanofiber inner layers arrayed disorderly are bonded together. The nanofiber inner layers arrayed disorderly and the medicine-carrying degraded fiber outer layer are boned together through meshes of the metal support, and the metal support is firmly fixed in a fiber membrane. The preparation method includes that electrostatic spinning equipment is adopted for electrostatic spinning. Compared with a micro-nano ball, the nanofiber membrane biliary stent has better structural stability, can be used for treating biliary stricture caused by tumors, has a mechanical expansion effect and a local treatment function, and can solve the biliary malignant stricture better than a common stent or a membrane-covering stent. In addition, the method can be applied to gastrointestinal tract stents and tracheal stents.
Description
Technical field
The present invention relates to a kind of biliary tract rack and preparation method thereof, belong to medical material tech field.
Background technology
The obstructive jaundice case increasing year by year causing because of tumor, and PTCD(percutaneous transhepatic cholangiography and drainage) case of postoperative jaundice recurrence still happens occasionally.Tracing it to its cause, is mainly because the bare metal stent using expansible biliary tract in a short time after implanting forms unobstructed path, but along with the development of tumor, tumor tissues is grown in edge climbing and mesh along support, makes bile duct occur restenosis, biliary drainage is obstructed, and causes jaundice again to occur.In order to solve the problem of biliary tract rack restenosis, be reported in metal rack and apply polyurethanes outward and carry out overlay film, can stop tumor by mesh to growth inside, but can't resolve tumor tissues, by climbing, spread growth and block support port.In order to prevent the too fast growth of tumor and bile duct restenosis, the overlay film frame of exploitation medicine carrying, can solve biliary tract stenosis problem.Patent 200510030443.6 discloses a kind of medicine-loading sustained-releasing nanosphere alimentary tract stent, comprising: support, backing layer, medicine carrying micro-nano ball, medicine carrying micro-nano ball storage layer, protective layer.Take micro-nano ball as carrier, can greatly improve drug loading, and contribute to the dissolution rate and the permeable membrane that improve medicine to absorb.But still need further improvement.
Summary of the invention
The present invention's discovery, than micro-nano ball, the pharmaceutical carrier consisting of fiber has better structural stability, for building medicine carrying overlay film, has obvious advantage.Development due to electrostatic spinning technique, various synthetic macromolecules and natural polymer all can be prepared into nanometer or micron order fiber by electrostatic spinning technique, its principle is: solution is divided into nanometer to micron-sized fiber under the effect of electric field force, solvent vapors away in the process that arrives receiving system, and resulting fiber mutually overlaps and forms porous material on receiving system surface.Because the prepared material of electrostatic spinning is to consist of fiber, its surface area is large, during for biomaterial, can increase the contact area of material and surrounding tissue or body fluid, can to a certain degree accelerate the degradation rate of material.Simultaneously, drug encapsulation also can be played to the slow releasing function to medicine in the fiber of micro/nano level, in addition, electrostatic spinning technique only needs to adjust receiving system, just can form the uniform fibrous layer with material appearance similar at tabular, tubulose, approximate tubulose or netted material surface, therefore the overlay film modification for biliary tract rack will have its significant advantage.
Technical scheme of the present invention is: a kind of medicament-carrying nano-fiber membrane biliary tract rack, it is characterized in that, comprise successively from inside to outside: the nanofiber internal layer of caliber direction orientations, the nanofiber internal layer of lack of alignment, metal rack (without the bare bracket of overlay film) and medicine carrying degradation of fibers are outer; Together with the nanofiber internal layer of described caliber direction orientations and the nanofiber internal layer of lack of alignment are attached on; Together with the nanofiber internal layer of described lack of alignment and the medicine carrying degradation of fibers skin mesh by metal rack is attached on, metal rack is securely fixed in fibrous membrane, prevents that support from installing and the disengaging of dispose procedure medium-height trestle and fibrous membrane.
The nanofiber internal layer of described caliber direction orientations, the nanofiber internal layer of lack of alignment and the outer field thickness proportion of medicine carrying degradation of fibers are 1-5:1-5:2-10.
Wherein said metal rack is sold netted or Z-type metal biliary tract rack by market.Described medicine carrying degradation of fibers is outer, its material is degradable polymeric biomaterial, by fibrous material with material modifiedly form, mass ratio 1 ~ 99:1 ~ 99 of the two, wherein fibrous material comprises one or more in following material: polycaprolactone, polylactic acid, polyurethane, polyethylene, described material modified one or more in fibroin albumen, fibrin of comprising; Contained medicine is: the cancer therapy drugs such as fluorouracil, cisplatin, amycin.The nanofiber internal layer of described caliber direction orientations and the nanofiber internal layer of lack of alignment are polymeric biomaterial, and it comprises one or more the composite in following material: polycaprolactone, polylactic acid, polyurethane, polyethylene etc.
The nanofiber internal layer of caliber direction orientations of the present invention can effectively reduce the frictional force of bile flow, increases bile flow velocity, thereby reduces bile at adhesion and the calculus of support intimal surface.The nanofiber internal layer of lack of alignment forms, and guarantees nanofiber fixing of caliber direction orientations.The brute force of metal rack expands and ensures that biliary tract is unobstructed.The outer field microcellular structure of medicine carrying degradation of fibers is beneficial to drug release, and medicine constantly discharges by the degraded of biodegradable fiber, makes tumor around in high concentration medicine environment, reaches the object that suppresses tumor growth and treat tumor.
Preparation method: adopt electrospinning device to carry out electrostatic spinning, electrospinning device is biological medicine special high-pressure electrostatic spinning machine, comprises the wire drawing device of high tension generator, Ultra-Low Speed, the nozzle system can horizontal direction moving, dual pathways dosing pump etc.Concrete steps are: first metal is accepted to rod and be fixed on the wire drawing device of electrospinning device, and give and certain rotating speed, nozzle system by electrospinning device move horizontally preparation along the nanofiber internal layer of caliber direction orientations, then stop the nanofiber internal layer that nozzle system moves horizontally preparation lack of alignment; Metal rack is enclosed within on the nanofiber internal layer of lack of alignment, by coaxial cospinning method, degradable macromolecule solution and medicine are formed to certain thickness medicine carrying degradation of fibers skin at metal support surface under the effect of electric field force, and make to be bonded together between each layer of fiber by interfibrous adhesion.
Specifically comprise the following steps:
(1) the cancer therapy drug C solution that the macromolecule A solution that compound concentration is 3-30wt%, the macromolecule B solution that concentration is 3-30 wt% and concentration are 1-10mg/ml;
(2) metal being accepted to rod is fixed on wire drawing device, it is that 0.5-2m/s, wire drawing device rotating speed are that 10-300 r/s and receiving range are 5-15cm that adjustment nozzle system moves horizontally speed, and adjustment spinning voltage is that the flow velocity of 9-15kV and macromolecular solution A is 0.1 ~ 3.0ml/h; After 0.5 ~ 1.5h, stop nozzle system and move horizontally, can obtain the nanofiber internal layer of caliber direction orientations;
(3) stop nozzle system and move horizontally, keep receiving range, the flow velocity of spinning voltage and macromolecular solution A is constant; Adjusting wire drawing device rotating speed is 10-300 r/s, and after 0.5 ~ 1.5h, powered-down, stops spinning, obtains the nanofiber internal layer of lack of alignment;
(4) metal rack is enclosed within on the nanofiber internal layer of lack of alignment;
(5) rotating speed of adjustment wire drawing device is that 10-500r/s and receiving range are 5-15cm, adjustment spinning voltage is 9-15kV, macromolecular solution B and cancer therapy drug solution C are carried out to coaxial cospinning, solution flow rate is 0.1 ~ 3.0ml/h, powered-down after 1.0 ~ 5.0h, stop spinning, obtain medicine carrying degradation of fibers outer;
(6) overlay film frame of having prepared, processes through methanol solution, after normal-temperature vacuum is dry, obtains finished product.
Wherein, described macromolecule A, comprises one or more the composite in following material: polycaprolactone, polylactic acid, polyurethane, polyethylene etc.; Described macromolecule B, by fibrous material with material modifiedly form, mass ratio 1 ~ 99:1 ~ 99(the preferred proportion of the two is 1 ~ 5:1), wherein fibrous material comprises one or more in following material: polycaprolactone, polylactic acid, polyurethane, polyethylene, described material modified one or more in fibroin albumen, fibrin of comprising; Described cancer therapy drug C, comprises the cancer therapy drugs such as fluorouracil, cisplatin, amycin.
Nano fibrous membrane biliary tract rack provided by the present invention, has better structural stability than micro-nano ball.Can be used for treating the biliary tract stenosis that tumor causes, not only there is mechanical expansion effect, also there is local therapeutic effects, will can better solve the narrow problem of malignant biliary than ordinary stent or overlay film frame.In addition, this method also can be used for gastrointestinal tract, trachea bracket.
Accompanying drawing explanation
Accompanying drawing 1 is structural representation of the present invention.Wherein, 1, the nanofiber internal layer of caliber direction orientations, 2, the nanofiber internal layer of lack of alignment, 3, metal rack, 4, medicine carrying degradation of fibers is outer.
The specific embodiment
Embodiment 1
As shown in Figure 1, a medicament-carrying nano-fiber membrane biliary tract rack, comprises from inside to outside successively: the nanofiber internal layer 1 of caliber direction orientations, the nanofiber internal layer 2 of lack of alignment, metal rack (without the bare bracket of overlay film) 3 and medicine carrying degradation of fibers skin 4; Together with the nanofiber internal layer 1 of described caliber direction orientations and the nanofiber internal layer 2 of lack of alignment are attached on; Together with the nanofiber internal layer 2 of described lack of alignment and medicine carrying degradation of fibers skin 4 mesh by metal rack 3 is attached on, metal rack 3 is securely fixed in fibrous membrane, prevent support install and dispose procedure in the disengaging of metal rack and fibrous membrane.
The present embodiment is used high-voltage electrostatic spinning Ji Wei Shenzhen concerted effort micro-nano Science and Technology Ltd. to produce TL-03 type high-voltage electrostatic spinning machine; Metal rack used is sold netted Ti-Ni alloy biliary tract rack, diameter 8mm, length 80mm by market.
Preparation method:
(1) along the preparation of the nanofiber internal layer of caliber direction orientations: the polyurethane solutions that compound concentration is 6%, solvent is N, the mixed solution of dinethylformamide and tetrachloromethane (the volume ratio 3:7 of the two), by diameter, be that 8mm metal is accepted rod and is fixed on wire drawing device, wire drawing device rotating speed is 30r/s, and receiving range is 10cm, it is 1m/s that nozzle system moves horizontally speed, spinning voltage is 11kV, and solution flow rate is 0.3 mL/h, after 0.5h, stops;
(2) preparation of the internal layer nanofiber of lack of alignment: stop nozzle system and move horizontally, wire drawing device adjustment of rotational speed is 15r/s, and receiving range, spinning voltage and solution flow rate are constant, stop after 0.5h;
(3) metal rack is enclosed within on the nanofiber internal layer of certain thickness lack of alignment;
(4) preparation of medicament-carrying nano-fiber layer: preparation polycaprolactone and the fibroin albumen solution that 1:1 melting concn is 8% in mass ratio, solvent is the mixed solution (the volume ratio 3:7 of the two) of DMF and tetrachloromethane.The solution that preparation cisplatin concentration is 5mg/mL, solvent is DMF.Adopt coaxial co spun technology, wire drawing device rotating speed is 15r/s, and receiving range is 10cm, and spinning voltage is 11kV, and solution flow rate is 0.3 mL/h, after 2h, stops.
(5) dried of overlay film frame: the overlay film frame of having prepared, be placed in 90% methanol solution and process 1h, normal-temperature vacuum is dried 24h, and obtaining thickness is 0.3mm, the medicine-carrying membrane-covered stent that caliber is 8mm.
The present embodiment is used high-voltage electrostatic spinning Ji Wei Shenzhen concerted effort micro-nano Science and Technology Ltd. to produce TL-03 type high-voltage electrostatic spinning machine; Metal rack used is sold netted Ti-Ni alloy biliary tract rack, diameter 8mm, length 80mm by market.
Preparation method:
(1) along the preparation of the nanofiber internal layer of caliber direction orientations: the polyurethane solutions that compound concentration is 6%, solvent is the mixed solution (the volume ratio 2:8 of the two) of DMF and tetrachloromethane; By diameter, be that 8mm metal is accepted rod and is fixed on wire drawing device, wire drawing device rotating speed is 30r/s, and receiving range is 10cm, and it is 1m/s that shower nozzle moves horizontally speed, and spinning voltage is 11kV, and solution flow rate is 0.3 mL/h, after 0.5h, stops;
(2) preparation of the internal layer nanofiber of lack of alignment: stop nozzle system and move horizontally, adjustment of rotational speed is 15r/s, and receiving range, spinning voltage and solution flow rate are constant, stop after 0.5h;
(3) metal rack is enclosed within on the nanofiber internal layer of certain thickness lack of alignment;
(4) preparation of medicament-carrying nano-fiber layer: preparation polycaprolactone and the fibroin albumen solution that 3:2 melting concn is 8% in mass ratio, solvent is the mixed solution (the volume ratio 2:8 of the two) of DMF and tetrachloromethane.The solution that preparation cisplatin concentration is 5mg/mL, solvent is DMF.Adopt coaxial co spun technology, receiving system rotating speed is 15r/s, and receiving range is 10cm, and spinning voltage is 11kV, and solution flow rate is 0.3 mL/h, after 2h, stops;
(5) dried of overlay film frame: the overlay film frame of having prepared, be placed in 90% methanol solution and process 1h, normal-temperature vacuum is dried 24h, and obtaining thickness is 0.3mm, the medicine-carrying membrane-covered stent that caliber is 8mm.
The present embodiment is used high-voltage electrostatic spinning Ji Wei Shenzhen concerted effort micro-nano Science and Technology Ltd. to produce TL-03 type high-voltage electrostatic spinning machine; Metal rack used is sold netted Ti-Ni alloy biliary tract rack, diameter 8mm, length 60mm by market.
Preparation method:
(1) along the preparation of the nanofiber internal layer of caliber direction orientations: the polylactic acid solution that compound concentration is 10%, solvent is the mixed solution (the volume ratio 2:8 of the two) of DMF and tetrachloromethane; The metal that is 8mm by diameter is accepted rod and is fixed on wire drawing device, and adjusting receiving system rotating speed is 30r/s, and receiving range is 15cm, and it is 0.5m/s that nozzle system moves horizontally speed, and spinning voltage is 10kV, and solution flow rate is 0.25 mL/h, after 1h, stops.
(2) preparation of the internal layer nanofiber of lack of alignment: stationary nozzle, adjustment of rotational speed is 15r/s, receiving range, spinning voltage and solution flow rate are constant, after 1h, stop.
(3) metal rack is enclosed within on the nanofiber internal layer of certain thickness lack of alignment;
(4) preparation of medicament-carrying nano-fiber layer: preparation polylactic acid and the fibroin albumen solution that 4:1 melting concn is 10% in mass ratio, solvent is the mixed solution (the volume ratio 2:8 of the two) of DMF and tetrachloromethane.The solution that preparation cisplatin concentration is 5mg/mL, solvent is DMF.Adopt coaxial co spun technology, receiving system rotating speed is 15r/s, and receiving range is 15cm, and spinning voltage is 10kV, and solution flow rate is 0.25 mL/h, after 3h, stops.
(5) dried of overlay film frame: the overlay film frame of having prepared, be placed in 90% methanol solution and process 1h, normal-temperature vacuum is dried 24h, and obtaining thickness is 0.25mm, the medicine-carrying membrane-covered stent that caliber is 8mm.
Claims (10)
1. a medicament-carrying nano-fiber membrane biliary tract rack, is characterized in that, comprises successively from inside to outside: the nanofiber internal layer of caliber direction orientations, the nanofiber internal layer of lack of alignment, metal rack and medicine carrying degradation of fibers are outer; Together with the nanofiber internal layer of described caliber direction orientations and the nanofiber internal layer of lack of alignment are attached on; Together with the nanofiber internal layer of described lack of alignment and the medicine carrying degradation of fibers skin mesh by metal rack is attached on, metal rack is securely fixed in fibrous membrane.
2. medicament-carrying nano-fiber membrane biliary tract rack as claimed in claim 1, is characterized in that, the nanofiber internal layer of described caliber direction orientations, the nanofiber internal layer of lack of alignment and the outer field thickness proportion of medicine carrying degradation of fibers are 1-5:1-5:2-10.
3. medicament-carrying nano-fiber membrane biliary tract rack as claimed in claim 1, is characterized in that, described metal rack is netted or Z-type metal biliary tract rack.
4. medicament-carrying nano-fiber membrane biliary tract rack as claimed in claim 1, is characterized in that, described medicine carrying degradation of fibers is outer, and its material is degradable polymeric biomaterial; Contained medicine is cancer therapy drug.
5. medicament-carrying nano-fiber membrane biliary tract rack as claimed in claim 1, is characterized in that, the material of the nanofiber internal layer of described caliber direction orientations and the nanofiber internal layer of lack of alignment is polymeric biomaterial.
6. the preparation method of the medicament-carrying nano-fiber membrane biliary tract rack as described in any one in claim 1-5, it is characterized in that, first metal being accepted to rod is fixed on the wire drawing device of electrospinning device, and give and certain rotating speed, nozzle system by electrospinning device move horizontally preparation along the nanofiber internal layer of caliber direction orientations, then stop the nanofiber internal layer that nozzle system moves horizontally preparation lack of alignment; Metal rack is enclosed within on the nanofiber internal layer of lack of alignment, by coaxial cospinning method, degradable macromolecule solution and medicine are formed to certain thickness medicine carrying degradation of fibers skin at metal support surface under the effect of electric field force, and make to be bonded together between each layer of fiber by interfibrous adhesion.
7. the preparation method of medicament-carrying nano-fiber membrane biliary tract rack as claimed in claim 6, is characterized in that,
(1) the cancer therapy drug C solution that the macromolecule A solution that compound concentration is 3-30wt%, the macromolecule B solution that concentration is 3-30 wt% and concentration are 1-10mg/ml;
(2) metal being accepted to rod is fixed on wire drawing device, it is that 0.5-2m/s, wire drawing device rotating speed are that 10-300 r/s and receiving range are 5-15cm that adjustment nozzle system moves horizontally speed, and adjustment spinning voltage is that the flow velocity of 9-15kV and macromolecular solution A is 0.1 ~ 3.0ml/h; After 0.5 ~ 1.5h, stop nozzle system and move horizontally, obtain the nanofiber internal layer of caliber direction orientations;
(3) stop nozzle system and move horizontally, keep receiving range, the flow velocity of spinning voltage and macromolecular solution A is constant; Adjusting wire drawing device rotating speed is 10-300 r/s, and after 0.5 ~ 1.5h, powered-down, stops spinning, obtains the nanofiber internal layer of lack of alignment;
(4) metal rack is enclosed within on the nanofiber internal layer of lack of alignment;
(5) rotating speed of adjustment wire drawing device is that 10-500r/s and receiving range are 5-15cm, adjustment spinning voltage is 9-15kV, macromolecular solution B and cancer therapy drug solution C are carried out to coaxial cospinning, the flow velocity of macromolecular solution B and cancer therapy drug solution C is 0.1 ~ 3.0ml/h, powered-down after 1.0 ~ 5.0h, stop spinning, obtain medicine carrying degradation of fibers outer;
(6) overlay film frame of having prepared, processes through methanol solution, after normal-temperature vacuum is dry, obtains finished product.
8. as claim, require the preparation method of the medicament-carrying nano-fiber membrane biliary tract rack as described in 7, it is characterized in that, the solute in described macromolecule A solution is one or more the composite in following material: polycaprolactone, polylactic acid, polyurethane, polyethylene.
9. as claim, require the preparation method of the medicament-carrying nano-fiber membrane biliary tract rack as described in 7, it is characterized in that, the solute in described macromolecular solution B is by fibrous material and material modifiedly form mass ratio 1 ~ 99:1 ~ 99 of the two; Wherein fibrous material comprises: one or more in polycaprolactone, polylactic acid, polyurethane, polyethylene, described material modified one or more in fibroin albumen, fibrin of comprising.
10. as claim, require the preparation method of the medicament-carrying nano-fiber membrane biliary tract rack as described in any one in 7-9, it is characterized in that, described cancer therapy drug C is fluorouracil, cisplatin or amycin.
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| CN108295316A (en) * | 2018-03-08 | 2018-07-20 | 戴庆涛 | A kind of intestinal stent and preparation method thereof |
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| CN109172071A (en) * | 2018-07-10 | 2019-01-11 | 东南大学 | A kind of full overlay film degradable biliary tract rack and preparation method thereof |
| CN110215540A (en) * | 2019-04-09 | 2019-09-10 | 盐城工业职业技术学院 | A kind of fibroin with three-dimensional order and unordered dual network structure/polymer matrix tubular bracket and its preparation and application |
| CN110923825A (en) * | 2019-09-02 | 2020-03-27 | 上海大学 | Preparation system and preparation method of high-elasticity drug-loaded thin film intravascular stent |
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