CN101156968A - Preparation method of shell core fibre tectorial membrana endovascular stent - Google Patents
Preparation method of shell core fibre tectorial membrana endovascular stent Download PDFInfo
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Abstract
The invention relates to a preparation method of a shell core fiber covered endovascular stent graft. The steps are as follows: firstly, a polymer is dissolved in adaptive dissolvent to obtain solution with a certain concentration; secondly, medicine or an artificial polymer and medicine, and a bio-active element are dissolved in the adaptive dissolvent to obtain solution or suspension liquid; thirdly, the solution of the polymer and the medicine or the solution or suspension liquid of the medicine or bio-active element are respectively filled in two injectors, the speed of a micro injection pump, the voltage of an electrostatic generator and the distance of a receiving device are adjusted, fiber is obtained through the static spinning preparation, and the fiber is received as a tube shape or film shape structure; fourthly, the endovascular stent graft is fixed on a revolution axle, through the revolution of the endovascular stent graft, the static spinning fiber are directly received as fibrous membrane covered on the endovascular stent graft. The invention can effectively prevent smooth muscle cells from hyperplasia in the stent graft or from narrowing in the stent graft caused by the other functions, and the shell core fiber for the medicine loading can slowly release the medicine to attain the purpose of curing.
Description
Technical field
The invention belongs to Wicresoft and hinder intervention medical product field, be specifically related to a kind of preparation method that static spins the endovascular stent of shell core fibrous layer overlay film that has.
Background technology
Static spin be one by making polymer solution or fused solution charged, thereby eject and finally make the simple and easy means of nanofiber.The fibre diameter that the static spinning technique prepares natural or synthetic polymer can reach tens nanometers to the hundreds of nanometer, and the material that success prepares comprises synthetic and natural material such as chitosan, collagen protein, polyurethane, polyvinyl alcohol, polylactic acid.Spin on the basis at general static, in recent years develop again and the preparation of coaxial cospinning and have the technology of shell-and-core structure fiber, in its patent, reported a kind of coaxial compound continuous nano/micron fibrous material and preparation method thereof (Chinese patent as Huang people such as contend, publication number: CN 1537981 A), the patent " preparation method of the nanofiber of a kind of packaging medicine or somatomedin " (Chinese patent, publication number: CN 1733311 A) of people such as Ren Jie application.The n cell epimatrix can be simulated through the fabric that electro-spinning obtains fully, sticking and breeding of cell can be promoted.The superfine fibre that these electrospinnings are prepared in various fields such as medical and health, food, clothing by extensive studies and application.
The atherosclerosis heart disease is to cause falling ill and one of dead reason, and this disease makes the narrow blood vessel blockage that finally makes of tremulous pulse caliber, and inserting endovascular stent is the important method of treatment cardiovascular disease.Endovascular stent can support stenosis occlusion section blood vessel, reach to keep the unobstructed purpose of tube chamber blood flow, but support is inserted the target that the restenosis phenomenon of back appearance has had a strong impact on treatment.The coating stent of medicine of people's employing at present suppresses the generation of restenosis, and the report that utilizes the drug-carrying polymer film to control restenosis is also arranged.Aneurysm is breakneck clinically a kind of angiopathy, reaches about 75% if data shows the mortality rate that its patient can not get in time treating in month, and the survival rate in 5 years only is 17%.Utilize film-coated vascular inner rack can completely cut off the tumor chamber, and make the tumor intracavity blood form thrombosis and fleshization gradually, thereby reach the aneurysmal purpose of treatment.
Summary of the invention
Technical problem to be solved by this invention provides a kind of preparation method of shell core fibre tectorial membrana endovascular stent, and this method is prepared as polymer, medicine or other bioactive ingredients nanometer or the micron order fiber with shell-and-core structure by the static spinning technique of preparation shell core fiber; And adopt different receive modes, fibrous membrane is made three dimensional structures such as membranaceous, tubulose, and through the interior or outer surface that film that fixing means obtains or tubular structure can be fixed on support such as making, bonding.
Technical scheme of the present invention is as follows:
A kind of preparation method of shell core fibre tectorial membrana endovascular stent, concrete steps are as follows:
(1) natural or artificial polymer is dissolved the uniform solution that obtains to have 0.01-0.08 grams per milliliter concentration in adaptive solvent;
(2) with medicine or artificial polymer and medicine, bioactive ingredients with the solution or the suspension that dissolve the acquisition homogeneous in the adaptive solvent, perhaps prepare the solution or the suspension that are mixed into homogeneous behind the solution respectively;
(3) uniform solution of natural or artificial polymer and medicine or artificial polymer and medicine, bioactive solution or suspension are added respectively in two syringes, the speed of regulating micro-injection pump be the 0.1-5.0 milliliter/hour, it is the 5000-30000 volt that the adjusting HV generator makes voltage, regulate receiving system, making receiving range is 5.0-30.0 centimetre, obtain fiber fully by electro-spinning, and fiber is received as tubulose or membrane structure;
(4) endovascular stent is fixed in the rotating shaft, regulating motor, to make slewing rate be 50-6000 rev/min, and the rotation by endovascular stent directly receives electrostatic spinning fiber and becomes the fibrous membrane that is wrapped on the endovascular stent.
Be loaded with static in the above-mentioned steps and spin the endovascular stent of shell core fibre tectorial membrana through making, paste the outside that further fibrous membrane is fixed on endovascular stent.
In the above-mentioned steps can also with polymer solution or with the mixed solution of the medicine electrostatic spinning device of packing into, obtain having the medicine carrying nano/micron fiber of shell-and-core structure fully through electro-spinning, and the membranaceous and tubular structure that constitutes by this fiber, again should be membranaceous or tubular structure further be fixed in the endovascular stent or outer surface through making or pasting.
Above-mentioned natural polymer includes but are not limited to: collagen protein, gelatin, chitosan, Fibrinogen; Artificial polymer includes but are not limited to: poly-Acetic acid, hydroxy-, bimol. cyclic ester, polylactide, polycaprolactone, polyglycolic acid and related copolymers thereof; Involved organic solvent includes but are not limited to: oxolane, hexafluoroisopropanol, acetone, trifluoroethanol, dichloromethane, chloroform, one or more compound systems of dimethyl formamide; Related medicine is including, but not limited to heparin, rapamycin, paclitaxel, aspirin, prostacyclin, hirudin; Related bioactive ingredients mainly refers to endothelial cell growth factor (ECGF), basic fibroblast growth factor, nerve growth factor, bone morphogenetic protein, glial growth factor, transforming growth factor, epidermal growth factor, platelet-derived somatomedin, hepatocyte growth factor.
Above-mentioned prepare have a polymer fiber film that endovascular stent that medicine carrying static spins the shell core fibrous membrane comprises at least a polymer fiber or medicine.
Can also adopt the syringe of at least more than one shower nozzle in the above-mentioned third step simultaneously, the prepared fiber of each shower nozzle is at least a kind of polymer or drug-carrying polymer fiber, and obtains different fibers by the blended overlay film of different proportion.
The above-mentioned support that has after obtaining hygrometric state or drying in endovascular stent that medicine carrying static spins the shell core fibrous membrane has medicine or bioactive ingredients by immersion the solution and handling.
The above-mentioned medicine carrying static that has spins the endovascular stent of shell core fibrous membrane through including, but not limited to the physics or the chemical method of plasma, chemical graft this drug-loading fibre film being modified the film-coated vascular inner rack that obtains.
Above-mentioned each shower nozzle and forms the overlay film that is made of at least two kinds of fibers at different time continuously or be interrupted to prepare and have two-layer at least fiber.
Above-mentionedly have the endovascular stent that medicine carrying static spins the shell core fibrous membrane and cultivate the complex that obtains being loaded with living cells through cell in vitro.
Beneficial effect of the present invention:
(1) equipment and the technology of the present invention's use are simple, easily industrialization production;
(2) the medicine carrying shell core fibre morphology for preparing is good, has biological safety and mechanical performance preferably, is easy to prepare film-coated vascular inner rack;
(3) film-coated vascular inner rack satisfactory mechanical property is because of being loaded with the different effects with prevention aneurysm blood supply, anticoagulant, antithrombotic or anti-restenosis of medicine.
(4) actively added new biological function simultaneously what keep medicine, obtained the function that overlay film frame has medicine and bioactive ingredients such as somatomedin simultaneously by this fiber production.
Among the present invention, this fiber also can directly be received in the outer surface of support, and formation has certain thickness by the fibrous membrane structure of shell core.This fibrous membrane has certain mechanical performance and closely covers on the endovascular stent, can prevent the in-stent restenosis that smooth muscle cell hypertrophy or other effects in support cause effectively, the shell core fiber of medicine carrying can reach the purpose of treatment at the diseased region slow releasing pharmaceutical.
Description of drawings
Fig. 1 is that the shell core fibre tectorial membrana support prepares sketch map;
Fig. 2 is the fiber transmission electron microscope photo that sandwich layer is loaded with medicine;
Fig. 3 is the overlay film frame sem photograph;
Fig. 4 is the scanning electron microscope enlarged drawing of overlay film fiber on the support.
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after the content of having read the present invention's instruction, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
The preparation method of shell core fibre tectorial membrana endovascular stent of the present invention, concrete steps are as follows:
(1) natural or artificial polymer is dissolved the uniform solution that obtains to have 0.01-0.08 grams per milliliter concentration in adaptive solvent;
(2) with medicine or artificial polymer and medicine, bioactive ingredients with the solution or the suspension that dissolve the acquisition homogeneous in the adaptive solvent, perhaps prepare the solution or the suspension that are mixed into homogeneous behind the solution respectively;
(3) as shown in Figure 1, the uniform solution of natural or artificial polymer and medicine or artificial polymer and medicine, bioactive solution or suspension are added two syringes 1,2 respectively, regulate micro-injection pump 3 speed and be the 0.1-5.0 milliliter/hour, it is the 5000-30000 volt that adjusting HV generator 7 makes voltage, regulate receiving system, making receiving range is 5.0-30.0 centimetre, obtains fiber 5 fully by electro-spinning, and fiber is received as tubulose or membrane structure;
(4) endovascular stent is fixed in the rotating shaft 6, regulating motor 8, to make slewing rate be 50-6000 rev/min, and the rotation by endovascular stent directly receives electrostatic spinning fiber and becomes the fibrous membrane (Fig. 4) that is wrapped on the endovascular stent (Fig. 3).
Be loaded with static in the above-mentioned steps and spin the endovascular stent of shell core fibre tectorial membrana through making, paste the outside that further fibrous membrane is fixed on endovascular stent.In the above-mentioned steps can also with polymer solution or with the mixed solution of the medicine electrostatic spinning device of packing into, obtain having the medicine carrying nano/micron fiber (Fig. 2) of shell-and-core structure fully through electro-spinning, and the membranaceous and tubular structure that constitutes by this fiber, again should be membranaceous or tubular structure further be fixed in the endovascular stent or outer surface through making or pasting.Can also adopt the syringe of at least more than one shower nozzle in the above-mentioned third step simultaneously, the prepared fiber of each shower nozzle is at least a kind of polymer or drug-carrying polymer fiber, and obtains different fibers by the blended overlay film of different proportion.Each shower nozzle and forms the overlay film that is made of at least two kinds of fibers at different time continuously or be interrupted to prepare and have two-layer at least fiber.
Natural polymer includes but are not limited to: collagen protein, gelatin, chitosan, Fibrinogen; Artificial polymer includes but are not limited to: poly-Acetic acid, hydroxy-, bimol. cyclic ester, polylactide, polycaprolactone, polyglycolic acid and related copolymers thereof; Involved organic solvent includes but are not limited to: oxolane, hexafluoroisopropanol, acetone, trifluoroethanol, dichloromethane, chloroform, one or more compound systems of dimethyl formamide; Related medicine is including, but not limited to heparin, rapamycin, paclitaxel, aspirin, prostacyclin, hirudin; Related bioactive ingredients mainly refers to endothelial cell growth factor (ECGF), basic fibroblast growth factor, nerve growth factor, bone morphogenetic protein, glial growth factor, transforming growth factor, epidermal growth factor, platelet-derived somatomedin, hepatocyte growth factor.
The endovascular stent that having of preparing, medicine carrying static spun the shell core fibrous membrane comprises the polymer fiber film of at least a polymer fiber or medicine.
Have the support after obtaining hygrometric state or drying in endovascular stent that medicine carrying static spins the shell core fibrous membrane has medicine or bioactive ingredients by immersion the solution and handling.Have medicine carrying static and spin the endovascular stent of shell core fibrous membrane through this drug-loading fibre film being modified the film-coated vascular inner rack that obtains including, but not limited to the physics or the chemical method of plasma, chemical graft.
Have the endovascular stent that medicine carrying static spins the shell core fibrous membrane and cultivate the complex that obtains being loaded with living cells through cell in vitro.
Embodiment:
Example one:
(1) the preparation heparin concentration is the solution of 0.08 grams per milliliter, and solvent for use is a water;
(2) preparation P (LLA-CL) concentration is the solution of 0.06 grams per milliliter, and solvent for use is a hexafluoroisopropanol.
(3) with heparin solution as the supply syringe of putting into internal layer, P (LLA-CL) solution is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.1 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having the fiber that contains heparin of shell-and-core structure;
(4) endovascular stent is fixed in the rotating shaft, voltage is 20.0 kilovolts, and receiving range is 20.0 centimetres, and motor speed is 50 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter fibrous membrane;
Example two:
(1) preparation paclitaxel concentration is the solution of 0.01 grams per milliliter, and solvent for use is an acetone;
(2) preparation P (LLA-CL) concentration is the solution of 0.06 grams per milliliter, and solvent for use is a trifluoroethanol.
(3) with paclitaxel solution as the supply syringe of putting into internal layer, P (LLA-CL) solution is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.3 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having the fiber that contains paclitaxel of shell-and-core structure;
(4) endovascular stent is fixed in the rotating shaft, voltage is 15.0 kilovolts, and receiving range is 15.0 centimetres, and motor speed is 100 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter fibrous membrane.
Example three:
(1) the preparation rapamycin concentrations is the solution of 0.02 grams per milliliter, and solvent for use is an acetone;
(2) preparation P (LLA-CL) concentration is the solution of 0.06 grams per milliliter, and solvent for use is that acetone is molten.
(3) with rapamycin solution as the supply syringe of putting into internal layer, P (LLA-CL) solution is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.15 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having the fiber that contains rapamycin of shell-and-core structure;
(4) endovascular stent is fixed in the rotating shaft, voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, and motor speed is 500 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter fibrous membrane.
Example four:
(1) the preparation heparin concentration is 0.08 grams per milliliter, and vascular endothelial cell growth factor concentration is the solution of 0.001 grams per milliliter, and solvent for use is a water;
(2) preparation P (LLA-CL) concentration is the solution of 0.06 grams per milliliter, and solvent for use is an acetone.
(3) with heparin solution as the supply syringe of putting into internal layer, P (LLA-CL) solution is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.1 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having the fiber that contains heparin of shell-and-core structure;
(4) endovascular stent is fixed in the rotating shaft, voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, and motor speed is 1000 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter fibrous membrane.
Example five:
(1) the preparation heparin concentration is 0.02 grams per milliliter, and gelatin concentration is the solution of 0.04 grams per milliliter, and solvent for use is the double solvents of trifluoroethanol/water;
(2) preparation PLLA concentration is the solution of 0.06 grams per milliliter, and solvent for use is a trifluoroethanol.
(3) with (1) solution as putting into the supply syringe of internal layer, (2) solution is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.1 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having the fibrous membrane that contains heparin or the tubular construction of shell-and-core structure;
(4) film that obtains in (3) or effective biogum or medical fine rule are fixed on the endovascular stent.
Example six:
(1) preparation aspirin concentration is the solution of 0.08 grams per milliliter, and solvent for use is an ethanol;
(2) preparation PCL concentration is the solution of 0.06 grams per milliliter, and solvent for use is a trifluoroethanol.
(3) with aspirin solution as the supply syringe of putting into internal layer, PCL solution is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.1 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having the fiber that contains aspirin of shell-and-core structure;
(4) endovascular stent is fixed in the rotating shaft, voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, and motor speed is 200 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter fibrous membrane.
Example seven:
(1) compound concentration is the heparin of 0.06 grams per milliliter bovine serum albumin, 0.02 grams per milliliter, vascular endothelial cell growth factor/fibroblast growth factor (1/1) mixed solution of 0.001 grams per milliliter, and solvent for use is a water;
(2) preparation P (LLA-CL) concentration is the solution of 0.06 grams per milliliter, and solvent for use is an acetone;
(3) with solution of describing in (1) as the supply syringe of putting into internal layer, the solution of describing in (2) is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.1 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having shell-and-core structure contain medicine and bioactive molecule fiber;
(4) endovascular stent is fixed in the rotating shaft, voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, and motor speed is 500 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter fibrous membrane.
Example eight:
(1) compound concentration is the prostacyclin derivatives of 0.06 grams per milliliter bovine serum albumin, 0.002 grams per milliliter, the vascular endothelial cell growth factor solution of 0.001 grams per milliliter, and solvent for use is a water;
(2) preparation P (LLA-CL) concentration is the solution of 0.06 grams per milliliter, and solvent for use is an acetone;
(3) with (1) solution as putting into the supply syringe of internal layer, (2) solution is put into outer field supply syringe, regulating the ectonexine delivery rate is 0.1 milliliter/hour and 0.9 milliliter/hour, under the effect of boost pump and HV generator, carry out electrostatic spinning, obtain having shell-and-core structure contain medicine and bioactive molecule fiber;
(4) endovascular stent is fixed in the rotating shaft, voltage is 20.0 kilovolts, and receiving range is 20.0 centimetres, and motor speed is 200 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter fibrous membrane.
Claims (10)
1. the preparation method of a shell core fibre tectorial membrana endovascular stent is characterized in that, concrete steps are as follows:
1) natural or artificial polymer is dissolved the uniform solution that obtains to have 0.01-0.08 grams per milliliter concentration in adaptive solvent;
2) with medicine or artificial polymer and medicine, bioactive ingredients with the solution or the suspension that dissolve the acquisition homogeneous in the adaptive solvent, perhaps prepare the solution or the suspension that are mixed into homogeneous behind the solution respectively;
3) uniform solution of natural or artificial polymer and medicine or artificial polymer and medicine, bioactive solution or suspension are added respectively in two syringes (1,2), regulate micro-injection pump (3) speed and be the 0.1-5.0 milliliter/hour, it is the 5000-30000 volt that adjusting HV generator (7) makes voltage, regulate receiving system, making receiving range is 5.0-30.0 centimetre, obtain fiber (5) fully by electro-spinning, and fiber is received as tubulose or membrane structure;
4) endovascular stent is fixed in the rotating shaft (6), regulating motor (8), to make slewing rate be 50-6000 rev/min, and the rotation by endovascular stent directly receives electrostatic spinning fiber and becomes the fibrous membrane that is wrapped on the endovascular stent.
2. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 1 is characterized in that, is loaded with static in the above-mentioned steps and spins the endovascular stent of shell core fibre tectorial membrana through making, paste the outside that further fibrous membrane is fixed on endovascular stent.
3. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 1, it is characterized in that, in the above-mentioned steps can also with polymer solution or with the mixed solution of the medicine electrostatic spinning device of packing into, obtain having the medicine carrying nano/micron fiber of shell-and-core structure fully through electro-spinning, and the membranaceous and tubular structure that constitutes by this fiber, again should be membranaceous or tubular structure further be fixed in the endovascular stent or outer surface through making or pasting.
4. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 1 is characterized in that, described natural polymer is collagen protein, gelatin, chitosan or Fibrinogen; Artificial polymer is poly-Acetic acid, hydroxy-, bimol. cyclic ester, polylactide, polycaprolactone, polyglycolic acid or related copolymers; Involved organic solvent is one or more compound systems of oxolane, hexafluoroisopropanol, acetone, trifluoroethanol, dichloromethane, chloroform or dimethyl formamide; Related medicine is heparin, rapamycin, paclitaxel, aspirin, prostacyclin or hirudin; Related bioactive ingredients is endothelial cell growth factor (ECGF), basic fibroblast growth factor, nerve growth factor, bone morphogenetic protein, glial growth factor, transforming growth factor, epidermal growth factor, platelet-derived somatomedin or hepatocyte growth factor.
5. according to the preparation method of claim 1 or 2 or 3 described shell core fibre tectorial membrana endovascular stents, it is characterized in that, described prepare have a polymer fiber film that endovascular stent that medicine carrying static spins the shell core fibrous membrane comprises at least a polymer fiber or medicine.
6. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 1, it is characterized in that, can also adopt the syringe of at least more than one shower nozzle in the above-mentioned third step simultaneously, the prepared fiber of each shower nozzle is at least a kind of polymer or drug-carrying polymer fiber, and obtains different fibers by the blended overlay film of different proportion.
7. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 5, it is characterized in that the described support that has after obtaining hygrometric state or drying in endovascular stent that medicine carrying static spins the shell core fibrous membrane has medicine or bioactive ingredients by immersion the solution and handling.
8. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 5, it is characterized in that the described medicine carrying static that has spins the endovascular stent of shell core fibrous membrane through including, but not limited to the physics or the chemical method of plasma, chemical graft this drug-loading fibre film being modified the film-coated vascular inner rack that obtains.
9. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 6 is characterized in that, described each shower nozzle and forms the overlay film that is made of at least two kinds of fibers at different time continuously or be interrupted to prepare and have two-layer at least fiber.
10. the preparation method of shell core fibre tectorial membrana endovascular stent according to claim 5 is characterized in that, describedly has the endovascular stent that medicine carrying static spins the shell core fibrous membrane and cultivates the complex that obtains being loaded with living cells through cell in vitro.
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2007
- 2007-10-26 CN CNA2007100474578A patent/CN101156968A/en active Pending
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