CN102727946A - Drug loaded coating and its preparation method - Google Patents
Drug loaded coating and its preparation method Download PDFInfo
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- CN102727946A CN102727946A CN201210224355XA CN201210224355A CN102727946A CN 102727946 A CN102727946 A CN 102727946A CN 201210224355X A CN201210224355X A CN 201210224355XA CN 201210224355 A CN201210224355 A CN 201210224355A CN 102727946 A CN102727946 A CN 102727946A
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Abstract
The invention relates to a drug loaded coating and its preparation method, especially to a thermoplastic degradable fiber woven scaffold coating and its preparation method. The drug loaded coating provided by the invention is a drug loaded thin layer formed on a chitosan thin layer on the surface of the scaffold. The preparation method of the degradable drug loaded coating comprises the following steps of: (1) coating the surface of the degradable fiber woven scaffold with a chitosan-acetic acid-aqueous solution, placing into anhydrous ethanol, removing ethanol to form a chitosan coating; (2) coating the chitosan coating with a drug loaded polymer microsphere dispersion, and removing moisture to form a drug loaded polymer coating; and (3) continuously coating the drug loaded polymer dispersion, and increasing and adjusting drug loading and drug loaded kind. The method for preparing the drug loaded coating is simple and is convenient to regulate and control drug loaded kind, coating thickness and drug loading.
Description
Technical field
The present invention relates to a kind of drug-carried coat and preparation method thereof; Particularly relate to coating of a kind of thermoplasticity biodegradable fiber braided support and preparation method thereof, specifically a kind of medicine carrying thin layer is formed at drug-carried coat on the chitosan thin layer of rack surface and preparation method thereof.
Background technology
Support is a kind of inside of human body pipeline that is used to support, and has these line cloggings of control or narrow function.Rack surface is often imposed the coating that contains medicine, and to prevent growth and gathering or the bacterial reproduction of tissue at rack surface, the assurance human pipeline's is unobstructed.The method of synthetic high polymer medicament-carrying nano-microsphere mainly contains emulsifier-free emulsion polymerization, dispersion copolymerization method and self-assembly method at present.Emulsifier-free emulsion polymerization is a kind of polymerization that on the emulsion polymerisation basis, grows up, and is meant not contain emulsifying agent in the system fully or only contain micro-emulsifying agent (being lower than the critical micelle concentration of emulsifying agent).Difficulty and emulsifying agent that it has solved the conventional emulsion post-polymerization treatment bring bad influence to product; Reduced production cost simultaneously, alleviated load environment.Do not add emulsifying agent owing to have in the soap-free polymerization system, the poor stability of microsphere in polymerization and the storing process, so solid content is generally lower, also there are some problems in large-scale application in coating and adhesive.Dispersin polymerization is meant that monomer is dissolved in medium, and the polymer that generates is insoluble to the polymerization in the medium, and dispersin polymerization also usually is considered to the precipitation polymerization of a specific type.The difference of dispersin polymerization and emulsion polymerisation is that its medium is generally organic facies; Before the reaction is homogeneous system; The polymer that polymerization forms must be not dissolved in medium; What this area research was maximum at present is dispersin polymerization and the dispersion copolymerization in polarizable medium, is used to prepare the mono dispersed micrograde polymer microsphere.Adopting self-assembling technique to prepare polymer micelle is one of the most popular in recent years research field; It is through intermolecular special interaction; Like electrostatic attraction, hydrogen bond, lyophobic association etc.; Be assembled into orderly nanostructured, realize high performance and multifunction. parents' copolymer is dissolved in (hydrophobic, hydrophilic segment all can be dissolved in wherein) in the cosolvent, under agitation splashes into selective solvent again or selective solvent is splashed in the copolymer good solvent; Bring out micelle formation; Remove good solvent after dialyse, also can directly polymer be dissolved in dialysis and formation micelle granule in the selective solvent, the size of microgranule and shape can be controlled through choice of Solvent and telomerized polymer concentration.
These methods that prepare the support drug-carried coat all are the organic solvent solutions that degradable high polymer material and medicine dissolution is formed degradable high polymer material and medicine in organic solvent; Again this solution is coated on rack surface; After treating the organic solvent volatilization, form drug-carried coat.Because organic solvent volatilizees easily, cause the organic solvent solution composition of degradable high polymer material and medicine to change easily, influence the quality of drug-carried coat; In addition, organic solvent also causes environmental pollution easily.
Summary of the invention
The purpose of this invention is to provide a kind of drug-carried coat and preparation method thereof; Coating of a kind of thermoplasticity biodegradable fiber braided support and preparation method thereof particularly is provided, and specifically a kind of medicine carrying thin layer is formed at drug-carried coat on the chitosan thin layer of rack surface and preparation method thereof.A kind of medicament-carrying nano-microsphere provided by the invention and preparation method thereof, provide a kind of inside and outside the method for preparing of double-deck Nano microsphere.The invention solves the problem for preparing medicament-carrying nano-microsphere by biodegradable polymers or random copolymer, remedied prior art and must use the amphipathic nature block polymer of synthetic difficulty or the deficiency that hydrophilic surface layer comes off easily with stable hydrophilic surface structure.
A kind of drug-carried coat of the present invention, described drug-carried coat are meant the medicine carrying thin layer on the chitosan thin layer that is formed at rack upper surface, and described chitosan thin layer is to be coated on the rack surface.Support of the present invention is the passive framework of general reference, and the support of this paper is meant inner support, is to be used for that the people is intravital to be used for fixing graft in the body, can be the framework that the tubular tissue of implementing anastomosis provides support.
As optimized technical scheme:
Aforesaid a kind of drug-carried coat, described chitosan thin layer are meant that the mass ratio that chitosan is dissolved in acetic acid and water is in the solution of 3 ~ 5:100, and wherein the mass concentration of chitosan is 2.0 ~ 4.0%; If the mass concentration of chitosan is too high; Can cause film thickness excessive, can cause like this drug-carried coat be coated with up after the thickness of two kinds of coatings excessive, coating agree come off from nail surface under action of gravity; Through ethanol elution acetic acid, dry the thin layer that obtains again; The thickness of said chitosan thin layer is between 1～2 μ m.Medicament-carrying nano-microsphere surface institute is electrically charged to be negative charge; Can government's charge effect take place with positively charged chitosan; Simultaneously the medicament-carrying nano-microsphere surface with hydrophilic hydroxyl groups and carboxyl, can with chitosan with hydroxyl, carboxyl and the amino hydrogen bond action that takes place, thereby; Through follow-up simple adsorption treatment, just can form one deck medicament-carrying nano-microsphere coating at the chitosan film surface.
Aforesaid a kind of drug-carried coat, described support are thermoplasticity biodegradable fiber braided supports, and braided support is formed by fibrage, and its surface is not a level and smooth face, and this helps combining of drug-carried coat and chitosan thin layer.The filament diameter of described thermoplasticity biodegradable fiber is the 0.1-0.6 millimeter.The diameter of monofilament can not be greater than 0.6, if because fibre diameter less than 0.1 so fiber enough radial support power can't be provided, like the diameter of fruit fiber greater than 0.6; So crooked amount just is too big; Fiber is difficult for braiding, though braiding come out, support in being used for blood vessel the time institute take up space too big; Limit is reduced the flowing space of blood, may cause discomfort human body.
Aforesaid a kind of drug-carried coat is characterized in that, described thermoplasticity biodegradable fiber is polylactide fiber, polyglycollide fibre, lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber or gathers the dioxanone fiber.
Aforesaid a kind of drug-carried coat; The thickness sum of the thickness of described medicine carrying thin layer and chitosan thin layer is not higher than 5 μ m; Because be higher than 5 μ m thin layers, in a single day thickness gain in weight must increase because the action of gravity coating just comes off above support than being easier to; Described medicine carrying thin layer is to be formed by medicament-carried nano-submicron particles aqueous dispersions; Said medicament-carried nano-submicron particles is degradable high polymer material polycaprolactone medicament-carried nano-submicron particles; It is the polycaprolactone polymer microsphere of coating medicine; Just polycaprolactone macromolecule bag medicine carrying thing forms a circular microsphere, is medicine in the ball, and skin is the polycaprolactone macromolecule; Described medicine can be selected according to the needs of treatment, can be antibacterials azithromycin, anti-cancer medicine paclitaxel or other drug.
A kind of drug-carried coat of the present invention provides a kind of can prevent and treat inside of human body pipeline obstruction and vegetative support degradable drug-carried coat.
Another object of the present invention provides a kind of method for preparing of drug-carried coat; Being a kind of method for preparing that adopts the support degradable drug-carried coat that the medicine carrying particle aqueous dispersion forms, is the method for preparing of the drug-carried coat on a kind of chitosan thin layer that the medicine carrying thin layer is formed at rack surface.
A kind of method for preparing of drug-carried coat may further comprise the steps:
(1) preparation of chitosan thin layer
Chitosan acetic acid-aqueous solution is coated on rack surface, immerses in the dehydrated alcohol again and take out support after 10-20 minute, rack surface promptly forms the chitosan thin layer, then oven dry; More than operation is carried out under gnotobasis usually; Ethanol in the chitosan thin layer can place 35-60 ℃ vacuum drying oven to dry.The chitosan coating of taking out later with soaked in absolute ethyl alcohol could really remove acetic acid, and dehydrated alcohol also plays certain bactericidal action simultaneously, and the bake out temperature of chitosan thin layer in vacuum drying oven should not be higher than 60 ℃, otherwise the chitosan thin film is degraded easily.
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Biodegradable Polymers is dissolved in the organic solvent first, and the concentration of dissolving back Biodegradable Polymers is 1～30mg/ml; Medicine is dissolved in the organic solvent second; With above-mentioned two kinds of solution common water that slowly injects under stirring condition, wherein the weight ratio of dewatering medicament and Biodegradable Polymers is 1 ︰ 1～19; Drug concentrations after the dissolving is 1～30mg/ml; The total amount of described organic solvent first and organic solvent second and the volume ratio of water are 1 ︰ 1～20; Injection length is 1～6h; Inject and finish continued stirring 0.5～4h, remove organic solvent first and organic solvent second then, promptly obtain the aqueous dispersions of biodegradable polymer medicament-carried nano-submicron particles;
Because the existence of water-wet side carboxyl and terminal hydroxy group in polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), poly butyric (PHB), polylactic acid-polyglycolic acid copolymer (PGLA) carrier material; The similar of this carrier material is in the micromolecule surfactant, and just the hydrophobic segment of carrier material is longer.When the organic solvent solution of carrier material and dewatering medicament was slowly injected a large amount of water, the microfacies counter-rotating had taken place.Concerning the hydrophobic segment and dewatering medicament of carrier material; Medium changes poor solvent into by original good solvent; Hydrophobic segment and dewatering medicament can be assembled the collapse into ball; And injection rate makes the carrier material macromole that its conformation of time enough adjustment arranged slowly, thus make its hydrophilic end group optionally enrichment be distributed in the surface of microgranule.Because the electrical charge rejection effect of ionized end carboxyl and the hydrophilic interaction of unionized end carboxyl and terminal hydroxy group, microgranule ability stable dispersion is in medium.
Described organic solvent first and described organic solvent second can be dissolved each other; Described organic solvent first is methanol, ethanol, acetone, acetonitrile, oxolane, dioxy six alkane, dimethyl formamide or dimethyl sulfoxide; Described organic solvent second is methanol, ethanol, acetone, acetonitrile, oxolane, dioxy six alkane, dimethyl formamide or dimethyl sulfoxide; And described organic solvent first and organic solvent second all be can be miscible with water organic solvent, also can be miscible between described organic solvent first and the organic solvent second.Said medicine be heparin, the anti-microbial type of the paclitaxel of the rapamycin of immunosuppressant, anti-subcutaneous lamination, anti-Trostin M azithromycin, prevent the statins of cholesterol lamination; Described macromolecular material is polycaprolactone (PCL) polyglycolic acid (PGA), polylactic acid (PLA), poly butyric (PHB), the polylactic acid-polyglycolic acid copolymer (PGLA) with good biocompatibility and biodegradable performance.
The present invention is coated on medicament-carried nano-submicron particles aqueous dispersions on the above-mentioned chitosan thin layer, removes moisture, and medicament-carried nano under the intermolecular force effect-submicron particles is assembled, and promptly forms the medicine carrying thin layer; The thickness of described chitosan thin layer and drug-carried coat should not be higher than 5 microns, if because thickness is higher than 5 microns owing to the action of gravity coating is prone to come off from rack surface.
(3) preparation of medicine carrying thin layer
Medicament-carried nano-submicron particles aqueous dispersions is coated on the above-mentioned chitosan thin layer; Medicament-carrying nano-microsphere surface institute is electrically charged be negative charge, can government's charge effect take place with positively charged chitosan, simultaneously medicament-carrying nano-microsphere surperficial with hydrophilic hydroxyl groups and carboxyl; Can with chitosan with hydroxyl, carboxyl and the amino hydrogen bond action that takes place; Thereby, through follow-up simple adsorption treatment, just can form one deck medicament-carrying nano-microsphere coating at the chitosan film surface.Remove moisture, medicament-carried nano-submicron particles is assembled, and promptly forms the medicine carrying thin layer, obtains described drug-carried coat.Medicament-carried nano-submicron particles general diameter is in 200nm, and said medicament-carried nano-submicron particles is the polymer microsphere of coating medicine, and just macromolecule bag medicine carrying thing forms a circular microsphere, is medicine in the ball, and skin is a macromolecule.Described medicine can be selected according to the needs of treatment, said medicine be heparin, the anti-microbial type of the paclitaxel of the rapamycin of immunosuppressant, anti-subcutaneous lamination, anti-Trostin M azithromycin, prevent the statins of cholesterol lamination.
The method for preparing of aforesaid a kind of drug-carried coat; On support, apply medicament-carried nano-submicron particles aqueous dispersions, continue again after the oven dry to apply, repeatedly apply medicament-carried nano-submicron particles aqueous dispersions; Improve the drug loading of support, finally obtain the coating of required drug loading.
The method for preparing of aforesaid a kind of drug-carried coat, the mass concentration of chitosan is 2.0 ~ 4.0% in described chitosan acetic acid-aqueous solution, the mass ratio of acetic acid and water is 3 ~ 5:100; Oven dry in the said step (1) is meant vacuum drying oven 10-60 minute that places 35-50 ℃; The method of removing organic solvent in the said step (2) is decompression rotary evaporation method or water dialysis; The moisture that removes in the said step (3) adopts vacuum drying oven to remove moisture, and temperature is 40-60 ℃, and the time is 20-40 minute; Temperature can not be too high, and the time is also unsuitable long, because temperature is too high, the overlong time bean milk causes the decomposition of chitosan.
The method for preparing of aforesaid a kind of drug-carried coat, described support are thermoplasticity biodegradable fiber braided supports, and the filament diameter of described thermoplasticity biodegradable fiber is 0.1 ~ 0.6 millimeter; Medicament-carried nano-submicron particles is a degradable high polymer material polycaprolactone medicine carrying granule in described medicament-carried nano-submicron particles aqueous dispersions, by water is disperseed.
The method for preparing of aforesaid a kind of drug-carried coat, described thermoplasticity biodegradable fiber are polylactide fiber, polyglycollide fibre, lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber or gather the dioxanone fiber.
The method for preparing of aforesaid a kind of drug-carried coat is characterized in that, medicament-carried nano-submicron particles is a degradable high polymer material polycaprolactone medicine carrying granule in described medicament-carried nano-submicron particles aqueous dispersions, by water is disperseed.
At the stent surface coated chitosan acetic acid-aqueous solution of thermoplasticity biodegradable fiber (for example, polylactide fiber, polyglycollide fibre, lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber and gather, diameter is the 0.1-0.6 millimeter) braiding (wherein to the dioxanone fiber; The mass concentration of chitosan is 2-4%, and the mass ratio of acetic acid and water is: 3-5:100), will prop up in the dehydrated alcohol that is placed on 20-30 ℃ 10-20 minute again; With the acetic acid eluting; Chitosan is separated out fast, forms the chitosan thin layer at rack surface, will prop up to be placed in the vacuum drying oven again; Descended dry 15-30 minute at 35-50 ℃, remove the ethanol in the chitosan thin layer.On the chitosan thin layer, apply medicament-carried nano-submicron particles aqueous dispersions, the medicine carrying granule is a degradable high polymer material polycaprolactone medicine carrying granule, by water is disperseed.Be placed in 40-60 ℃ the vacuum drying oven 20-40 minute with what apply medicament-carried nano-submicron particles aqueous dispersions, the water evaporation forms the polycaprolactone drug-carried coat.
Can the above-mentioned medicament-carried nano of repetitive coatings-submicron particles aqueous dispersions, the process of oven dry, increase and the drug loading of adjustment support; Medicine in each medicament-carried nano-submicron particles aqueous dispersions that applies can be different, contain the drug-carried coat of medicine more than 2 kinds or 2 kinds with formation.
Beneficial effect
1, chitosan coating of the present invention has elimination or alleviates the stimulation of scaffold degradation product to body.
2, chitosan coating surface porous of the present invention is coarse, helps the adhesion of drug-carried coat.
3, degradable drug-carried coat of the present invention has the medicament slow release ability, the cycle that can prolong drug discharges.
4, degradable drug-carried coat of the present invention has and can in human body, degrade fully.
5, employing medicament-carried nano of the present invention-submicron particles aqueous dispersions does not contain organic solvent as coating liquid, can avoid contaminated environment.
6, the present invention can form the drug-carried coat that contains medicine more than 2 kinds or 2 kinds with the medicament-carried nano that is loaded with different pharmaceutical-the submicron particles aqueous dispersions applies respectively, drying.
7, method of the present invention can increase the drug loading of support easily.
The specific embodiment
Below in conjunction with the 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 the restriction scope of the present invention.Should be understood that in addition those skilled in the art can do various changes or modification to 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.
A kind of drug-carried coat of the present invention, described drug-carried coat are meant the medicine carrying thin layer on the chitosan thin layer that is formed at rack surface.
Described chitosan thin layer is meant that the mass ratio that chitosan is dissolved in acetic acid and water is in the solution of 3 ~ 5:100, and wherein the mass concentration of chitosan is 2.0 ~ 4.0%, through ethanol elution acetic acid, and the thin layer that obtains of oven dry again; The thickness of said chitosan thin layer is between 1～2 μ m.
Described support is a thermoplasticity biodegradable fiber braided support; The filament diameter of described thermoplasticity biodegradable fiber is 0.1 ~ 0.6 millimeter.
Described thermoplasticity biodegradable fiber is polylactide fiber, polyglycollide fibre, lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber or gathers the dioxanone fiber.
The thickness sum of the thickness of described medicine carrying thin layer and chitosan thin layer is not higher than 5 μ m; Described medicine carrying thin layer is to be formed by medicament-carried nano-submicron particles aqueous dispersions, and said medicament-carried nano-submicron particles is degradable high polymer material polycaprolactone medicament-carried nano-submicron particles, is the polycaprolactone polymer microsphere of coating medicine.
Embodiment 1
(1) preparation of chitosan thin layer
In main body is that (mass concentration of chitosan is 2% to stainless metal support surface coating chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 3:100); Coated weight is 0.08 gram; The metal rack that will be coated with chitosan acetic acid-aqueous solution then places 20 ℃ of dehydrated alcohol, shakes after 20 minutes and takes out; Place 20 ℃ of fresh dehydrated alcohol again, shake after 20 minutes and take out, with thorough eluting acetic acid; In 35 ℃ of vacuum drying ovens dry 30 minutes again, remove ethanol, promptly obtain having lactide and the Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of chitosan coating, the amount of chitosan is 1.6mg, after AFM was tested, coating layer thickness was 1.2 μ m.
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Get polycaprolactone 20mg, add the acetone of 20ml, being made into concentration is the appearance liquid of 1mg/ml; Get azithromycin 25mg, add the oxolane of 25ml, be made into the solution that concentration is 1mg/ml; Above-mentioned two kinds of solution are respectively got 20ml mix, promptly wherein the weight ratio of azithromycin and polycaprolactone is 1:1, and the volume ratio of two kinds of solvents is 1:1; Get above-mentioned solvent 1ml and inject water with the speed of 1ml/h; Injection in 1 hour finishes back restir 30min, removes organic solvent through decompression rotary evaporation method at last, obtains azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions.
(3) preparation of medicine carrying thin layer
Azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions is coated on the above-mentioned chitosan thin layer (potency of azithromycin is 2.15mg/g, and polycaprolactone content is 3.58mg/g); Coated weight is 0.107g, and dry 40 minutes removal moisture in 40 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with azithromycin again; The amount of azithromycin is 0.23mg; The amount of polycaprolactone is 0.38mg, and through the AFM test, total coating thickness is 3.2 μ m.
Embodiment 2
(1) preparation of chitosan thin layer
(acid anhydride ester) salicylic acid stent surface coated chitosan-acetic acid-(mass concentration of chitosan is 4% to aqueous solution gathering; The mass ratio of acetic acid and water is: 5:100); Coated weight is 0.05 gram; The metal rack that will be coated with chitosan acetic acid-aqueous solution then places 30 ℃ of dehydrated alcohol, shakes after 10 minutes and takes out; Place 30 ℃ of fresh dehydrated alcohol again, shake after 10 minutes and take out, with thorough eluting acetic acid; In 55 ℃ of vacuum drying ovens dry 15 minutes again, remove ethanol, what promptly obtain having the chitosan coating gathers (acid anhydride ester) salicylic acid support, and the amount of chitosan is 2mg, and after the AFM test, coating layer thickness is 1.4 μ m.
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Get polycaprolactone 900mg, add the acetone of 30ml, being made into concentration is the appearance liquid of 30mg/ml; Get azithromycin 600mg, add the oxolane of 20ml, be made into the solution that concentration is 30mg/ml; The polycaprolactone of getting azithromycin solution 1ml and 19ml holds solution and mixes, and promptly wherein the weight ratio of azithromycin and polycaprolactone is 1:19, and the volume ratio of two kinds of solvents is 1:19; Get above-mentioned solvent 6ml and inject water with the speed of 1ml/h; Injection in 6 hours finishes back restir 120min, and last water dialysis is removed organic solvent, obtains azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions.
(3) preparation of medicine carrying thin layer
Above-mentioned have gathering of chitosan coating apply azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions on (acid anhydride ester) salicylic acid support (potency of azithromycin be 2.15mg/g; Polycaprolactone content is 3.58mg/g); Coated weight is 0.1070g, and dry 20 minutes removal moisture in 60 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with azithromycin again; The amount of azithromycin is 0.23mg; The amount of polycaprolactone is 0.38mg, and through the AFM test, total coating thickness is 2.8 μ m.
Embodiment 3
(1) preparation of chitosan thin layer
Be that the internal diameter that the lactide of 0.2mm becomes with Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber interlacing is 6mm at diameter; Length is 45mm, has on the cancellated tube, and (mass concentration of chitosan is 4% to apply chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 5:100); Coated weight is 0.06 gram, and the metal rack that will be coated with chitosan acetic acid-aqueous solution then places 30 ℃ of dehydrated alcohol, shakes after 10 minutes and takes out; Place 30 ℃ of fresh dehydrated alcohol again, shake after 10 minutes and take out, with thorough eluting acetic acid; In 50 ℃ of vacuum drying ovens dry 15 minutes again, remove ethanol, promptly obtain having lactide and the Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of chitosan coating, the amount of chitosan is 2.4mg, after AFM was tested, coating layer thickness was 1.6 μ m.
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Get polycaprolactone 900mg, add the acetone of 30ml, being made into concentration is the appearance liquid of 30mg/ml; Get azithromycin 600mg, add the oxolane of 20ml, be made into the solution that concentration is 30mg/ml; The polycaprolactone of getting azithromycin solution 1ml and 19ml holds solution and mixes, and promptly wherein the weight ratio of azithromycin and polycaprolactone is 1:19, and the volume ratio of two kinds of solvents is 1:19; Get above-mentioned solvent 6ml and inject water with the speed of 1ml/h; Injection in 6 hours finishes back restir 120min, and last water dialysis is removed organic solvent, obtains azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions.
(3) preparation of medicine carrying thin layer
(potency of azithromycin is 2.15mg/g on above-mentioned lactide with chitosan coating and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support, to apply azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions; Polycaprolactone content is 3.58mg/g), coated weight is 0.098g, drier 20 minutes removal moisture in 60 ℃ of vacuum drying ovens; In the rack surface coating, increase azithromycin 0.21mg and polycaprolactone 0.35mg; In the final polycaprolactone coating that is loaded with azithromycin that forms, the amount of azithromycin is 0.44mg, and the amount of polycaprolactone is 0.73mg; Through the AFM test, total coating thickness is 3.1 μ m.
Embodiment 4
(1) preparation of chitosan thin layer
At diameter is that the internal diameter that the polyglycollide fibre interlacing of 0.10mm becomes is 3mm; Length is 20mm, has on the cancellated tube, and (mass concentration of chitosan is 2% to apply chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 3:100); Coated weight is 0.06 gram, and the metal rack that will be coated with chitosan acetic acid-aqueous solution then places 20 ℃ of dehydrated alcohol, shakes after 30 minutes and takes out; Place 20 ℃ of fresh dehydrated alcohol again, shake after 30 minutes and take out, with thorough eluting acetic acid; In 35 ℃ of vacuum drying ovens dry 30 minutes again, remove ethanol, promptly obtain having the polyglycollide fibre support of chitosan coating, the amount of chitosan is 1.2mg, after the AFM test, coating layer thickness is 1.3 μ m.
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Get polycaprolactone 900mg, add the acetone of 30ml, being made into concentration is the appearance liquid of 30mg/ml; Get azithromycin 600mg, add the oxolane of 20ml, be made into the solution that concentration is 30mg/ml; The polycaprolactone of getting azithromycin solution 1ml and 19ml holds solution and mixes, and promptly wherein the weight ratio of azithromycin and polycaprolactone is 1:19, and the volume ratio of two kinds of solvents is 1:19; Get above-mentioned solvent 6ml and inject water with the speed of 1ml/h; Injection in 6 hours finishes back restir 120min, and last water dialysis is removed organic solvent, obtains azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions
(3) preparation of medicine carrying thin layer
(potency of azithromycin is 2.15mg/g on above-mentioned polyglycollide fibre support with chitosan coating, to apply azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions; Polycaprolactone content is 3.58mg/g); Coated weight is 0.026g, and dry 40 minutes removal moisture in 40 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with azithromycin again; The amount of azithromycin is 0.0056mg; The amount of polycaprolactone is 0.087mg, and through the AFM test, total coating thickness is 2.5 μ m.
Case study on implementation 5
(1) preparation of chitosan thin layer
At diameter is that the internal diameter that the polyglycollide fibre interlacing of 0.10mm becomes is 3mm; Length is 20mm, has on the cancellated tube, and (mass concentration of chitosan is 4% to apply chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 5:100); Coated weight is 0.10 gram, and the metal rack that will be coated with chitosan acetic acid-aqueous solution then places 30 ℃ of dehydrated alcohol, shakes after 10 minutes and takes out; Place 30 ℃ of fresh dehydrated alcohol again, shake after 10 minutes and take out, with thorough eluting acetic acid; In 50 ℃ of vacuum drying ovens dry 15 minutes again, remove ethanol, promptly obtain having the polyglycollide fibre support of chitosan coating, the amount of chitosan is 4mg, after the AFM test, coating layer thickness is 1.8 μ m.
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Get polycaprolactone 300mg, add the acetone of 30ml, being made into concentration is the appearance liquid of 10mg/ml; Get paclitaxel 200mg, add the oxolane of 20ml, be made into the solution that concentration is 10mg/ml; The polycaprolactone of getting paclitaxel solution 1ml and 19ml holds solution and mixes, and promptly wherein the weight ratio of paclitaxel and polycaprolactone is 1:1, and the volume ratio of two kinds of solvents is 1:1; Get above-mentioned solvent 1ml and inject water with the speed of 1ml/h; Injection in 1 hour finishes back restir 30min, removes organic solvent through decompression rotary evaporation method at last, obtains Ah's paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions
(3) preparation of medicine carrying thin layer
On above-mentioned polyglycollide fibre support with chitosan coating, apply paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions (content of taxol is 0.60mg/g, and polycaprolactone content is 3.00mg/g), coated weight is 0.12g; Drying was removed moisture in 20 minutes in 60 ℃ of vacuum drying ovens again; Promptly form the polycaprolactone coating that is loaded with paclitaxel, the amount of paclitaxel is 0.072mg, and the amount of polycaprolactone is 0.36mg; Through the AFM test, total coating thickness is 3.3 μ m.
Case study on implementation 6
(1) preparation of chitosan thin layer
At diameter is that the internal diameter that the polyglycollide fibre interlacing of 0.10mm becomes is 3mm; Length is 20mm, has on the cancellated tube, and (mass concentration of chitosan is 3% to apply chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 4:100); Coated weight is 0.07 gram, and the metal rack that will be coated with chitosan acetic acid-aqueous solution then places 25 ℃ of dehydrated alcohol, shakes after 15 minutes and takes out; Place 25 ℃ of fresh dehydrated alcohol again, shake after 15 minutes and take out, with thorough eluting acetic acid; In 40 ℃ of vacuum drying ovens dry 20 minutes again, remove ethanol, promptly obtain having lactide and the Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of chitosan coating, the amount of chitosan is 2.1mg, tests through AFM, coating layer thickness is 1.8 μ m.
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Get polycaprolactone 600mg, add the acetone of 30ml, being made into concentration is the appearance liquid of 20mg/ml; Get paclitaxel 200mg, add the acetone of 10ml, be made into the solution that concentration is 20mg/ml; The polycaprolactone of getting paclitaxel solution 1ml and 2ml holds solution and mixes, and promptly wherein the weight ratio of paclitaxel and polycaprolactone is 1:2, and the volume ratio of two kinds of solvents is 1:2; Get above-mentioned solvent 1ml and inject water with the speed of 1ml/h; Injection in 1 hour finishes back restir 30min, removes organic solvent through the water dialysis at last, obtains Ah's paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions
(3) preparation of medicine carrying thin layer
(content of taxol is 0.60mg/g on above-mentioned polyglycollide fibre support with chitosan coating, to apply paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions; Polycaprolactone content is 3.00mg/g); Coated weight is 0.40g, and dry 30 minutes removal moisture in 50 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with paclitaxel again; The amount of paclitaxel is 0.24mg, and the amount of polycaprolactone is 1.2mg.
(content of taxol is 0.60mg/g to apply paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions once more; Polycaprolactone content is 3.00mg/g); Coated weight is 0.095g, and dry 30 minutes removal moisture in 50 ℃ of vacuum drying ovens increases paclitaxel 0.057mg and polycaprolactone 0.29mg in the rack surface coating again; The final polycaprolactone coating that is loaded with paclitaxel that forms the wherein amount of paclitaxel is 0.297mg; The amount of polycaprolactone is 1.49mg, and through the AFM test, total coating thickness is 3.7 μ m.
Embodiment 7
Be that the internal diameter that the lactide of 0.2mm becomes with Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber interlacing is 6mm at diameter; Length is 45mm, has on the cancellated tube, and (mass concentration of chitosan is 2% to apply chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 3:100); Coated weight is 0.08 gram, will be coated with chitosan acetic acid-aqueous solution tubulose thing then and place 20 ℃ of dehydrated alcohol, shakes after 10 minutes and takes out; Place 20 ℃ of fresh dehydrated alcohol again, shake after 10 minutes and take out, with thorough eluting acetic acid; In 35 ℃ of vacuum drying ovens dry 30 minutes again, remove ethanol, promptly obtain having the lactide and the Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of chitosan coating, the amount of chitosan is 1.6mg.
(potency of azithromycin is 2.15mg/g on above-mentioned lactide with chitosan coating and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support, to apply azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions; Polycaprolactone content is 3.58mg/g); Coated weight is 0.107g, and dry 40 minutes removal moisture in 40 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with azithromycin again; The amount of azithromycin is 0.23mg, and the amount of polycaprolactone is 0.38mg.
Embodiment 8
Have chitosan coating and the polycaprolactone that is loaded with azithromycin that in embodiment 1, obtain are received on the lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of coating; (content of taxol is 0.60mg/g to apply paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions once more; Polycaprolactone content is 3.00mg/g); Coated weight is 0.095g, and dry 40 minutes removal moisture in 40 ℃ of vacuum drying ovens increases paclitaxel 0.057mg and polycaprolactone 0.29mg in the rack surface coating again; In the final polycaprolactone coating that is loaded with azithromycin and paclitaxel that forms; The amount of azithromycin is 0.23mg, and the amount of paclitaxel is 0.057mg, and the amount of polycaprolactone is 0.67mg.
Embodiment 9
Have chitosan coating and the polycaprolactone that is loaded with azithromycin that in embodiment 1, obtain are received on the lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of coating; (potency of azithromycin is 2.15mg/g to apply azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions once more; Polycaprolactone content is 3.58mg/g), coated weight is 0.098g, drier 20 minutes removal moisture in 60 ℃ of vacuum drying ovens; In the rack surface coating, increase azithromycin 0.21mg and polycaprolactone 0.35mg; In the final polycaprolactone coating that is loaded with azithromycin that forms, the amount of azithromycin is 0.44mg, and the amount of polycaprolactone is 0.73mg.
Embodiment 10
At diameter is that the internal diameter that the polyglycollide fibre interlacing of 0.10mm becomes is 3mm; Length is 20mm, has on the cancellated tube, and (mass concentration of chitosan is 2% to apply chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 3:100); Coated weight is 0.03 gram, will be coated with chitosan acetic acid-aqueous solution tubulose thing then and place 30 ℃ of dehydrated alcohol, shakes after 5 minutes and takes out; Place 20 ℃ of fresh dehydrated alcohol again, shake after 5 minutes and take out, with thorough eluting acetic acid; In 50 ℃ of vacuum drying ovens dry 15 minutes again, remove ethanol, promptly obtain having the lactide and the Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of chitosan coating, the amount of chitosan is 0.6mg.
(potency of azithromycin is 2.15mg/g on above-mentioned polyglycollide fibre support with chitosan coating, to apply azithromycin-polycaprolactone nanometer-submicron particles aqueous dispersions; Polycaprolactone content is 3.58mg/g); Coated weight is 0.026g, and dry 40 minutes removal moisture in 40 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with azithromycin again; The amount of azithromycin is 0.0056mg, and the amount of polycaprolactone is 0.087mg.
Embodiment 11
At diameter is that the internal diameter that the polylactide cross fibers of 0.25mm is woven into is 6mm; Length is 50mm, has on the cancellated tube, and (mass concentration of chitosan is 2% to apply chitosan-acetic acid-aqueous solution; The mass ratio of acetic acid and water is: 3:100); Coated weight is 0.10 gram, will be coated with chitosan acetic acid-aqueous solution tubulose thing then and place 20 ℃ of dehydrated alcohol, shakes after 10 minutes and takes out; Place 20 ℃ of fresh dehydrated alcohol again, shake after 10 minutes and take out, with thorough eluting acetic acid; In 35 ℃ of vacuum drying ovens dry 30 minutes again, remove ethanol, promptly obtain having the lactide and the Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber support of chitosan coating, the amount of chitosan is 2.0mg.
(content of taxol is 0.60mg/g on above-mentioned polylactide fibrous framework with chitosan coating, to apply paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions; Polycaprolactone content is 3.00mg/g); Coated weight is 0.12g, and dry 40 minutes removal moisture in 40 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with paclitaxel again; The amount of paclitaxel is 0.072mg, and the amount of polycaprolactone is 0.36mg.
Embodiment 12
At diameter is that the internal diameter that gathering of 0.6mm the dioxanone cross fibers is woven into is 14mm, and length is 40mm, has on the cancellated tube; (mass concentration of chitosan is 4%, and the mass ratio of acetic acid and water is: 5:100), coated weight is 0.25 gram to apply chitosan-acetic acid-aqueous solution; To be coated with chitosan acetic acid-aqueous solution tubulose thing then and place 30 ℃ of dehydrated alcohol, and shake after 10 minutes and take out; Place fresh dehydrated alcohol again, shake after 10 minutes and take out, with thorough eluting acetic acid; In 50 ℃ of vacuum drying ovens dry 15 minutes again, remove ethanol, what promptly obtain having the chitosan coating gathers to the dioxanone fibrous framework chitosan amount 10.0mg.
(content of taxol is 0.60mg/g on above-mentioned polylactide fibrous framework with chitosan coating, to apply paclitaxel-polycaprolactone nanometer-submicron particles aqueous dispersions; Polycaprolactone content is 3.00mg/g); Coated weight is 0.40g, and dry 40 minutes removal moisture in 40 ℃ of vacuum drying ovens promptly forms the polycaprolactone coating that is loaded with paclitaxel again; The amount of paclitaxel is 0.24mg, and the amount of polycaprolactone is 1.2mg.
Claims (10)
1. drug-carried coat, it is characterized in that: described drug-carried coat is meant the medicine carrying thin layer on the chitosan thin layer that is formed at rack surface.
2. a kind of drug-carried coat according to claim 1; It is characterized in that; Described chitosan thin layer is meant that the mass ratio that chitosan is dissolved in acetic acid and water is in the solution of 3 ~ 5:100; Wherein the mass concentration of chitosan is 2.0 ~ 4.0%, through ethanol elution acetic acid, dries the thin layer that obtains again; The thickness of said chitosan thin layer is between 1～2 μ m.
3. a kind of drug-carried coat according to claim 1 is characterized in that, described support is a thermoplasticity biodegradable fiber braided support; The filament diameter of described thermoplasticity biodegradable fiber is 0.1 ~ 0.6 millimeter.
4. a kind of drug-carried coat according to claim 3 is characterized in that, described thermoplasticity biodegradable fiber is polylactide fiber, polyglycollide fibre, lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber or gathers the dioxanone fiber.
5. a kind of drug-carried coat according to claim 1 is characterized in that, the thickness sum of the thickness of described medicine carrying thin layer and chitosan thin layer is not higher than 5 μ m; Described medicine carrying thin layer is to be formed by medicament-carried nano-submicron particles aqueous dispersions, and said medicament-carried nano-submicron particles is degradable high polymer material polycaprolactone medicament-carried nano-submicron particles, is the polycaprolactone polymer microsphere of coating medicine.
6. the method for preparing of a kind of drug-carried coat as claimed in claim 1, its characteristic may further comprise the steps:
(1) preparation of chitosan thin layer
Chitosan acetic acid-aqueous solution is coated on rack surface, immerses in the dehydrated alcohol again and take out support after 10-20 minute, rack surface promptly forms the chitosan thin layer, then oven dry;
(2) preparation of medicament-carried nano-submicron particles aqueous dispersions
Biodegradable Polymers is dissolved in the organic solvent first, and the concentration of dissolving back Biodegradable Polymers is 1～30mg/ml; Medicine is dissolved in the organic solvent second, and the drug concentrations after the dissolving is 1～30mg/ml; With above-mentioned two kinds of solution common water that slowly injects under stirring condition, wherein the weight ratio of dewatering medicament and Biodegradable Polymers is 1 ︰ 1～19; The total amount of described organic solvent first and organic solvent second and the volume ratio of water are 1 ︰ 1～20; Injection length is 1～6h; Inject and finish continued stirring 0.5～4h; Remove organic solvent first and organic solvent second then, promptly obtain the aqueous dispersions of biodegradable polymer medicament-carried nano-submicron particles;
Described organic solvent first and described organic solvent second can be dissolved each other; Described organic solvent first is methanol, ethanol, acetone, acetonitrile, oxolane, dioxy six alkane, dimethyl formamide or dimethyl sulfoxide; Described organic solvent second is methanol, ethanol, acetone, acetonitrile, oxolane, dioxy six alkane, dimethyl formamide or dimethyl sulfoxide;
(3) preparation of medicine carrying thin layer
Medicament-carried nano-submicron particles aqueous dispersions is coated on the above-mentioned chitosan thin layer, removes moisture, medicament-carried nano-submicron particles is assembled, and promptly forms the medicine carrying thin layer, obtains described drug-carried coat.
7. the method for preparing of a kind of drug-carried coat according to claim 6 is characterized in that, further, through repeating step (3), repeatedly applies medicament-carried nano-submicron particles aqueous dispersions, improves the drug loading of support, finally obtains required drug-carried coat.
8. the method for preparing of a kind of drug-carried coat according to claim 6 is characterized in that, the mass concentration of chitosan is 2.0 ~ 4.0% in described chitosan acetic acid-aqueous solution, and the mass ratio of acetic acid and water is 3 ~ 5:100; The method of removing organic solvent in the said step (2) is decompression rotary evaporation method or water dialysis; The moisture that removes in the said step (3) adopts vacuum drying oven to remove moisture, and temperature is 40-60 ℃, and the time is 20-40 minute.
9. the method for preparing of a kind of drug-carried coat according to claim 6 is characterized in that, described support is a thermoplasticity biodegradable fiber braided support, and the filament diameter of described thermoplasticity biodegradable fiber is 0.1 ~ 0.6 millimeter; Medicament-carried nano-submicron particles is a degradable high polymer material polycaprolactone medicine carrying granule in described medicament-carried nano-submicron particles aqueous dispersions, by water is disperseed.
10. the method for preparing of a kind of drug-carried coat according to claim 9 is characterized in that, described thermoplasticity biodegradable fiber is polylactide fiber, polyglycollide fibre, lactide and Acetic acid, hydroxy-, bimol. cyclic ester copolyester fiber or gathers the dioxanone fiber.
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