CN100346847C - Medical coating system having double-term and/or multi-term release speed rate - Google Patents
Medical coating system having double-term and/or multi-term release speed rate Download PDFInfo
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- CN100346847C CN100346847C CNB2005100539802A CN200510053980A CN100346847C CN 100346847 C CN100346847 C CN 100346847C CN B2005100539802 A CNB2005100539802 A CN B2005100539802A CN 200510053980 A CN200510053980 A CN 200510053980A CN 100346847 C CN100346847 C CN 100346847C
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Abstract
The present invention relates to a medical coating system with double-term and/or multi-term release speed and an application thereof. The medical coating system comprises at least a basal layer and an outer layer, wherein the basal layer is composed of high molecular weight polyethylene oxide of which the molecular weight is from 1*10 <6> to 1*10 <8> or a polyethyleneglycol carried medicine or a bioactive substance, and an additive, and the outer layer is composed of low molecular weight polyethylene oxide of which the molecular weight is from 1*10 <3> to 5*10 <8> or a polyethyleneglycol carried medicine or a bioactive substance. The present invention uses the degradability and the expansibility of the polyethylene oxide with different molecular weights and is coated on the surface of a medical material in layering, the carried active substance is quickly released by the outer layer to quickly obtain the effective concentration, the carried active substance is slowly released by the inner layer to maintain the effective concentration to a certain period, and the system is in accordance with the drug therapy principle and is effectively applied to the medical treatment. The coating system can be applied to various medical materials/appliances for external application, blood vessel or vivo implantation, and various medicines such as antimicrobials and various bioactive substances such as growth factors, etc., are transported and released.
Description
Technical field
The present invention relates to a kind of medical coating system and application thereof with two phases or rate of release of many phases.The invention particularly relates to a kind of medical catheter and method for making thereof.
Background technology
Although biomaterial and extremely extensive by the application of medical devices in modern medical service of its manufacturing, their effect is still unsatisfactory.Be a basic and general problem with bio-incompatibility of different nature in various degree, be in particular in the immunoreation that causes blood coagulation and various body fluid and cell.To be biomaterial cause forming on the surface easily this characteristic of bacterial membrane to the adhesive attraction of antibacterial makes the application of the biomaterial/medical devices infection that usually occurs together in the problem that causes extensive concern in recent years for another, and this class infects and is difficult to treatment, consequently in most of the cases has to stop the use of this biomaterial/medical devices.The biocompatibility that improves biomaterial/medical devices based on above-mentioned condition just has its necessity and urgency, and one of this improved approach commonly used carries out modification to biomaterial surface exactly.
Bacterial infection is one of severe complication during all kinds of medical catheters are used, for example the incidence rate that infects in the blood due to the central venous catheter is between 0.9%-8%, but the dead probability that this conduit infections relating causes can be up to 14%-28% (Widmer AF, In Catheter-Related Infection (Ed.Seifert H, Jansen B Farr BM), 1997, P183-215).It is 5%-10% every day that the catheter of closed drainage type causes infection rate, and the infection rate of opening catheter is higher, and whole body use antibiotics can not prevention infection (Kaye D ﹠amp; Hessen MT, Infections Associated with Indwelling MedicalDevices (Ed.Bisno A ﹠amp; Waldvogel FA), 1994, P291-307).
For the infection complication that prevents that these are common and serious, invented a large amount of infection coatings in recent years.These coatings are many sneaks into antibiotics/anti-infective in the hydrophilic macromolecular compounds, in the hope of bacteria growing inhibiting or kill bacteria (United States Patent (USP): 5752941 by the release of these antibiotics/anti-infectives, 5928174, U.S. Patent application 20040010215,20040086568), domestic also have the method that adopts vacuum plating silver to cover one deck silverskin at catheter surface, and the release by silver ion reaches infection purpose (Chinese patent authorization bulletin 2289571).
Summary of the invention
All above-mentioned coatings all are single delivery system, promptly discharge its contained antibiotic substance by single-rate.The limitation of this system is if rate of release is too fast, makes that the antibiotic time limit is limited thereby then shorten deenergized period, and excessive in a short time release is arranged and produces the danger of untoward reaction; If rate of release is slower, then reach the required overlong time of treatment concentration, may miss the opportunity of suppressing the bacterial reproduction diffusion, spread thereby make to infect to form.A lot of clinical trials prove that the relevant infection of established conduit is very difficult in treatment.So ideal delivery system should be two phases or many phases, early stage rapid release slowly discharges to keep valid density thereafter to reach treatment concentration rapidly.Can obtain effective and secular infection effect like this.
Have only a kind of single rate of release and cause the unfavorable problem of therapeutic effect at above-mentioned existing medical devices or medical material, the inventor provides a kind of medical coating system with rate of release of many phases, it is characterized in that, at least comprise basal layer and skin, described basal layer is made of high molecular weight polyethylene oxide or Polyethylene Glycol carrying medicament or bioactive substance and additive, described skin is made of low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol carrying medicament or bioactive substance, wherein, the molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is 1 * 10
6～1 * 10
8, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is 1 * 10
3～5 * 10
4, described additive comprises cross-linking agent, stabilizing agent etc.
The molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is preferably 3 * 10
6～4 * 10
6In the scope, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is preferably 2 * 10
3～2 * 10
4In the scope.
Medical coating system of the present invention also can comprise the intermediate layer as required, and this intermediate layer is made of the poly(ethylene oxide) carrying medicament or the bioactive substance of molecular weight between described high molecular weight polyethylene oxide and described low-molecular-weight poly(ethylene oxide).
As the poly(ethylene oxide) in intermediate layer as required, can also loaded cross-linked dose.
When the medicine of basal layer of the present invention, intermediate layer and outer field poly(ethylene oxide) or Polyethylene Glycol load is anti-infective, can realize that many phases discharge the effect of anti-infective.
Described anti-infective is to be selected from antibiotics, poly hexamethylene biguanide class, hibitane and acetic acid thereof, gluconic acid, hydrochloric acid, Sulfates, any in nanometer and non-nano level silver and the salt thereof.
Another form of the present invention is a kind of medical coating system with two phase rates of release, it is characterized in that, constitute by basal layer and skin, described basal layer is made of high molecular weight polyethylene oxide or Polyethylene Glycol carrying medicament or bioactive substance and additive, described skin is made of low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol carrying medicament or bioactive substance, wherein, the molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is 1 * 10
6～1 * 10
8, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is 1 * 10
3～5 * 10
4, described additive comprises cross-linking agent, stabilizing agent etc.
The molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is preferably 3 * 10
6～4 * 10
6In the scope, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is preferably 2 * 10
3～2 * 10
4In the scope.
When the medicine of described basal layer and outer field poly(ethylene oxide) or Polyethylene Glycol load is anti-infective, can realize that two phases discharge the function of anti-infective.
Described anti-infective is to be selected from antibiotics, poly hexamethylene biguanide class, hibitane and acetic acid thereof, gluconic acid, hydrochloric acid, Sulfates, any in nanometer and non-nano level silver and the salt thereof.
Medical coating system with two phases or rate of release of many phases of the present invention can be applicable in external, the blood vessel or body is implanted into medical material or equipment.
Another form of the present invention is a kind of medical catheter.
Another form of the present invention is a kind of manufacture method of medical catheter, it is characterized in that, at first, prepares the basal layer and the outer field coating liquid of the medical coating system of desire formation respectively; Then, latex catheter be impregnated in the described basal layer coating liquid, oven dry forms the basal layer coating on conduit; The conduit that then this is had basal layer impregnated in the described outer coating liquid, and oven dry forms have basal layer and outer field medical catheter of the present invention.
Coat system of the present invention can be applied to all kinds of externals, contact with blood as the various medicines and the carrier of bioactive substance safely and effectively, and inserts intravital medical devices surface for a long time.
The present invention utilizes the degradability and the dilatancy of the poly(ethylene oxide) of different molecular weight, layering is applied to the medical material surface, the contained active substance of outer rapid release is to reach valid density rapidly, internal layer slowly discharges and keeps valid density to the regular period, and this system more meets the Drug therapy principle and more effective being applied in the medical treatment.Medical material/equipment that this release coat system can be applicable in all kinds of externals, blood vessel or body is implanted into transports and discharges various medicines such as antibacterial, and anti-inflammatory agent or anticarcinogen etc. and various bioactive substance are as somatomedin, hormone or anti-hyperplasia etc.
As medical catheter coat system of the present invention, also has the characteristic that increases the catheter surface lubricity, poly(ethylene oxide) or Polyethylene Glycol have very strong hydrophilic, highly lubricated behind the chance water, greatly reduce coefficient of friction, thereby reduced wound that causes when conduit is inserted and the untoward reaction of inserting back skin or mucosa.For catheter, the lubricant that needs in the alternative routine operation of this coating.Thereby make conduit insert easier should going.The conduit that evidence medical coating system load of the present invention anti-infective is made has good anti-infection property, has realized that rate of release is fast in advance, the slow function of rate of release thereafter, thus given play to good therapeutic effect.
Description of drawings
Fig. 1 is the rate curve comparison diagram that the poly(ethylene oxide) of three kinds of different molecular weights discharges the silver oxide of institute's load;
Fig. 2 is the rate profile that the conduit with duplex coating system of the present invention discharges the silver oxide of institute's load.
The specific embodiment
The inventor is in order to overcome the limitation that the single releasing mechanism of existing medical coating material exists, discover repeatedly, the degraded and the expansion characteristics of the hydrogel that the poly(ethylene oxide) of different molecular weight (PEO) is made are different, thereby the rate of release of its contained material is also different.Low-molecular-weight poly(ethylene oxide) gel is the contained medicine of rapid release by hydrolysis mainly, and high-molecular weight poly(ethylene oxide) gel then mainly slowly discharges by expanding.The difference of this rate of release also can make its expansion or dwindles by the control crosslinking degree.Based on these features, the inventor successfully develops a kind of bilayer or multi-layer coating system, promptly is basal layer with the high molecular weight polyethylene oxide, and the low-molecular-weight poly(ethylene oxide) is outer, if necessary can, be inter coat with the poly(ethylene oxide) of intermediate molecular weight.This coat system has double speed or the many rapid releases of two phases or many phases and puts speed, to satisfy the needs of medical prophylaxis and treatment.The control of this rate of release can also be by adding or not adding cross-linking agent and further realize.
Laminated coating of the present invention is made up of poly(ethylene oxide) that contains different molecular weight or Polyethylene Glycol hydrogel respectively.Basal layer is by high molecular weight polyethylene oxide or Polyethylene Glycol carrying medicament or bioactive substance and other additives such as cross-linking agent, compositions such as stabilizing agent, and outer coating is made up of low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol carrying medicament or bioactive substance.Concrete, the selection of poly(ethylene oxide) or molecular weight polyethylene glycol is decided by required rate of release, and receives the influence of cross-linking agent-free.Rate of release is relevant with contained molecular weight of material size, physicochemical property etc. with application requirements again.The poly(ethylene oxide) of basal layer or the molecular weight of Polyethylene Glycol are generally 1 * 10
6～1 * 10
8Suit in the scope, preferably 3 * 10
6～4 * 10
6In the scope.The molecular weight ranges of outer field poly(ethylene oxide) or Polyethylene Glycol is generally 1 * 10
3～5 * 10
4Suit in the scope, preferably 2 * 10
3～2 * 10
4In the scope.External coating does not generally add cross-linking agent to keep quick degradation characteristic.Inter coat obtains releasing effect of many phases if desired, can select for use poly(ethylene oxide) (or Polyethylene Glycol) load required medicine or the bioactive substance of molecular weight between above-mentioned skin and basal layer to form.Cross-linking agent can be selected according to applicable cases to add or do not add.The cross-linking agent that is used for the basal layer of coat system of the present invention and intermediate layer can be that crosslinked cross-linking agent takes place any poly(ethylene oxide) or Polyethylene Glycol of making such as azacyclopropane.
Bilayer of the present invention or multilamellar medical coating system can be applicable in external, the blood vessel or body is implanted into medical material or equipment.Preferably, bilayer of the present invention or multi-layer coating system are used for medical catheter.More preferably, duplex coating of the present invention system is used for medical catheter.Especially preferred is to make duplex coating system load anti-infective of the present invention make the medical catheter with infection coating.
When having the medical catheter of infection coating, at first, prepare the basal layer and the outer field coating liquid of the medical coating system of desire formation respectively by bilayer of the present invention or multi-layer coating system manufacturing; Then, latex catheter be impregnated in the described basal layer coating liquid, oven dry forms the basal layer coating on conduit; The conduit that then this is had the basal layer coating impregnated in the described outer coating liquid, and oven dry forms medical catheter.
But selecting for use of anti-infective comprises antibiotics such as Tobe mycin, gentamycin, isoniazid, bacitracin, neomycin, chloromycetin, miconazole, tolnaftate, many glutinosins, tetracycline, mute quinoline acid, norfloxacin, nalidixan, pefloxacin, enoxacin, ciprofloxacin, amoxicillin, ampicillin, cephalosporin or model mycin.Other anti-infectives comprise poly-six subunit biguanideses, hibitane and acetic acid thereof, the acid of Fructus Vitis viniferae Tang, hydrochloric acid, Sulfates, various nanometers and non-nano level silver and silver salt thereof, as silver acetate, silver benzoate, Disilver carbonate, silver iodate, silver iodide, actol, lauric acid silver, silver nitrate, silver oxide, Palmic acid silver, argentoproteinum, TGA silver and silver sulfadiazine etc.In these anti-infectives, preferred ciprofloxacin and silver oxide.
The selected poly(ethylene oxide) (or Polyethylene Glycol) of coat system of the present invention is the macromolecular compound of low toxicity as safe as a house, is widely used in food additive and various injection, the additive of oral and topical agent.Many researchs also show material list with poly(ethylene oxide) structure and owing to have excellent biological compatibility, can reduce protein adsorption (Lee JH, et al., J, Biomed Mater Res., 1989,23:351-368), anticoagulation (Lee JH, et al.Biomaterials, 2000,21:683-691; Nagaoka S, et al., Biomaterials, 1990,11:119-121) with repulsion bacterial adhesion (Desai NP, et al., Biomaterials, 1992,13:417-420), these good characteristics make this coat system can be safely and effectively be applied to all kinds of externals as the carrier of various medicines and bioactive substance, contact with blood, and insert intravital medical devices surface for a long time.
As the medical catheter coating, this coating also has the characteristic that increases the catheter surface lubricity, poly(ethylene oxide) and Polyethylene Glycol have very strong hydrophilic, highly lubricated behind the chance water, greatly reduce coefficient of friction, thereby reduced wound that causes when conduit is inserted and the untoward reaction of inserting back skin or mucosa.For catheter, the lubricant that needs in the alternative routine operation of this coating.Thereby make conduit insert easier should going.
Below by specific embodiment in detail the present invention is described in detail.Following embodiment is used for explaining technical scheme of the present invention, and form of implementation of the present invention is not limited to following embodiment.
Embodiment
At first, the test method of employing atomic spectrophotometer detection silver concentration and the operational approach of inhibition zone test in the embodiments of the invention are described below:
1. atomic spectrophotometer detects the silver concentration test:
Detect coating and discharge silver amount employing atomic spectrophotometer Varian Model Spectr AA-200.During test, earlier silver-colored release test gained solution is got 0.5ml, add 10% nitric acid/1% tartaric acid solution of 4.5ml again, mix the back and under 105 ℃, left standstill 20 minutes.With above-mentioned nitric acid/tartaric acid solution liquid to be measured being diluted to instrument institute after cooling can detected scope.Testing conditions is as follows:
Wavelength: 328.1nm;
Electric current: 4mA;
Combustion head: air/acetylene 10cm;
Flame type: tilt (oxidant 12.5L/min, acetylene 1.6L/min).
2. inhibition zone determination test:
1) planting used antibacterial in its agar content earlier is in the Mueller Hinton culture medium (Difo Laboratories) of 1.7% (w/w), and in 37 ℃ of following overnight incubation.Then, select 2～3 commentaries on classics of independent pure bacterium colony to plant in Trypsin enzymolysis soy broth (TSB, Difco Laboratories), being cultured to 625nm wavelength absorbance was 0.08～0.1 (being equivalent to the 0.5McFarland standard).
2) with aseptic cotton rod above-mentioned bacterial suspension is evenly planted on Mueller Hinton culture medium.
3) coated catheters is cut into the long segment of 2cm, gets one section and place above-mentioned culture dish center.
4) in 37 ℃ of incubators, cultivated 18～24 hours.
5) transparent aseptic area footpaths, measuring guide section both sides (perpendicular to conduit) are inhibition zone.
Embodiment 1
The preparation of the poly(ethylene oxide) coating liquid of three kinds of different molecular weights.
Coating liquid 1: with PEO (molecular weight 4 * 10
6, Union Carbide Corp. system) and be 2%, silver oxide (Sigma sells) is 0.2% ratio, and PEO and silver oxide uniform mixing are mixed with coating liquid 1 in isopropanol (80: 20) solution.
Coating liquid 2: with PEO (molecular weight 3 * 10
5, Union Carbide Corp. system) and be 3%, silver oxide (Sigma sells) is 0.2% ratio, and PEO and silver oxide uniform mixing are mixed with coating liquid 2 in isopropanol (80: 20) solution.
Coating liquid 3: with PEO (molecular weight 2 * 10
4, Union Carbide Corp. system) and be 8%, silver oxide (Sigma sells) is 0.2% ratio, and PEO and silver oxide uniform mixing are mixed with coating liquid 3 in isopropanol (80: 20) solution.
Three latex catheters be impregnated in respectively in above-mentioned three kinds of coating liquid, in 80 ℃ baking oven, dry subsequently, repeat above-mentioned steps once, form three conduits respectively with poly(ethylene oxide) coating of different molecular weight.
The cated latex catheter of above-mentioned formation inserted make static silver-colored release test in the normal saline, silver-colored burst size detects its result such as Fig. 1 with the atom spectrophotometer.
As seen from Figure 1, when the poly(ethylene oxide) load silver oxide of different molecular weight was coated on the conduit, it discharged the speed difference of contained silver, and along with molecular weight reduces, the speed that discharges silver increases gradually.
On latex catheter, form and have basal layer and outer field duplex coating system.
At first, the basal layer and the outer field coating liquid of preparation conduit are as follows.
Basal layer: with PEO (molecular weight 4 * 10
6Union Carbide Corp. system) be 2%, with the ratio of silver oxide for (Sigma sells) 0.2%, with PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20), and the stoichiometric proportion with azacyclopropane and PEO is 1: 1 adding azacyclopropane in this solution, forms basal layer coating liquid.
Outer: with PEO (molecular weight 2 * 10
4, Union Carbide Corp. system) be 8%, be 0.2% ratio with silver oxide (Sigma sells), with PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20).
Then, latex catheter is flooded in basal layer coating liquid earlier,, in outer coating liquid, flood again,, be formed with the conduit of basal layer and outer duplex coating 80 ℃ of oven dry down 80 ℃ of oven dry down.
The conduit that will be formed with duplex coating is inserted and is made silver-colored release test in the normal saline, and silver concentration detects with atomic spectrophotometer in the solution, and its result as shown in Figure 2.
As seen from Figure 2, when being used for coat system of the present invention on the conduit, conduit has fast, the slow two phase rates of release of later stage rate of release of rate of release in early stage.
Embodiment 3
Infection measure of merit with conduit of coat system of the present invention.
The run with basal layer and outer field duplex coating system to forming among the embodiment 2 carries out inhibition zone determination test (not making silver-colored release test), tests its infection effect.
In the inhibition zone test, test medium is a Muller=Hinton agar, and the test antibacterial is escherichia coli.Inhibition zone after 24 hours is measured as 8.5mm.
Embodiment 4
Infection measure of merit with conduit of coat system of the present invention.
At first, the basal layer and the outer field coating liquid of preparation conduit are as follows.
Basal layer: with PEO (molecular weight 8.6 * 10
7, Union Carbide Corp. system) and be 2%, silver oxide (Sigma sells) is 0.2% ratio, and PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20), are formed basal layer coating liquid.
Outer: with PEO (molecular weight 5.2 * 10
4, Union Carbide Corp. system) be 6%, silver oxide (Sigma sells) is 0.2% ratio, with PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20).
Then, latex catheter is taken up in order of priority impregnated in basal layer and the outer masking liquid,, forms conduit with basal layer and outer duplex coating 80 ℃ of oven dry down.
Then, the run with duplex coating of above-mentioned formation is done the inhibition zone determination test, test medium is a Muller=Hinton agar, and the test antibacterial is escherichia coli.Inhibition zone after 24 hours is measured as 6.0mm.
Embodiment 5
Infection measure of merit with conduit of coat system of the present invention.
At first, the basal layer and the outer field coating liquid of preparation conduit are as follows.
Basal layer: with PEO (molecular weight 1 * 10
6Union Carbide Corp. system) be 3%, silver oxide (Sigma sells) is 0.2% ratio, with PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20), and the stoichiometric proportion with azacyclopropane and PEO is 1: 1 adding azacyclopropane in this solution, forms basal layer coating liquid.
Outer: with PEO (molecular weight 2 * 10
3, Union Carbide Corp. system) and be 10%, be 0.2% ratio with silver oxide (Sigma sells), PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20), are formed outer coating liquid.
Then, latex catheter is taken up in order of priority impregnated in basal layer and the outer masking liquid, and, forms conduit with basal layer and outer duplex coating 80 ℃ of oven dry down.
Then, the above-mentioned run that obtains is done inhibition zone determination test (Muller=Hinton culture medium, escherichia coli), recording inhibition zone is 9.0mm.
Embodiment 6
Infection measure of merit with conduit of coat system of the present invention.
At first, the basal layer and the outer field coating liquid of preparation conduit are as follows.
Basal layer: with PEO (molecular weight 4 * 10
6Union Carbide Corp. system) being 2%, is 0.3% ratio with ciprofloxacin, with PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20), and the stoichiometric proportion with azacyclopropane and PEO is 1: 1 adding azacyclopropane in this solution, forms basal layer coating liquid.
Outer: with PEO (molecular weight 2 * 10
4, Union Carbide Corp. system) and be 8%, be 0.3% ratio with ciprofloxacin, PEO and silver oxide uniform mixing in the solution of isopropanol (80: 20), are formed outer coating liquid.
Then, latex catheter is taken up in order of priority impregnated in basal layer and the outer masking liquid, and, forms conduit with basal layer and outer duplex coating 80 ℃ of oven dry down.
Then, the run with duplex coating that obtains is done the inhibition zone determination test, culture medium is a Muller=Hinton agar, and the test antibacterial is bacillus pyocyaneus and escherichia coli, records its inhibition zone and is respectively 21.0mm and 18.6mm.
Can find out that by the foregoing description 1-6 medical coating system of the present invention has fast, the slow release function of many phases of later stage rate of release of rate of release in early stage, when medical coating system of the present invention is used for medical material, has given play to good infection effect.
Claims (15)
1. medical coating system with rate of release of many phases, it is characterized in that, at least comprise basal layer and skin, described basal layer is made of high molecular weight polyethylene oxide or Polyethylene Glycol carrying medicament or bioactive substance and additive, described skin is made of low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol carrying medicament or bioactive substance, wherein, the molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is 1 * 10
6～1 * 10
8, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is 1 * 10
3～5 * 10
4, described additive comprises cross-linking agent.
2. the medical coating system with rate of release of many phases according to claim 1 is characterized in that the molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is 3 * 10
6～4 * 10
6, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is 2 * 10
3～2 * 10
4
3. the medical coating system with rate of release of many phases according to claim 1 and 2, it is characterized in that, also comprise the intermediate layer, described intermediate layer is made of the poly(ethylene oxide) carrying medicament or the bioactive substance of molecular weight between described high molecular weight polyethylene oxide and described low-molecular-weight poly(ethylene oxide).
4. the medical coating system with rate of release of many phases according to claim 3 is characterized in that the poly(ethylene oxide) in described intermediate layer also load has cross-linking agent.
5. the medical coating system with rate of release of many phases according to claim 4 is characterized in that, the medicine of described basal layer, intermediate layer and outer field poly(ethylene oxide) or Polyethylene Glycol load is an anti-infective.
6. the medical coating system with rate of release of many phases according to claim 5, it is characterized in that described anti-infective is to be selected from antibiotics, the poly hexamethylene biguanide class, hibitane and acetic acid thereof, gluconic acid, hydrochloric acid, Sulfates, a kind of in nanometer and non-nano level silver and the salt thereof.
7. medical coating system with two phase rates of release, it is characterized in that, constitute by basal layer and skin, described basal layer is made of high molecular weight polyethylene oxide or Polyethylene Glycol carrying medicament or bioactive substance and additive, described skin is made of low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol carrying medicament or bioactive substance, wherein, the molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is 1 * 10
6～1 * 10
8, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is 1 * 10
3～5 * 10
4, described additive comprises cross-linking agent.
8. the medical coating system with two phase rates of release according to claim 7 is characterized in that the molecular weight of described high molecular weight polyethylene oxide or Polyethylene Glycol is 3 * 10
6～4 * 10
6, the molecular weight of described low-molecular-weight poly(ethylene oxide) or Polyethylene Glycol is 2 * 10
3～2 * 10
4
9. according to claim 7 or 8 described medical coating systems, it is characterized in that the medicine of described basal layer and outer field poly(ethylene oxide) or Polyethylene Glycol load is an anti-infective with two phase rates of release.
10. the medical coating system with two phase rates of release according to claim 9, it is characterized in that described anti-infective is to be selected from antibiotics, the poly hexamethylene biguanide class, hibitane and acetic acid thereof, gluconic acid, hydrochloric acid, Sulfates, a kind of in nanometer and non-nano level silver and the salt thereof.
11. the medical coating system with two phase rates of release according to claim 10 is characterized in that described anti-infective is an antibiotics.
12. the medical coating system with two phase rates of release according to claim 10 is characterized in that, described anti-infective is ciprofloxacin or silver oxide.
13. claim 1 or 7 described medical coating systems are in external, blood vessel or the medical material that is implanted into of body or the application in the equipment.
14. medical catheter with each described medical coating system of claim 7-9.
15. the manufacture method of the described medical catheter of claim 14 is characterized in that, at first, prepares the basal layer and the outer field coating liquid of each described medical coating system of claim 7-9 respectively; Then, latex catheter be impregnated in the described basal layer coating liquid, oven dry forms the basal layer coating on conduit; The conduit that then this is had the basal layer coating impregnated in the described outer coating liquid, and oven dry forms the medical catheter with each described medical coating system of claim 7-9.
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| US8808724B2 (en) * | 2009-10-28 | 2014-08-19 | Ethicon, Inc. | Antimicrobial coatings with preferred microstructure for medical devices |
| AP2013006939A0 (en) * | 2010-11-26 | 2013-06-30 | Univ Witwatersrand Jhb | A drug delivery device |
| CN106075577A (en) * | 2016-07-21 | 2016-11-09 | 南京工业大学 | Based on organic guanidinesalt and the antimicrobial coating of Polyethylene Glycol |
| CN107754022A (en) * | 2017-11-10 | 2018-03-06 | 辽宁垠艺生物科技股份有限公司 | A kind of medication coat and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5041100A (en) * | 1989-04-28 | 1991-08-20 | Cordis Corporation | Catheter and hydrophilic, friction-reducing coating thereon |
| US5645931A (en) * | 1994-09-22 | 1997-07-08 | Union Carbide Chemicals & Plastics Technology Corporation | One step thromboresistant lubricious coating |
| US20020016574A1 (en) * | 1999-05-07 | 2002-02-07 | Lixiao Wang | Hydrophilic lubricity coating for medical devices comprising an antiblock agent |
-
2005
- 2005-03-15 CN CNB2005100539802A patent/CN100346847C/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5041100A (en) * | 1989-04-28 | 1991-08-20 | Cordis Corporation | Catheter and hydrophilic, friction-reducing coating thereon |
| US5645931A (en) * | 1994-09-22 | 1997-07-08 | Union Carbide Chemicals & Plastics Technology Corporation | One step thromboresistant lubricious coating |
| US20020016574A1 (en) * | 1999-05-07 | 2002-02-07 | Lixiao Wang | Hydrophilic lubricity coating for medical devices comprising an antiblock agent |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1833734A (en) | 2006-09-20 |
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