CN1221603C - Infection-resisting high-molecular material, its preparation method and application - Google Patents
Infection-resisting high-molecular material, its preparation method and application Download PDFInfo
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- CN1221603C CN1221603C CN 01144892 CN01144892A CN1221603C CN 1221603 C CN1221603 C CN 1221603C CN 01144892 CN01144892 CN 01144892 CN 01144892 A CN01144892 A CN 01144892A CN 1221603 C CN1221603 C CN 1221603C
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Abstract
The present invention relates to a medical infection resistant high molecular material composition for preparing a high molecular medical appliance. The composition contains 0.01 to 10 weight portions of infection resistant agent, 0 to 20 weight portions of lubrication modifying agent, 0 to 10 weight portions of dispersing agent and 0 to 15 weight portions of stabilizing agent on the basis of 100 weight portions of medical high molecular resin in addition, to contain ordinary medical high molecular resin. The present invention also relates to a method for preparing the infection resistant high molecular material and the application of the infection resistant high molecular material for preparing the medical appliance.
Description
Technical field
The present invention relates to the macromolecular material that a class is used to prepare the polymeric medical apparatus, particularly a class is added medical use anti-infection macromolecular material that auxiliary agent such as anti-infection agent is prepared from and its production and application.
Background technology
Macromolecular material is because excellent performance, structure is various, suitability is wide, therefore prepare a kind of trend that various medical device product are international medical device industry development by traditional materials such as medical macromolecular materials substituted metals, obtained development at full speed in recent years especially.Nineteen ninety-five consumes the cost of the macromolecular material on medicine equipment in the world above 12,000,000,000 dollars according to statistics, and the average growth rate per annum with 7～12% increases progressively (S Ramakrishna, J Mayer, E Wintermantel, et al, Biomedicalapplications of polymer-composite materials::a review, Composites Scienceand Technology, 2001,61:1189～1224).
But owing to contain the material that can be used as the microbial nutrition material inevitably in the macromolecular material, and the suitable microorganism of polymer surface commonly used decide grow, so microorganism is easy in its surface adhesion around in polymeric medical instrumentation process, and then grows surely, multiplies.Therefore, what some polymeric medical apparatuses of getting involved human bodies also often became microorganism decides to grow the procreation place, and may become the human infection reason, Here it is so-called " the polymeric catheter relationship type infects (Polymer Catheter-related Infection) ".As respirator dependency pneumonia is exactly a kind of severe complication in the mechanical ventilation process, its incidence is up to 18～60%, and prolong with mechanical aeration time and to raise, its case fatality rate can be up to 50% (Sun Tieying, Li Yanming, the clinical study of respirator dependency pneumonia, whole nation severe infection control academic discussion, Shantou, 2000, p53).It is reported, the medical expense that is used for the infection of conduit relationship type at average each the operation light of the U.S. is about 4000 dollars, and the European Community is used for the treatment of the expense that the polymeric catheter relationship type infects every year and is about 5,000 ten thousand Euros, the annual number that infects death because of the conduit relationship type is above 5000 people (J M Schierholz, J Beuth, A F E Rump, et al, A Difficult Search for Effective Slow DeliverySystems, J Mat wiss u Werkstofftech, 1999,30:869-875).So the conduit relationship type infects the rehabilitation that has had a strong impact on patient, has increased patient's misery and burden, even has caused patient's death.Therefore the anti-infective problem of polymeric medical apparatus is paid attention to by people very early, and all medicine equipments before use all will be through strict sterilization.Medical personnel also will be aided with the anti-infectives of suitable dosage to reduce the possibility that infects in carrying out medicine equipment implant surgery process.But these measures can only partly reduce the possibility of patient infection, can not solve the problem that conduit relationship type that medicine equipment in use taken place infects.At present, the external grade adopted in polymeric medical apparatus surface daub on a wall anti-infection agent or the infection of antibiotic method solution medical polymer conduit relationship type, certain effect (DE0057933, Coating reducing bacteriaadhesion to polymersurface have been played; EP590348, Catheter coated with lipodalbaheptideantibiotics for prevent of catheter-related infections).But finding in actual use has following shortcoming by the infection-resisting high-molecular medicine equipment that covering with paint anti-infection agent or microbiotic prepare: 1. the application type coating lose anti-infectious function thereby may break away from from polymer surface under the immersion of body fluid.And stratum disjunction may influence the health of human body.2. coating useful effect phase weak point can't guarantee anti-infection property during life-time service.3. the anti-infectious medicine equipment of preparation coating must need increase equipment through applying operation on production technique when making, and has increased extra cost of manufacture.4. when the complicated polymeric medical apparatus of preparation structure, covers with paint, lacquer, colour wash, etc. anti-infective layer and on technology, often can't realize, that is to say that covering with paint technology is subjected to the goods structural limitations.
Summary of the invention
The present invention has selected suitable organic and inorganic or organic/inorganic mixing anti-infection agent, with anti-infection agent and other auxiliary agents and the medical grade macromolecule resin material is composite, after the blend by extrude, method such as mixing or banburying prepares the medical infection-resisting high-molecular material that material monolithic has anti-infective function, solved that the medical infection-resisting high-molecular material validity period of present coating type is short, vulnerability is big, reliability is low, shortcomings such as narrow application range.Because the medical infection-resisting high-molecular material integral body of preparation all has anti-infection property, therefore to have anti-infective performance reliable for the medical infection-resisting high-molecular material among the present invention, effective acting time is long, has a broad antifungal spectrum, advantages such as material adaptability is strong, and be applicable to the preparation multiple medical use anti-infection polymeric medical apparatus, for example trachea cannula, catheter, suction tube and tracheostomy cannula etc.It is as broad as long that the medical infection-resisting high-molecular material that makes with the present invention prepares the complete processing and the common medical macromolecular materials raw material of polymeric medical apparatus, therefore can prepare corresponding infection-resisting high-molecular medicine equipment on original processing unit.
The invention provides the medical infection-resisting high-molecular material composition that a class is used to prepare the polymeric medical apparatus, said composition is except that containing common medical grade macromolecule resin, medical grade macromolecule resin based on 100 weight parts, the anti-infection agent that also contains 0.01～10 weight part is preferably 0.05～5 weight part; Lubricating modification agent 0～20 weight part is preferably 0～5 weight part; Dispersion agent 0～10 weight part is preferably 0～3 weight part; Stablizer 0～15 weight part is preferably 0～5 weight part.
Above-mentioned medical grade macromolecule resin refers to meet the polymer that GB/T16886-1997 " medicine equipment biological assessment " requires, and is preferably medical grade polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), polycarbonate (PC), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene (POM), polystyrene (PS), nylon (PA), tetrafluoroethylene (PTEE), styrene/acrylonitrile copolymer (SAN), acrylonitrile/butadiene/styrene multipolymer (ABS), vinyl cyanide/phenylethylene ethylene/propenoic acid ester copolymer (ASA), ethylene/vinyl acetate copolymer (EVA), polymethylmethacrylate all kinds of medical grade thermoplastic resins and two or more mixtures and material modified thereof such as (PMMA); All kinds of medical grade elastomeric materials and two or more mixtures and material modified thereof such as caoutchouc latex, acrylic elastomer, polybutadiene rubber, paracril, styrene-butadiene rubber(SBR), isoprene-isobutylene rubber, ethylene-propylene rubber(EPR), silicon rubber, viton, chloroprene rubber, natural rubber, thermoplastic elastomer; The above-mentioned thermoplastic resin and the mixture of rubber.
Above-mentioned anti-infection agent is preferably with Ag for the material that the suppressed pathogenic bacterium that meet GB/T16886-1997 " medicine equipment biological assessment " requirement grow or breed at material surface
+For the inorganic silver of effective anti-infective composition be anti-infection agent, 3-hydroxyl three chlorodiphenyl ethers (triclosan), chlohexidine, glycopeptide, trilaurylamine (Tridodecylamine (TDA), Aminopenicillin, epoxyeicosatrienoic acid quaternary ammonium salt and meet below the various of (1), (2) structural formula can be used for organic anti-infection agent of food or medicine equipment and two or more mixtures in them by FDA or similar means authentication.
R wherein
1, R
2, R
3, R
4Group is respectively hydrogen atom, C
1-C
5Alkyl, C
1-C
5Alkylene, C
1-C
5Hydroxyalkyl, especially preferred hydrogen atom, methyl, ethyl, propyl group, sec.-propyl, butyl, isobutyl-, amyl group, allyl group, hydroxyethyl.
Above-mentioned anti-infection agent has higher heat resistance, can tolerate 220 ℃ and do not decompose, do not produce any toxic substance, can meet GB/T16886-1997 " medicine equipment biological assessment " related request with the infection-resisting high-molecular material of above-mentioned macromolecular material compound back preparation, use the article of infection-resisting high-molecular material preparation can suppress the material of pathogenic bacterium in material surface growth or breeding.
Above-mentioned lubricating modification agent reduces the material of its frictional coefficient for can improve the polymer surface slickness, is preferably the lubricating modification agent that contains siloxanes.
Above-mentioned dispersion agent refers to improve interface avidity between small-molecule substance and polymer substance, improve consistency, improve small-molecule substance dispersive material in macromolecular material, only limit to can be used for the dispersion agent used in food or the medical treatment product by FDA or similar means authentication.Be preferably N, stearic acid dispersion agent such as stearic amide class such as N '-diethylene bis-stearamides or oxystearic acid and two or more mixtures in them.
The aforementioned stable agent only limits to authenticate the stablizer that can be used in food or the medical treatment product by FDA or similar means.As antioxidant 1010, antioxidant 1076, rare-earth stabilizer, Zn-Ca powder stablizer or two or more mixtures in them.The add-on of stablizer must not surpass FDA or the similar means maximum limiting quantity to this kind stablizer.
The invention provides a kind of medical infection-resisting high-molecular material preparation of compositions method that is used to prepare the polymeric medical apparatus, may further comprise the steps:
For thermoplastic resin:
(1) by weight with 100 parts of medical thermoplastic resins, the anti-infection agent of 0.01～10 weight part; The lubricating modification agent of 0～20 weight part; The dispersion agent of 0～20 weight part; The stablizer of 0～15 weight part thorough mixing in clean container;
(2) pass through the forcing machine extruding pelletization under the proper temperature in clean environment, packing promptly makes the medical use anti-infection plastics described in the present invention.
In above-mentioned steps (2), also can open refining or clean Banbury mixer banburying mixture, and then by clean dicing machine pelletizing, packing makes medical use anti-infection plastics of the present invention by two roller mills of cleaning.
For rubber:
(1) by weight 100 parts of medical grade rubber rubbers is mixed with the anti-infection agent of 0.01～10 weight part; The dispersion agent of 0～20 weight part; The stablizer of 0～15 weight part is thorough mixing in suitable container;
(2) with obtain mixture and vulcanizing agent in (1), properties-correcting agent is mixing jointly, sulfuration, pelletizing, packing promptly makes anti-infective rubber.
In above-mentioned steps (2), also can use ball mill or colloidal mill that the mixture that obtains in the step (1) and vulcanizing agent, properties-correcting agent are milled jointly and obtain stabilized latex, casting in the regulation mould directly obtains anti-infective product then.
In the method for the present invention, based on the medical grade macromolecule resin of 100 parts of weight parts, employed anti-infection agent is preferably 0.05～5 weight part; The lubricating modification agent is preferably 0～5 weight part; Dispersion agent is preferably 0～5 weight part; Stablizer is preferably 0～15 weight part.
Employed medical grade macromolecule resin refers to meet the polymer that requires of GB/T16886-1997 " medicine equipment biological assessment ", and is preferably medical grade polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), polycarbonate (PC), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene (POM), polystyrene (PS), nylon (PA), polytetrafluoroethylene (PTFE), styrene/acrylonitrile copolymer (SAN), acrylonitrile/butadiene/styrene multipolymer (ABS), vinyl cyanide/phenylethylene ethylene/propenoic acid ester copolymer (ASA), ethylene/vinyl acetate copolymer (EVA), polymethylmethacrylate all kinds of medical grade thermoplastic resins and two or more mixtures and material modified thereof such as (PMMA); All kinds of medical grade elastomeric materials and two or more mixtures and material modified thereof such as caoutchouc latex, acrylic elastomer, polybutadiene rubber, paracril, styrene-butadiene rubber(SBR), isoprene-isobutylene rubber, ethylene-propylene rubber(EPR), silicon rubber, viton, chloroprene rubber, natural rubber, thermoplastic elastomer; The above-mentioned thermoplastic resin and the mixture of rubber.
Employed anti-infection agent is preferably with Ag for the material that the suppressed pathogenic bacterium that meet GB/T16886-1997 " medicine equipment biological assessment " requirement grow or breed at material surface
+For the inorganic silver of effective anti-infective composition be anti-infection agent, 3-hydroxyl three chlorodiphenyl ethers (triclosan), chlohexidine, glycopeptide, trilaurylamine (Tridodecylamine (TDA), Aminopenicillin, epoxyeicosatrienoic acid quaternary ammonium salt and meet below the various of (1), (2) structural formula can be used for organic anti-infection agent of food or medicine equipment and two or more mixtures in them by FDA or similar means authentication.
R wherein
1, R
2, R
3, R
4Group is respectively hydrogen atom, C
1-C
5Alkyl, C
1-C
5Alkylene, C
1-C
5Hydroxyalkyl, especially preferred hydrogen atom, methyl, ethyl, propyl group, sec.-propyl, butyl, isobutyl-, amyl group, allyl group, hydroxyethyl.
Above-mentioned anti-infection agent has higher heat resistance, can tolerate 220 ℃ and do not decompose, do not produce any toxic substance, can meet GB/T16886-1997 " medicine equipment biological assessment " related request with the infection-resisting high-molecular material of above-mentioned macromolecular material compound back preparation, use the article of infection-resisting high-molecular material preparation can suppress the material of pathogenic bacterium in material surface growth or breeding.Employed lubricating modification agent reduces the material of its frictional coefficient for can improve the polymer surface slickness, is preferably the lubricating modification agent that contains siloxanes.
Employed dispersion agent refers to improve interface avidity between small-molecule substance and polymer substance, improves the material of consistency, only limits to can be used for by FDA or similar means authentication the dispersion agent of food or medicine equipment.Be preferably N, stearic acid dispersion agent such as stearic amide class such as N '-ethylene bis stearamide or oxystearic acid and two or more mixtures in them.
Employed stablizer only limit to by the authentication of FDA or similar means can be used for food or medicine equipment stablizer.As antioxidant 1010, antioxidant 1076, rare-earth stabilizer, Zn-Ca powder stablizer or two or more mixtures in them.The add-on of stablizer must not surpass FDA or the similar means maximum limiting quantity to this kind stablizer.
The medical infection-resisting high-molecular material that the present invention makes has the good mechanical performance, the toxicological experiment result of material meets the requirement of GB/T16886-1997 " medicine equipment biological assessment " to the medical grade macromolecule resin material, complete processing is good, can on common medicine equipment production unit, process, do not need equipment and production line are changed, the polymeric medical apparatus that uses the resulting material preparation of the present invention is to causing the common streptococcus aureus of infection in the present hospital, staphylococcus epidermidis, enterococcus faecalis, streptococcus avium, suis, Pseudomonas aeruginosa, Klebsiella Pneumoniae, the husky thunder bacterium of sticking fat, red husky thunder bacterium, bacillus cloacae, Acinetobacter bauamnnii, bacteria escherichia coli, the luxuriant and rich with fragrance acinetobacter calcoaceticus in Lip river, pseudomonas aeruginosa, have a liking for the Fructus Hordei Germinatus bacillus, bacillus citrate, pathogenic gram-positive such as bacillus alcaligenes, negative aerophil and propionibacterium, bifidus bacillus, the nuclear fusiform bacilarmature, the melanochrome genera bacillus, anerobes such as dyspepsiacoccus have good inhibition killing effect, it detects effect sample table 1,2, shown in 3, but material of the present invention do not shown in the relevant any restriction of result.
The anti-infective material of table 1 to the gram-positive that causes a disease to the highest bacteriocidal concentration of bacterium
| Tried the bacterium title | Institute adds bacterial concentration | ||
| 10 9CFu/ml | 10 8CFu/ml | 10 6CFu/ml | |
| Golden yellow grape ball | - | - | - |
| Gold Portugal 1 | - | - | - |
| Gold Portugal 2 | - | - | - |
| Gold Portugal 3 | - | - | - |
| Gold Portugal 4 | - | - | - |
| Gold Portugal 5 | - | - | - |
| Gold Portugal 6 | - | - | - |
| Gold Portugal 7 | - | - | - |
| Gold Portugal 8 | - | - | - |
| Staphylococcus epidermidis | - | - | - |
| Enterococcus faecalis 1 | - | - | - |
| Enterococcus faecalis 2 | - | - | - |
| Enterococcus faecalis 3 | + | - | - |
| Enterococcus faecalis 4 | - | - | - |
| Suis C group | - | - | |
| Streptococcus avium 1 | - | - | - |
| Streptococcus avium 2 | - | - | - |
| Blank training base | |||
Annotate :-asepsis growth+be shown with bacteria growing significantly grow (down with) shown
The anti-infective material The anti-bacterial result of table 2 (to gram negative bacilli)
| Tried the bacterium title | Institute adds bacterial concentration | ||
| 10 9CFu/ml | 10 8CFu/ml | 10 6CFu/ml | |
| Pseudomonas aeruginosa | - | - | - |
| (ATCC278531) | - | - | - |
| Klebsiella Pneumoniae 1 | + | - | - |
| Klebsiella Pneumoniae 2 | + | - | - |
| Klebsiella Pneumoniae 3 | + | + | - |
| Klebsiella Pneumoniae 4 | + | + | - |
| Klebsiella Pneumoniae 5 | - | - | - |
| Klebsiella Pneumoniae 6 | - | - | - |
| Klebsiella Pneumoniae 7 | - | - | - |
| Klebsiella Pneumoniae 8 | - | - | - |
| Klebsiella Pneumoniae 9 | - | - | - |
| The husky thunder bacterium 1 of sticking fat | - | - | - |
| The husky thunder bacterium 2 of sticking fat | + | - | - |
| The husky thunder bacterium 3 of sticking fat | - | - | - |
| Red husky thunder bacterium 1 | - | - | - |
| Red husky thunder bacterium 2 | + | - | - |
| Bacillus cloacae | - | - | - |
| Acinetobacter bauamnnii | - | - | - |
| Bacteria escherichia coli 1 | - | - | - |
| Bacteria escherichia coli 2 | - | - | - |
| Bacteria escherichia coli 3 | - | - | - |
| The luxuriant and rich with fragrance acinetobacter calcoaceticus 1 in Lip river | - | - | - |
| The luxuriant and rich with fragrance acinetobacter calcoaceticus 2 in Lip river | - | - | - |
| Pseudomonas aeruginosa 1 | - | - | - |
| Pseudomonas aeruginosa 2 | + | - | - |
| Pseudomonas aeruginosa 3 | - | - | - |
| Pseudomonas aeruginosa 4 | - | - | - |
| Pseudomonas aeruginosa 5 | - | - | - |
| Pseudomonas aeruginosa 6 | - | - | - |
| Pseudomonas aeruginosa 7 | - | - | - |
| Have a liking for Fructus Hordei Germinatus bacillus 1 | - | - | - |
| Have a liking for Fructus Hordei Germinatus bacillus 2 | + | - | - |
| Bacillus citrate 1 | - | - | - |
| Citron fusobacterium 2 | - | - | - |
| Bacillus alcaligenes 1 | - | - | - |
| Bacillus alcaligenes 2 | - | - | - |
| Blank training base | |||
The anti-infective material The anti-bacterial result of table 3
| Tried the bacterium title | Institute adds bacterial concentration | ||
| 10 9CFu/ml | 10 8CFu/ml | 10 6CFu/ml | |
| Propionibacterium | - | - | - |
| Bifidus bacillus | - | - | - |
| The nuclear fusiform bacilarmature | - | - | - |
| The melanochrome genera bacillus | - | - | - |
| Dyspepsiacoccus | - | - | - |
| Blank training base | |||
Embodiment
Embodiment 1.
With 2000 gram medical grade polyethylene (PE); the compound anti-infection agent of 4 Ke Yin-zeolite; 10 gram chlohexidines; after the siliceous lubricated master batch MB50-002 of 40 grams thorough mixing in the 5L of cleaning high-speed mixer is even; extrude under 160-200 ℃ of temperature at φ 25 twin screw extruders; use the dicing machine granulation, packing obtains medical Antiinfection polyethylene of the present invention.This material can be used for making medicine equipments such as tracheostomy tube, trachea cannula, respirator connecting pipeline.This material carries out toxicity according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detects, and prepared tracheostomy tube carries out anti-infective situation contrast experiment, and test, experimental result see Table 4.
Embodiment 2.
With 10 kilograms of medical grade polyvinyl chloride (PVC); 30 gram 3-hydroxyls, three chlorodiphenyl ethers; 400 gram rare-earth stabilizer XW, 50g 2-hydroxystearic acid in clean container thorough mixing evenly after; be smelt sheet 160-180 ℃ of following opening with two roller mills; pelletizing on dicing machine; packing promptly obtains medical infection resistant polychloroethylene of the present invention.Can be used for preparing medicine equipments such as tracheostomy tube, trachea cannula, catheter, packing bag.This material carries out toxicity according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detects, and prepared trachea cannula carries out anti-infective situation contrast experiment, and test, experimental result see Table 4.
Embodiment 3.
With 1000 gram medical grade ethylene/vinyl acetate copolymer (EVA); the compound anti-infection agent of 100 Ke Yin-zeolite; 50 gram N; N '-ethylene bis stearamide; mixed 5 minutes with the low machine that mixes; carry out banburying and make sheet on the airtight three roller Banbury mixeies of cleaning, pelletizing on dicing machine promptly obtains the medical anti-infective master batch of general purpose grade of the present invention.This master batch and 25 kilograms of medical grade polyvinyl chloride is composite, mix, can extrude medicine equipments such as preparation catheter, catheter, drainage tube, packing bag, breathing apparatus, aerosol generator.This material carries out toxicity according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detects, and prepared breathing apparatus carries out anti-infective situation contrast experiment, and test, experimental result see Table 4.
Embodiment 4.
With 2000g medical grade polypropylene (PP), 10g anti-infection agent A, 5g Aminopenicillin; the 1g antioxidant 1010 mixed 1 minute in clean 5L high-speed mixer, extruded pelletizing on dicing machine on single screw extrusion machine; packing promptly obtains medical anti-infective polypropylene of the present invention.This material can be owing to making disposable syringe, infusion bottle, and respirator connects first-class medicine equipment.This material carries out toxicity according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detects, and prepared disposable syringe carries out anti-infective situation contrast experiment, and test, experimental result see Table 4.
Anti-infection agent A
Embodiment 5.
With 2000 gram medical grade thermoplastic polyurethanes (TPU), the compound anti-infection agent of 30 Ke Yin-zeolite, the 10g trilaurylamine (Tridodecylamine mixes, and extrudes on twin screw extruder, and pelletizing on dicing machine promptly obtains medical anti-infective thermoplastic polyurethane of the present invention.Can be used for medicine equipments such as preparing centre venous cannula, biliary drainage pipe.This material carries out toxicity according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detects, and prepared central vein intubate is carried out anti-infective situation contrast experiment, and test, experimental result see Table 4.
Embodiment 6.
With 1500gK resin (divinyl-styrol copolymer), 12g anti-infection agent B behind the mixing, puts on the twin screw extruder and extrudes in the container of cleaning, and pelletizing on dicing machine promptly obtains medical anti-infective K resin of the present invention.Can be used for preparing medicine equipments such as disposable transfusion device.This material carries out toxicity according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detects, and prepared disposable transfusion device carries out anti-infective situation contrast experiment, and test, experimental result see Table 4.
Anti-infection agent B
Embodiment 7.
In the 3000 medical natural rubber latex emulsions of gram (solid content 45%), add 10 gram 3-hydroxyls, three chlorodiphenyl ethers, 10 gram chlohexidines, 40g sulphur, the 5g titanium dioxide mixes.The emulsion that mixes is put into pipe mold carry out polymerization under 30 ℃, steaming desolventizes, and heating is vulcanized, cooling, and aftertreatment as requested then promptly obtains medical anti-infective natural gum latex product of the present invention.Can prepare medicine equipments such as catheter, liquid discharge pipe, sputum aspirator tube in this way.Carry out toxicity through this kind of sulfurized material according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detect, prepared sputum aspirator tube carries out anti-infective situation contrast experiment, and test, experimental result see Table 4.
Embodiment 8.
With 2000 gram medical grade raw-silastic continuouslies, the compound anti-infection agent of 10 Ke Yin-zeolite adds rubber mixing machine bag roller, thin-pass 5 times, following sheet, blank.Promptly obtain medical anti-infective raw-silastic continuously of the present invention, through mixing with other properties-correcting agent, on Rubber Extruder, extrude, vulcanize medicine equipments such as can preparing catheter, liquid discharge pipe, stomach catheter, renal plevis drainage catheter.Carry out toxicity through this kind of sulfurized material according to the requirement of GB/T16886-1997 " medicine equipment biological assessment " and detect, prepared stomach catheter carries out anti-infective situation contrast experiment, and test, experimental result see Table 4.
The medical infection-resisting high-molecular material performance of table 4 table
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | Embodiment 7 | Embodiment 8 | |
| Title material | Antiinfection polyethylene | Infection resistant polychloroethylene | Anti-infective ethylene/vinyl acetate | Anti-infective polypropylene | Anti-infective heat plasticity polyurethane | Anti-infective K resin | Anti-infective natural gum latex | Anti-infective silicon rubber |
| Make the sample title | Tracheostomy tube | Trachea cannula | The bile drainage tube | Disposable syringe | The central vein intubate | Disposable transfusion device | Catheter | Stomach catheter |
| Mechanical property | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| The toxicological experiment result | Meet GB/T1688 6-1997 requirement | Meet GB/T1688 6-1997 requirement | Meet GB/T1688 6-1997 requirement | Meet GB/T1688 6-1997 requirement | Meet GB/T1688 6-1997 requirement | Meet GB/T1688 6-1997 requirement | Meet GB/T1688 6-1997 requirement | Meet GB/T1688 6-1997 requirement |
| Anti-infective effect | Reach table 1,2,3 levels | Reach table 1,2,3 levels | Reach table 1,2,3 levels | Reach table 1,2,3 levels | Reach table 1,2,3 levels | Reach table 1,2,3 levels | Reach table 1,2,3 levels | Reach table 1,2,3 levels |
Claims (21)
1. a class is used to prepare the medical infection-resisting high-molecular material composition of polymeric medical apparatus, said composition is except that containing common medical grade macromolecule resin, based on the medical grade macromolecule resin of 100 weight parts, also contain the anti-infection agent of 0.01～10 weight part; Lubricating modification agent 0～20 weight part; Dispersion agent 0～10 weight part; Stablizer 0～15 weight part; Wherein said anti-infection agent is with Ag
+For the inorganic silver of effective anti-infective composition be anti-infection agent, 3-hydroxyl three chlorodiphenyl ethers, glycopeptide, trilaurylamine (Tridodecylamine, Aminopenicillin, epoxyeicosatrienoic acid quaternary ammonium salt and meet below the various anti-infection agents that can be used for food or medicine equipment by FDA or similar means authentication of (1) or (2) structural formula, or two or more mixtures in them
R wherein
1, R
2, R
3, R
4Group is selected from hydrogen atom, C respectively
1-C
5Alkyl, C
1-C
5Alkylene or C
1-C
5Hydroxyalkyl.
2. according to the described medical infection-resisting high-molecular material composition that is used to prepare the polymeric medical apparatus of claim 1, wherein said anti-infection agent is 0.05～5 weight part; The lubricating modification agent is 0～5 weight part; Dispersion agent is 0～3 weight part; Stablizer is 0～5 weight part.
3. according to the described medical infection-resisting high-molecular material composition that is used to prepare the polymeric medical apparatus of claim 1, wherein said medical grade macromolecule resin is for being selected from the medical grade polyethylene, polypropylene, polyvinyl chloride, thermoplastic polyurethane, polycarbonate, polyethylene terephthalate, polybutylene terephthalate, polyoxymethylene, polystyrene, nylon, tetrafluoroethylene, styrene/acrylonitrile copolymer, the acrylonitrile/butadiene/styrene multipolymer, vinyl cyanide/phenylethylene ethylene/propenoic acid ester copolymer, ethylene/vinyl acetate copolymer, the medical grade thermoplastic resin of polymethylmethacrylate and two or more mixture and material modified thereof; Be selected from the medical grade elastomeric material and two or more the mixture and material modified thereof of caoutchouc latex, acrylic elastomer, polybutadiene rubber, paracril, styrene-butadiene rubber(SBR), isoprene-isobutylene rubber, ethylene-propylene rubber(EPR), silicon rubber, viton, chloroprene rubber, natural rubber, thermoplastic elastomer; The above-mentioned thermoplastic resin and the mixture of rubber.
4. according to the described medical infection-resisting high-molecular material composition that is used to prepare the polymeric medical apparatus of claim 1, wherein said lubricating modification agent is the lubricating modification agent that contains siloxanes.
5. according to the described medical infection-resisting high-molecular material composition that is used to prepare the polymeric medical apparatus of claim 1, wherein dispersion agent is stearic amide class or stearic acid dispersion agent and two or more mixtures in them.
6. according to the described medical infection-resisting high-molecular material composition that is used to prepare the polymeric medical apparatus of claim 1, wherein said stablizer is antioxidant 1010, antioxidant 1076, rare-earth stabilizer, Zn-Ca powder stablizer or two or more mixtures in them.
7. preparation method who is used to prepare the medical anti-infective thermoplastic resin composition of polymeric medical apparatus may further comprise the steps:
(1) by weight with 100 parts of medical thermoplastic resins, the anti-infection agent of 0.01～10 weight part; The lubricating modification agent of 0～20 weight part; The dispersion agent of 0～20 weight part; The stablizer of 0～15 weight part thorough mixing in clean container; Wherein said anti-infection agent is with Ag
+For the inorganic silver of effective anti-infective composition be anti-infection agent, 3-hydroxyl three chlorodiphenyl ethers, glycopeptide, trilaurylamine (Tridodecylamine, Aminopenicillin, epoxyeicosatrienoic acid quaternary ammonium salt and meet below the various anti-infection agents that can be used for food or medicine equipment by FDA or similar means authentication of (1) or (2) structural formula, or two or more mixtures in them
R wherein
1, R
2, R
3, R
4Group is selected from hydrogen atom, C respectively
1-C
5Alkyl, alkylene or hydroxyalkyl;
(2) in clean environment, pass through forcing machine extruding pelletization, packing under the proper temperature.
8. according to the described preparation method of claim 7, wherein, in above-mentioned steps (2), also can open refining or clean Banbury mixer banburying mixture by two roller mills of cleaning, and then by clean dicing machine pelletizing, packing.
9. according to the described preparation method of claim 7, wherein, described anti-infection agent is 0.05～5 weight part; The lubricating modification agent is 0～5 weight part; Dispersion agent is 0～3 weight part; Stablizer is 0～5 weight part.
10. according to the described preparation method of claim 7, wherein, described medical grade macromolecule resin is for being selected from the medical grade polyethylene, polypropylene, polyvinyl chloride, thermoplastic polyurethane, polycarbonate, polyethylene terephthalate, polybutylene terephthalate, polyoxymethylene, polystyrene, nylon, tetrafluoroethylene, styrene/acrylonitrile copolymer, the acrylonitrile/butadiene/styrene multipolymer, vinyl cyanide/phenylethylene ethylene/propenoic acid ester copolymer, ethylene/vinyl acetate copolymer, the medical grade thermoplastic resin of polymethylmethacrylate and two or more mixture and material modified thereof.
11. according to the described preparation method of claim 7, wherein, described lubricating modification agent is the lubricating modification agent that contains siloxanes.
12. according to the described preparation method of claim 7, wherein, dispersion agent is stearic amide class or stearic acid dispersion agent and two or more mixtures in them.
13. according to the described preparation method of claim 7, wherein, described stablizer is antioxidant 1010, antioxidant 1076, rare-earth stabilizer, Zn-Ca powder stablizer or two or more mixtures in them.
14. a preparation method who is used to prepare the medical anti-infective rubber combination of polymeric medical apparatus may further comprise the steps:
(1) by weight with 100 parts of medical grade rubbers, the anti-infection agent of 0.01～10 weight part; The lubricating modification agent of 0～20 weight part; The dispersion agent of 0～20 weight part; The stablizer of 0～15 weight part thorough mixing in clean container; Wherein said anti-infection agent is with Ag
+For the inorganic silver of effective anti-infective composition be anti-infection agent, 3-hydroxyl three chlorodiphenyl ethers, glycopeptide, trilaurylamine (Tridodecylamine, Aminopenicillin, epoxyeicosatrienoic acid quaternary ammonium salt and meet below the various anti-infection agents that can be used for food or medicine equipment by FDA or similar means authentication of (1) or (2) structural formula, or two or more mixtures in them
R wherein
1, R
2, R
3, R
4Group is selected from hydrogen atom, C respectively
1-C
5Alkyl, C
1-C
5Alkylene or C
1-C
5Hydroxyalkyl;
(2) in clean environment, open refining or clean Banbury mixer banburying mixture by two roller mills of cleaning under the proper temperature, and then by clean dicing machine pelletizing, packing.
15. according to the described preparation method of claim 14, wherein, in above-mentioned steps (2), also can in ball mill or colloidal mill mixture in the step (1) be ground to form even colloid, then by the corresponding mould casting, sulfuration directly makes corresponding apparatus.
16. according to the described preparation method of claim 14, wherein, described anti-infection agent is 0.05～5 weight part; The lubricating modification agent is 0～5 weight part; Dispersion agent is 0～3 weight part; Stablizer is 0～5 weight part.
17. according to the described preparation method of claim 14, wherein, described medical grade rubber is medical grade elastomeric material and two or more the mixture and material modified thereof that is selected from latex, acrylic elastomer, polybutadiene rubber, paracril, styrene-butadiene rubber(SBR), isoprene-isobutylene rubber, ethylene-propylene rubber(EPR), silicon rubber, viton, chloroprene rubber, natural rubber, thermoplastic elastomer.
18. according to the described preparation method of claim 14, wherein, described lubricating modification agent is the lubricating modification agent that contains siloxanes.
19. according to the described preparation method of claim 14, wherein, dispersion agent is stearic amide class or stearic acid dispersion agent and two or more mixtures in them.
20. according to the described preparation method of claim 14, wherein, described stablizer is antioxidant 1010, antioxidant 1076, rare-earth stabilizer, Zn-Ca powder stablizer or two or more mixtures in them.
21. the application of the medical infection-resisting high-molecular material composition of claim 1-6 in the preparation medicine equipment.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01144892 CN1221603C (en) | 2001-12-28 | 2001-12-28 | Infection-resisting high-molecular material, its preparation method and application |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01144892 CN1221603C (en) | 2001-12-28 | 2001-12-28 | Infection-resisting high-molecular material, its preparation method and application |
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| CN1428368A CN1428368A (en) | 2003-07-09 |
| CN1221603C true CN1221603C (en) | 2005-10-05 |
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|---|---|---|---|
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2001
- 2001-12-28 CN CN 01144892 patent/CN1221603C/en not_active Expired - Fee Related
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