CN109735042A - A kind of medical AMTPS material, medical instrument and preparation method - Google Patents
A kind of medical AMTPS material, medical instrument and preparation method Download PDFInfo
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Abstract
The invention discloses provide a kind of medical AMTPS material, medical instrument and preparation method, the raw material comprising following weight proportion: styrene-butadiene-styrene block copolymer SEBS 50-80 parts by weight, reinforced resin polypropylene PP 25-50 parts by weight, green composite antioxidant ECLL 0.05-0.3 parts by weight, slipping agent 0.05-0.2 parts by weight, antiplastering aid or reinforcing agent 0.005-0.02 parts by weight, antibacterial agent 0.002-0.02 parts by weight.The application does not add plasticizer DEHP, avoids harm of the metal ion to patient, it is safe and non-toxic, to drug without absorption, guarantee the advantages such as curative effect of medication.The carcinogenic dioxin gas of energy will not be generated by burning simultaneously; syringe, perfusion tube performance are able to satisfy the use standard of current medical infusion lines; simultaneously; because of addition composite antioxidant and antibacterial agent; make the material itself that there are antibacterial functions; the risk that syringe, perfusion tube can be prevented to be contaminated by bacterial in transport storage use process, it is ensured that the safety of patient.
Description
Technical field
The invention belongs to medical instruments field more particularly to a kind of medical AMTPS materials, medical instrument and preparation method.
Background technique
Polyvinyl chloride (PVC) perfusion tube has not that cracky, the transparency are high, and when normal use does not twist together and good mechanical property
The advantages that.For a long time, at home and abroad medical infusion lines are produced using Corvic (PVC).But due to PVC
Material is harder, in process of production in order to guarantee the flexibility and resilience of infusion apparatus, needs to be added plasticizer, generally DEHP
(i.e. dioctyl phthalate, additive amount are about 35%-40%), stabilizer: the heavy metal chemical combination containing elements such as Ca, Zn, Ba
Object.In infusion process, the DEHP of PVC perfusion tube, heavy metal ion can be released into medical fluid, make the particulate matter in medical fluid
It obviously increases, and enters human body with medical fluid, do harm to huamn body；It may also interact with drug, influence drug matter
Amount.Currently, a large number of studies show that PVC class containers for medical use and conduit have suction-operated to a variety of drugs.DEHP is to human health
There are potential risks, may interfere with human hormone and secrete, and excessive contact plasticizer, will cause Children and teenager morning
Ripe, the short and small equal reproductions of genitals and developmental disorder damage male reproductive function, lead to female precocious puberty, infertile, pregnant age woman
Female's ovarian cyst, the harm such as pregnant woman's Zn-ef ficiency loss.State Food and Drug Administration issues " primary in March, 2011
Property use delivery device equipment registration technological audit guideline " regulation: newborn, prepuberal male, period of pregnancy and the food in one's mouth
The women of newborn phase should not use the product containing DEHP to be transfused drug.In May, 2011, the illegal toxic modeling of addition of Taiwan beverage/food
Agent is exposed, which is DEHP.The another PVC bag drugs packed during storage, Some Drugs meeting and PVC material
Migration adsorption reaction occurs, the drug effect so as to cause drug, which reduces, or even generation is rotten to use.PVC and its copolymer burning
After will form hydrochloric acid, cause humans and animals respiratory tract injure and the erosion to building, PVC burn when be also easy to produce dioxin to ring
Border generates far-reaching influence.Dioxin toxicity is very strong, and is easy to be absorbed by the body by food such as beef, milk, fish etc..Cause
This, relevant expert suggests, should use alternative materials comprehensively as early as possible.
The medical management board of U.S.'s food (FDA) thinks that styrene-hydrogenated diene hydrocarbon block copolymer material transparent degree is high, heat
Stability is good, totally nontoxic, will not generate allergy, variation and rejection to tissue, has heatproof, ageing-resistant and anti-purple
Outer performance can use thermophilic digestion and ultraviolet light directly to sterilize, meet the food medical standard of promulgation.Therefore Shell Co. Ltd, the U.S.
The styrene of production-hydrogenated diene hydrocarbon copolymer product obtained the medical management board of U.S.'s food (FDA) food doctor in 1980
It treats and uses licensing.This just illustrates that styrene-hydrogenated diene hydrocarbon block copolymer can be used as the basic material of production medical instrument
Material.However, the medical infusion lines that the TPE based on styrene-hydrogenated diene hydrocarbon block copolymer and polyolefin is prepared
Performance differ greatly with PVC ratio, be not able to satisfy the use standard of current medical infusion lines.
Styrene-butadiene-styrene block copolymer SEBS mobility of hydrogenation is bad, so when being TPE
It is all often not oil-filled for the medical TPE material such as all wanting oil-filled, but do infusion bag perfusion tube.It is non-to do medical devices call
Chang Yange, biocompatibility, cytotoxicity, sensitization, carcinogenicity etc. will measure, and the reason of causing these is all often
Some small molecules haunt.Macromolecular tends towards stability, and will not influence too much, and in addition to various inorganic salts inside TPE elastomer
Outside, oil is the important source of small molecule, and the appearances such as transparency, slickness, flexibility are also critically important, therefore intermingling material formula group
At and its process conditions such as processing temperature it is the most key.
The disclosure of the invention and a kind of medical rubber-plastic composite material that number of patent application is 200910020027.6, are improved
PVC plastic, by groups such as polyvinyl chloride (PVC) resin-oatmeal, compound rubber and plastic particle, phthalic acid ester, stabilizer and lubricants
At every 10~30 parts of 100 parts by weight polyvinyl chloride (PVC) resin-oatmeal composite rubber and plastic particle, phthalic acid ester 20~40
Part, 3~10 parts of epoxidized soybean oil, 0.5~2 part of stearate, 0.5~1 part of organic phosphite, 0.1~0.5 part of silicone oil.Institute
It obtains composite material chemical property to stablize, flexible, elasticity, good toughness are easily worked and are not easily decomposed；The blood bag biological property of manufacture
Good, chemical leachable is few, be for storing blood it is extremely safe, can be used for making female bag and son in simply connected bag or multiple-bag
Bag carries out the separation of blood constituent, saves.But a large amount of phthalic acid ester is added in the patent formulation, therefore to human body
Blood can have potentially hazardous property.
Summary of the invention
In order to overcome the above problems of the prior art, the present invention provide a kind of medical AMTPS material, syringe and
Preparation method does not add plasticizer DEHP, and processing aid or the migration of plasticizer will not occur to the problems in blood or medical fluid, no
The stabilizer for adding metal ion, avoids harm of the metal ion to patient, it is safe and non-toxic, to drug without absorption, guarantee
The advantages such as curative effect of medication, it is ensured that the treatment safety of patient, thermal stability is good, will not to tissue generate allergy, variation and
Rejection has heatproof, ageing-resistant and uvioresistant performance.
A kind of medical AMTPS material, the raw material comprising following weight proportion: styrene-butadiene-styrene block is total
Polymers SEBS (SEBS is title abbreviation) 50-80 parts by weight, reinforced resin polypropylene PP 25-50 parts by weight, the compound antioxygen of green
Agent ECLL (ECLL is title abbreviation) 0.05-0.3 parts by weight, slipping agent 0.05-0.2 parts by weight, antiplastering aid or reinforcing agent
0.005-0.02 parts by weight, antibacterial agent 0.002-0.02 parts by weight.Preferably, the raw material comprising following weight proportion: benzene second
It is alkene-butadiene-styrene block copolymer SEBS 58-70 parts by weight, reinforced resin polypropylene PP 30-42 parts by weight, green
Color composite antioxidant ECLL 0.055-0.25 parts by weight, slipping agent 0.08-0.15 parts by weight, antiplastering aid 0.01-0.02 weight
Part, antibacterial agent 0.005-0.015 parts by weight.
Any of the above-described scheme is preferably, the raw material comprising following weight proportion: styrene-butadiene-styrene is embedding
70 parts by weight of section copolymer SEBS, 30 parts by weight of reinforced resin polypropylene PP, green 0.055 weight of composite antioxidant ECLL
Part, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, 0.005 parts by weight of antibacterial agent.Any of the above-described scheme is preferably, packet
Raw material containing following weight proportion: styrene-butadiene -66 parts by weight of styrene block copolymer SEBS, reinforced resin are poly-
34 parts by weight of propylene PP, green 0.105 parts by weight of composite antioxidant ECLL, 0.1 parts by weight of slipping agent, 0.01 weight of antiplastering aid
Part, 0.008 parts by weight of antibacterial agent.Any of the above-described scheme is preferably, the raw material comprising following weight proportion: styrene-fourth two
Alkene -62 parts by weight of styrene block copolymer SEBS, 38 parts by weight of reinforced resin polypropylene PP, green composite antioxidant
0.02 parts by weight of ECLL, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, 0.01 parts by weight of antibacterial agent.
Any of the above-described scheme is preferably, the raw material comprising following weight proportion: styrene-butadiene-styrene is embedding
58 parts by weight of section copolymer SEBS, 42 parts by weight of reinforced resin polypropylene PP, green 0.205 weight of composite antioxidant ECLL
Part, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, 0.015 parts by weight of antibacterial agent.Any of the above-described scheme is preferably, institute
Stating styrene-butadiene-styrene block copolymer is hydrogenated styrene-butadiene-styrene block copolymer.
In any of the above-described scheme preferably, the reinforced resin polypropylene PP comprising isotactic polypropylene, rule poly- third
One or more of alkene, random polypropylene.
Any of the above-described scheme is preferably, the green composite antioxidant ECLL be vitamin E, vitamin C, lecithin,
One or more of chlorogenic acid, isopropyl myristate.Vitamin E is natural inhibitor, nontoxic.
Any of the above-described scheme is preferably, and the green composite antioxidant is the total at least one of vitamin E, chlorogenic acid.
Any of the above-described scheme is preferably, and the green composite antioxidant is vitamin E and chlorogenic acid.Vitamin E is multiple
Close vitamin E.
Vitamin E (alpha-tocopherol) chemistry: (±)-(2RS, 4 ' RS, 8 ' RS) -2,5,7,8- tetramethyl -2- (4 ', 8 ',
12 '-trimethyltridecvls) -6- benzodihydropyran alcohol acetate；Vitamin E refers to one group of compound, natural type d-
Alpha-tocopherol acetate, synthesis type are dl- alpha-tocopherol acetate.In various various forms of VE, Gamma-Tocopherol is most normal
See.All contain in corn oil, soybean oil, butter and certain flavouring.Alpha-tocopherol is the most shape of bioactivity in VE
Formula, at the same be also North American diet in the second common VE form (Gamma-Tocopherol ranked first), be common in safflower oil, Semen Benincasae oil and
In wheat germ oil.Alpha-tocopherol is a kind of fat-soluble antioxidant, activating oxide when can effectively prevent fat oxidation
It is formed.
Alpha-tocopherol also shows antioxygen property, and it is many insoluble drugs that alpha-tocopherol, which is highly lipophilic compound,
Good solvent.Since it is widely regulation license, there is its importance in the formulation products of oiliness or fatty matrix, usually
The concentration range used is 0.001~0.05%v/v.It, which is acted on, has an optium concentration, and the alpha-tocopherol of low concentration can subtract
The autoxidation of low linoleic acid and linolenic acid methyl esters, and higher concentration then accelerates this effect.Oil-soluble synergist is added
Antioxidant effect can be enhanced, such as lecithin and ascorbyl palmitate.Tocopherol and peroxide and metal ion, especially
Iron, copper and silver ion, there is incompatibility.Tocopherol can be absorbed by plastics.
Chlorogenic acid is a kind of effective phenolic antioxidant, and oxidation resistance is better than caffeic acid, to oxybenzene acid, asafoetide
Acid, syringic acid, butylated hydroxy anisole (BHA) and tocopherol.Chlorogenic acid why Wheat Protein, be because it contain one
Quantitative R-OH base can form the hydroperoxyl radical with antioxidation, to eliminate hydroxyl radical free radical and superoxide anion etc. certainly
By the activity of base, thus damage of the protective tissue from oxidation.
In any of the above-described scheme preferably, it is described green composite antioxidant ECLL's the preparation method comprises the following steps: by vitamin E,
Vitamin C, lecithin, chlorogenic acid, glue mill uniformly mixing in isopropyl myristate Yu Yan Portland.
In any of the above-described scheme preferably, vitamin E: vitamin C: lecithin: chlorogenic acid: isopropyl myristate according to
The mixing of 2:0.2:2:1:1 ratio.
Any of the above-described scheme is preferably, and the slipping agent is at least one of erucyl amide, stearic amide.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.05-0.2.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.05.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.2.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.1.
Any of the above-described scheme is preferably, and the antiplastering aid or reinforcing agent are nm-class boron nitride.Nanoscale, it is nontoxic,
Anti-adhesion effectiveness is preferable.Common antiplastering aid generally uses gas-phase silica.
Any of the above-described scheme is preferably, and the antibacterial agent is at least one of Octenidine or chlorogenic acid.Antibacterial effect
Fruit is preferable.
A kind of preparation method of medical instrument, medical instrument include perfusion tube, syringe, and preparation method includes following step
It is rapid:
(1), claim raw material according to weight ratio, raw material includes styrene-butadiene-styrene block copolymer SEBS, increases
Strong polypropylene, green composite antioxidant ECLL, slipping agent, antiplastering aid or reinforcing agent, antibacterial agent；
(2), weighed raw material is put into high-speed mixer and mixing according to parts by weight, discharged spare；
(3), double screw extruder extruding pelletization is added in the raw material after mixing step (2)；
(4), by step (3) resulting product, in 180--190 DEG C of vacuum injection into mold, and under vacuum conditions,
Keep the temperature 2~8 hours, cooling and solidifying obtains perfusion tube, syringe.
Any of the above-described scheme is preferably, and the raw material in step (1) includes that styrene-butadiene-styrene block is total
Polymers SEBS 50-80 parts by weight, reinforced resin polypropylene PP 25-50 parts by weight, green composite antioxidant ECLL 0.05-0.3
Parts by weight, slipping agent 0.05-0.2 parts by weight, antiplastering aid or reinforcing agent 0.005-0.02 parts by weight, antibacterial agent 0.002-0.02 weight
Measure part.
Any of the above-described scheme is preferably, and the raw material in step (1) includes that styrene-butadiene-styrene block is total
Polymers SEBS 58-70 parts by weight, reinforced resin polypropylene PP 30-42 parts by weight, green composite antioxidant ECLL 0.055-
0.25 parts by weight, slipping agent 0.08-0.15 parts by weight, antiplastering aid 0.01-0.02 parts by weight, antibacterial agent 0.005-0.015 weight
Part.
Any of the above-described scheme is preferably, and the raw material in step (1) includes that styrene-butadiene-styrene block is total
70 parts by weight of polymers SEBS, green 0.055 parts by weight of composite antioxidant ECLL, are felt well at 30 parts by weight of reinforced resin polypropylene PP
0.1 parts by weight of lubrication prescription, 0.01 parts by weight of antiplastering aid, 0.005 parts by weight of antibacterial agent.Any of the above-described scheme is preferably, step (1)
In raw material include styrene-butadiene -66 parts by weight of styrene block copolymer SEBS, reinforced resin polypropylene PP 34
Parts by weight, green 0.105 parts by weight of composite antioxidant ECLL, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, antibacterial agent
0.008 parts by weight.Any of the above-described scheme is preferably, and the raw material in step (1) includes that styrene-butadiene-styrene is embedding
62 parts by weight of section copolymer SEBS, 38 parts by weight of reinforced resin polypropylene PP, green 0.02 weight of composite antioxidant ECLL
Part, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, 0.01 parts by weight of antibacterial agent.
Any of the above-described scheme is preferably, and the raw material in step (1) includes that styrene-butadiene-styrene block is total
58 parts by weight of polymers SEBS, green 0.205 parts by weight of composite antioxidant ECLL, are felt well at 42 parts by weight of reinforced resin polypropylene PP
0.1 parts by weight of lubrication prescription, 0.01 parts by weight of antiplastering aid, 0.015 parts by weight of antibacterial agent.
Any of the above-described scheme is preferably, and styrene-butadiene-styrene block copolymer in step (1) is hydrogen
Change styrene-butadiene-styrene block copolymer.Styrene-butadiene-styrene block copolymer is hydrogenation of benzene second
Alkene-butadiene-styrene block copolymer.Hydrogenated styrene-butadiene-styrene block copolymers (SEBS), are thermoplastics
Property Styrene-Butadiene-Styrene Block Copolymer (SBS) molecule in rubber segments polybutadiene unsaturated double-bond by selection plus
New modified thermoplastic elastomer (TPE) prepared by hydrogen.Polybutadiene block is converted to ethylene and 1- butylene in SBS after adding hydrogen
Random copolymerization section and become SEBS, be using butadiene, styrene as monomer, hexamethylene is solvent, and butyl lithium is initiator, tetrahydro
Furans (THF) is structure regulator, and silicon tetrachloride is coupling agent, the basis SEBS glue is synthesized through anionic polymerisation, then using cyclopentadienyl
It is that butadiene segment in SBS molecule (including 1,2- structure and 1,4- structure) double bond is selected in the chosen property completion of catalyst system
It selects and adds hydrogen.Glue after hydrogenation is dried after elutriation method is condensed into particle, is finally ground into powder.Possess high extension
Property, the high grade of transparency, thermal stability be good, ageing-resistant and uvioresistant performance, totally nontoxic, allergy will not be generated to tissue, is become
The characteristics of different and rejection, can be used thermophilic digestion and ethylene oxide and ultraviolet light directly sterilizes.SEBS white in appearance or
Light color, is free of mechanical admixture and greasy dirt, powder or equigranular, and density only has 0.90--0.91g/cm3, and brittle temperature≤-
60 DEG C, its decomposition temperature is greater than 270 DEG C under oxygen atmosphere.The decline of its performance of one week of aging in artificial accelerated aging case
Rate less than 10%, pull apart tensile strength and reach as high as 38Mpa, elongation at break: 500% -800% by mechanics.
In any of the above-described scheme preferably, the reinforced resin polypropylene PP comprising isotactic polypropylene, rule poly- third
One or more of alkene, random polypropylene.It is " medical infusion, defeated that reinforced resin polypropylene PP raw material should meet YY0242-2007
Blood, instrument used for injection polypropylene dedicated material " requirement, sanitation performance index, medicine is functional and biocompatibility, physical force
Learning the indexs such as performance and processing performance should be able to be met simultaneously.Reinforced resin polypropylene PP under the conditions of 230 DEG C/2.16kg,
Melt flow rate (MFR) is 10-25g/10min, stretching yield stress 25-35MPa.
In any of the above-described scheme preferably, green composite antioxidant ECLL be vitamin E, it is vitamin C, lecithin, green
One or more of ortho acid, isopropyl myristate.Green composite antioxidant ECLL not only has good antioxidation,
And property safe to the human body is high, has no toxic side effect, for replacing the tert-butyl of widely used toxic side effect to hydroxyl fennel
The chemical antioxidants such as ether (BHA), 2,6-di-tert-butyl p-cresol (BHT), gallate (PG).In this medical AMTPS material
In invention, dosage is few, and the 10-30% of only traditional phenols oxidant is nearly free from carcinogenic nitrosamine in process, cures
Treat the finished products frees from extraneous odour such as utensil such as infusion apparatus.
In any of the above-described scheme preferably, it is described green composite antioxidant ECLL's the preparation method comprises the following steps: by vitamin E,
Vitamin C, lecithin, chlorogenic acid, glue mill uniformly mixing in isopropyl myristate Yu Yan Portland.
In any of the above-described scheme preferably, vitamin E: vitamin C: lecithin: chlorogenic acid: isopropyl myristate according to
The mixing of 2:0.2:2:1:1 ratio.
In any of the above-described scheme preferably, the slipping agent is at least one of erucyl amide, stearic amide.It is refreshing
Lubrication prescription (erucyl amide, stearic amide) as anti-stick and smooth processing aid, bonds product not in the present invention, increases
Add lubricity, thermoplastic and heat resistance, product safety is nontoxic, and erucyl amide mixing stearic amide uses, and not only increases
Anti-adhesion effectiveness, and gloss, transparency, intensity, elasticity and the surface smoothness of the finished products such as medical apparatus such as infusion apparatus are all significantly
It improves.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.05-0.2.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.05.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.2.
In any of the above-described scheme preferably, the slipping agent is uniformly mixed using erucyl amide, stearic amide,
Erucyl amide: stearic amide=1:0.1.
In any of the above-described scheme preferably, the antiplastering aid or reinforcing agent are nm-class boron nitride, plastics can be made to become
It is finer and close, improve the compression denaturation of elastomer.
In any of the above-described scheme preferably, the antibacterial agent is at least one of Octenidine or chlorogenic acid.Green original
Sour Nantural non-toxic is suitable for long-term transport, saves.
Beneficial effect
The present invention provides a kind of medical AMTPS material, medical instrument and preparation method, does not add plasticizer DEHP, will not
Processing aid or the migration of plasticizer occurs to the problems in blood or medical fluid, does not add the stabilizer of metal ion, avoids
Harm of the metal ion to patient, it is safe and non-toxic, to drug without absorption, guarantee the advantages such as curative effect of medication.Burning simultaneously will not produce
Raw dioxin gas that can be carcinogenic.PH value variable quantity, reducing substances, content of beary metal, cytotoxicity, ultraviolet absorptivity, sensitization
The important indicators such as reaction and hemolytic reaction surmount polyvinyl chloride product, and syringe, perfusion tube performance are able to satisfy medical defeated at present
The use standard of liquid pipe, it is ensured that the treatment safety of patient, composite antioxidant use vitamin E and chlorogenic acid, nontoxic, ring
It ensures safety, antiplastering aid is nm-class boron nitride, and nanoscale, anti-adhesion effectiveness is preferable, and antibacterial agent is Octenidine or chlorogenic acid, antibacterial effect
Fruit is preferable, is readily transported or long term storage.The experimental results showed that medical AMTPS material provided by the invention, to large intestine bar
The anti-microbial property of bacterium and staphylococcus aureus reaches 96% or more, and medical instrument impregnates after two months in aqueous solution,
Anti-microbial property remains to be maintained at 96% or more.
Specific embodiment
In order to be best understood from technical solution of the present invention and advantage, the present invention is done into one below by way of specific embodiment
Walk explanation.
Embodiment 1.1
A kind of medical AMTPS material, the raw material comprising following weight proportion: styrene-butadiene-styrene block is total
70 parts by weight of polymers SEBS, green 0.055 parts by weight of composite antioxidant ECLL, are felt well at 30 parts by weight of reinforced resin polypropylene PP
0.1 parts by weight of lubrication prescription, 0.01 parts by weight of antiplastering aid, 0.005 parts by weight of antibacterial agent.
In the present embodiment, styrene-butadiene-styrene block copolymer is styrene-butadiene-benzene of hydrogenation
Ethylene block copolymer.Reinforced resin polypropylene PP comprising isotactic polypropylene, syndiotactic polypropylene, random polypropylene.
Green composite antioxidant ECLL's the preparation method comprises the following steps: by vitamin E, vitamin C, lecithin, chlorogenic acid, myristic acid
Glue mill uniformly mixing in isopropyl ester Yu Yan Portland.Vitamin E: vitamin C: lecithin: chlorogenic acid: isopropyl myristate=2:
0.2:2:1:1。
Slipping agent includes erucyl amide and stearic amide, erucyl amide: stearic amide=1:0.05.Antiplastering aid or increasing
Strong agent is nm-class boron nitride.
Antibacterial agent is Octenidine.
Reinforced resin polypropylene PP is the mixture of isotactic polypropylene, syndiotactic polypropylene and random polypropylene.
The preparation method of medical AMTPS material, medical instrument are perfusion tube, preparation method the following steps are included:
(1) styrene-butadiene-styrene block copolymer SEBS of hydrogenation, reinforced resin are weighed according to weight ratio
Polypropylene PP, green composite antioxidant (vitamin E vitamin C lecithin chlorogenic acid isopropyl myristate) ECLL, it is smooth
Agent (erucyl amide, stearic amide), antiplastering aid or reinforcing agent, antibacterial agent；
(1.1) in the step, the preparation method of green composite antioxidant ECLL: by vitamin E: vitamin C: lecithin:
Chlorogenic acid: isopropyl myristate is mixed according to the ratio of 2:0.2:2:1:1, and glue mill is uniform in Yu Yan Portland.
(1.2) in the step, the preparation method of slipping agent: erucyl amide: stearic amide according to 1:0.05-0.2 ratio
Example is uniformly mixed.
(2) by the raw material for preparing above, being put into 5~10min of high-speed mixer and mixing by weight, (revolving speed when mixing is
80-120r/min), it discharges spare；
(3) double screw extruder extruding pelletization is added in the raw material after mixing step (2), and squeezing out unit frequency is 200
~600 revs/min；
(4) it by step (3) resulting product, in 180--190 DEG C of vacuum injection into mold, and under vacuum conditions, protects
Hold the temperature 2~8 hours, cooling and solidifying obtains TPE infusion apparatus.
Embodiment 1.2
A kind of medical AMTPS anti-biotic material and embodiment 1.1 are identical, unlike, the original comprising following weight proportion
Material: styrene-butadiene -66 parts by weight of styrene block copolymer SEBS, 34 parts by weight of reinforced resin polypropylene PP, green
0.105 parts by weight of color composite antioxidant ECLL, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, 0.008 weight of antibacterial agent
Part.Antibacterial agent is chlorogenic acid.
Embodiment 1.3
A kind of medical AMTPS anti-biotic material and embodiment 1.1 are identical, unlike, styrene-butadiene-styrene
62 parts by weight of Block copolymer SEBS, 38 parts by weight of reinforced resin polypropylene PP, green 0.2 weight of composite antioxidant ECLL
Part, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, 0.01 parts by weight of antibacterial agent.Antibacterial agent is Octenidine and chlorogenic acid
Equal proportion mixture.
Embodiment 1.4
A kind of medical AMTPS anti-biotic material and embodiment 1.1 are identical, unlike, the original comprising following weight proportion
Material: styrene-butadiene -58 parts by weight of styrene block copolymer SEBS, 42 parts by weight of reinforced resin polypropylene PP, green
0.3 parts by weight of color composite antioxidant ECLL, 0.1 parts by weight of slipping agent, 0.01 parts by weight of antiplastering aid, 0.02 parts by weight of antibacterial agent.
Antibacterial agent is the weight ratio mixing according to 1:2 of Octenidine and chlorogenic acid.
In the present embodiment, styrene-butadiene-styrene block copolymer is styrene-butadiene-benzene of hydrogenation
Ethylene block copolymer.
Green composite antioxidant includes vitamin E, vitamin C, lecithin, chlorogenic acid and isopropyl myristate, vitamin
E: vitamin C: lecithin: chlorogenic acid: isopropyl myristate=2:0.2:2:1:1.
Slipping agent includes erucyl amide and stearic amide, erucyl amide: stearic amide=1:0.2.
Antiplastering aid is gas-phase silica.
Antiplastering aid or reinforcing agent are nm-class boron nitride.
Reinforced resin polypropylene PP is the mixture of isotactic polypropylene, syndiotactic polypropylene and random polypropylene.
Embodiment 2.1
Unlike embodiment 1.1, reinforced resin polypropylene PP is isotactic polypropylene.
Embodiment 2.2
Unlike embodiment 1.1, reinforced resin polypropylene PP is syndiotactic polypropylene.
Embodiment 2.3
Unlike embodiment 1.1, reinforced resin polypropylene PP is random polypropylene.
Embodiment 2.3
Unlike embodiment 1.1, reinforced resin polypropylene PP be isotactic polypropylene and/or random polypropylene and/or
Isotactic polypropylene.
Embodiment 3.1
It is identical with embodiment 1.1, unlike, medical instrument is syringe.
Performance detection
Tensile strength and elongation at break are all made of U.S.'s Instron universal testing machine and measure, and resist vapor permeability, resist dry
Hot mark according to GB10010 executes.According to the requirement and regulation test of standard GB/T/T8804.1-88 and GB/T8805-88
Its tensile strength and bending elastic modulus and compression strength etc. are tested, tensile strength, elongation at break in test result,
Resist vapor permeability and resist xeothermic property, shore hardness data that there is good performance, flexibility and mobility are all preferable, as a result such as table 1
It is shown, it is able to satisfy relevant use demand.
1 material mechanical performance of table
Chemical property and biology performance detection are carried out to the material of embodiment 1.1-1.4, according in concerned countries standard
Test method results it is as follows
2 chemical properties of materials of table
Haemolysis, Acute systemic toxicity, pyrogen, intradermal stimulation, cytotoxicity, skin anaphylactic test are carried out to test specimen,
Experimental result is as shown in table 3.
3 material biology performance of table
Antibacterial test
By the anti-biotic material of embodiment 1.1~1.4 according to embodiment 1.1 method be made medical infusion lines biocidal property into
Row test (referring to testing standard ASTM E2149-01), test result is as shown in table 4:
Table 4: the antibacterial test result of embodiment product
Above-mentioned medical infusion lines are placed after two months, carry out biocidal property test (referring to testing standard ASTM E2149-
01), test result is as shown in table 5:
Table 5: the antibacterial test result of embodiment product after two months
Above-mentioned experimental result further confirms, the present invention provides a kind of medical AMTPS material and preparation method, does not add increasing
Agent DEHP is moulded, processing aid or the migration of plasticizer will not occur to the problems in blood or medical fluid, do not add metal ion
Stabilizer, avoids harm of the metal ion to patient, it is safe and non-toxic, to drug without absorption, guarantee curative effect of medication, antibiotic property
Good, the antibacterial advantages such as persistently, it is ensured that the treatment safety of patient, thermal stability are good, and allergy, variation will not be generated to tissue
And rejection, there is heatproof, ageing-resistant and uvioresistant performance, used convenient for long-distance transport, storage or for patient.
It should be noted that the above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；Although
Present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: it is still
It is possible to modify the technical solutions described in the foregoing embodiments, or some or all of the technical features is carried out
Equivalent replacement；And these are modified or replaceed, it does not separate the essence of the corresponding technical solution various embodiments of the present invention technical side
The range of case.
Claims (10)
1. a kind of medical AMTPS material, it is characterised in that: the raw material comprising following weight proportion: styrene-butadiene-benzene
Ethylene block copolymer SEBS 50-80 parts by weight, reinforced resin polypropylene PP 25-50 parts by weight, green composite antioxidant
ECLL 0.05-0.3 parts by weight, slipping agent 0.05-0.2 parts by weight, antiplastering aid or reinforcing agent 0.005-0.02 parts by weight, antibacterial
Agent 0.002-0.02 parts by weight.
2. a kind of medical AMTPS material as described in claim 1, it is characterised in that: the raw material comprising following weight proportion: benzene
Ethylene-butadiene-styrene block copolymer SEBS 58-70 parts by weight, reinforced resin polypropylene PP 30-42 parts by weight,
Green composite antioxidant ECLL 0.055-0.25 parts by weight, slipping agent 0.08-0.15 parts by weight, antiplastering aid 0.01-0.02 weight
Part, antibacterial agent 0.005-0.015 parts by weight.
3. a kind of medical AMTPS material as described in claim 1, it is characterised in that: the styrene-butadiene-benzene second
Alkene block copolymer is hydrogenated styrene-butadiene-styrene block copolymer.
4. a kind of medical AMTPS material as described in claim 1, it is characterised in that: the green composite antioxidant is dimension life
One or more of plain E, vitamin C, lecithin, chlorogenic acid, isopropyl myristate.
5. a kind of medical AMTPS material as described in claim 1, it is characterised in that: the slipping agent is erucyl amide, tristearin
At least one of sour amide.
6. a kind of medical AMTPS material as described in claim 1, it is characterised in that: the antiplastering aid or reinforcing agent are nanometer
Boron nitride.
7. a kind of medical AMTPS material as described in claim 1, it is characterised in that: the antibacterial agent is Octenidine or green
Ortho acid.
8. a kind of preparation method of medical instrument, medical instrument includes perfusion tube, syringe, preparation method the following steps are included:
(1), claim raw material according to weight ratio, raw material includes that styrene-butadiene-styrene block copolymer, reinforced resin are poly-
Propylene, green composite antioxidant, slipping agent, antiplastering aid or reinforcing agent, antibacterial agent；
(2), weighed raw material is put into high-speed mixer and mixing according to parts by weight, discharged spare；
(3), double screw extruder extruding pelletization is added in the raw material after mixing step (2)；
(4), it by step (3) resulting product, in 180--190 DEG C of vacuum injection into mold, and under vacuum conditions, keeps
The temperature 2~8 hours, cooling and solidifying obtain perfusion tube, syringe, blood bag.
9. preparing the preparation method of medical instrument as claimed in claim 8, it is characterised in that: the raw material in step (1) includes benzene
Ethylene-butadiene-styrene block copolymer SEBS 50-80 parts by weight, reinforced resin polypropylene PP 25-50 parts by weight,
Green composite antioxidant ECLL 0.05-0.3 parts by weight, slipping agent 0.05-0.2 parts by weight, antiplastering aid or reinforcing agent 0.005-
0.02 parts by weight, antibacterial agent 0.002-0.02 parts by weight.
10. preparing the preparation method of medical instrument as claimed in claim 8, it is characterised in that: the raw material in step (1) includes benzene
Ethylene-butadiene-styrene block copolymer SEBS 58-70 parts by weight, reinforced resin polypropylene PP 30-42 parts by weight,
Green composite antioxidant ECLL 0.055-0.25 parts by weight, slipping agent 0.08-0.15 parts by weight, antiplastering aid or reinforcing agent 0.01-
0.02 parts by weight, antibacterial agent 0.005-0.015 parts by weight.
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