CN101519517A - Medical rubber-plastic composite material - Google Patents
Medical rubber-plastic composite material Download PDFInfo
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- CN101519517A CN101519517A CN200910020027A CN200910020027A CN101519517A CN 101519517 A CN101519517 A CN 101519517A CN 200910020027 A CN200910020027 A CN 200910020027A CN 200910020027 A CN200910020027 A CN 200910020027A CN 101519517 A CN101519517 A CN 101519517A
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- polyvinyl chloride
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- 229920003023 plastic Polymers 0.000 title claims abstract description 38
- 239000004033 plastic Substances 0.000 title claims abstract description 38
- 239000002131 composite material Substances 0.000 title claims abstract description 19
- 239000004800 polyvinyl chloride Substances 0.000 claims abstract description 47
- 229920000915 polyvinyl chloride Polymers 0.000 claims abstract description 37
- 239000011347 resin Substances 0.000 claims abstract description 21
- 229920005989 resin Polymers 0.000 claims abstract description 21
- 239000002245 particle Substances 0.000 claims abstract description 19
- 239000004593 Epoxy Substances 0.000 claims abstract description 12
- 239000000203 mixture Substances 0.000 claims abstract description 12
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000003549 soybean oil Substances 0.000 claims abstract description 11
- 235000012424 soybean oil Nutrition 0.000 claims abstract description 11
- XNGIFLGASWRNHJ-UHFFFAOYSA-N o-dicarboxybenzene Natural products OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 claims abstract description 10
- 150000008301 phosphite esters Chemical class 0.000 claims abstract description 10
- -1 phthalic acid ester Chemical class 0.000 claims abstract description 7
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 claims description 23
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 claims description 23
- 150000002148 esters Chemical class 0.000 claims description 19
- 239000004902 Softening Agent Substances 0.000 claims description 18
- 150000001875 compounds Chemical class 0.000 claims description 18
- 229920001971 elastomer Polymers 0.000 claims description 18
- 229920002545 silicone oil Polymers 0.000 claims description 9
- 239000004433 Thermoplastic polyurethane Substances 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 8
- 239000004014 plasticizer Substances 0.000 claims description 8
- 229920002803 thermoplastic polyurethane Polymers 0.000 claims description 8
- HBGGXOJOCNVPFY-UHFFFAOYSA-N diisononyl phthalate Chemical compound CC(C)CCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCC(C)C HBGGXOJOCNVPFY-UHFFFAOYSA-N 0.000 claims description 6
- 239000002994 raw material Substances 0.000 claims description 6
- 239000003112 inhibitor Substances 0.000 claims description 4
- 230000003647 oxidation Effects 0.000 claims description 4
- 238000007254 oxidation reaction Methods 0.000 claims description 4
- 238000006116 polymerization reaction Methods 0.000 claims description 4
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 2
- 239000004411 aluminium Substances 0.000 claims description 2
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 2
- 239000008116 calcium stearate Substances 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
- WYMSBXTXOHUIGT-UHFFFAOYSA-N paraoxon Chemical compound CCOP(=O)(OCC)OC1=CC=C([N+]([O-])=O)C=C1 WYMSBXTXOHUIGT-UHFFFAOYSA-N 0.000 claims description 2
- 229910052725 zinc Inorganic materials 0.000 claims description 2
- 239000011701 zinc Substances 0.000 claims description 2
- 210000004369 blood Anatomy 0.000 abstract description 50
- 239000008280 blood Substances 0.000 abstract description 50
- 238000000034 method Methods 0.000 abstract description 10
- 230000008569 process Effects 0.000 abstract description 6
- 239000000126 substance Substances 0.000 abstract description 4
- 230000008901 benefit Effects 0.000 abstract description 3
- 239000000843 powder Substances 0.000 abstract description 3
- 230000004071 biological effect Effects 0.000 abstract description 2
- 239000003381 stabilizer Substances 0.000 abstract description 2
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 abstract 1
- 239000012503 blood component Substances 0.000 abstract 1
- 238000004140 cleaning Methods 0.000 abstract 1
- 238000000605 extraction Methods 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000003921 oil Substances 0.000 abstract 1
- 235000019198 oils Nutrition 0.000 abstract 1
- 229910052710 silicon Inorganic materials 0.000 abstract 1
- 239000010703 silicon Substances 0.000 abstract 1
- 239000000463 material Substances 0.000 description 18
- 206010018910 Haemolysis Diseases 0.000 description 14
- 230000008588 hemolysis Effects 0.000 description 14
- 238000006243 chemical reaction Methods 0.000 description 13
- 238000013508 migration Methods 0.000 description 13
- 230000005012 migration Effects 0.000 description 12
- SOGAXMICEFXMKE-UHFFFAOYSA-N Butylmethacrylate Chemical compound CCCCOC(=O)C(C)=C SOGAXMICEFXMKE-UHFFFAOYSA-N 0.000 description 6
- 230000001154 acute effect Effects 0.000 description 6
- 239000000523 sample Substances 0.000 description 6
- 230000000052 comparative effect Effects 0.000 description 5
- 230000034659 glycolysis Effects 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 231100000331 toxic Toxicity 0.000 description 5
- 230000002588 toxic effect Effects 0.000 description 5
- 206010002198 Anaphylactic reaction Diseases 0.000 description 4
- 230000036783 anaphylactic response Effects 0.000 description 4
- 208000003455 anaphylaxis Diseases 0.000 description 4
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 4
- 238000010438 heat treatment Methods 0.000 description 4
- 239000001301 oxygen Substances 0.000 description 4
- 229910052760 oxygen Inorganic materials 0.000 description 4
- 238000009423 ventilation Methods 0.000 description 4
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 3
- CQEYYJKEWSMYFG-UHFFFAOYSA-N butyl acrylate Chemical compound CCCCOC(=O)C=C CQEYYJKEWSMYFG-UHFFFAOYSA-N 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 239000012633 leachable Substances 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 231100000135 cytotoxicity Toxicity 0.000 description 2
- 230000003013 cytotoxicity Effects 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 229920000578 graft copolymer Polymers 0.000 description 2
- 238000000703 high-speed centrifugation Methods 0.000 description 2
- 238000005453 pelletization Methods 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 238000004321 preservation Methods 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 230000004044 response Effects 0.000 description 2
- 150000003384 small molecules Chemical class 0.000 description 2
- MYMOFIZGZYHOMD-UHFFFAOYSA-N Dioxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 description 1
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 description 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 206010070834 Sensitisation Diseases 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- IHBCFWWEZXPPLG-UHFFFAOYSA-N [Ca].[Zn] Chemical compound [Ca].[Zn] IHBCFWWEZXPPLG-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 210000001772 blood platelet Anatomy 0.000 description 1
- 239000003638 chemical reducing agent Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000000254 damaging effect Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 229960000935 dehydrated alcohol Drugs 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 229910001882 dioxygen Inorganic materials 0.000 description 1
- 238000010894 electron beam technology Methods 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000010559 graft polymerization reaction Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000006101 laboratory sample Substances 0.000 description 1
- 239000000944 linseed oil Substances 0.000 description 1
- 235000021388 linseed oil Nutrition 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000002932 luster Substances 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000035484 reaction time Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000000452 restraining effect Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 230000008313 sensitization Effects 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000004381 surface treatment Methods 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
The invention relates to a medical rubber-plastic composite material, which is improved PVC plastic and consists of polyvinyl chloride (PVC) resin powder, composite rubber-plastic particles, phthalic acid ester, stabilizing agent, lubricating agent and the like, wherein each 100 portions of the PVC resin powder by weight is blended with 10 to 30 portions of the composite rubber-plastic particles, 20 to 40 portions of the phthalic acid ester, 3 to 10 portions of epoxy soybean oil, 0.5 to 2 portions of stearate, 0.5 to 1 portion of organic phosphite ester, and 0.1 to 0.5 portion of silicon oil. The obtained composite material has the advantages of stable chemical property and good flexibility, elasticity and toughness, is easy to process, and is not easy to decompose; and a blood bag made of the composite material has good biological property and little chemical extraction, is extremely safe to store blood, and can be applied to manufacturing a primary bag and a secondary bag in a single bag or multiple bags to separate and store blood components. The composite material has reasonable formulation and stable performance, and can be produced on a large scale in a cleaning workshop.
Description
Technical field
The present invention relates to a kind of macromolecular material, specifically a kind of improved medical rubber-plastic composite material, it is exclusively used in makes the compound blood bag of disposable use rubber and plastic.
Background technology
We know that polyvinyl chloride (PVC) is one of medical macromolecular materials commonly used, can make storage blood bag, transfusion bags etc.Medical PVC blood bag uses with the soft goods form mostly, adopts the method for adding small molecules softening agent (as phthalate) usually, reaches the purpose that reduces material hardness.Small molecules softening agent (as the own ester DEHP of phthalic acid two (2-ethyl)) can constantly ooze out in the use of PVC goods and move, not only cause the decline of material property, reduction of service life, also can pollute the blood of contact with it, accumulate and the health (liver that DEHP has been proved to be to the people has certain damaging effect) of harmful to human in vivo.But research finds that also DEHP has the effect of the hemolysis rate when reducing the red corpuscle preservation.Therefore people actively seek the stripping quantity that a kind of method can reduce DEHP, can guarantee the restraining effect of DEHP to erythrocyte hemolysis again.In order to suppress migration of plasticizer among the PVC, can adopt surface treatment usually at present, as low-temperature plasma radiation, electron beam emission, uviolizing etc.But these method complex process, cost height have limited their application.
Summary of the invention
Technical problem to be solved by this invention is to overcome above-mentioned the deficiencies in the prior art, provide a kind of prescription rationally, stable performance, have higher draw tensile strength, resistance toheat is good, the bag of making is difficult for breaking, the medical rubber-plastic composite material that does not stick together at 114 ℃ of condition lower bag bodies of temperature.
The technical scheme that the present invention solves the problems of the technologies described above employing is: a kind of medical rubber-plastic composite material, it is characterized in that: it is a soft polyvinyl chloride plastic, raw material is by polyvinyl chloride (PVC) resin-oatmeal, compound rubber and plastic particle, phthalic ester, epoxy soybean oil, stearate, organophosphite and silicone oil are formed, and contain 10～30 parts on compound rubber and plastic particle in per 100 weight part polyvinyl chloride (PVC) resins in the composition, 20～40 parts of phthalic esters, 3～10 parts of epoxy soybean oils, 0.5～2 part of stearate, 0.5～1 part of organophosphite, 0.1～0.5 part of silicone oil.
Compound rubber and plastic particle main component of the present invention is polyacrylic ester, thermoplastic polyurethane and MBS blending resin, and the content of each component is (weight part):
Composition consumption (weight part)
Polyacrylic ester 20
Thermoplastic polyurethane 68
MBS resin 10
Oxidation inhibitor 2
Compound rubber and plastic particle mainly is as PVC softening agent and properties-correcting agent.This compound rubber and plastic particle can play and suppress DEHP migration and stripping, increases the transparent and stable on heating effect of PVC, has greatly expanded the range of application of PVC.Thermoplastic polyurethane is used to increase the toughness of PVC in this plasticiser system, reduces plasticizer dosage; Polyacrylic ester is used to reduce softening agent DEHP stripping; MBS is used to improve compatibility between components and increases blood bag transparency.
Advantage of the present invention is that prescription is reasonable, stable performance, the resulting product soft and transparent, Heat stability is good, resistance toheat is good, have higher draw tensile strength, the blood bag that it is suitable for making, the high speed centrifugation bag is difficult for breaking, carry out steam sterilizing after 40 minutes under 114 ℃ of conditions of pressure 0.09MPa temperature, bag does not stick together.The blood bag that it is suitable for making can be used as female bag or son bag in the multi-linked blood bag, is used to preserve blood ingredient.
Embodiment
The invention will be further described below in conjunction with embodiment, but scope of the present invention is not limited to these.
Medical rubber-plastic composite material of the present invention is improved PVC plastics, it is made up of polyvinyl chloride (PVC) resin-oatmeal, compound rubber and plastic particle, phthalic ester, epoxy soybean oil, stearate, organophosphite and silicone oil, contains 10～30 parts on compound rubber and plastic particle, 20～40 parts of phthalic esters, 3～10 parts of epoxy soybean oils, 0.5～2 part of stearate, 0.5～1 part of organophosphite, 0.1～0.5 part of silicone oil in per 100 weight part polyvinyl chloride (PVC) resins in the compositing formula.
The preferred raw material compositing formula of the present invention is:
Composition consumption (weight part)
Polyvinyl chloride (PVC) RESINS (PVC) 100
Compound rubber and plastic particle 15～25
Phthalic ester 25～35
Epoxy soybean oil 3～5
Stearate (calcium stearate, zinc and aluminium) 0.8～1
Organophosphite 0.8～1
Silicone oil 0.1～0.3
The described polyvinyl chloride resin polymerization degree is 1000～2500.The preferred polyvinyl chloride resin polymerization degree is 1700.Plasticizer phthalic acid ester comprises phthalic acid two (the 2-ethyl is own) ester (DEHP), dimixo-octyl phthalate (DIOP), diisononyl phthalate (DINP), wherein softening agent DEHP accounts for 60%～80% of softening agent gross weight, softening agent DIOP accounts for 10%～20% of softening agent total mass, and softening agent DINP accounts for 10%～20% of total softening agent weight.Said epoxy soybean oil replaces with epoxy linseed oil.Said stearate replaces with calcium-zinc composite stabilizing agent.
Compound rubber and plastic particle main component of the present invention is polyacrylic ester, thermoplastic polyurethane and MBS blending resin, and the content of each component is (weight part):
Composition consumption (weight ratio)
Polyacrylic ester 20
Thermoplastic polyurethane 68
MBS resin 10
Oxidation inhibitor 2
It mainly is as PVC softening agent and properties-correcting agent.This compound rubber and plastic particle can play and suppress DEHP migration and stripping, increases the transparent and stable on heating effect of PVC, has greatly expanded the range of application of PVC.Thermoplastic polyurethane is used to increase the toughness of PVC in this plasticiser system, reduces plasticizer dosage; Polyacrylic ester is used to reduce softening agent DEHP stripping; MBS is used to improve compatibility between components and increases blood bag transparency.
The technical process that the present invention prepares compound rubber and plastic particle is: get polyacrylic ester, urethane, MBS resin and oxidation inhibitor by 100 parts of gross weights and carry out proportioning.The raw material that proportioning is good joins that mechanically mixing obtained Preblend in 2～10 minutes in the mixing tank; Again Preblend is joined twin screw extruder, setting forcing machine is 140～210 ℃ along charging opening to a mouthful mould direction temperature, and die temperature is 180～220 ℃; The residence time of blend material in forcing machine is 1.5～3.0 minutes, and each component obtains thorough mixing in molten state in this process; At last, blend per os mould is extruded, pelletizing, is drying to obtain compound rubber and plastic particle.
The MBS resin that the present invention uses is to adopt graft polymerization methyl methacrylate, butyl acrylate and the resulting ternary graft copolymer of butyl methacrylate.Three kinds of composition proportion (weight ratio):
Composition consumption (weight ratio)
Methyl methacrylate 90
Butyl acrylate 6
Butyl methacrylate 4
The technical process that the present invention prepares ternary graft copolymer is: take by weighing methyl methacrylate (M), butyl acrylate, butyl methacrylate with electronic balance, pour the there-necked flask internal reaction into, temperature of reaction is controlled at 65～70 ℃, and the reaction times is 3～4h.Obtain the MBS powder through cohesion, dehydration, drying.
Advantage of the present invention is that prescription is reasonable, stable performance, the resulting product soft and transparent, Heat stability is good, resistance toheat is good, have higher draw tensile strength, the blood bag that it is suitable for making, the high speed centrifugation bag is difficult for breaking, carry out steam sterilizing after 40 minutes under 114 ℃ of conditions of pressure 0.09MPa temperature, bag does not stick together.The blood bag that it is suitable for making can be used as female bag or son bag in the multi-linked blood bag, is used to preserve blood ingredient.
The present invention fills a prescription and raw materials usedly mixed in high speed agitator 5 minutes after metering, obtains Preblend.Above-mentioned Preblend is transported in the response type twin screw extruder, and the screw diameter of forcing machine is 40mm, and length-to-diameter ratio is 36, and setting forcing machine is 140～175 ℃ along charging opening to a mouthful mould direction temperature, and die temperature is 170 ℃.Blend per os mould is extruded, cooling, pelletizing, obtains blending resin, blending resin is injection molded into the standard batten, test surfaces hardness and mechanical property.The compositing formula of each specific embodiment is listed table 1 in, and its mechanical property sees Table 2.
The compositing formula of each specific embodiment of table 1
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| PVC | 100 | 100 | 100 | 100 |
| Compound rubber and plastic particle | 30 | 25 | 15 | 10 |
| Phthalic ester | 20 | 25 | 35 | 40 |
| Epoxy soybean oil | 3 | 5 | 8 | 10 |
| Stearate | 0.5 | 1 | 1 | 2 |
| Organophosphite | 0.5 | 0.5 | 1 | 1 |
| Silicone oil | 0.1 | 0.3 | 0.5 | 0.5 |
The mechanical property of table 2 material
| Interventions Requested | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | National standard |
| Shore hardness H A | 70 | 78 | 69 | 62 | ≤80 |
| Water-intake rate % | 0.1 | 0.2 | 0.2 | 0.3 | ≤0.3 |
| Elongation at break % | 378 | 432 | 467 | 356 | ≥250 |
| Tensile strength (MPa) | 13.6 | 13.2 | 13.4 | 13.9 | ≥13.0 |
The pellet that the present invention makes is made required blood bag in normal forming process condition.The resulting product soft and transparent, Heat stability is good, resistance toheat is good.According to the GB14232-93 regulation, through measuring its chemistry and biological property according to standard GB 15593-1995 " blood transfusion (liquid) utensil soft polyvinyl chloride plastic " regulation behind the ethylene oxide sterilizing, the result is shown in table 3 and table 4.
Table 3 materials chemistry performance
| Interventions Requested | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | National standard |
| Potential of hydrogen | 0.2 | 0.3 | 0.2 | 0.2 | ≤1.0 |
| Heavy metal μ g/mL | Do not detect | Do not detect | Do not detect | Do not detect | ≤0.3 |
| Reducing substance (0.02mol/LKMnO 4Consumption) ml/20mL | 0.1 | 0.1 | 0.1 | 0.1 | ≤0.3 |
| Non-volatile matter mg/100mL | 0.1 | 0.2 | 0.1 | 0.1 | ≤2.0 |
| Color and luster | Clear | Clear | Clear | Clear | Clear |
| Alcohol leachable (DEHP) mg/100mL | 1.0 | 1.0 | 1.1 | 1.3 | ≤10 |
| Ultraviolet absorption (230 ~ 360nm) | 0.05 | 0.05 | 0.06 | 0.09 | ≤0.3 |
| Ash content mg/g | Do not detect | Do not detect | Do not detect | Do not detect | ≤1 |
| Vinyl chloride monomer μ g/g | 0.01 | 0.06 | 0.03 | 0.04 | ≤1 |
Table 4 material biology performance
| Interventions Requested | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Assay |
| Acute general toxicity | There is not acute general toxic reaction | There is not acute general toxic reaction | There is not acute general toxic reaction | There is not acute general toxic reaction | There is not acute general toxic reaction |
| Pyrogen | The pyrogen-free reaction | The pyrogen-free reaction | The pyrogen-free reaction | The pyrogen-free reaction | The pyrogen-free reaction |
| Haemolysis | Hemolysis rate 0.2 % | Hemolysis rate 0.2% | Hemolysis rate 0.2 % | Hemolysis rate 0.2 % | Hemolysis rate≤5% |
| Intracutaneous stimulates | No intracutaneous stimulates | No intracutaneous stimulates | No intracutaneous stimulates | No intracutaneous stimulates | No intracutaneous stimulates |
| Cytotoxicity | Cell-cytotoxic reaction: 0 grade | Cell-cytotoxic reaction: 0 grade | Cell-cytotoxic reaction: 0 grade | Cell-cytotoxic reaction: 0 grade | ≤ 2 grades |
| Allergic | No anaphylaxis | No anaphylaxis | No anaphylaxis | No anaphylaxis | Sensitivity response≤2 grade, irritated rate≤28% |
| Blood is preserved | The blood bag is preserved blood down at 4 ± 2 ℃ and haemolysis was not taken place, red corpuscle glycolysis rate 89% in 21 days | The blood bag is preserved blood down at 4 ± 2 ℃ and haemolysis was not taken place, red corpuscle glycolysis rate 90% in 21 days | The blood bag is preserved blood down at 4 ± 2 ℃ and haemolysis was not taken place, red corpuscle glycolysis rate 92% in 21 days | The blood bag is preserved blood down at 4 ± 2 ℃ and haemolysis was not taken place, red corpuscle glycolysis rate 94% in 21 days | The blood bag is preserved blood down at 4 ± 2 ℃ and was not answered haemolysis in 21 days, red corpuscle glycolysis rate 〉=70% |
The blood bag that material of the present invention is made carries out the every check test of biology, prove material non-toxic reaction of the present invention, and no intracutaneous stimulation, sensitization rate are 0%, pyrogen-free reaction, hemolysis rate and cytotoxicity experiment are qualified.The blood bag that these assay explanations material of the present invention is made is the storing blood bag of low chemical leachable, safety.
Another key character of blood bag is a ventilation property.For PVC blood bag material, along with the minimizing of plasticizer consumption, ventilation property generally reduces.The reduction of ventilation property is disadvantageous to some blood ingredient such as hematoblastic storage.The air permeability test result that the various embodiments described above of the present invention are carried out improved PVC blood bag is as follows:
Press the method for GB/T 19789-2005 and measure oxygen gas permeability.Used test equipment is the MOCONOX-TRAN2/21MH of U.S. Mocon Inc. gas-permeable instrument.Laboratory sample is of a size of 10.8 * 10.8cm
2, useful area is 50cm
2, thickness of sample is at 0.40～0.5mm, test duration 48h, oxygen concentration 10%.Gained the results are shown in the following table 5.
Table 5. embodiment make the blood bag the oxygen transit dose and with the comparison of PVC material
| Material number | Oxygen transit dose (cc/m 2/d) |
| Comparative example 1 | 46.94 |
| Comparative example 2 | 86.67 |
| Embodiment 1 | 88.51 |
| Embodiment 2 | 89.53 |
| Embodiment 3 | 99.64 |
| Embodiment 4 | 113.22 |
The red corpuscle blood bag PVC material that comparative example 1 is produced for Medical High Molecular Product Co., Ltd., Shandong Weigao Group; Comparative example 2 is the thrombocyte blood bag PVC material that Dutch higher bit company produces.
Contrast finds, the OTR oxygen transmission rate of the blood bag of embodiment 1～embodiment 4 preparations is all greater than two kinds of comparative example PVC blood bag film materials, and PVC blood bag promptly provided by the invention has better ventilation property, is suitable for red corpuscle and hematoblastic storage.
PVC blood bag prepared among the present invention has the characteristic of low DEHP stripping, with reference to GB/T 3830-1994 standard, cuts 3 on the sample of 40mm * 60mm, should organize and take out sample is placed 4h in moisture eliminator after, weigh piecewise, and, accurately to 0.0001g.Sample is put into baking oven be heated to (100 ± 2) ℃, take out behind the constant temperature some hrs, put into moisture eliminator immediately and be cooled to room temperature, use the dehydrated alcohol clean surface, weigh piecewise again, accurately to 0.0001g.Table 6 makes blood bag and its DEHP migration loss rate of common PVC blood bag situation over time for embodiment.The migration loss rate is calculated as follows:
n＝(m
0-m)/m
0
N in the formula---migration loss rate, %
m
0---quality before the sample heating, g
M---sample heating back quality, g
Can find that by table 6 contrast the DEHP migration loss rate of the blood bag of embodiment 1～embodiment 4 preparations is all less than common PVC blood bag, PVC blood bag promptly provided by the invention has low chemical leachable, is very safe to the preservation of blood.
Table 6. embodiment makes the DEHP migration loss rate of blood bag and common PVC and shows over time
| Material number | DEHP migration loss rate % (6h) | DEHP migration loss rate % (12h) | DEHP migration loss rate % (24h) | DEHP migration loss rate % (36h) | DEHP migration loss rate % (48h) |
| Common PVC blood bag | 2.2 | 2.5 | 4.3 | 6.1 | 7.4 |
| Embodiment 1 | 1.0 | 1.2 | 1.5 | 1.6 | 1.7 |
| Embodiment 2 | 1.0 | 1.1 | 1.4 | 1.5 | 1.6 |
| Embodiment 3 | 1.1 | 1.3 | 1.7 | 1.9 | 2.0 |
| Embodiment 4 | 1.3 | 1.5 | 1.9 | 2.1 | 2.2 |
Claims (6)
1. medical rubber-plastic composite material, it is characterized in that: it is a soft polyvinyl chloride plastic, raw material is made up of polyvinyl chloride (PVC) resin-oatmeal, compound rubber and plastic particle, phthalic ester, epoxy soybean oil, stearate, organophosphite and silicone oil, contains 10～30 parts on compound rubber and plastic particle, 20～40 parts of phthalic esters, 3～10 parts of epoxy soybean oils, 0.5～2 part of stearate, 0.5～1 part of organophosphite, 0.1～0.5 part of silicone oil in per 100 weight part polyvinyl chloride (PVC) resins in the composition.
2. medical rubber-plastic composite material according to claim 1 is characterized in that: its raw material compositing formula is:
Composition consumption (weight part)
Polyvinyl chloride (PVC) RESINS (PVC) 100
Compound rubber and plastic particle 15～25
Phthalic ester 25～35
Epoxy soybean oil 3～5
Stearate (calcium stearate, zinc and aluminium) 0.8～1
Organophosphite 0.8～1
Silicone oil 0.1～0.3.
3. medical rubber-plastic composite material according to claim 1 is characterized in that: the described polyvinyl chloride resin polymerization degree is 1000～2500.
4. medical rubber-plastic composite material according to claim 1 is characterized in that: the described polyvinyl chloride resin polymerization degree is 1700.
5. medical rubber-plastic composite material according to claim 1 is characterized in that: described compound rubber and plastic particle main component is polyacrylic ester, thermoplastic polyurethane and MBS blending resin, and the content of each component is (weight part):
Composition consumption (weight part)
Polyacrylic ester 20
Thermoplastic polyurethane 68
MBS resin 10
Oxidation inhibitor 2.
6. medical rubber-plastic composite material according to claim 1, it is characterized in that: plasticizer phthalic acid ester comprises phthalic acid two (the 2-ethyl is own) ester (DEHP), dimixo-octyl phthalate (DIOP), diisononyl phthalate (DINP), wherein softening agent DEHP accounts for 60%～80% of softening agent total mass, softening agent DIOP accounts for 10%～20% of softening agent total mass, and softening agent DINP accounts for 10%～20% of total softening agent quality.
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| CN103012996A (en) * | 2012-12-25 | 2013-04-03 | 上海新上化高分子材料有限公司 | Medical low-temperature resistant low-mobility polyvinyl chloride calendered film material and preparation method thereof |
| TWI507433B (en) * | 2014-12-01 | 2015-11-11 | Univ Nat Taiwan | Polymeric composite material, medical tube, and infusion bag |
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- 2009-03-24 CN CN200910020027A patent/CN101519517B/en active Active
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| CN103012996A (en) * | 2012-12-25 | 2013-04-03 | 上海新上化高分子材料有限公司 | Medical low-temperature resistant low-mobility polyvinyl chloride calendered film material and preparation method thereof |
| TWI507433B (en) * | 2014-12-01 | 2015-11-11 | Univ Nat Taiwan | Polymeric composite material, medical tube, and infusion bag |
| CN105175939A (en) * | 2015-09-09 | 2015-12-23 | 深圳恒方大高分子材料科技有限公司 | High-oxygen-permeability medical PVC (polyvinyl chloride) material and preparation method of high-oxygen-permeability medical PVC material |
| CN105778333A (en) * | 2016-03-21 | 2016-07-20 | 仙桃永利医疗用品有限公司 | Medical antibacterial light-resistant polyvinyl chloride plastic |
| CN106963640A (en) * | 2017-05-02 | 2017-07-21 | 浙江绿蔻生物技术有限公司 | Blood sampling separation bag |
| CN107722607A (en) * | 2017-10-31 | 2018-02-23 | 惠州市顺利包装制品有限公司 | One kind is packed for environment-friendly type rubber-plastics material |
| CN108359192A (en) * | 2018-03-02 | 2018-08-03 | 付主枝 | A kind of preparation method and applications of medical rubber-plastic composite material |
| CN109517290A (en) * | 2018-09-12 | 2019-03-26 | 谢彪 | A kind of high transparency trachea cannula special-purpose polychloroethylene pellet |
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