CN100475899C - Medical polyvinyl chloride plastic and product thereof - Google Patents
Medical polyvinyl chloride plastic and product thereof Download PDFInfo
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- CN100475899C CN100475899C CNB031420931A CN03142093A CN100475899C CN 100475899 C CN100475899 C CN 100475899C CN B031420931 A CNB031420931 A CN B031420931A CN 03142093 A CN03142093 A CN 03142093A CN 100475899 C CN100475899 C CN 100475899C
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- iatrical
- polyvinyl chloride
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Abstract
This invention refers to a kind of iatrical plastic of PVC and its products. The plastic is composed of, in amounts of weight, 100 of polyvinyl chloride resin, between 20 and 80 of plasticizer, between 1 and 5 of epoxy soybean oil, between 0.1 and 0.5 of stabilizer of ortho phosphorous acid III (nonyl phenyl ester), between 0.1 and 0.5 of polymethylphenyl siloxane fluid, between 0.4 and 1.5 of composite stabilizer of calcium and zinc and between 0 and 5 of ethane-vinyl acetate copolymer. The polyvinyl chloride resin is mainly made through mixing the rosin with low degree of polymerization with that with high degree of polymerization in proportion; the plasticizer is one or the compound of the near benzene dicarbonic acid di-seperated pelargonic ester. The products includes iatrical begs and iatrical burettes. The iatrical plastic of PVC in the invention has the advantages of low alcohol stripping and little reducing substances in the water stripping and is especially adaptable to the iatrical begs for blood filtering and transfusion and iatrical canula.
Description
Technical field
The present invention relates to a kind of plastics and goods thereof, relate in particular to a kind of be used for making blood transfusion or transfusion medical polyvinyl plastics and goods thereof.
Background technology
The blood transfusion of widespread usage at present or infuse medical bag or medical catheter are mostly made by medical polyvinyl plastics, and this plastics general property is good, easy to use, and is very popular with users.But also have some problems, these problems all are that its subject matter is because the constituent and the complete processing of employed medical polyvinyl plastics are caused: the pure leachable of the medical bag of 1, transfusing blood or infuse surpasses the requirement of national standard and international standard.National standard and international standard require the pure leachable of medical bag must not be greater than 10 milligrams/100 milliliters, and the medical bag that China uses at present particularly the pure leachable of small dimension bag all surpassed this requirement.The alcohol leachable mainly is (DEHP) to be produced by plasticizer phthalic acid contained in the medical polyvinyl plastics-two (2-ethylhexyl).2, the reducing substance of transfusing blood or infusing in the water leachable of medical bag exceeds standard, and the reducing substance in the water leachable is produced by stablizer phosphorous acid benzene di-isooctyl contained in the medical polyvinyl plastics.3,, make it when being processed into goods, need higher processing temperature because the mean polymerisation degree of the polyvinyl chloride (PVC) RESINS that is adopted in the existing medical polyvinyl plastics new variety is higher.
Summary of the invention
The present invention existing is used for making blood transfusion or problem that the reducing substance of the pure leachable of the medical polyvinyl plastics of infuse medical bag and medical catheter and water leachable exceeds standard and a kind of medical polyvinyl plastics and goods thereof that formed by new formulation are provided in order to solve.
The technical measures that the present invention taked are, a kind of medical polyvinyl plastics is mixed with by appended weight part by following material and forms:
100 parts of polyvinyl chloride (PVC) RESINS;
Softening agent 20-80 part;
Epoxy soybean oil 1-5 part;
Tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part;
Polymethylphenyl siloxane fluid 0.1-0.5 part;
Calcium-zinc composite stabilizing agent 0.4-1.5 part.
Above-mentioned medical polyvinyl plastics also comprises ethylene-vinyl acetate copolymer 1-5 part in the described prescription.
Described polyvinyl chloride (PVC) RESINS is a mean polymerisation degree more than or equal to 1000 oligomeric resin and the mean polymerisation degree mixture more than or equal to 2000 high-polymerization degree resin.
Described polyvinyl chloride (PVC) RESINS is a mean polymerisation degree more than or equal to 1000 oligomeric resin.
Described polyvinyl chloride (PVC) RESINS is a mean polymerisation degree more than or equal to 2000 high-polymerization degree resin.
Described softening agent is a diisononyl phthalate.
Described softening agent is the mixture of diisononyl phthalate and phthalic acid-two (2-ethylhexyl).
Described softening agent is phthalic acid-two (a 2-ethylhexyl).
The conduit that a kind of medical blood transfusion, infusion bag, this blood transfusion, infusion bag comprise bag, be connected with bag and be communicated with, described bag, the conduit that connects with bag all adopt medical polyvinyl plastics to make.
A kind of medical blood transfusion, transfusion drip tube, this dropper comprises dropper body, ingress pipe, delivery line, ingress pipe is connected the upper end of dropper body and inserts the dropper body and is communicated with the inner chamber of dropper body, delivery line connects in the lower end of dropper body, and described dropper body, ingress pipe, delivery line adopt the medical polyvinyl plastics material made.
Medical polyvinyl plastics of the present invention is owing to adopted above-mentioned new prescription and used the medical infusion bags and the medical dropper of this production, compare with medical dropper with the medical polyvinyl plastics of prior art and the medical infusion bags of using this plastic production, have following tangible advantage:
1, because many two carbon of molecular ratio phthalic acid-two (2-ethylhexyl) molecule (DEHP) of used plasticizer phthalic acid dinonyl (DINP), its molecular weight is also big slightly, therefore the consistency of itself and polyvinyl chloride (PVC) RESINS is better, be difficult for separating out, its volatility, transport property and toxicity all are better than phthalic acid-two (2-ethylhexyl).Oneself is confirmed to do foodstuff additive by U.S. FDA diisononyl phthalate.Begin just regulation mid-term from the eighties of last century the eighties abroad, when making toy for children, be used as plastifying raw material phthalic acid-two (2-ethylhexyl) in its igelite and should all use diisononyl phthalate instead with igelite.The present invention can be with all or part of replacement phthalic acid-two of diisononyl phthalate (2-ethylhexyl) as the softening agent of producing medical polyvinyl plastics, the pure leachable of the medical polyvinyl plastics that makes greatly reduces, and prove that through biological experiment its pyrogen, acute toxicity, haemolysis, intracutaneous stimulation, cytotoxicity and blood are preserved all up to specification.
2, chemical property is good.Medical polyvinyl plastics of the present invention is through project testings such as ignition residue, polyvinyl chloride monomer, water leachable, pure leachables, the result all meets national standard, particularly pure leachable obviously adopts phthalic acid-two (2-ethylhexyl) few more merely, sees also table 1.When all replacing phthalic acid-two (2-ethylhexyl) with diisononyl phthalate, its pure leachable only is 4-5 milligram/100 milliliter; When partly replacing phthalic acid-two (2-ethylhexyl) with diisononyl phthalate, its pure leachable is 7-8 milligram/100 milliliter; And when all adopting phthalic acid-two (2-ethylhexyl), its pure leachable is 10-12 milligram/100 milliliter.
Table 1 survey report
| Interventions Requested | Technical requirements | Assay | Individual event is judged |
| Vinyl chloride monomer | Be not more than 1 μ g/g | Less than 0.2 μ g/g | Meet |
| Ignition residue | Be not more than 0.1% | 0.05％ | Meet |
| Proterties | Achromatism and clarity | Achromatism and clarity | Meet |
| PH value variable quantity | Be not more than 1.0 | 0.03 | Meet |
| Reducing substance (0.02mol/L potassium permanganate consumption) | Be not more than 0.3ml/20ml | 0.08ml/20ml | Meet |
| Muriate | Be not more than 3 μ g/ml | Up to specification | Meet |
| Zinc | Be not more than 0.4 μ g/ml | 0.2μg/ml | Meet |
| Heavy metal | Be not more than 1 μ g/ml | Up to specification | Meet |
| Non-volatile matter | Be not more than 2mg/100ml | 0.2mg/100ml | Meet |
| Ultraviolet absorptivity (230-360nm) | Be not more than 0.3 | Maximum 0.08 (230nm) | Meet |
| Alcohol leachable (DEHP) | Be not more than 10mg/100ml | 5.4mg/100ml | Meet |
| Pyrogen | No pyrogeneous substance | Up to specification | Meet |
| Acute general toxicity | Do not produce acute general toxicity | Up to specification | Meet |
| Hemolytic test | Hemolysis rate is not more than 5% | Hemolysis rate is less than 1.7% | Meet |
| Intracutaneous stimulates | Rabbit after the injection vat liquor, no obvious erythema or oedema in 72 hours | Up to specification | Meet |
| Cytotoxicity | L-929 cell strain propagation degree is not more than 2 grades | Up to specification | Meet |
3, the regulation of the reducing substance conformance with standard in the water leachable.Replace original phosphorous acid benzene di-isooctyl used as stabilizers with tricresyl phosphite (nonyl phenyl ester), the reducing substance in the water leachable of the medical polyvinyl plastics that makes is controlled in the scope of 0.01-0.2 milliliter/20 milliliter (0.02 mol potassium permanganate consumption).And during with phosphorous acid benzene di-isooctyl, the reducing substance in its water leachable often exceeds standard.
4, polyvinyl chloride (PVC) RESINS of the present invention adopts mean polymerisation degree to be mixed in proportion when using more than or equal to 2000 high-polymerization degree resin more than or equal to 1000 oligomeric resin and mean polymerisation degree.Can reduce simple with mean polymerisation degree the processing temperature during more than or equal to 2000 high-polymerization degree resin, and other performance such as lower temperature resistance, flexibility, elastic sensation etc. still can satisfy service requirements.
Description of drawings
Fig. 1 uses medical bag the synoptic diagram that medical polyvinyl plastics of the present invention is made;
Fig. 2 is a synoptic diagram of using the medical dropper of medical polyvinyl plastics making of the present invention.
Embodiment
Embodiment 1
Be averaged the polymerization degree more than or equal to high-polymerization degree resin 60-80 part of 2000, mean polymerisation degree is mixed into base-material more than or equal to oligomeric resin 20-40 part of 1000, add plasticizer phthalic acid dinonyl 50-80 part, stablizer tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part, epoxy soybean oil 1-5 part, polymethylphenyl siloxane fluid 0.1-0.5 part, calcium-zinc composite stabilizing agent 0.4-1.5 part, ethylene-vinyl acetate copolymer 0-5 part, adopt conventional method in kneader, to mix the plasticizing extruding pelletization of heating, get a kind of medical polyvinyl plastics of the present invention, in forcing machine, make required film with this medical polyvinyl plastics, conduit, cut by required specification, be made into medical bag by high-frequency thermocompressor again, or be bonded into the pipeline goods.The good physical and chemical properties such as low-temperature pliability of prepared medical bag or pipeline goods, processing temperature is hanged down 5 ℃ than the simple plastics that adopt mean polymerisation degree to make more than or equal to 2000 high-polymerization degree resin, the DEHP amount of separating out can be less than 5mg/100ml in the particularly pure leachable, the reducing substance amount of separating out can be less than 0.2ml/20ml in the water leachable, be applicable to the collection and the preservation of whole blood, blood component, be specially adapted to make the small dimension blood bag that nominal capacity is less than or equal to 200 milliliters.
Embodiment 2
Be averaged the polymerization degree more than or equal to high-polymerization degree resin 60-80 part of 2000, mean polymerisation degree is mixed into base-material more than or equal to oligomeric resin 20-40 part of 1000, add plasticizer phthalic acid dinonyl 20-50 part and phthalic acid-two (2-ethylhexyl) 20-50 part, stablizer tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part, epoxy soybean oil 1-5 part, polymethylphenyl siloxane fluid 0.1-0.5 part, calcium-zinc composite stabilizing agent 0.4-1.5 part, ethylene-vinyl acetate copolymer 0-5 part, adopt conventional method in kneader, to mix the plasticizing extruding pelletization of heating, draw a kind of medical polyvinyl plastics of the present invention, in forcing machine, make required film with this medical polyvinyl plastics, conduit, cut by required specification, be made into medical bag by high-frequency thermocompressor again, or be bonded into the pipeline goods.The reducing substance amount of separating out gained medical polyvinyl plastics in the embodiment 1 all in the low-temperature pliability of prepared medical bag or pipeline goods, processing temperature, the water leachable, the DEHP amount of separating out can be less than 8mg/100ml in its pure leachable, is applicable to make nominal capacity more than or equal to 300 milliliters middle specification and above blood bag.
Be averaged the polymerization degree more than or equal to high-polymerization degree resin 60-80 part of 2000, mean polymerisation degree is mixed into base-material more than or equal to oligomeric resin 20-40 part of 1000, add plasticizer phthalic acid-two (2-ethylhexyl) 50-80 part, stablizer tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part, epoxy soybean oil 1-5 part, polymethylphenyl siloxane fluid 0.1-0.5 part, calcium-zinc composite stabilizing agent 0.4-1.5 part, ethylene-vinyl acetate copolymer 0-5 part, adopt conventional method in kneader, to mix the plasticizing extruding pelletization of heating, draw a kind of medical polyvinyl plastics of the present invention, in forcing machine, make required film with this medical polyvinyl plastics, conduit, cut by required specification, be made into medical bag by high-frequency thermocompressor again, or be bonded into the pipeline goods.The reducing substance amount of separating out gained medical polyvinyl plastics in the embodiment 1 all in the low-temperature pliability of prepared medical bag or pipeline goods, processing temperature, the water leachable, owing to still use phthalic acid-two (2-ethylhexyl) to make softening agent, its DEHP separates out higher, is suitable for making nominal capacity more than or equal to 400 milliliters big specification blood bags and low temperature resistant.
Be averaged the polymerization degree and make base-material for 100 parts more than or equal to 2000 high-polymerization degree resin, add plasticizer phthalic acid dinonyl 20-80 part and phthalic acid-two (2-ethylhexyl) 0-60 part, stablizer tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part, epoxy soybean oil 1-5 part, polymethylphenyl siloxane fluid 0.1-0.5 part, calcium-zinc composite stabilizing agent 0.4-1.5 part, ethylene-vinyl acetate copolymer 1-5 part, adopt conventional method in kneader, to mix the plasticizing extruding pelletization of heating, get a kind of medical polyvinyl plastics of the present invention, in forcing machine, make required film with this medical polyvinyl plastics, conduit, cut by required specification, be made into medical bag by high-frequency thermocompressor again, or be bonded into the pipeline goods.In the water leachable of prepared medical bag or pipeline goods in reducing substance amount of separating out and the pure leachable DEHP amount of separating out similar in appearance to embodiment 2.Because all use mean polymerisation degree to make base-material for 100 kilograms more than or equal to 2000 high-polymerization degree resin, its low-temperature resistant soft is better, is specially adapted to make the plasma bags of ability cryopreservation transportation.
Be averaged the polymerization degree and make base-material for 100 parts more than or equal to 1000 oligomeric resin, add plasticizer phthalic acid dinonyl 40-60 part, stablizer tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part, epoxy soybean oil 1-5 part, polymethylphenyl siloxane fluid 0.1-0.5 part, calcium-zinc composite stabilizing agent 0.4-1.5 part, ethylene-vinyl acetate copolymer 0-5 part, adopt conventional method in kneader, to mix the plasticizing extruding pelletization of heating, get a kind of medical polyvinyl plastics of the present invention, in forcing machine, make required film with this medical polyvinyl plastics, conduit, cut by required specification, be made into medical bag by high-frequency thermocompressor again, or be bonded into the pipeline goods.The processing temperature of prepared medical bag or pipeline goods is low, and the reducing substance amount of separating out can be less than 0.2ml/20ml in the water leachable, and the DEHP amount of separating out can be less than 5mg/100ml in the pure leachable, is applicable to make the small dimension blood bag that normal temperature uses down.
Embodiment 6
Be averaged the polymerization degree and make base-material for 100 parts more than or equal to 1000 oligomeric resin, add plasticizer phthalic acid dinonyl 15-50 part and phthalic acid-two (2-ethylhexyl) 15-50 part, stablizer tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part, epoxy soybean oil 1-5 part, polymethylphenyl siloxane fluid 0.1-0.5 part, calcium-zinc composite stabilizing agent 0.4-1.5 part, ethylene-vinyl acetate copolymer 0-5 part, adopt conventional method in kneader, to mix the plasticizing extruding pelletization of heating, get a kind of medical polyvinyl plastics of the present invention, in forcing machine, make required film with this medical polyvinyl plastics, conduit, cut by required specification, be made into medical bag by high-frequency thermocompressor again, or be bonded into the pipeline goods.The processing temperature of prepared medical bag or pipeline goods is low, and the reducing substance amount of separating out can be less than 0.2ml/20ml in the water leachable, and the DEHP amount of separating out can be less than 8mg/100ml in the pure leachable, is applicable to make the middle specification blood bag that normal temperature uses down.
Embodiment 7
Be averaged the polymerization degree and make base-material for 100 parts more than or equal to 1000 oligomeric resin, add plasticizer phthalic acid-two (2-ethylhexyl) 40-60 part, stablizer tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part, epoxy soybean oil 1-5 part, polymethylphenyl siloxane fluid 0.1-0.5 part, calcium-zinc composite stabilizing agent 0.4-1.5 part, ethylene-vinyl acetate copolymer 0-5 part, adopt conventional method in kneader, to mix the plasticizing extruding pelletization of heating, get a kind of medical polyvinyl plastics of the present invention, in forcing machine, make required film with this medical polyvinyl plastics, conduit, cut by required specification, be made into medical bag by high-frequency thermocompressor again, or be bonded into the pipeline goods.The processing temperature of prepared medical bag or pipeline goods is low, and the reducing substance amount of separating out can be less than 0.2ml/20ml in the water leachable.Owing to still use phthalic acid-two (2-ethylhexyl) to make softening agent, its DEHP separates out higher, is applicable to make the big specification blood bag that normal temperature uses down.
Figure 1 shows that and use the medical bag that medical polyvinyl plastics of the present invention is made, shown in the figure, 1 is bag, and 2 is conduit.The all size goods that vary in size can be arranged.Can be used as the blood bag of storing blood or the liquid bag of store injection liquid.
Figure 2 shows that and use the medical dropper that medical polyvinyl plastics of the present invention is made, shown in the figure, 3 is the dropper body, and 4 is ingress pipe, and 5 is delivery line.Ingress pipe 4 is connected the upper end of dropper body 3 and inserts the dropper body and is communicated with the inner chamber of dropper body, and delivery line 5 is connected the lower end of dropper body.Medical dropper is used for blood transfusion or transfusion.
Claims (4)
1, a kind of medical polyvinyl plastics is characterized in that, is mixed with by appended weight part by following material to form:
100 parts of polyvinyl chloride (PVC) RESINS;
Softening agent 20-80 part;
Epoxy soybean oil 1-5 part;
Tricresyl phosphite (nonyl phenyl ester) 0.1-0.5 part;
Polymethylphenyl siloxane fluid 0.1-0.5 part;
Calcium-zinc composite stabilizing agent 0.4-1.5 part;
Wherein: described polyvinyl chloride (PVC) RESINS is a mean polymerisation degree more than or equal to 1000 oligomeric resin and the mean polymerisation degree mixture more than or equal to 2000 high-polymerization degree resin; Perhaps,
Described polyvinyl chloride (PVC) RESINS is a mean polymerisation degree more than or equal to 1000 oligomeric resin;
Described softening agent is the mixture of diisononyl phthalate or diisononyl phthalate and phthalic acid-two (2-ethylhexyl).
2, medical polyvinyl plastics according to claim 1 is characterized in that: also comprise ethylene-vinyl acetate copolymer 1-5 part in the described prescription.
3, a kind of medical blood transfusion, infusion bag, this blood transfusion, infusion bag comprise bag and the conduit that is connected with bag and is communicated with, and it is characterized in that: the conduit that described bag and bag connect all adopts medical polyvinyl plastics as claimed in claim 1 made.
4, a kind of medical blood transfusion, transfusion drip tube, this dropper comprises dropper body, ingress pipe and delivery line, ingress pipe is connected the upper end of dropper body and inserts the dropper body and is communicated with the inner chamber of dropper body, delivery line connects in the lower end of dropper body, it is characterized in that: described dropper body, ingress pipe and delivery line all adopt medical polyvinyl plastics as claimed in claim 1 made.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031420931A CN100475899C (en) | 2003-08-06 | 2003-08-06 | Medical polyvinyl chloride plastic and product thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031420931A CN100475899C (en) | 2003-08-06 | 2003-08-06 | Medical polyvinyl chloride plastic and product thereof |
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| CN1580117A CN1580117A (en) | 2005-02-16 |
| CN100475899C true CN100475899C (en) | 2009-04-08 |
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| CNB031420931A Expired - Lifetime CN100475899C (en) | 2003-08-06 | 2003-08-06 | Medical polyvinyl chloride plastic and product thereof |
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Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101550259B (en) * | 2009-05-14 | 2011-02-09 | 威海洁瑞医用制品有限公司 | Medical multifunctional polyvinyl chloride composite material |
| 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 |
| CN103342868A (en) * | 2013-07-10 | 2013-10-09 | 江苏德威新材料股份有限公司 | Environment-friendly ethanol migration resistance elastomer sheathing compound and preparation method thereof |
| CN104045935A (en) * | 2014-06-19 | 2014-09-17 | 上海新上化高分子材料有限公司 | Polyvinyl chloride material with high oxygen permeability and preparation method thereof |
| US20170022351A1 (en) * | 2014-10-22 | 2017-01-26 | Shenzhen Yuantai Medical Equipment Co., Ltd. | Breathing bag |
| CN104371219B (en) * | 2014-11-07 | 2016-08-24 | 北京奥精医药科技有限公司 | A kind of medical heat-resisting ageing-resisting composite plastic and preparation method thereof |
| CN105086292A (en) * | 2015-09-23 | 2015-11-25 | 江苏蓝湾生物科技有限公司 | Preparation method of medical antistatic flame-resistant material |
| CN105419168A (en) * | 2015-12-31 | 2016-03-23 | 东莞市祺龙电业有限公司 | Medical environmental protection PVC modified material and preparation method therefor |
| CN106188985A (en) * | 2016-08-30 | 2016-12-07 | 胡何辉 | A kind of medical PVC anti-microbial catheter material and preparation method thereof |
| CN106237476B (en) * | 2016-10-08 | 2017-10-13 | 宋兴荣 | A kind of medical esophageal tube and preparation method thereof and air-breather |
| CN110373029A (en) * | 2019-07-31 | 2019-10-25 | 杭州超德斯实业有限公司 | A kind of oxygen mask and its material used |
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2003
- 2003-08-06 CN CNB031420931A patent/CN100475899C/en not_active Expired - Lifetime
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