CN101798428A - Special N-phthalate reinforced soft polyethylene plastics for circulation loop and preparation method thereof - Google Patents
Special N-phthalate reinforced soft polyethylene plastics for circulation loop and preparation method thereof Download PDFInfo
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- CN101798428A CN101798428A CN 201010122958 CN201010122958A CN101798428A CN 101798428 A CN101798428 A CN 101798428A CN 201010122958 CN201010122958 CN 201010122958 CN 201010122958 A CN201010122958 A CN 201010122958A CN 101798428 A CN101798428 A CN 101798428A
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Abstract
The invention discloses special N-phthalate reinforced soft polyethylene plastics for a circulation loop, which comprises the following ingredients by weight parts: 100 weight parts of PVC resin powder, 20 to 50 weight parts of N-phthalate plasticizers, 5 to 35 weight parts of auxiliary stabilizing agents, 0.5 to 5.0 weight parts of stabilizing agents, 0.1 to 2.0 weight parts of lubricating agents and 0.1 to 1.0 weight part of antioxidants. The invention also discloses a preparation method of the special N-phthalate reinforced soft polyethylene plastics for the circulation loop. The method comprises the following steps: carrying out high-speed mixing on ingredients; using a double-screw extruding machine for plastification; and using a single screw for cooling and forming to obtain rubber grains. The recipe of the invention is suitable for the manufacture of the circulation loop, particularly the varieties with high processing precision and long operation time and the varieties needing ray sterilization.
Description
Technical field
The present invention relates to a kind of medical macromolecular materials and preparation method thereof, non-adjacent benzene class plasticized soft polyvinyl chloride plastic of specifically a kind of improved circulation loop special use and preparation method thereof.
Background technology
Therefore PVC is the main raw of making Dispoable medical infusion apparatus owing to have intensity and modulus is higher, soft, rebound resilience is good, transparent and plurality of advantages such as low price.The plastifying soft pvc has been widely used in transfusion such as the Dispoable medical of making transfusion device, blood bag, catheter, breathing mask, intestinal feeding pipe, peritoneal dialysis bag, extracorporeal circulation pipeline, membrane oxygenator, hemodialysis pipeline and various medical catheters apparatus.Inherent naturies such as the hardness of pure PVC material, flexibility can be improved by the interpolation of softening agent.Various softening agent can make PVC become soft, yet the most frequently used softening agent is dioctyl phthalate (DOP) (DEHP).
U.S. FDA subordinate's utensil and irradiation health center (Center for Devices andRadiological Health) discharge DEHP to the medical equipment of making of DEHP plastifying PVC and have done a safety assessment report (Safety Assessment of Di (2-ethylhexyl) phthalate (DEHP) Released from PVC Medical Devices), the harm of the relevant DEHP that provided in 08 year with SCENIHR (European Union) and softening agent substitute and have drawn closely similar conclusion, that is: the amount of the DEHP that discharges from relevant appliance is less, the danger that influenced by DEHP for children crowd increases, and warning reduces the chance that exposes this kind of contact medicine equipment in special population.
In daily life, some individual DEHP by special medical article contact high density, in soup and process that plastics contact, DEHP can be from medical article dialysis in soup, the speed dependent of DEHP dialysis is in the time that the fat content and the soup of temperature, soup contacts with plastics.The patient who suffers from grave illness often needs more than a kind of medical product, so they just have an opportunity to contact the DEHP of greater concn.
Be exposed among the DEHP, breadboard animal produced adverse influence.But what attract people's attention most is the influence of DEHP to young baby's seminal fluid quantity of male reproductive system growth and animal.Also do not receive at present report, do not get rid of people's adverse influence but study about DEHP adverse events on the person yet.But, consider the available animal data, the restriction that is necessary to take preventive measures is exposed to the developmental male sex among the DEHP.Two factors have determined the degree of risk of the DEHP that exposes in medical device.The firstth, patient is to the susceptibility of DEHP, and based on the above evidence of enumerating, male fetus, boy baby and budding boy be the excessive risk crowd seemingly.Second factor is the amount of the DEHP that arrives of contact patients.This depends mainly on the contact frequency and the time of contact process and these processes.Wherein circulation loop as equipment such as dialysis, owing to its long action time, belongs to high risk contact process.Simultaneously because the circulation loop structure is complicated, the requirement on machining accuracy height, its course of processing time is longer, temperature is higher, therefore adopt the soft pvc plastics of traditional single-screw machine device plasticizing forming because its secondary plasticizing operating space is less, therefore have relatively high expectations for the aspects such as machinery of following process, the defect ware ratio is higher in causing producing, and has increased production cost.And tend to reduce the thermostability of finished product, make radiation sterilization to finish
Summary of the invention
The objective of the invention is to overcome the prior art deficiency, provide a kind of prescription rationally, stable performance, can guarantee nontoxic, the softening agent stripping is less, the secondary plasticizing operating space is bigger, satisfy simultaneously after its secondary plasticizing moulding can radiation sterilization soft polyvinyl chloride plastic.
Another object of the present invention provides a kind of preparation method of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use.
Technical scheme: the invention provides a kind of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, it comprises the component of following weight part:
Polyvinyl chloride resin powder 100 weight part non-o-benzene plasticiser 20-50 weight parts
Auxiliary stabilizer 5-35 weight part stablizer 0.5-5.0 weight part
Lubricant 0.1-2.0 weight part antioxidant 0.1-1.0 weight part
As preferably, described non-o-benzene plasticiser is ATBC, DINCH, DOA, BTHC, TOTM, one or more among the DOTP.
As preferably, in described auxiliary stabilizer epoxy soybean oil, the appropriate youngster's oil of epoxy, the epoxy Tegin 55G one or more.
As preferably, described stablizer is calcium-zinc, tin-zinc, one or more in tin-calcium bimetallic salt complex.
As preferably, described lubricant is a polymethylphenyl siloxane fluid, stearic acid Tegin 55G, 12-oxystearic acid, stearyl alcohol, octadecyl stearate, glyceryl monostearate, Tristearoylglycerol, the hard ester acid esters of ethylene glycol bis, one or more in hexanodioic acid two (18) ester.
As preferably, described antioxidant is a butyl through in basic toluene (BHT), gallic acid third cruel (PG), tertiarybutylhydroquinone (TBHQ), vitamin-E (VE) one or more of the fragrant ether (BHA) of basic mattress, dibutyl.
The invention provides a kind of preparation method of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, this method with raw material through high-speed mixing, the twin screw extruder plasticizing, single screw rod cooling forming makes micelle,
Concrete steps are as follows:
1) with polyvinyl chloride resin powder 100 weight part, non-o-benzene plasticiser 20-50 weight part, auxiliary stabilizer 5-35 weight part, stablizer 0.5-5.0 weight part, lubricant 0.1-2.0 weight part, antioxidant 0.1-1.0 weight part, first low speed 100r/min mixed 6 minutes, high speed 500r/min mixed 6 minutes again, the blowing cooling;
2) described raw material is cooled to 80 ℃, adds in the elevating hopper of twin screw extruder, through parallel double-screw extrusion plasticizing, 140 ℃ of outlet temperatures;
3) twin screw plastifies after screw rod transmission enters single screw rod, 120 ℃ of coolings, pelletizing moulding.
The present invention is directed to the characteristics of circulation loop, simultaneously in order to tackle the toxic problem of softening agent.By adding non-toxic plasticizer and specific medical auxiliary agent, and plastify by twin-screw set.The invention enables novel plastic softening agent rate of migration in 10% ethanol to be reduced to currently available products 10%, not only satisfy existing requirement, environmental protection simultaneously.
The invention has the beneficial effects as follows: the present invention has adopted the composite elasticizer system of novel non-adjacent benzene class, in conjunction with the multiple auxiliary agent that meets medical standard, by the parallel double-screw plasticizing forming.This system not only can obviously reduce pure leachable index, also has better machining property simultaneously.The present invention fills a prescription and is fit to make circulation loop, and especially working accuracy is higher, and the operating time is the kind of length, needs the kind of radiation sterilization.
Embodiment
The invention will be further described below in conjunction with embodiment:
Embodiment 1
A kind of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, it comprises the component of following weight part:
Polyvinyl chloride resin powder 100 weight part ATBC 20 weight parts
Epoxy soybean oil 5 weight parts calcium-zinc composite salt 0.5 weight part
Polymethylphenyl siloxane fluid 0.1 weight part butyl is through fragrant ether (BHA) 0.1 weight part of basic mattress
A kind of preparation method of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, these method concrete steps are as follows:
1) with polyvinyl chloride resin powder 100 weight part, ATBC 20 weight parts, epoxy soybean oil 5 weight parts, calcium-zinc composite salt 0.5 weight part, polymethylphenyl siloxane fluid 0.1 weight part, butyl is through fragrant ether (BHA) 0.1 weight part of basic mattress, and first low speed 100r/min mixed 6 minutes, high speed 500r/min mixed 6 minutes again, the blowing cooling;
2) described raw material is cooled to 80 ℃, adds in the elevating hopper of twin screw extruder, through parallel double-screw extrusion plasticizing, 140 ℃ of outlet temperatures;
3) twin screw plastifies after screw rod transmission enters single screw rod, 120 ℃ of coolings, pelletizing moulding.
Embodiment 2
A kind of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, it comprises the component of following weight part:
Polyvinyl chloride resin powder 100 weight part DOA 35 weight parts
The appropriate youngster's oil of epoxy 20 weight part tin-zincs 3 weight parts
Stearyl alcohol 1 weight part gallic acid third cruel (PG) 0.6 weight part
A kind of preparation method of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, these method concrete steps are as follows:
1) with polyvinyl chloride resin powder 100 weight parts, DOA 35 weight parts, the appropriate youngster's oil of epoxy 20 weight parts, tin-zinc 3 weight parts, stearyl alcohol 1 weight part, gallic acid third cruel (PG) 0.6 weight part, the low speed 100r/min of elder generation mixed 6 minutes, and high speed 500r/min mixed 6 minutes again, the blowing cooling;
2) described raw material is cooled to 80 ℃, adds in the elevating hopper of twin screw extruder, through parallel double-screw extrusion plasticizing, 140 ℃ of outlet temperatures;
3) twin screw plastifies after screw rod transmission enters single screw rod, 120 ℃ of coolings, pelletizing moulding.
Embodiment 3
The invention provides a kind of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, it comprises the component of following weight part:
Polyvinyl chloride resin powder 100 weight part DOTP 50 weight parts
Epoxy Tegin 55G 35 weight part tin-calcium 5.0 weight parts
The hard ester acid esters 2.0 weight part vitamin-Es (VE) of ethylene glycol bis 1.0 weight parts
A kind of preparation method of soft polyvinyl chloride plastic of N-phthalate of circulation loop special use, these method concrete steps are as follows:
1) with polyvinyl chloride resin powder 100 weight part, DOTP 50 weight parts, epoxy Tegin 55G 35 weight parts, tin-calcium 5.0 weight parts, hard ester acid esters 2.0 weight parts of ethylene glycol bis, vitamin-E (VE) 1.0 weight parts, first low speed 100r/min mixed 6 minutes, high speed 500r/min mixed 6 minutes again, the blowing cooling;
2) described raw material is cooled to 80 ℃, adds in the elevating hopper of twin screw extruder, through parallel double-screw extrusion plasticizing, 140 ℃ of outlet temperatures;
3) twin screw plastifies after screw rod transmission enters single screw rod, 120 ℃ of coolings, pelletizing moulding.
The present invention has adopted the softening agent and the compound prescription stablizer of non-adjacent benzene class, and the performance that has improved its composition of tensile property and correspondence is as shown in table 1, and wherein data detect based on GB 15593-1995, GB8368-2005, EN14372-2004 in the table.
The special-purpose soft pvc plastic formula of table 1 circulation loop is formed
As shown in table 1, four prescriptions all meet GB 15593-1995 requirement.The PVC mean polymerisation degree is high more, and its tensile strength is big more, though softening agent kind difference, the plasticization effect basically identical, hardness is all about 75.Based on EN 14372-2004 six kinds of adjacent benzene class softening agent of REACH rules and regulations are detected simultaneously, the result proves and does not contain adjacent benzene class softening agent really.Prescription 2 and prescription 3 basically identicals, only processing mode there are differences, and is as shown in table 1, illustrates that twin screw extrudes its physicals and be better than single screw rod.
To the prescription described in table 1, its pure leachable and vinyl chloride monomer detect, and the result is as shown in table 2:
Pure leachable of table 2 and vinyl chloride monomer
As known from Table 2, in 4 kinds of softening agent, the finished product alcohol leachable that ATBC and DOA make is higher, illustrates that its transport property is stronger, the anti-extraction ability of TOTM the best, so TOTM more preferably selects.
Study with regard to processing characteristics simultaneously, the result is as shown in table 3, twin screw is extruded and is better than it and has better physical performance and lower processing temperature, so the secondary plasticizing operating space is big, and the apparatus higher for the circulation loop requirement on machining accuracy has special advantages.
Table 3 processing conditions and secondary plasticizing temperature
Claims (7)
1. the soft polyvinyl chloride plastic of the N-phthalate of a circulation loop special use, it is characterized in that: it comprises the component of following weight part:
Polyvinyl chloride resin powder 100 weight part non-o-benzene plasticiser 20-50 weight parts
Auxiliary stabilizer 5-35 weight part stablizer 0.5-5.0 weight part
Lubricant 0.1-2.0 weight part antioxidant 0.1-1.0 weight part.
2. the soft polyvinyl chloride plastic of the N-phthalate of a kind of circulation loop special use according to claim 1 is characterized in that: described non-o-benzene plasticiser is ATBC, DINCH, DOA, BTHC, TOTM, one or more among the DOTP.
3. the soft polyvinyl chloride plastic of the N-phthalate of a kind of circulation loop special use according to claim 1 is characterized in that: in described auxiliary stabilizer epoxy soybean oil, the appropriate youngster's oil of epoxy, the epoxy Tegin 55G one or more.
4. the soft polyvinyl chloride plastic of the N-phthalate of a kind of circulation loop special use according to claim 1 is characterized in that: described stablizer is calcium-zinc, tin-zinc, one or more in tin-calcium bimetallic salt complex.
5. the soft polyvinyl chloride plastic of the N-phthalate of a kind of circulation loop special use according to claim 1, it is characterized in that: described lubricant is a polymethylphenyl siloxane fluid, the stearic acid Tegin 55G, the 12-oxystearic acid, stearyl alcohol, octadecyl stearate, glyceryl monostearate, Tristearoylglycerol, the hard ester acid esters of ethylene glycol bis, one or more in hexanodioic acid two (18) ester.
6. the soft polyvinyl chloride plastic of the N-phthalate of a kind of circulation loop special use according to claim 1 is characterized in that: described antioxidant is a butyl through in basic toluene (BHT), gallic acid third cruel (PG), tertiarybutylhydroquinone (TBHQ), vitamin-E (VE) one or more of the fragrant ether (BHA) of basic mattress, dibutyl.
7. the preparation method of the soft polyvinyl chloride plastic of the N-phthalate of a circulation loop special use is characterized in that: this method with raw material through high-speed mixing, the twin screw extruder plasticizing, single screw rod cooling forming makes micelle, concrete steps are as follows:
1) with polyvinyl chloride resin powder 100 weight part, non-o-benzene plasticiser 20-50 weight part, auxiliary stabilizer 5-35 weight part, stablizer 0.5-5.0 weight part, lubricant 0.1-2.0 weight part, antioxidant 0.1-1.0 weight part, first low speed 100r/min mixed 6 minutes, high speed 500r/min mixed 6 minutes again, the blowing cooling;
2) described raw material is cooled to 80 ℃, adds in the elevating hopper of twin screw extruder, through parallel double-screw extrusion plasticizing, 140 ℃ of outlet temperatures;
3) twin screw plastifies after screw rod transmission enters single screw rod, 120 ℃ of coolings, pelletizing moulding.
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| WO2012140054A1 (en) * | 2011-04-11 | 2012-10-18 | Chemson Polymer-Additive Ag | Hydroquinone compounds for reducing photoblueing of halogen-containing polymers |
| CN102807717A (en) * | 2011-05-30 | 2012-12-05 | 贝恩医疗设备(广州)有限公司 | Special non-o-benzene polyvinyl chloride plastic for blood transfusion, and preparation process thereof |
| CN103550831A (en) * | 2013-11-13 | 2014-02-05 | 山东威高新生医疗器械有限公司 | Artificial heart-lung machine extracorporeal circulation pipeline |
| CN103602006A (en) * | 2013-11-13 | 2014-02-26 | 山东威高新生医疗器械有限公司 | Polyvinyl chloride composite for extracorporeal circulation pipeline of artificial heart-lung machine |
| US8772382B2 (en) | 2008-11-26 | 2014-07-08 | Chemson Polymer-Additive Ag | Heavy metal-free stabilizer composition for halogenated polymers |
| CN104045936A (en) * | 2014-06-19 | 2014-09-17 | 成都鑫成鹏线缆材料有限公司 | Composition for ultralow-temperature resistant wires and cables and preparation method of composition |
| US8975315B2 (en) | 2011-03-21 | 2015-03-10 | Chemson Polymer-Additive Ag | Stabilizer composition for halogen-containing polymers |
| WO2015072741A1 (en) * | 2013-11-15 | 2015-05-21 | Hanwha Chemical Corporation | Vinyl chloride based resin composition |
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| CN104893274A (en) * | 2015-06-25 | 2015-09-09 | 司徒建辉 | Water-soluble plasticizer |
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| CN104961925A (en) * | 2015-06-27 | 2015-10-07 | 司徒建辉 | Ester plasticizer |
| CN105037993A (en) * | 2015-05-28 | 2015-11-11 | 苏州厚利春塑胶工业有限公司 | Low temperature soft pipe and production method thereof |
| CN105670161A (en) * | 2015-12-30 | 2016-06-15 | 蓝帆医疗股份有限公司 | Benzene-free PVC gloves and production method thereof |
| CN107118468A (en) * | 2017-06-20 | 2017-09-01 | 广东雄星新材料有限公司 | A kind of medical PVC infusion bag and preparation method thereof |
| CN107718587A (en) * | 2017-10-23 | 2018-02-23 | 沈坤 | A kind of multifunctional medical conduit and preparation method thereof, application |
| US10398625B2 (en) | 2013-03-13 | 2019-09-03 | Fenwal, Inc. | Medical containers with terephthalate plasticizer for storing red blood cell products |
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| US8772382B2 (en) | 2008-11-26 | 2014-07-08 | Chemson Polymer-Additive Ag | Heavy metal-free stabilizer composition for halogenated polymers |
| US8975315B2 (en) | 2011-03-21 | 2015-03-10 | Chemson Polymer-Additive Ag | Stabilizer composition for halogen-containing polymers |
| AU2012241926B2 (en) * | 2011-04-11 | 2015-09-03 | Chemson Polymer-Additive Ag | Hydroquinone compounds for reducing photoblueing of halogen-containing polymers |
| US9403964B2 (en) | 2011-04-11 | 2016-08-02 | Chemson Polymer-Additive Ag | Hydroquinone compounds for reducing photoblueing of halogen-containing polymers |
| WO2012140054A1 (en) * | 2011-04-11 | 2012-10-18 | Chemson Polymer-Additive Ag | Hydroquinone compounds for reducing photoblueing of halogen-containing polymers |
| CN102807717A (en) * | 2011-05-30 | 2012-12-05 | 贝恩医疗设备(广州)有限公司 | Special non-o-benzene polyvinyl chloride plastic for blood transfusion, and preparation process thereof |
| CN110256857A (en) * | 2012-12-29 | 2019-09-20 | 美国圣戈班性能塑料公司 | Flexible pipe |
| CN110256857B (en) * | 2012-12-29 | 2022-01-04 | 美国圣戈班性能塑料公司 | Flexible pipe |
| US11957639B2 (en) | 2013-03-13 | 2024-04-16 | Fenwal, Inc. | Medical containers with terephthalate plasticizer for storing red blood cell products |
| US10398625B2 (en) | 2013-03-13 | 2019-09-03 | Fenwal, Inc. | Medical containers with terephthalate plasticizer for storing red blood cell products |
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| CN103550831A (en) * | 2013-11-13 | 2014-02-05 | 山东威高新生医疗器械有限公司 | Artificial heart-lung machine extracorporeal circulation pipeline |
| WO2015072741A1 (en) * | 2013-11-15 | 2015-05-21 | Hanwha Chemical Corporation | Vinyl chloride based resin composition |
| CN105764978A (en) * | 2013-11-15 | 2016-07-13 | 韩华石油化学株式会社 | Controlling a size of a pylorus |
| KR101615529B1 (en) * | 2013-11-15 | 2016-04-26 | 한화케미칼 주식회사 | Vinyl chloride based resin composition |
| US11160728B2 (en) | 2014-02-20 | 2021-11-02 | Fresenius Kabi Deutschland Gmbh | Medical containers and system components with non-DEHP plasticizers for storing red blood cell products, plasma and platelets |
| CN104045936A (en) * | 2014-06-19 | 2014-09-17 | 成都鑫成鹏线缆材料有限公司 | Composition for ultralow-temperature resistant wires and cables and preparation method of composition |
| CN104045936B (en) * | 2014-06-19 | 2016-06-08 | 成都鑫成鹏高分子科技股份有限公司 | For composition and the working method thereof of the electric wire of resistance to very low temperature |
| CN105037993A (en) * | 2015-05-28 | 2015-11-11 | 苏州厚利春塑胶工业有限公司 | Low temperature soft pipe and production method thereof |
| CN104892976A (en) * | 2015-06-25 | 2015-09-09 | 司徒建辉 | Efficient plasticizer |
| CN104892983A (en) * | 2015-06-25 | 2015-09-09 | 司徒建辉 | Plasticizer composite |
| CN104893274A (en) * | 2015-06-25 | 2015-09-09 | 司徒建辉 | Water-soluble plasticizer |
| CN104961925A (en) * | 2015-06-27 | 2015-10-07 | 司徒建辉 | Ester plasticizer |
| CN104893195A (en) * | 2015-06-27 | 2015-09-09 | 司徒建辉 | Novel plasticizer material |
| CN105670161A (en) * | 2015-12-30 | 2016-06-15 | 蓝帆医疗股份有限公司 | Benzene-free PVC gloves and production method thereof |
| CN107118468A (en) * | 2017-06-20 | 2017-09-01 | 广东雄星新材料有限公司 | A kind of medical PVC infusion bag and preparation method thereof |
| CN107718587A (en) * | 2017-10-23 | 2018-02-23 | 沈坤 | A kind of multifunctional medical conduit and preparation method thereof, application |
| CN113321882A (en) * | 2021-07-22 | 2021-08-31 | 河南科圣新材料科技有限公司 | Plasticizing system for PVDC product |
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Open date: 20100811 |