CN1032014C - Soft polyvinyl chloride plastics for blood (fluid) transfusion - Google Patents
Soft polyvinyl chloride plastics for blood (fluid) transfusion Download PDFInfo
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- CN1032014C CN1032014C CN 90103644 CN90103644A CN1032014C CN 1032014 C CN1032014 C CN 1032014C CN 90103644 CN90103644 CN 90103644 CN 90103644 A CN90103644 A CN 90103644A CN 1032014 C CN1032014 C CN 1032014C
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Abstract
The present invention provides a novel soft polyvinyl chloride plastic for blood (fluid) transfusion, which is suitable to be processed into disposable medical apparatuses for blood (fluid) transfusion in clinic. The present invention is characterized in that acetyl tri-2-ethylhexyl citrate is used as a primary plasticizer, a proper amount of di-2-ethylhexyl phthalate is added as a plasticiser, and thus, toxicity can be reduced and operation performance can be improved. The present invention is a novel polyvinyl chloride product different from a product plasticized by using the di-2-ethylhexyl phthalate as the primary plasticizer. The present invention comprises components of the following parts by weight: 100 parts of polyvinyl chloride resin, 15 to 35 parts of the acetyl tri-2-ethylhexyl citrate, 10 to 25 parts of the di-2-ethylhexyl phthalate, 0 to 15 parts of di-2-ethylhexyl adipate, 0 to 10 parts of epoxy soybean oil or epoxy linseed oil, 0.1 to 0.3 parts of phenylmethyl silicone oil, 0.1 to 0.8 parts of organic phosphite and 0.2 to 0.5 parts of stearate.
Description
The present invention relates to a kind of blood transfusion or transfusion soft polyvinyl chloride plastic composite, belong to the medical macromolecular materials field.
Be used to the nontoxic soft polyvinyl chloride plastic of transfusing blood and infusing, it is that phthalic acid two (2-ethyl is own) ester (DEHP) is as the main body softening agent that past is mostly adopted dioctyl phthalate (DOP) (DOP), because this softening agent has certain infringement to liver in the human body, the scientific research personnel seeks the littler softening agent of toxicity once to have made extensive work both at home and abroad, and the part or all of method that replaces DEHP of general employing reduces the influence to human body.
Chinese patent (publication number CN1031546A, application number 87106027.2) disclosing with phthalic acid two (2-ethyl is own) ester and epoxy tetrahydro-2-ethylhexyl phthalate is the main body softening agent, wherein based on the former, and add the method for an amount of ethylene vinyl acetate modification.
Described among the European patent EP 51414A with the fatty acid ester do not extracted out by blood plasma as first softening agent and with compatible, that can suppress hemolytic action, the fatty acid ester that can be extracted out by blood plasma or phosphoric acid ester as second softening agent, the content of both softening agent in whole plastized polyvinyl chloride prescription is respectively 5-30% (weight) and 10-25% (weight).The fatty acid ester of first softening agent has 3 ester groups at least, and has 4 C in each fat hydrocarbon chain at least; The fatty acid ester of other second softening agent has 2 ester groups at least, and 4-12 C are arranged in each fat hydrocarbon chain, if phosphoric acid ester then contains 2 ester groups at least and has C number in the same hydrocarbon chain.
Among European patent EP 138147 A; the polyvinyl chloride container of a kind of blood and blood product has been described; its used softening agent is citric acid three (4-10C straight-chain fatty alcohol) ester of citric acid three ester or acylations; as Tributyl O-acetylcitrate; positive butyryl radicals citric acid tri-n-hexyl ester, ethanoyl citric acid three n-octyls, ethanoyl citric acid three ester in the positive last of the ten Heavenly stems.The composition of this plastifying igelite is: polyvinyl chloride (PVC) 40-80% (weight), citrate 20-60% (weight), epoxy soybean oil or epoxy linseed oil 3-35% (weight) and metallic stearate 1% (weight).This softening agent can hold out against steam disinfection and can not leached by blood plasma.
More than these plastifying igelites desirable not enough at some aspect of performance, for example plastifying processing characteristics, still will improve aspects such as human safety, resistance to migration, lower temperature resistance, chemical stability or thermostabilitys, and raw material straight-chain fatty alcohol etc. are at present also inadequate in China, will be to producing influence to some extent.
The purpose of this invention is to provide a kind of novel almost completely avirulent, plastifying igelite with good resistance to migration, volatility resistance, lower temperature resistance, chemical stability and thermostability.
Another object of the present invention provides a kind of medically technical recipe of the new plasticized polyvinyl chloride plastics of clinical blood transfusion transfusion usefulness that is suitable for.
Principal character of the present invention is to adopt phthalic acid two (2-ethyl is own) when ester is softening agent; replace the former of major part with ethanoyl citric acid three (2-ethyl is own) ester; to constitute the main body plasticiser system; also can contain a small amount of Octyl adipate is the low temperature softening agent, and epoxy oils is stabilizing plasticizer.Strengthen stabilising system with high effect nontoxic organophosphite sequestrant in addition.
Novel blood transfusion and infusion of the present invention with mainly contain polyvinyl chloride (PVC) RESINS, phthalic acid two (2-ethyl oneself) ester, ethanoyl citric acid three (2-ethyl oneself) ester, hexanodioic acid two (2-ethyl oneself) ester, epoxy soybean oil or epoxy linseed oil, polymethylphenyl siloxane fluid, phosphorous acid ester, stearate in the prescription of soft polyvinyl chloride plastic, its each components contents is: (weight part)
Polyvinyl chloride (PVC) RESINS (PVC) 100
Ethanoyl citric acid three (2-ethyl is own) ester
(ATEHC) 15—35
Phthalic acid two (2-ethyl is own) ester
(DEHP) 10—25
Hexanodioic acid two (2-ethyl is own) ester
(DEHA) 0—15
Epoxy soybean oil (ESO) or epoxy Asia
Fiber crops benevolence oil (ELO) 0-10
Organophosphite (phosphorous acid 4,4 '-two
Isopropylidene bis-phenol (10-16) carbon alkane
The base ester) (IDAP or 8601) 0.1-0.8
Polymethylphenyl siloxane fluid (PMSiO) 0.1-0.3
Stearate (aluminum stearate, zinc or tristearin
Acid calcium, zinc)
(AlSt+ZnSt or
CaSt＋ZzSt) 0.2—0.5
Owing to igelite is used in the blood transfusion (liquid) that with phthalic acid two (2-ethyl is own) ester (DEHP) is the main body softening agent, blood in the shelf lives this softening agent can separate out in blood and cause toxicity, so the problem that how to replace DEHP is being studied by the parties concerned always; But DEHP is favourable to the erythrocytic preservation in the blood, and the moulding processability that adds this softening agent again is better, and for this reason, it is desirable doing the major part replacement with the littler ethanoyl citric acid three of toxicity (2-ethyl is own) ester (ATEHC).
Flexible PVC of the present invention replaces major part DEHP as the main body softening agent with the littler ATEHC of toxicity, and other adds a small amount of Octyl adipate [being hexanodioic acid two (2-ethyl is own) ester] (DEHA) as the low temperature softening agent, to improve the low-temperature performance of plastics.In addition, in the prescription of the present invention also with epoxy soybean oil (ESO) [or epoxy linseed oil (ELO)], high effect nontoxic organophosphite (IDAP) and stearate soap class are lubricating system as the composite transparent stabilising system with polymethylphenyl siloxane fluid (PMSiO) and stearate soap class.
The medical polyvinyl plastics of being made by prescription of the present invention has obvious superiority, and its each performance is as follows:
1. toxicity is atomic
Measure 50% lethal dose LD of intraperitoneal injection of mice through units concerned
50As follows:
Classification LD
50(mg/kg)
DEHP plasticiser system 37871
ATEHC new plasticizer system 85000
The toxicity of new plasticizer system is significantly less than the DEHP plasticiser system.
2. resistance to migration is good:
Pressing ISO177 (international standard) method measures:
DEHP plasticising film, migration amount are 0.620 gram
Novel Plasticising system film, migration amount are 0.190 gram
The film migration amount that novel plastic is made is little, good stability.
3. volatility little (100 ℃ * 7 days):
DEHP plasticising film, quality loss are 8.3%
Novel Plasticising system film, quality loss are 0.7%
So the plastics film volatility of novel Plasticising system is little, good endurance can tolerate high pressure steam sterilization.
4. lower temperature resistance is good
Press ISOR974 (international standard) method and measure, its temperature limit of brittleness is as follows:
DEHP plasticising film-35 ℃
The film of novel Plasticising system-43 ℃
The lower temperature resistance of the plastics film of novel Plasticising system is good, and promptly its low-temperature pliability is good, is suitable for prolonged preservation when 4 ℃ of temperature.Under low temperature more, also can staticly preserve.
5. chemical stability (steam sterilizing in 121 ℃/30 minutes is preserved in 40 incubators), press the official method test result:
Project 0 day 14 days (1) Δ pH value (decline) 0.75 0.80 (2) readily oxidizable substance (KMnO
4Consumption) ml 0.12 0.26 (3) chlorion ppm＜0.4＜0.4 (4) uv-absorbing (270 mm-wave strong point) 0.068 0.070 (5) NH
3, ppm＜0.2＜0.2 (6) heavy metal, ppm＜0.3＜0.3
Trample experience factually, the aging preservation 14 days is equivalent to room temperature preservation more than 1 year approximately, this shows, that every index changes is little, meet the requirements, and chemical stability is good.
6. thermostability (180 ℃ time, congo-red test paper variable color time):
Old stabilising system (without IDAP) 32-43 minutes, variable color is very fast.
New stabilising system (adopting IDAP) 75-54 minutes, variable color is slower.
During the expression forming process, plastics tolerance at high temperature, visible herein novel plastic is higher.
7. novel plasticized polyvinyl chloride plastics of the present invention when daily use operation, be difficult for taking place being clamminess behind the high-pressure steam sterilization and+4 ℃ of refrigeration after disadvantages such as embrittlement easily splits.Plastics of the present invention also better are applicable to blowing (or calendering) film and conduit material simultaneously because of low-temperature performance, make the general starting material of two kinds of products.
Now embodiments of the invention are illustrated in down:
Embodiment 1
The prescription of medical flexible polyvinyl chloride plastic is as follows:
Composition consumption (weight part)
Polyvinyl chloride (PVC) 100
Ethanoyl citric acid three (2-ethyl is own) ester
(ATEHC) 20—30
Phthalic acid two (2-ethyl is own) ester
(DEHP) 15—20
Hexanodioic acid two (2-ethyl is own) ester
(DEHA) 5—10
Epoxy soybean oil (ESO) 2-5
Polymethylphenyl siloxane fluid (PMSiO) 0.1-0.3
Phosphorous acid 4,4 '-diisopropyl fork bis-phenol
(10-16) carbon alkyl ester
(IDAP) 0.2—0.6
Aluminum stearate and Zinic stearas (AlSt+ 0.3-0.5
ZnSt)
This prescription is raw materials used to be produced by the ordinary production step after metering, makes pellet, can further make various equipment by normal forming process condition again and produce required Bag Material and conduit etc.The goods soft and transparent is little to the susceptibility of temperature than common product, and thermal losses is low, Heat stability is good, and lower temperature resistance is good.But therefore high temperature steam sterilization does not stick together; Also can low temperature resistantly store, be difficult for breaking.
Because citric acid ester plasticizer is in all softening agent thrombocyte to be preserved one of best new variety, with its plastifying pvc material, its oxygen-permeable even surpass trioctyl trimellitate (TOTM) plastifying polyvinyl chloride is so can obviously prolong hematoblastic preservation period.
Embodiment 2
The prescription of medical flexible polyvinyl chloride plastic is as follows:
Composition consumption (weight part)
PVC 100
ATEHC 25—35
DEHP 20—25
DEHA 0
ELO (epoxy linseed oil) 5-10
PMSiO 0.1—0.3
IDAP 0.2—0.4
CaSt＋ZnSt 0.2—0.5
The characteristic of this prescription is the same substantially, owing to adopt ATEHC more, uses ELO for ESO again, and CaSt is for AlSt etc., and the security of prescription is better, and thermostability is also higher.Its forming process is with embodiment 1.
Embodiment 3
Medical flexible polyvinyl chloride plastic prescription of the present invention is as follows:
Composition consumption (weight part)
PVC 100
ATEHC 30—35
DEHP 10—15
DEHA 10—15
ESO 3—8
PMSiO 0.1—0.3
IDAP 0.1—0.5
CaSt＋ZnSt 0.3—0.5
This formula property is the same substantially, because the DEHA consumption is more, low-temperature performance is better, and temperature limit of brittleness can reach-45 ℃.
Embodiment 4
It is as follows to fill a prescription:
Composition consumption (weight part)
PVC 100
ATEHC 30—35
DEHP 15—25
DEHA 10—15
ELO or ESO 0
PMSiO 0.2—0.3
IDAP 0.5—0.8
AlSt＋ZnSt 0.4—0.5
This prescription characteristics are under the situation without ELO or ESO, suitably to increase the primary plasticizer consumption, strengthen IDAP and AlSt+ZnSt stable system, can make the product that meets service requirements equally.
Embodiment 5
It is as follows to fill a prescription:
Composition consumption (weight part)
PVC 100
ATEHC 15—20
DEHP 20—25
DEHA 10—15
ELO 5—10
PMSiO 0.1—0.3
IDAP 0.1—0.5
AlSt＋ZnSt 0.3—0.5
The characteristics of this prescription are that ATEHC is less, and DEHP and DEHA are more, and ELO is more, and its thermostability and low-temperature performance are all good.
Can preferably filling a prescription of medical flexible polyvinyl chloride plastic of the present invention is the prescription of embodiment 1, and this is comparatively ideal prescription.
Claims (5)
1. soft polyvinyl chloride plastic composite use in novel blood transfusion or transfusion, and it is characterized in that adopting ethanoyl citric acid three (2-ethyl oneself) ester is primary plasticizer, and adds phthalic acid two (2-ethyl oneself) ester plasticizer, the formation plasticiser system, and its prescription comprises:
Composition consumption (weight part)
Polyvinyl chloride (PVC) RESINS 130
Ethanoyl citric acid three (2-ethyl is own) ester 15-35
Phthalic acid two (2-ethyl is own) ester 10-25
Phosphorous acid 4,4 '-diisopropyl fork bis-phenol
(10-16) carbon alkyl ester 0.1-0.8
Polymethylphenyl siloxane fluid 0.1-0.3
Aluminum stearate and Zinic stearas or calcium stearate and 0.2-0.5
Zinic stearas
2. polyvinyl chloride plastic composite as claimed in claim 1 is characterized in that also can containing epoxy soybean oil or epoxy linseed oil and/or hexanodioic acid two (the 2-ethyl is own) ester in prescription.
3. polyvinyl chloride plastic composite as claimed in claim 2 is characterized in that its alternative prescription is as follows:
Composition consumption (weight part)
Polyvinyl chloride (PVC) RESINS 130
Ethanoyl citric acid three (2-ethyl is own) ester 20-30
Phthalic acid two (2-ethyl is own) ester 15-20
Hexanodioic acid two (2-ethyl is own) ester 5-10
Epoxy soybean oil 2-5
Polymethylphenyl siloxane fluid 0.1-0.3
Phosphorous acid 4,4 '-diisopropyl fork bis-phenol
(10-16) carbon alkyl ester 0.2-0.6
Aluminum stearate and Zinic stearas 0.3-0.5
4. polyvinyl chloride plastic composite as claimed in claim 3 is characterized in that epoxy available Semen Lini oil replaces described epoxy soybean oil.
5. polyvinyl chloride plastic composite as claimed in claim 3 is characterized in that available calcium stearate and Zinic stearas replace described aluminum stearate and Zinic stearas.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 90103644 CN1032014C (en) | 1990-05-15 | 1990-05-15 | Soft polyvinyl chloride plastics for blood (fluid) transfusion |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 90103644 CN1032014C (en) | 1990-05-15 | 1990-05-15 | Soft polyvinyl chloride plastics for blood (fluid) transfusion |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1056507A CN1056507A (en) | 1991-11-27 |
| CN1032014C true CN1032014C (en) | 1996-06-12 |
Family
ID=4878174
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 90103644 Expired - Fee Related CN1032014C (en) | 1990-05-15 | 1990-05-15 | Soft polyvinyl chloride plastics for blood (fluid) transfusion |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1032014C (en) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100335553C (en) * | 2004-05-12 | 2007-09-05 | 威海威高创新有限公司 | Soft PVC plastic in use for apparatus transfusions |
| CN101152582B (en) * | 2006-09-30 | 2011-11-16 | 山东威高集团医用高分子制品股份有限公司 | Thin-film material for medical purpose |
| CN104667354A (en) * | 2015-03-10 | 2015-06-03 | 丁莉 | Catheter for neural interventional angiography |
| CN104927153A (en) * | 2015-06-08 | 2015-09-23 | 苏州乔纳森新材料科技有限公司 | Light-proof polyethylene material and preparation method thereof |
| CN105175939B (en) * | 2015-09-09 | 2017-04-26 | 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 |
| CN107531937B (en) * | 2015-10-27 | 2020-01-10 | 株式会社Lg化学 | Plasticizer composition, resin composition and method for producing the same |
| EP3275930B1 (en) | 2015-11-27 | 2020-09-30 | LG Chem, Ltd. | Plasticizer composition, resin composition, and preparation methods therefor |
| CN106243565A (en) * | 2016-08-18 | 2016-12-21 | 刘世超 | White domestic appliances plastics |
| CN109749272A (en) * | 2017-11-01 | 2019-05-14 | 丹阳市景顺塑料制品有限公司 | A kind of plastics with fluorized marking |
| CN109749280A (en) * | 2017-11-02 | 2019-05-14 | 丹阳市景顺塑料制品有限公司 | A kind of degradable environment-friendly plastics |
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1990
- 1990-05-15 CN CN 90103644 patent/CN1032014C/en not_active Expired - Fee Related
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| Publication number | Publication date |
|---|---|
| CN1056507A (en) | 1991-11-27 |
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