CN100335553C - Soft PVC plastic in use for apparatus transfusions - Google Patents
Soft PVC plastic in use for apparatus transfusions Download PDFInfo
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- CN100335553C CN100335553C CNB2004100238961A CN200410023896A CN100335553C CN 100335553 C CN100335553 C CN 100335553C CN B2004100238961 A CNB2004100238961 A CN B2004100238961A CN 200410023896 A CN200410023896 A CN 200410023896A CN 100335553 C CN100335553 C CN 100335553C
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- trimellitate
- polyvinyl chloride
- citrate
- blood transfusion
- ester
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Abstract
The present invention relates to a soft PVC plastic for blood transfusion apparatuses, which is prepared from components of the following mass percent: polyvinyl chloride resin with the degree of polymerization of 1700 to 2500 as a plastic main body, 15% to 40% of phthalic acid, 15% to 40% of trimellitate and 5% to 30% of citrate as plasticizers, 5% to 10% of epoxy soybean oil and 1% to 2% of a composite calcium zinc stabilizer as stabilizers, and 0.1% to 0.5% of silicone oil as a lubricant. The present invention adopts a novel plasticizer system composed of the phthalic acid, the trimellitate and the citrate. The plasticizer system inhibits erythrocyte hemolysis, reduces the dissolved quantity of the trimellitate, and reduces toxicity. The present invention is suitable for manufacturing the blood transfusion apparatuses, manufactured blood bags are used for preserving blood ingredients, and particularly, the performance of erythrocytes is reliable and stable.
Description
Technical field
The present invention relates to a kind of macromolecular material, specifically a kind of improved blood transfusion utensil soft polyvinyl chloride plastic, this igelite is used to make blood and blood ingredient storage bag.
Background technology
We know that polyvinyl chloride (PVC) material itself does not possess the condition of making the blood bag firmly, but add softening agent in the PVC material after, PVC is easy to forming process with regard to becoming soft and flexible, can make the medical product of different shape.Thereby become the material of the making blood bag that generally uses at present extensively.Softening agent has played crucial effects in PVC blood Bag Material.Phthalate (DEHP) softening agent that tradition blood bag uses has certain detrimental effect owing to being proved to the human liver, and its use is restricted, but points out in the United States Patent (USP) 4222379 that DEHP has suppressed haemolysis.Therefore, use the softening agent that hangs down stripping partly or entirely to replace DEHP and become present main direction of studying.
Replace phthalic acid two (the 2-ethyl the is own) ester (DEHP) of major part in the Chinese patent 90103644.7 with the littler acetyl tributyl citrate three of toxicity (the 2-ethyl is own) ester (ATEHC), reduce toxicity.But, although pointing out citric acid ester type in the literary composition is the non-toxic alternative of softening agent, their stripping quantity is higher than DEHP to Richard C.Adams at " A Comparison of Plasticizers for Use in FlexibleVinyl Medical Products ".To increase when therefore, the stripping quantity of gained plastics ratio uses DEHP separately in this patent.
Adopt tri trimellitate (the 2-ethyl is own) ester (TOTM) and citrate to be used as softening agent in the Chinese patent 93102095.6, made blood bag is particularly excellent to preserving hematoblastic function, but not favourable for preserving red corpuscle.
Someone also adopts tri trimellitate (the 2-ethyl is own) ester (TOTM) to make softening agent, part substitutes phthalate (DEHP) softening agent, but the plasticizing efficiency of TOTM is low, and the blood bag bag that the gained plastics are made hardens, and bag easily breaks when standing centrifugation.
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 reasonable, stable performance, plasticization effect is good, has higher draw tensile strength, the high speed centrifugation bag is difficult for breaking, and carries out steam sterilizing after 40 minutes under 114 ℃ of conditions of pressure 0.09MPa temperature, the blood transfusion utensil soft polyvinyl chloride plastic that bag does not stick together.
The technical scheme that the present invention solves the problems of the technologies described above employing is: a kind of blood transfusion utensil soft polyvinyl chloride plastic, it is characterized in that: used plastic body is that the polymerization degree is 1700～2500 polyvinyl chloride (PVC) resin, phthalic ester, trimellitate and citrate are softening agent, epoxy soybean oil (ESO), calcium-zinc composite stabilizing agent (CZ11) is a stablizer, silicone oil is lubricant, wherein each ingredients constitute PVC polymer quality percentage ratio is: phthalic ester 15%～40%, trimellitate 15%～40%, citrate 5%～30%, epoxy soybean oil (ESO) 5%～10%, calcium-zinc composite stabilizing agent (CZ11) 1-2%, silicone oil 0.1-0.5%.The total amount of plasticiser system is 40%～70% of a PVC polymer quality,
The polyvinyl chloride resin polymerization degree of the present invention is 1700.
Phthalic ester of the present invention comprises phthalic acid two (the 2-ethyl is own) ester (DEHP), dimixo-octyl phthalate (DIOP), diisononyl phthalate (DINP), Di Iso Decyl Phthalate (DIDP) etc.Phthalic acid two (2-ethyl oneself) ester (DEHP) particularly.
Trimellitate of the present invention comprises tri n hexyl trimellitate, triisooctyl trimellitate, tri trimellitate n-octyl, triisodecyl trimellitate, tri trimellitate (the 2-ethyl is own) ester.Tri trimellitate (2-ethyl oneself) ester (TOTM) particularly.
Citrate of the present invention comprises acetyl tributyl citrate three n-octyls, acetyl tributyl citrate three ester in the positive last of the ten Heavenly stems, positive butyryl citric acid tri-n-hexyl ester (BTHC), acetyl tributyl citrate three (2-ethyl oneself) ester (ATEHC), ATBC (ATBC).ATBC (ATBC) particularly.
The present invention adopts a new plasticizer system of being made up of phthalic ester, trimellitate and citrate.Phthalic ester is used to suppress erythrocyte hemolysis in this plasticiser system; Trimellitate is used to reduce stripping quantity; Citrate is used to reduce toxicity.The present invention's prescription has obvious superiority, and the present invention is suitable for making the blood transfusion utensil, and made blood bag is used for preserving blood ingredient, particularly hemocyte dependable performance, stable.
Embodiment
The invention will be further described below in conjunction with embodiment:
A kind of blood transfusion utensil of the present invention soft polyvinyl chloride plastic, its used plastic body is that the polymerization degree is 1700～2500 polyvinyl chloride (PVC) resin, phthalic ester, trimellitate and citrate are softening agent, epoxy soybean oil (ESO), calcium-zinc composite stabilizing agent (CZ11) is a stablizer, silicone oil is lubricant, wherein each ingredients constitute PVC polymer quality percentage ratio is: phthalic acid two (the 2-ethyl is own) ester (DEHP) 15%～40%, tri trimellitate (the 2-ethyl is own) ester (TOTM) 15%～40%, ATBC (ATBC) 5%～30%, epoxy soybean oil (ESO) 5%～10%, calcium-zinc composite stabilizing agent (CZ11) 1-2%, silicone oil 0.1-0.5%.The plasticiser system total amount is 40%～70% of a polymer quality.
The present invention selects the polyvinyl chloride resin of high-polymerization degree for use, has improved the tensile strength of plastics film.Be exemplified below for further specifying: prescription 1-6 detects according to GB/T 2411 and GB/T 1040 and obtains table 1 result.
Table 1
| Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | |
| PVC (degree of polymerization 1000) PVC (degree of polymerization 1700) DEHP TOTM ATBC ESO CZ11 silicone oil hardness (Shao Shi A) hot strength (MPa) elongation at break (%) | 100 - 46 - 10 5 1.5 0.2 69 15.5 382.3 | - 100 46 - 10 5 1.5 0.2 71 18.3 374.9 | - 100 48 - 10 5 1.5 0.2 69 18.1 382.2 | 100 - - 46 10 5 1.5 0.2 74 15.8 424.4 | - 100 - 46 10 5 1.5 0.2 76 19.1 420.6 | - 100 - 48 10 5 1.5 0.2 74 19.5 432.8 |
As can be seen from Table 1, be all DEHP plastifying prescription 1,2 and 3, the prescription 1 that the DEHP consumption is identical is compared with 2, hardness of 2 gained plastics of filling a prescription and tensile strength are all greater than prescription 1, and the hardness identical with prescription 1 that increased that the consumption of DEHP has obtained in 3 of filling a prescription, but its tensile strength still is much higher than prescription 1.Same situation also occurs in and is all on the TOTM plastifying prescription 5 and 6,7, can reach a conclusion, the plastics that the polyvinyl chloride resin that uses the tensile strength of the plastics that the polyvinyl chloride resin of the polymerization degree 1700 makes to be greater than to use polymerization degree 1000-1300 is made.
Can find out also that from table 1 polyvinyl chloride resin of the polymerization degree 1700 is to the good absorption of softening agent, plastics film flexibility that processes and the elasticity obviously product of polymerizable medium degree 1000-1300PVC resin treatment commonly used will be got well.The polyvinyl chloride resin polymerization degree of the present invention is 1700-2500.
In the table 2 the present invention filled a prescription and make pure drug release test, the gained result is as follows.
Table 2
| Prescription 7 | Prescription 8 | Prescription 9 | Prescription 10 | Prescription 11 | |
| PVC (degree of polymerization 1700) DEHP TOTM ATBC ESO CZ11 silicone oil alcohol leachable (mg/100ml) | 100 30 15 20 5 1 0.1 14 | 100 38 18 12 8 1 0.2 13(-) | 100 23 23 10 8 1 0.2 10 | 100 18 28 25 8 1 0.5 5 | 100 15 38 10 10 2 0.2 3 |
The measuring method of alcohol leachable carries out according to the regulation of GB 14232-93, and check sample is a 200ml volumetrical blood bag, pure leachable≤13mg/100ml conformance with standard requirement.
As can be seen from Table 2, along with the increase of TOTM consumption, pure leachable constantly reduces.Prescription 9 is ideal prescriptions comparatively, and this is because prescription 9 not only pure leachables meet GB 14232-93 requirement, helps red corpuscle and preserves, and and fill a prescription and 10,11 compare and reduced blood bag cost.Detect according to GB 15593-1995, the total amount of plasticiser system is 56% of a PVC polymer quality in the prescription 9, and wherein phthalic ester accounts for 23% of PVC polymer quality.Trimellitate accounts for 23% of polymer quality, and citrate accounts for 10% of polymer quality.Its physics, chemistry and biological property index result are as follows
Table 3 physicals
| Interventions Requested | Assay |
| Hardness (Shao Shi A) tensile strength, the MPa elongation at break, 180 ℃ of heat-stable times of %, min | 78 19 434 55 |
Table 4 chemical property
| Interventions Requested | Assay |
| Reducing substances ml acid-base value alcohol leachable (DEHP) mg/100ml nonvolatile matter mg/100ml color and luster heavy metal μ g/ml zinc μ g/ml ultraviolet absorptivity ash content mg/g VCM μ g/g | 0.2 0.5 6 0.4 meet the requirements＜0.3 0.2 0.1 1 (-) 1 (-) |
Annotate: when pure leachable detected, used test sample was a 400ml volumetrical blood bag, pure leachable≤10mg/100ml conformance with standard requirement.
Table 5 biological property
| Test item | Detected result |
| Pyrogen | The pyrogen-free reaction |
| Haemolysis | Hemolysis rate: 1.1% |
| Acute whole body is poisoned | Non-toxic reaction |
| Cytotoxicity | 0～5 grade of classification: 1 grade |
| Intracutaneous stimulates | No intracutaneous irritant reaction |
| Irritated | Sensitization rate: 0% |
The present invention adopts a new plasticizer system of being made up of phthalic ester, trimellitate and citrate.Phthalic ester is used to suppress erythrocyte hemolysis in this plasticiser system; Trimellitate is used to reduce stripping quantity; Citrate is used to reduce toxicity.The present invention's prescription has obvious superiority, and the present invention is suitable for making the blood transfusion utensil, and made blood bag is used for preserving blood ingredient, particularly hemocyte dependable performance, stable.Can be used for making female bag and son bag in the multi-linked blood bag.
Claims (6)
1. blood transfusion utensil soft polyvinyl chloride plastic, it is characterized in that: used plastic body is that the polymerization degree is 1700～2500 polyvinyl chloride (PVC) resin, phthalic ester, trimellitate and citrate are softening agent, epoxy soybean oil (ESO), calcium-zinc composite stabilizing agent (CZ11) is a stablizer, silicone oil is lubricant, wherein each ingredients constitute PVC polymer quality percentage ratio is: phthalic ester 15%～40%, trimellitate 15%～40%, citrate 5%～30%, epoxy soybean oil (ESO) 5%～10%, calcium-zinc composite stabilizing agent (CZ11) 1-2%, silicone oil 0.1-0.5%, the total amount of plasticiser system is 40%～70% of a PVC polymer quality.
2. blood transfusion utensil soft polyvinyl chloride plastic as claimed in claim 1 is characterized in that: the used polyvinyl chloride resin polymerization degree is 1700.
3. blood transfusion utensil soft polyvinyl chloride plastic as claimed in claim 1 is characterized in that: the phthalic ester in the plasticiser system is phthalic acid two (the 2-ethyl is an own) ester (DEHP).
4. blood transfusion utensil soft polyvinyl chloride plastic as claimed in claim 1 is characterized in that: the trimellitate in the plasticiser system is tri trimellitate (the 2-ethyl is an own) ester (TOTM).
5. blood transfusion utensil soft polyvinyl chloride plastic as claimed in claim 1 is characterized in that: the citrate in the plasticiser system is ATBC (ATBC).
6. blood transfusion utensil soft polyvinyl chloride plastic as claimed in claim 1 is characterized in that: the total amount of plasticiser system is 56% of a PVC polymer quality, and wherein phthalic ester accounts for 23% of PVC polymer quality.Trimellitate accounts for 23% of polymer quality, and citrate accounts for 10% of polymer quality.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100238961A CN100335553C (en) | 2004-05-12 | 2004-05-12 | Soft PVC plastic in use for apparatus transfusions |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100238961A CN100335553C (en) | 2004-05-12 | 2004-05-12 | Soft PVC plastic in use for apparatus transfusions |
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| CN1696189A CN1696189A (en) | 2005-11-16 |
| CN100335553C true CN100335553C (en) | 2007-09-05 |
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| CNB2004100238961A Expired - Fee Related CN100335553C (en) | 2004-05-12 | 2004-05-12 | Soft PVC plastic in use for apparatus transfusions |
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Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101536961B (en) * | 2009-04-21 | 2012-01-25 | 中国科学院长春应用化学研究所 | Safe blood or blood component storage container and preparation method thereof |
| CN101787168A (en) * | 2010-03-12 | 2010-07-28 | 扬州凯尔化工有限公司 | Non-o-benzene plasticized soft polyvinyl chloride plastic special for blood bag |
| CN103232650A (en) * | 2013-04-27 | 2013-08-07 | 苏州市德莱尔建材科技有限公司 | Dense mesh type plastic safety net for buildings and preparation method thereof |
| CN103819851A (en) * | 2014-03-06 | 2014-05-28 | 江苏大海塑料股份有限公司 | High-temperature resistant and viscidity resistant membrane |
| WO2015146382A1 (en) * | 2014-03-26 | 2015-10-01 | テルモ株式会社 | Blood reservoir |
| CN104448618A (en) * | 2014-11-27 | 2015-03-25 | 苏州市贝克生物科技有限公司 | Composite material for medical plastic products and preparation method thereof |
| KR101784100B1 (en) * | 2015-04-06 | 2017-10-10 | 주식회사 엘지화학 | Plasticizer, resin composition and method for preparing them |
| WO2016163742A1 (en) * | 2015-04-06 | 2016-10-13 | 주식회사 엘지화학 | Resin composition comprising plasticizer composition, and preparation method therefor |
| WO2016163744A1 (en) * | 2015-04-06 | 2016-10-13 | 주식회사 엘지화학 | Plasticizer composition, resin composition, and methods for preparing same |
| KR101846066B1 (en) | 2015-04-06 | 2018-04-06 | 주식회사 엘지화학 | Resin composition comprising plasticizer and method for preparing them |
| CN106963640A (en) * | 2017-05-02 | 2017-07-21 | 浙江绿蔻生物技术有限公司 | Blood sampling separation bag |
| CN110551349A (en) * | 2019-09-03 | 2019-12-10 | 湖南博隽生物医药有限公司 | Material with blood stabilizing function for blood transfusion bag and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1056507A (en) * | 1990-05-15 | 1991-11-27 | 上海化工厂 | Soft polyvinyl chloride plastic is used in novel blood transfusion (liquid) |
| CN1072428A (en) * | 1992-12-23 | 1993-05-26 | 中国医学科学院输血研究所 | The soft polyvinyl chloride that storage bag of blood platelet is used |
| CN1091443A (en) * | 1993-02-24 | 1994-08-31 | 上海市血液中心血制品输血器材经营公司 | Medical polyvinyl plastics and goods thereof |
| US5955519A (en) * | 1996-06-04 | 1999-09-21 | Hospal Ag | Use of a chemical agent for increasing radiation resistance of polyvinyl chloride compositions |
| JP2003052806A (en) * | 2001-08-13 | 2003-02-25 | Kawasumi Lab Inc | Blood bag |
-
2004
- 2004-05-12 CN CNB2004100238961A patent/CN100335553C/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1056507A (en) * | 1990-05-15 | 1991-11-27 | 上海化工厂 | Soft polyvinyl chloride plastic is used in novel blood transfusion (liquid) |
| CN1072428A (en) * | 1992-12-23 | 1993-05-26 | 中国医学科学院输血研究所 | The soft polyvinyl chloride that storage bag of blood platelet is used |
| CN1091443A (en) * | 1993-02-24 | 1994-08-31 | 上海市血液中心血制品输血器材经营公司 | Medical polyvinyl plastics and goods thereof |
| US5955519A (en) * | 1996-06-04 | 1999-09-21 | Hospal Ag | Use of a chemical agent for increasing radiation resistance of polyvinyl chloride compositions |
| JP2003052806A (en) * | 2001-08-13 | 2003-02-25 | Kawasumi Lab Inc | Blood bag |
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| CN1696189A (en) | 2005-11-16 |
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