CN1031137C - Soft polyvinyl chloride for storage bag of blood platelet - Google Patents
Soft polyvinyl chloride for storage bag of blood platelet Download PDFInfo
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- CN1031137C CN1031137C CN 92113636 CN92113636A CN1031137C CN 1031137 C CN1031137 C CN 1031137C CN 92113636 CN92113636 CN 92113636 CN 92113636 A CN92113636 A CN 92113636A CN 1031137 C CN1031137 C CN 1031137C
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Abstract
The present invention provides soft polyvinyl chloride material suitable for manufacturing blood platelet storage bags. Under the condition of not changing PVC resin and various conventional auxiliary additive components, a plasticizing agent system containing acetylized citric acid trihexyl (2-ethyl) ester and trimellitic formic acid trihexyl (2-ethyl) ester used if necessary is adopted, so that not only is the extracting quantity of plasticizing agents reduced, but also the oxygen penetrating performance of blood bags can be improved and adjusted to make blood platelets can be stored for five to seven days.
Description
What the present invention relates to is a kind of soft polyvinyl chloride that the blood products storage bag is used that is used to make, and specifically is to be applicable to make the material that storage bag of blood platelet is used.
More component blood transfusion has a blood to use, saves the blood source, reduces advantages such as transfusion reaction and raising clinical effectiveness, also is to reflect one of the sign of state of the art of transfusing blood.Be used for storing with infusion whole blood, red corpuscle and hematoblastic soft polyvinyl chloride plastic (PVC) blood bag mostly adopts the own ester of phthalic acid two (2-ethyl) (DOP or DEHP) as the main body softening agent in the past.Because its migration amount in blood products is big, animal experiment has confirmed the intoxicating phenomenon of organ such as liver, therefore tissue is had potential harm.Experiment shows, though that DEHP enters blood is favourable to erythrocytic storage, not only unhelpful to the storage of thrombocyte (PC), harmful on the contrary.Because its PC migration amount in storage process big (reaching 150～450 μ g/ml/ days), experiment have confirmed that influences such as hypotonic shock, aggregation capability to PC are very big, are one of important factors that influences the PC period of storage.
Testing the certified important factor that another influences the PC storage is the oxygen permeability of material.The eubolism of PC is aerobic metabolism.When oxygen-supplying amount is not enough, because of carrying out anaerobic glycolysis, PC make the speed that generates lactic acid increase several times, and cause medium for storing (blood plasma) pH value sharply to descend.Because the total number of blood platelet of storing in the requirement of oxygen and the bag roughly is directly proportional, and when blood bag material oxygen-permeable when excessive and/or storage total number of blood platelet is very few, excessive because of oxygen-supplying amount, cause the CO of metabolism generation
2Too much discharge, destroyed buffer system, cause that the pH value raises.Oxygen supply is not enough or the excessive pH change that causes can have a strong impact on and damage form and the function of PC, so should keep pH to preserve under the condition near physiological level (7.2) to PC.
It is the main body softening agent with DOP and epoxy tetrahydro-2-ethylhexyl phthalate that Chinese patent 87106027.2 discloses a kind of, and adds the material of an amount of ethylene-vinyl acetate copolymer modification.Though can because of the DOP consumption reduce reduce its extraction amount, still have DOP to exist, and because of the reason of aspects such as oxygen-permeable, only 3 days storage period of PC.
It is the PVC material of main body softening agent with the own ester of trimellitic acid three (2-ethyl) (TEHTM) that United States Patent (USP) 4280497 has been described a kind of.It is the PVC material of softening agent that European patent 138147A has described with citric acid three ester or acylated citrate three (4-10 carbon straight-chain fatty alcohol) ester.These softening agent all have difficult advantage of being extracted out by blood plasma, and oxygen-permeable is good, and PC can store 5～7 days in the blood bag that these materials are made.But these materials still have undesirable part on plasticizing processibility and some performance index.In addition, because that PC requires the oxygen permeability of material with what of PC quantity in the blood bag when storing is different, the oxygen permeability variation range of these materials is less, is difficult for regulating, and makes the scope of application of material limited.In addition, also will to be subjected to the influence of raw material sources also be its deficiency to the employed softening agent of these materials.
The objective of the invention is provides a kind of anti-migration by changing plasticiser system, have aspect performances such as good physics, chemistry, biology, and the PVC material that the manufacturing storage bag of blood platelet that can regulate blood bag oxygen permeating amount is used makes thrombocyte can store 5～7 day time equally.
What material of the present invention adopted is the own ester of acetylize citric acid three (2-ethyl) (ATEHC), and preferably cooperates the own ester of trimellitic acid three (2-ethyl) (TEHTM) as softening agent more simultaneously.The usage quantity of these softening agent is that per 100 parts (weight, as follows) polyvinyl chloride resin ATEHC are 5～60 parts, and TEHTM is 0～55 part, and the total amount of softening agent should be 45～60 parts.Except that PVC and softening agent, material of the present invention can need routinely and consumption uses other necessary additive component, comprise the stable composition system that stablizer, co-stabilizer, sequestrant by salts such as epoxy soybean oil (ESO) or epoxy linseed oil (ELO), high effect nontoxic organophosphite (as IDAP) and aluminum foil stearate, zinc, calcium constitute, the lubricating system of polymethylphenyl siloxane fluid and stearate soap class etc.The ATEHC that one of characteristics of the above-mentioned Plasticising system of the present invention are to use is the side chain alcohol ester of acetylize citric acid, and its remarkable advantage just is that the raw material sources limitation is little, and production cost greatly reduces.On the other hand, though can use ATEHC separately, by following various experiments as can be seen,, can obtain the effect more superior than single type plasticiser system if can be used with TEHTM simultaneously.As, constant when the softening agent total amount, ATEHC is 15～45 parts, when TEHTM is 10～40 parts, can obtain well-content effect.Adopt the material and the chemical stability test-results such as the table 1 that adopt existing plasticiser system material of the above-mentioned plasticiser system of the present invention.By this table as can be seen, the chemical stability of material of the present invention is good, and every index all meets the requirements, even all is in best level.All other performance test comparing result such as tables 2.Indexs such as its toxic, resistance to migration, volatility, weather resistance, anti-extractibility also substantially all are in good or best level.The excellent properties of thermostability and adhesion degree aspect has shown that all this material more helps machine-shaping.
The test-results of relevant oxygen-permeable sees Table 3, it has shown that not only the oxygen-permeable of material of the present invention all is better than present material, but also be not difficult to find out, by changing the different ratios of TEHTM and two kinds of a plasticiser component of ATEHC, can also be as requested the oxygen-permeable of material be adjusted to desirable proper range, this is the another distinguishing feature of material of the present invention.
The oppose test-results of external preservation platelet function influence of the storage blood bag that adopts material of the present invention to make shows, to PC＞700 * 10
9/ liter platelet storage after 7 days, pH is 6.8～7.5, aggregation capability changes 〉=45%, hypotonic shock 〉=85%, the inspection of items such as counting, cell electrophoresis, form and ultrastructure was compared with first day and is had no significant change.Carry out the every check test of biology, prove that material of the present invention does not have positive reactions such as haemolysis, pyrogen, allergy and intracutaneous stimulation.Behind the inferior chronic animal toxicity test, tested animal appearance, blood picture and liver, renal function are normal substantially; " three cause " test nothing causes prominent effect, and also not seeing has malignant conversioning cell to occur.These biology check result explanations material of the present invention is safe to storing PC.
Clinical observation to the blood PC that bag is stored of infusion material manufacturing of the present invention, infusion is stored 5～6 days PC and the clinical examination index of 1～2 day PC of infusion storage does not have remarkable change, still can play hemostasis and prevent hemorrhage purpose, clinical effective rate can reach more than 82%, has shown that it is effective, safe and reliable that above-mentioned materials of the present invention is used to store PC.
What below introduce is the example of this bright above-mentioned materials, but scope of the present invention is not limited only to these examples.
The composition of each example and consumption (weight part) see Table 4.After various raw materials in the example measure in accordance with regulations, make pellet according to a conventional method earlier, the forming process condition promptly can be made into the PC storage bag routinely again.
By the PC bag soft and transparent that example 1 material is made, thermal losses is little, and thermostability, volatility and anti-extractibility are all good, and can high pressure resistant steam sterilizing, is difficult for sticking together.Oxygen-permeable is big, can show the storage period that prolongs high density PC.Relevant performance is referring to each subordinate list.
The PC bag performance and the forming process of example 2 materials are same as example 1 substantially, referring to each subordinate list.Only the adhesive behind the disinfection with high pressure steam is bigger.Oxygen-permeable is less, so can obviously prolong the storage period of lower concentration PC.
The similar example 1 of the basic characteristics of example 3 materials, its oxygen-permeable is moderate, is applicable to the PC of prolonged preservation intermediate concentration.
The tensile strength of example 4 materials reduces, and the adhesion behind the disinfection with high pressure steam is more serious.Oxygen-permeable is relatively poor, is applicable to the long storage of platelet rich plasma.
Example 5 is owing to all adopt ATEHC plasticising, and material is harder, and processing characteristics is not as good as above each example, but good permeability, can obviously prolong the storage period of high density PC.All the other performances are referring to each subordinate list.
Table 1
| The DEHP system | The TEHTM system | ATEHC system (example 5) | Composite system (example 1) | Composite system (example 2) | |
| Proterties | Colourless, clear and bright | Colourless, clear and bright | Colourless, clear and bright | Colourless, clear and bright | Colourless, clear and bright |
| Δ pH descends | 0.44 | 0.25 | 0.49 | 0.27 | 0.25 |
| Readily oxidizable substance (potassium permanganate consumption ml) | 0.18 | 0.22 | 0.17 | 0.21 | 0.20 |
| Heavy metal | Qualified | Qualified | Qualified | Qualified | Qualified |
| Ultraviolet absorptivity (275nm) | 0.061 | 0.076 | 0.062 | 0.039 | 0.038 |
| Zine ion (μ g/ml) | 0.32 | 0.40 | 0.26 | 0.25 | 0.11 |
| Chlorion (μ g/ml) | ＜0.4 | ＜0.4 | ＜0.4 | ＜0.4 | ＜0.4 |
| Ammonium ion (μ g/ml) | ＜0.2 | ＜0.2 | ＜0.2 | ＜0.2 | ＜0.2 |
Annotate: chemical stability is after steam sterilizing in 121 ℃ * 30 minutes, by " the Chinese pharmacopoeia prescriptive procedure is measured.
Table 2
| The DEHP system | The TEHTM system | ATEHC system (example 5) | Composite system (example 1) | Composite system (example 2) | |
| Toxicity: LD50 (mg/kg) | 37871 | 85000 | |||
| Transport property: migration amount (gram) (ISO.177 method) | 0.0741 | 0.0515 | 0.0392 | ||
| Volatility (100 ℃ * 3 days): quality loss (%) | 1.83 | 0.21 | 0.14 | ||
| Thermostability: 180 ℃ of congo-red test paper variable color times (branch) | 65 | 75 | 73 | 62 | 65 |
| Anti-extractibility: (mg/100ml) (ISO/DIN3826.4 method) | 6.57 | 0.25 | 0.32 | 0.38 | 0.40 |
| Adhesive (121 ℃ * 20 '): stripping strength (N/30mm) | 10.1 | 12.2 | 5.4 | 3.9 | 9.2 |
Table 3 (test of Archer improved method, μ mol/ hour/92cm
2)
| DEHP system (thickness 0.38mm) | TEHIM system (thickness 0.33mm) | ATEHC system (example 5, thickness 0.28mm) | Compound system (example 1, thickness 0.28mm) | Compound system (example 2, thickness 0.28mm) |
| 1.42 | 2.01 | 3.51 | 3.24 | 2.48 |
Table 4
| Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | |
| PVC | 100 | 100 | 100 | 100 | 100 |
| ATEHC | 45 | 15 | 35 | 5 | 55 |
| TEHTM | 10 | 40 | 25 | 40 | 0 |
| ESO | 5 | 5 | 5 | 5 | / |
| ELO | / | / | / | / | 5 |
| Polymethylphenyl siloxane fluid | 0.3 | 0.3 | 0.5 | 0.1 | 0.3 |
| IDAP | 0.3 | 0.3 | 0.3 | 0.5 | 0.3 |
| Aluminum stearate | 0.1 | 0.1 | 0.1 | / | / |
| Zinic stearas | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 |
| Calcium stearate | / | / | / | 0.3 | 0.1 |
Claims (3)
1, a kind of soft polyvinyl chloride that is used to make storage bag of blood platelet is made up of polyvinyl chloride (PVC) RESINS, softening agent and auxiliary added ingredients, it is characterized in that forming comprising (by weight):
100 parts of polyvinyl chloride (PVC) RESINS
5～45 parts of the own esters of acetylize citric acid three (2-ethyl)
10～55 parts of the own esters of trimellitic acid three (2-ethyl)
The own ester of acetylize citric acid three (2-ethyl) and
45～60 parts of the total amounts of the own ester of trimellitic acid three (2-ethyl).
2, want 1 described material as right, it is characterized in that wherein:
15～45 parts of the own esters of acetylize citric acid three (2-ethyl)
10～40 parts of the own esters of trimellitic acid three (2-ethyl).
3, material as claimed in claim 1 or 2 is characterized in that also comprising 0.3～0.5 part of organic phosphite chelator (weight).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 92113636 CN1031137C (en) | 1992-12-23 | 1992-12-23 | Soft polyvinyl chloride for storage bag of blood platelet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 92113636 CN1031137C (en) | 1992-12-23 | 1992-12-23 | Soft polyvinyl chloride for storage bag of blood platelet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1072428A CN1072428A (en) | 1993-05-26 |
| CN1031137C true CN1031137C (en) | 1996-02-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 92113636 Expired - Fee Related CN1031137C (en) | 1992-12-23 | 1992-12-23 | Soft polyvinyl chloride for storage bag of blood platelet |
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| Country | Link |
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| CN (1) | CN1031137C (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003029339A1 (en) * | 2001-09-25 | 2003-04-10 | Exxonmobil Chemical Patents Inc. | Plasticised polyvinyl chloride |
| 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 |
| DE102005059143A1 (en) * | 2005-12-08 | 2007-06-14 | J. S. Staedtler Gmbh & Co. Kg | Modeling clay and its use |
| EP2872099B1 (en) * | 2012-07-12 | 2016-05-25 | Terumo BCT, Inc. | Hybrid blood component storage bag and method of making such bag |
| EP3210642A4 (en) * | 2014-10-22 | 2018-06-13 | Shenzhen Yuantai Medical Equipment Co., Ltd. | Breathing bag |
| 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 |
| EP3476891B1 (en) * | 2017-02-10 | 2022-09-28 | LG Chem, Ltd. | Plasticizer composition and resin composition comprising same |
-
1992
- 1992-12-23 CN CN 92113636 patent/CN1031137C/en not_active Expired - Fee Related
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| Publication number | Publication date |
|---|---|
| CN1072428A (en) | 1993-05-26 |
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