JPH038778B2 - - Google Patents
Info
- Publication number
- JPH038778B2 JPH038778B2 JP62321344A JP32134487A JPH038778B2 JP H038778 B2 JPH038778 B2 JP H038778B2 JP 62321344 A JP62321344 A JP 62321344A JP 32134487 A JP32134487 A JP 32134487A JP H038778 B2 JPH038778 B2 JP H038778B2
- Authority
- JP
- Japan
- Prior art keywords
- blood
- medical device
- normal
- dehp
- phthalate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 210000004369 blood Anatomy 0.000 claims description 30
- 239000008280 blood Substances 0.000 claims description 30
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Natural products OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 28
- -1 Citric acid ester Chemical class 0.000 claims description 18
- 206010018910 Haemolysis Diseases 0.000 claims description 13
- 230000008588 hemolysis Effects 0.000 claims description 13
- 239000011347 resin Substances 0.000 claims description 10
- 229920005989 resin Polymers 0.000 claims description 10
- XNGIFLGASWRNHJ-UHFFFAOYSA-N phthalic acid Chemical compound OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 claims description 8
- 229920000915 polyvinyl chloride Polymers 0.000 claims description 7
- 239000004800 polyvinyl chloride Substances 0.000 claims description 7
- 125000005907 alkyl ester group Chemical group 0.000 claims description 5
- PGIBJVOPLXHHGS-UHFFFAOYSA-N Di-n-decyl phthalate Chemical group CCCCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCCCC PGIBJVOPLXHHGS-UHFFFAOYSA-N 0.000 claims description 4
- 230000002401 inhibitory effect Effects 0.000 claims description 3
- 125000002777 acetyl group Chemical group [H]C([H])([H])C(*)=O 0.000 claims description 2
- 125000004063 butyryl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 2
- 229910052739 hydrogen Inorganic materials 0.000 claims description 2
- 239000001257 hydrogen Substances 0.000 claims description 2
- 125000004435 hydrogen atom Chemical class [H]* 0.000 claims description 2
- TUUQISRYLMFKOG-UHFFFAOYSA-N trihexyl 2-acetyloxypropane-1,2,3-tricarboxylate Chemical group CCCCCCOC(=O)CC(C(=O)OCCCCCC)(OC(C)=O)CC(=O)OCCCCCC TUUQISRYLMFKOG-UHFFFAOYSA-N 0.000 claims description 2
- BJQHLKABXJIVAM-UHFFFAOYSA-N Diethylhexyl phthalate Natural products CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 19
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 description 18
- 239000004014 plasticizer Substances 0.000 description 11
- 210000003743 erythrocyte Anatomy 0.000 description 9
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- 238000009472 formulation Methods 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 230000035699 permeability Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- 210000002381 plasma Anatomy 0.000 description 3
- 102000001554 Hemoglobins Human genes 0.000 description 2
- 108010054147 Hemoglobins Proteins 0.000 description 2
- KRADHMIOFJQKEZ-UHFFFAOYSA-N Tri-2-ethylhexyl trimellitate Chemical compound CCCCC(CC)COC(=O)C1=CC=C(C(=O)OCC(CC)CCCC)C(C(=O)OCC(CC)CCCC)=C1 KRADHMIOFJQKEZ-UHFFFAOYSA-N 0.000 description 2
- PUFGCEQWYLJYNJ-UHFFFAOYSA-N didodecyl benzene-1,2-dicarboxylate Chemical compound CCCCCCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCCCCCC PUFGCEQWYLJYNJ-UHFFFAOYSA-N 0.000 description 2
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 2
- ARCGXLSVLAOJQL-UHFFFAOYSA-N trimellitic acid Chemical compound OC(=O)C1=CC=C(C(O)=O)C(C(O)=O)=C1 ARCGXLSVLAOJQL-UHFFFAOYSA-N 0.000 description 2
- BJQHLKABXJIVAM-BGYRXZFFSA-N 1-o-[(2r)-2-ethylhexyl] 2-o-[(2s)-2-ethylhexyl] benzene-1,2-dicarboxylate Chemical compound CCCC[C@H](CC)COC(=O)C1=CC=CC=C1C(=O)OC[C@H](CC)CCCC BJQHLKABXJIVAM-BGYRXZFFSA-N 0.000 description 1
- BSXJTDJJVULBTQ-UHFFFAOYSA-N 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononan-1-ol Chemical compound OCC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F BSXJTDJJVULBTQ-UHFFFAOYSA-N 0.000 description 1
- 239000004808 2-ethylhexylester Substances 0.000 description 1
- 239000004804 Butyryltrihexylcitrate Substances 0.000 description 1
- MQIUGAXCHLFZKX-UHFFFAOYSA-N Di-n-octyl phthalate Chemical compound CCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCC MQIUGAXCHLFZKX-UHFFFAOYSA-N 0.000 description 1
- 229920012485 Plasticized Polyvinyl chloride Polymers 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 239000012503 blood component Substances 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 125000004432 carbon atom Chemical group C* 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- DROMNWUQASBTFM-UHFFFAOYSA-N dinonyl benzene-1,2-dicarboxylate Chemical compound CCCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCCC DROMNWUQASBTFM-UHFFFAOYSA-N 0.000 description 1
- DISZQMPRUTYNJL-UHFFFAOYSA-N ditetradecyl benzene-1,2-dicarboxylate Chemical compound CCCCCCCCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCCCCCCCC DISZQMPRUTYNJL-UHFFFAOYSA-N 0.000 description 1
- YCZJVRCZIPDYHH-UHFFFAOYSA-N ditridecyl benzene-1,2-dicarboxylate Chemical compound CCCCCCCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCCCCCCC YCZJVRCZIPDYHH-UHFFFAOYSA-N 0.000 description 1
- QQVHEQUEHCEAKS-UHFFFAOYSA-N diundecyl benzene-1,2-dicarboxylate Chemical compound CCCCCCCCCCCOC(=O)C1=CC=CC=C1C(=O)OCCCCCCCCCCC QQVHEQUEHCEAKS-UHFFFAOYSA-N 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000004898 kneading Methods 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 210000004623 platelet-rich plasma Anatomy 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 239000003761 preservation solution Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 125000005591 trimellitate group Chemical group 0.000 description 1
- 125000005590 trimellitic acid group Chemical class 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Materials For Medical Uses (AREA)
Description
（産業上の利用分野）
本発明は、医療用具に関し、特に、極めて高い
安全性を有し、且つ血液を保存したときの溶血を
抑制する医療用具に関する。
（従来の技術）
従来、使用されているジエチルヘキシルフタレ
ート（以下、DEHPと称する）可塑化塩化ビニル
製の保存容器で血液を保存すると、血液中に
DEHPが溶出してくることが知られている。この
DEHPは、血小板の凝集能を抑制することが報告
されており（例えば、「日本輸血学会雑誌、28(3)
282（1982）」参照）、DEHPが輸血の際に保存血と
共に体内に入ることは血小板への影響の面から問
題があつた。しかし、この問題を解決するため
に、保存容器の材質をDEHPを含まない材質に代
えると、保存中に赤血球が溶血してしまうという
現象が生じた。そこで、この原因を調べたとこ
ろ、これは、DEHPに溶血抑制効果があるためで
あるということがわかつた（Blood64 ６ 1270
−（1984））。つまり、従来のDEHP可塑化塩化ビ
ニル製の血液保存容器で血液を保存したときは、
血液中に溶出してきたDEHPが赤血球の溶血を抑
制していたのである。
このような理由から、生体に対するDEHPの作
用を危惧しながらも、保存中の赤血球の溶血を避
けるために止むをえずDEHP可塑化塩化ビニル製
の保存容器を用いているのが現状である。
また、血液中に溶出するDEHP量を最小限に抑
えるために、血液中に溶出しにくい可塑剤である
TOTM（トリメリツト酸２−エチルヘキシル）と
DEHPとを組み合わせて用いるという手法も提案
されている（EP0051414、BAXTER
TRAVENOL LABORATORIES、INC）が、
れによつてDEHPの溶出の問題が解決されるわけ
ではない。
そこで最近では、DEHPよりも安全性の高いク
エン酸エステルを可塑剤とする塩化ビニル樹脂製
の保存容器が提案されている。（EP0138147、
MILES LABORATORIES、INC）。この可塑剤
はDEHPと同じように、血液中に溶出して赤血球
の溶血を抑える。しかし、この塩化ビニル製樹脂
は水蒸気透過性が高いために内容液中の水分が蒸
散しやすいという問題点があつた。また、可塑剤
が体内に入ることには変わりがないために、この
量を可能なかぎり抑えることが必要であつた。
（解決しようとする問題点）
本発明は、新規な溶血抑制作用を有する医療用
具を提供することを目的とする。本発明は、ま
た、赤血球に対する保存性に優れる医療用具を提
供することを目的とする。本発明は更に、生理的
安全性の高い医療用具を提供することを目的とす
る。
（問題点を解決するための手段）
すなわち、本発明は、ポリ塩化ビニル系樹脂に
対し、式(1)で示されるクエン酸エステル
式中、R1はアセチル基、ブチリル基、もしく
は水素で、また、ｌ，ｍ，ｎは３ないし７の整数
を示す。
を10〜30重量％と、可塑剤として式(2)で示される
フタル酸ジノルマルアルキルエステル
式中、n′は７〜13の整数を表す。
を５〜45重量％とが配合されたポリ塩化ビニル系
樹脂から成形されたことを特徴とする溶血抑制作
用を有する医療用具である。
本発明で使用するクエン酸エステルにおける
ｌ，ｍ，ｎは３ないし７であり、この条件をはず
れると塩ビとの相溶性がなくなつてしまう。特に
望ましくはアセチルクエン酸トリヘキシル、もし
くはブチリルクエン酸トリヘキシルである。
また、本発明で使用するクエン酸エステルの配
合量は、樹脂に対し10ないし30重量％である。10
重量％以下だと溶血抑制作用を発揮する量のクエ
ン酸エステルが血中に溶出せず、30重量％以上だ
と必要以上に溶出してしまう。
本発明で使用するフタル酸ジノルマルアルキル
エステのn′は、７〜14であつて、７以下だと血液
中に溶出しやすくなり、14以上だと塩ビ系樹脂と
の相溶性がなくなつてしまう。また、側鎖が分岐
構造をとる場合も、血液中に溶出しやすくなつて
しまう。
本発明で使用するフタル酸ジノルマルアルキル
エステの具体例としては、フタル酸ジノルマルオ
クチル、フタル酸ジノルマルノニル、フタル酸ジ
ノルマルデシル、フタル酸ジノルマルウンデシ
ル、フタル酸ジノルマルドデシル、フタル酸ジノ
ルマルトリデシル、フタル酸ジノルマルテトラデ
シルが挙げられ、特に望ましくはフタル酸ジノル
マルデシルもしくはフタル酸ジノルマルドデシル
などがある。
本発明では可塑剤としては、フタル酸ジノルマ
ルアルキルエステルの他、血液中もしくは血液成
分分画中に実質的に溶出しない可塑剤を、更に、
配合することが好ましい。かかる可塑剤として
は、トリメリツト酸エステルなどがある。本発明
で使用するできるトリメリツト酸エステルの具体
的例として、トリメリツト酸トリ２−エチルヘキ
シルやトリメリツト酸トリノルマルオクチル、ト
リメリツト酸トリノルマルデシルなどがある。ト
リメリツト酸にエステル結合でつながる側鎖の炭
素数が７以下だと血液中に溶出しやすくなり11以
上だと塩ビとの相溶性がなくなつてしまう。
本発明において、フタル酸ジノルマルアルキル
エステルの添加量は、樹脂に対して５ないし45重
量％であり、これは医療用具用材料として機能す
るための柔軟性を付与するために必要な量であ
る。特に、好ましくは10ないし30重量％である。
本発明における医療用具としては安全性、加工
性、柔軟性、耐熱性等が要求される医療器具を言
うのであつて、例えば血液バツグ等の体液保存容
器、カテーテル、輸血セツト血液回路等の医療用
具などがあり、特に、その安全性と溶血抑制効果
から、血液バツグであることが望ましい。
本発明にかかる医療用具は、DEHP可塑化
PVC製の医療用具と同様の赤血球溶出抑制効果
を必要最小限のクエン酸エステルの血中への移行
で発揮し、しかもこのクエン酸エステルはDEHP
にくらべ安全性にも優れる。つまり、本発明の医
療用具は従来のDEHPの安全性の問題を解決し、
且つまた、保存時の溶血の問題も同時に解決した
優れた医療用具である。
以下、実施例をもつてさらに本発明を詳細に説
明する。
（実施例）
本発明の実施例において、使用した医療用具
は、表１に示す配合割合の組成物をロール混練、
プレス成形によつて0.4mmの厚みのシートに成形
し、次に、このシートの所定部を高周波融着する
ことにより作製した７ml容量のバツグである。
(Industrial Application Field) The present invention relates to a medical device, and particularly to a medical device that has extremely high safety and suppresses hemolysis when blood is stored. (Prior art) When blood is stored in a conventionally used storage container made of diethylhexyl phthalate (hereinafter referred to as DEHP) plasticized vinyl chloride,
It is known that DEHP is eluted. this
DEHP has been reported to suppress the aggregation ability of platelets (for example, "Journal of the Japanese Society of Blood Transfusion, 28(3)
282 (1982)), DEHP entering the body together with stored blood during blood transfusions was problematic in terms of its effect on platelets. However, in order to solve this problem, when the material of the storage container was replaced with a material that does not contain DEHP, a phenomenon occurred in which red blood cells were hemolyzed during storage. When we investigated the cause of this, we found that it was because DEHP has a hemolysis suppressing effect (Blood64 6 1270
- (1984)). In other words, when blood is stored in a conventional DEHP plasticized PVC blood storage container,
DEHP eluted into the blood suppressed hemolysis of red blood cells. For these reasons, despite concerns about the effects of DEHP on living organisms, it is currently necessary to use storage containers made of DEHP-plasticized vinyl chloride to avoid hemolysis of red blood cells during storage. In addition, in order to minimize the amount of DEHP that elutes into the blood, it is a plasticizer that does not easily elute into the blood.
TOTM (2-ethylhexyl trimellistate) and
A method of using it in combination with DEHP has also been proposed (EP0051414, BAXTER
TRAVENOL LABORATORIES, INC.)
This does not solve the DEHP leaching problem. Therefore, recently, storage containers made of vinyl chloride resin have been proposed that use citric acid ester as a plasticizer, which is safer than DEHP. (EP0138147,
MILES LABORATORIES, INC.). Like DEHP, this plasticizer is eluted into the blood and suppresses hemolysis of red blood cells. However, since this vinyl chloride resin has high water vapor permeability, there is a problem in that water in the content liquid easily evaporates. Furthermore, since the plasticizer still enters the body, it was necessary to suppress this amount as much as possible. (Problems to be Solved) An object of the present invention is to provide a medical device having a novel hemolysis suppressing effect. Another object of the present invention is to provide a medical device that has excellent preservation properties for red blood cells. A further object of the present invention is to provide a medical device with high physiological safety. (Means for Solving the Problems) That is, the present invention provides polyvinyl chloride resin with a citric acid ester represented by formula (1). In the formula, R 1 is an acetyl group, a butyryl group, or hydrogen, and l, m, and n are integers of 3 to 7. 10 to 30% by weight, and phthalic acid di-normal alkyl ester represented by formula (2) as a plasticizer. In the formula, n' represents an integer of 7 to 13. This medical device is characterized by being molded from a polyvinyl chloride resin blended with 5 to 45% by weight of hemolysis. l, m, and n in the citric acid ester used in the present invention are 3 to 7, and if these conditions are exceeded, the citric acid ester loses its compatibility with vinyl chloride. Particularly preferred are acetyl trihexyl citrate or butyryl trihexyl citrate. The amount of citric acid ester used in the present invention is 10 to 30% by weight based on the resin. Ten
If it is less than 30% by weight, the amount of citric acid ester that exerts the hemolysis-inhibiting effect will not be eluted into the blood, and if it is more than 30% by weight, more than necessary will be eluted. The n' of the di-normal alkyl ester of phthalate used in the present invention is 7 to 14; if it is less than 7, it will easily elute into the blood, and if it is more than 14, it will be incompatible with the PVC resin. Put it away. Furthermore, when the side chain has a branched structure, it becomes easier to elute into the blood. Specific examples of the di-normal alkyl phthalate used in the present invention include di-normal octyl phthalate, di-normal nonyl phthalate, di-normal decyl phthalate, di-normal undecyl phthalate, di-normal dodecyl phthalate, and di-normal phthalate. Examples include di-normal tridecyl phthalate and di-normal tetradecyl phthalate, and particularly preferred are di-normal decyl phthalate and di-normal dodecyl phthalate. In the present invention, the plasticizer includes, in addition to phthalic acid di-normal alkyl ester, a plasticizer that does not substantially dissolve in blood or blood component fractions.
It is preferable to mix them. Such plasticizers include trimellitic acid esters and the like. Specific examples of trimellitate esters that can be used in the present invention include tri-2-ethylhexyl trimellitate, tri-normal octyl trimellitate, and tri-normal decyl trimellitate. If the number of carbon atoms in the side chain connected to trimellitic acid via an ester bond is 7 or less, it will easily elute into the blood, and if it is 11 or more, it will be incompatible with PVC. In the present invention, the amount of phthalic acid di-normal alkyl ester added is 5 to 45% by weight based on the resin, which is the amount necessary to impart flexibility to function as a material for medical devices. . In particular, it is preferably 10 to 30% by weight. Medical devices in the present invention refer to medical devices that require safety, workability, flexibility, heat resistance, etc., such as body fluid storage containers such as blood bags, catheters, blood transfusion sets, blood circuits, etc. Blood bags are particularly desirable due to their safety and hemolysis inhibiting effect. The medical device according to the present invention includes DEHP plasticized
It exhibits the same effect of suppressing red blood cell elution as PVC medical devices by transferring the necessary minimum amount of citric acid ester into the blood, and this citric ester is DEHP.
It is also safer than the In other words, the medical device of the present invention solves the safety problems of conventional DEHP,
Moreover, it is an excellent medical device that also solves the problem of hemolysis during storage. Hereinafter, the present invention will be further explained in detail with reference to Examples. (Example) In the examples of the present invention, the medical devices used were roll-kneaded by roll-kneading a composition with the blending ratio shown in Table 1.
A 7 ml bag was produced by press molding into a 0.4 mm thick sheet, and then high frequency welding a predetermined portion of this sheet.
【表】
（実施例 １）
あらかじめ７mlのCPD液をみたしたシリンジ
に、健常成人男子の肘静脈より50ml採血して
CPD加全血を得た。このCPD加全血を375G、
20min室温で遠心した後、多血小板血漿およびバ
ツフイーコートを除去して濃厚赤血球液（以下
CRC）を得、Htc値が70％になるように乏血小板
血漿だ調整した。このCRCを７mlずつ前述のバ
ツグに分注し、４℃で３週間静置保存した後、血
漿ヘモグロビン濃度及び各可塑剤の血中への移行
量を調べた。結果を表２に示す。[Table] (Example 1) 50 ml of blood was collected from the elbow vein of a healthy adult male into a syringe pre-filled with 7 ml of CPD solution.
CPD-enriched whole blood was obtained. 375G of this CPD added whole blood,
After centrifugation at room temperature for 20 min, platelet-rich plasma and buffer coat are removed and concentrated red blood cell fluid (hereinafter referred to as
CRC) was obtained and platelet-poor plasma was adjusted so that the Htc value was 70%. After dispensing 7 ml of this CRC into the aforementioned bags and storing it for 3 weeks at 4°C, the plasma hemoglobin concentration and the amount of each plasticizer transferred into the blood were examined. The results are shown in Table 2.
【表】
表２からわかるように、本発明（配合１）の優
れた点は、配合２に比べてCRC中に溶出するク
エン酸エステルの量が抑えられていることであ
る。
この結果として、配合１のバツグに保存された
血液の血漿ヘモグロビン濃度は配合２のバツグよ
りも高い値を示すが、配合３程高くはなく、その
値は、「保存３週目で50mg／dl以下」という日本
赤十字社の業務標準に定められている規格に十分
適合するものである。クエン酸エステルは、
DEHPに比べ安全性が高いと言われているが、た
とえ安全な物質であつても体内に入る量を最少限
に抑えることは必要なことである。
（実施例 ２）
実施例１で用いた各シートの水蒸気透過性を表
３に示す。[Table] As can be seen from Table 2, the advantage of the present invention (Formulation 1) is that the amount of citric acid ester eluted into the CRC is suppressed compared to Formulation 2. As a result, the plasma hemoglobin concentration of blood stored in the bag of Formulation 1 is higher than that of the bag of Formulation 2, but not as high as that of Formulation 3; It fully complies with the standards stipulated in the Japanese Red Cross Society's business standards: Citric acid ester is
It is said to be safer than DEHP, but even if it is a safe substance, it is necessary to minimize the amount that enters the body. (Example 2) Table 3 shows the water vapor permeability of each sheet used in Example 1.
【表】
表３からわかるように、クエン酸エステルのみ
だと高い水蒸気透過性を示す。これは、抗凝固液
や赤血球保存液などをバツグ内にいれた時に内容
液が蒸散しやすいことを示している。本発明のよ
うに２種の可塑剤を組み合わせることによつて水
蒸気透過性を抑えることができる。
（効果）
本発明の医療用具は以上述べてきたように、赤
血球の溶血を抑制するクエン酸エステル、及び実
質的に血中に溶出しない可塑剤を配合した塩化ビ
ニル系樹脂よりなることを特徴としているので、
必要最小限のクエン酸エステルで溶血を抑制する
ことが可能となり、より高い安全性が保証でき
る。このことから血液と接触する医療用具、特に
血液保存容器に用いた場合に効果的である。[Table] As can be seen from Table 3, citric acid ester alone exhibits high water vapor permeability. This indicates that when anticoagulant, red blood cell preservation solution, etc. are placed in the bag, the contents tend to evaporate. By combining two types of plasticizers as in the present invention, water vapor permeability can be suppressed. (Effects) As described above, the medical device of the present invention is characterized by being made of a vinyl chloride resin containing a citric acid ester that suppresses hemolysis of red blood cells and a plasticizer that does not substantially dissolve into the blood. Because there are
It becomes possible to suppress hemolysis with the minimum necessary amount of citric acid ester, and higher safety can be guaranteed. For this reason, it is effective when used in medical devices that come into contact with blood, especially blood storage containers.
Claims (1)
るクエン酸エステル 式中、R1はアセチル基、ブチリル基、もしく
は水素で、また、ｌ，ｍ，ｎは３ないし７の整数
を示す。 を10〜30重量％と、式(2)で示されるフタル酸ジノ
ルマルアルキルエステル （式中、n′は７〜13の整数を表す。） を５〜45重量％とが配合されたポリ塩化ビニル系
樹脂から成形されたことを特徴とする溶血抑制作
用を有する医療用具。 ２ クエン酸エステルがアセチルクエン酸トリヘ
キシルもしくはブチルクエン酸トリヘキシルであ
る特許請求の範囲第１項記載の医療用具。 ３ フタル酸ジノルマルアルキルエステルがフタ
ル酸ジノルマルデシルもしくはフタル酸ジノルマ
ルデシルである特許請求の範囲第１項記載の医療
用具。 ４ 医療用具が血液バツグである特許請求の範囲
第１項記載の医療用具。[Claims] 1. Citric acid ester represented by formula (1) for polyvinyl chloride resin In the formula, R 1 is an acetyl group, a butyryl group, or hydrogen, and l, m, and n are integers of 3 to 7. 10 to 30% by weight of phthalic acid di-normal alkyl ester represented by formula (2) (In the formula, n' represents an integer of 7 to 13.) A medical device having a hemolysis inhibiting effect, characterized in that it is molded from a polyvinyl chloride resin containing 5 to 45% by weight of . 2. The medical device according to claim 1, wherein the citric acid ester is acetyl trihexyl citrate or butyl trihexyl citrate. 3. The medical device according to claim 1, wherein the di-normal alkyl phthalate ester is di-normal decyl phthalate or di-normal decyl phthalate. 4. The medical device according to claim 1, wherein the medical device is a blood bag.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62321344A JPH01164372A (en) | 1987-12-21 | 1987-12-21 | Hemolysis inhibitor and medical utensil obtained by compounding the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62321344A JPH01164372A (en) | 1987-12-21 | 1987-12-21 | Hemolysis inhibitor and medical utensil obtained by compounding the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH01164372A JPH01164372A (en) | 1989-06-28 |
| JPH038778B2 true JPH038778B2 (en) | 1991-02-06 |
Family
ID=18131534
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP62321344A Granted JPH01164372A (en) | 1987-12-21 | 1987-12-21 | Hemolysis inhibitor and medical utensil obtained by compounding the same |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH01164372A (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5262303A (en) * | 1989-10-13 | 1993-11-16 | Trustees Of Boston University | Ligand/anti-ligand assays for adherent proteins |
| JPH0422363A (en) * | 1990-05-17 | 1992-01-27 | Nissho Corp | Bag for preserving platelet and composite bag using the same |
| JP3557248B2 (en) * | 1994-05-31 | 2004-08-25 | テルモ株式会社 | Platelet bag and bag assembly |
| JPH08117316A (en) * | 1994-10-25 | 1996-05-14 | Nippon Sekijiyuujishiya | Container and combined containers for storing blood component |
| JP3932586B2 (en) * | 1995-12-04 | 2007-06-20 | 株式会社ジェイ・エム・エス | Platelet storage container |
| JPH10176089A (en) * | 1996-12-17 | 1998-06-30 | Jms Co Ltd | Medical container |
| JP4763317B2 (en) * | 2005-03-01 | 2011-08-31 | テルモ株式会社 | Medical device made of polyvinyl chloride resin |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60259264A (en) * | 1984-06-07 | 1985-12-21 | テルモ株式会社 | Medical device |
-
1987
- 1987-12-21 JP JP62321344A patent/JPH01164372A/en active Granted
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60259264A (en) * | 1984-06-07 | 1985-12-21 | テルモ株式会社 | Medical device |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH01164372A (en) | 1989-06-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EXPY | Cancellation because of completion of term |