JP2753772B2 - Medical bag - Google Patents
Medical bagInfo
- Publication number
- JP2753772B2 JP2753772B2 JP3103133A JP10313391A JP2753772B2 JP 2753772 B2 JP2753772 B2 JP 2753772B2 JP 3103133 A JP3103133 A JP 3103133A JP 10313391 A JP10313391 A JP 10313391A JP 2753772 B2 JP2753772 B2 JP 2753772B2
- Authority
- JP
- Japan
- Prior art keywords
- weight
- parts
- bag
- plasticizer
- blood
- 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 - Fee Related
Links
- 239000004014 plasticizer Substances 0.000 claims description 11
- GPZYYYGYCRFPBU-UHFFFAOYSA-N 6-Hydroxyflavone Chemical compound C=1C(=O)C2=CC(O)=CC=C2OC=1C1=CC=CC=C1 GPZYYYGYCRFPBU-UHFFFAOYSA-N 0.000 claims description 10
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 claims description 8
- 238000010438 heat treatment Methods 0.000 claims description 8
- 239000011347 resin Substances 0.000 claims description 8
- 229920005989 resin Polymers 0.000 claims description 8
- 239000003381 stabilizer Substances 0.000 claims description 5
- 238000004555 blood preservation Methods 0.000 claims description 4
- 238000001802 infusion Methods 0.000 claims description 4
- 239000003761 preservation solution Substances 0.000 claims description 4
- 239000011342 resin composition Substances 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 238000004659 sterilization and disinfection Methods 0.000 claims description 2
- 239000008280 blood Substances 0.000 description 8
- 210000004369 blood Anatomy 0.000 description 8
- 230000000740 bleeding effect Effects 0.000 description 6
- 239000000203 mixture Substances 0.000 description 4
- 239000004593 Epoxy Substances 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 239000000344 soap Substances 0.000 description 3
- 239000012503 blood component Substances 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 239000003978 infusion fluid Substances 0.000 description 2
- 239000008188 pellet Substances 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- 238000006116 polymerization reaction Methods 0.000 description 2
- 238000004321 preservation Methods 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 239000005639 Lauric acid Substances 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 229910052788 barium Inorganic materials 0.000 description 1
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000003013 cytotoxicity Effects 0.000 description 1
- 231100000135 cytotoxicity Toxicity 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 235000021388 linseed oil Nutrition 0.000 description 1
- 239000000944 linseed oil Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 231100001083 no cytotoxicity Toxicity 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
Landscapes
- Materials For Medical Uses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
【０００１】[0001]
【産業上の利用分野】本発明は、血液バッグ、輸液バッ
グ等の軟質塩化ビニル樹脂が主な材料として使用されて
いる医療用バッグに関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical bag using a soft vinyl chloride resin as a main material, such as a blood bag and an infusion bag.
【０００２】[0002]
【従来技術の課題および課題を解決するための手段】出
願人は、特願昭６３−３３３８７７号（出願日：昭和６
３年１２月２８日）に、可塑剤の溶出が少なく、ガス透
過性が良好で、細胞毒性がなく、血液および血液成分の
保存性が優れた医療用具を提案した。ところがこれらの
医療用具は、アジピン酸ジイソノニルを多量に添加する
と、シート状に成形して使用する場合、シート表面にブ
リードしやすいという欠点があった。そこで本願発明者
は、これらの課題を解決するために鋭意検討を重ねた結
果次の発明に到達した。2. Description of the Related Art The applicant has filed Japanese Patent Application No. 63-333877 (filing date: Showa 6).
On December 28, March 3), a medical device was proposed in which the dissolution of a plasticizer was small, gas permeability was good, there was no cytotoxicity, and blood and blood components were excellent in preservation. However, these medical devices have a drawback that when a large amount of diisononyl adipate is added, when they are used in the form of a sheet, they tend to bleed on the sheet surface. The inventor of the present application has made intensive studies to solve these problems, and has arrived at the following invention.
【０００３】[0003]
【課題を解決するための手段】本発明は、可塑剤の溶
出、ガス透過性、細胞毒性、血液および血液成分の保存
性等の医療用バッグに必要な諸条件を充足し、かつ可塑
剤として添加されるアジピン酸ジイソノニルのブリード
を抑制した医療用バッグを提供することにある。本発明
は、塩化ビニル樹脂１００重量部に対して、アジピン酸
ジイソノニル１０〜２００重量部及び安定剤１〜２０重
量部を配合した樹脂組成物で成形され、７５゜Ｃ以上の
温度で加熱処理を施した医療用バッグを提供するもので
ある。DISCLOSURE OF THE INVENTION The present invention satisfies various conditions required for medical bags such as dissolution of plasticizer, gas permeability, cytotoxicity, and preservation of blood and blood components, and as a plasticizer. An object of the present invention is to provide a medical bag in which bleeding of diisononyl adipate to be added is suppressed. The present invention is formed from a resin composition containing 10 to 200 parts by weight of diisononyl adipate and 1 to 20 parts by weight of a stabilizer based on 100 parts by weight of a vinyl chloride resin, and subjected to heat treatment at a temperature of 75 ° C. or more. The medical bag provided is provided.
【０００４】本発明による医療用バッグに使用される塩
化ビニル樹脂としては、平均重合度が、７００〜３，０
００、好ましくは１，０００〜２，５００のものが使用
される。The vinyl chloride resin used in the medical bag according to the present invention has an average degree of polymerization of 700 to 3.0.
00, preferably 1,000 to 2,500.
【０００５】本発明で使用される可塑剤は、アジピン酸
ジイソノニル（ＤＩＮＡ）で、塩化ビニル樹脂１００重
量部に対して１０〜２００重量部、好ましくは、４０〜
１００重量部使用される。その理由は、１０重量部以下
では可塑剤としての効果が充分でなく、２００重量部以
上になると塩化ビニル樹脂との混合が困難となるためで
ある。The plasticizer used in the present invention is diisononyl adipate (DINA), which is 10 to 200 parts by weight, preferably 40 to 200 parts by weight, per 100 parts by weight of the vinyl chloride resin.
100 parts by weight are used. The reason is that if it is less than 10 parts by weight, the effect as a plasticizer is not sufficient, and if it is more than 200 parts by weight, it is difficult to mix with a vinyl chloride resin.
【０００６】また安定剤としては、エポキシ化合物、例
えばエポキシ化大豆油、エポキシ化アマニ油等のエポキ
シ化植物油やカルシウム、亜鉛、バリウム、マグネシウ
ム等とステアリン酸、ラウリン酸等との金属石鹸類、例
えばステアリン酸カルシウム、ステアリン酸亜鉛等、あ
るいは前記エポキシ化合物と金属石鹸類との混合物が配
合される。Examples of the stabilizer include epoxy compounds, for example, epoxidized vegetable oils such as epoxidized soybean oil and epoxidized linseed oil, and metal soaps of calcium, zinc, barium, magnesium and the like with stearic acid and lauric acid. Calcium stearate, zinc stearate, or the like, or a mixture of the epoxy compound and a metal soap is blended.
【０００７】その量は、塩化ビニル樹脂１００重量部に
対して通常１〜２０重量部である。前記安定剤は、それ
ぞれ単独でも使用可能であるが、前記エポキシ化合物と
金属石鹸を併用することが好ましい。次に、実施例を挙
げて本発明をさらに詳細に説明する。The amount is usually 1 to 20 parts by weight based on 100 parts by weight of the vinyl chloride resin. The stabilizer can be used alone, but it is preferable to use the epoxy compound and a metal soap in combination. Next, the present invention will be described in more detail with reference to examples.
【０００８】[0008]
【実施例】ポリ塩化ビニル（平均重合度Ｐ＝１，３０
０）１００重量部に対して下記表EXAMPLES Polyvinyl chloride (average degree of polymerization P = 1,30)
0) The following table for 100 parts by weight
【０００９】[0009]
【表１】[Table 1]
【００１０】に示す可塑剤及び安定剤等を同表に示す割
合で混合し、押出成形によりペレットを作製した。さら
にこのペレットをシート状に成形し二枚重ね合せ、高周
波溶着によって血液バッグを製造した。配合例３の条件
で製造した血液バッグを下記表The plasticizers and stabilizers shown in Table 1 were mixed in the proportions shown in the same table, and pellets were formed by extrusion molding. Further, the pellets were formed into a sheet shape, and two sheets were overlaid, and a blood bag was manufactured by high frequency welding. The blood bag manufactured under the conditions of Formulation Example 3 is shown in the table below.
【００１１】[0011]
【表２】[Table 2]
【００１２】に示す種々の条件（乾燥加熱、蒸気加熱、
各種温度）で加熱処理を施した後、〜の各保存条件
で一定期間保存した場合の血液バッグの袋状本体内面へ
のブリードの状態を観察した。表２の保存条件は、厚
生省薬審７１８の加速試験基準に従って実施した。表２
の結果により、乾燥加熱した後７０゜Ｃで保存したとき
以外は可塑剤（ＤＩＮＡ）のブリードは完全に抑制で
き、蒸気加熱が特に有効であることが確認できた。Various conditions (drying heating, steam heating,
After performing a heat treatment at various temperatures), the state of bleeding on the inner surface of the bag-shaped main body of the blood bag when stored for a certain period under each of the storage conditions (1) to (3) was observed. The storage conditions in Table 2 were performed according to the accelerated test standards of the Ministry of Health, Labor and Welfare 718. Table 2
As a result, it was confirmed that bleeding of the plasticizer (DINA) could be completely suppressed except when stored at 70 ° C. after drying and heating, and that steam heating was particularly effective.
【比較例】配合例１から３の条件で実施例と同様に製造
した血液バッグを加熱処理することなく厚生省薬審７１
８の加速試験基準に従って４０゜Ｃ×７０％ＲＨで２ケ
月間加速保存して、可塑剤（ＤＩＮＡ）のブリード状況
を確認した。配合例２及び３ではブリードが確認され
た。Comparative Example A blood bag manufactured under the conditions of Formulation Examples 1 to 3 in the same manner as in the Example was heated without any heat treatment.
According to the accelerated test standard of No. 8, the sample was accelerated and stored at 40 ° C. × 70% RH for 2 months to check the bleeding state of the plasticizer (DINA). Bleed was confirmed in Formulation Examples 2 and 3.
【００１３】[0013]
【発明の効果】以上の実施例と比較例の結果により、本
発明によれば可塑剤としてアジピン酸ジイソノニルを塩
化ビニル樹脂に多量に添加してシート状に成形して医療
用バッグを形成する場合、アジピン酸ジイソノニルがシ
ート表面（袋状本体の内面）へブリードするのを抑制す
ることができる。このためシートを用いて袋状に形成し
た後、袋状の本体内に血液保存液または輸液を充填し、
その後に高圧蒸気滅菌処理が必要な血液バッグ、輸液バ
ッグ等の医療用バッグにおいては、袋状本体内に血液保
存液または輸液を充填しても既にシート表面（袋状本体
の内面）への可塑剤のブリードは抑制されているので、
可塑剤が血液保存液または輸液の中に溶出するのを確実
に防ぐことができる。According to the results of the above Examples and Comparative Examples, according to the present invention, when a large amount of diisononyl adipate is added as a plasticizer to a vinyl chloride resin and molded into a sheet to form a medical bag. In addition, bleeding of diisononyl adipate onto the sheet surface (the inner surface of the bag-shaped main body) can be suppressed. For this reason, after forming into a bag using a sheet, filling the bag-shaped body with a blood preservation solution or infusion ,
In the case of a medical bag such as a blood bag or an infusion bag that requires high-pressure steam sterilization thereafter, even if the bag-shaped main body is filled with a blood preservation solution or an infusion solution, the plasticization of the sheet surface (the inner surface of the bag-shaped main body) is already performed. Because the bleeding of the agent is suppressed,
The plasticizer can be reliably prevented from eluting into the blood preservation solution or the infusion solution.
───────────────────────────────────────────────────── フロントページの続き 合議体 審判長 吉村 康男 審判官 深津 弘 審判官 中島 庸子 (56)参考文献 特開 平１−104264（ＪＰ，Ａ) 特開 平１−151459（ＪＰ，Ａ) 特開 昭61−257653（ＪＰ，Ａ) 特表 昭59−501612（ＪＰ，Ａ) ──────────────────────────────────────────────────続 き Continuation of the front page Judge Yasuo Yoshimura Judge Hiroshi Fukatsu Judge Yoko Nakajima (56) References JP-A-1-104264 (JP, A) JP-A-1-151459 (JP, A) JP Showa 61-257653 (JP, A) Special table Showa 59-501612 (JP, A)
Claims (1)
部及び安定剤１〜２０重量部を配合した樹脂組成物で成
形されたシートより構成され、７５゜Ｃ以上の温度で加
熱処理した後に血液保存液または輸液を充填し、最後に
高圧蒸気滅菌処理したことを特徴とする医療用バッグ。1. A sheet formed of a resin composition obtained by mixing 10 to 200 parts by weight of diisononyl adipate and 1 to 20 parts by weight of a stabilizer as a plasticizer with respect to 100 parts by weight of a vinyl chloride resin. Fill with blood preservation solution or infusion after heating at 温度 C or more , and finally
A medical bag that has been subjected to high-pressure steam sterilization .
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3103133A JP2753772B2 (en) | 1991-04-08 | 1991-04-08 | Medical bag |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3103133A JP2753772B2 (en) | 1991-04-08 | 1991-04-08 | Medical bag |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0614990A JPH0614990A (en) | 1994-01-25 |
| JP2753772B2 true JP2753772B2 (en) | 1998-05-20 |
Family
ID=14346042
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP3103133A Expired - Fee Related JP2753772B2 (en) | 1991-04-08 | 1991-04-08 | Medical bag |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2753772B2 (en) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4505708A (en) * | 1982-09-27 | 1985-03-19 | Baxter Travenol Laboratories, Inc. | Blood component storage container and method utilizing a polyvinyl chloride plastic formulation free or essentially free of leachable materials |
| JPS61257653A (en) * | 1985-05-13 | 1986-11-15 | 株式会社ナイガイ | Medical tool |
| JPH01104264A (en) * | 1987-10-19 | 1989-04-21 | Terumo Corp | Medical soft resin composition and medical utensil |
| JPH01151459A (en) * | 1987-12-10 | 1989-06-14 | Terumo Corp | Composition for medical device and medical device using the same |
-
1991
- 1991-04-08 JP JP3103133A patent/JP2753772B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0614990A (en) | 1994-01-25 |
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