JP4335334B2 - Drug infusion container - Google Patents

Drug infusion container Download PDF

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Publication number
JP4335334B2
JP4335334B2 JP28488998A JP28488998A JP4335334B2 JP 4335334 B2 JP4335334 B2 JP 4335334B2 JP 28488998 A JP28488998 A JP 28488998A JP 28488998 A JP28488998 A JP 28488998A JP 4335334 B2 JP4335334 B2 JP 4335334B2
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JP
Japan
Prior art keywords
container
flexible container
drug
mouth member
infusion
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
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JP28488998A
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Japanese (ja)
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JP2000107255A (en
Inventor
学 中村
陽平 蔭山
明彦 坂田
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Hosokawa Yoko KK
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Hosokawa Yoko KK
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Priority to JP28488998A priority Critical patent/JP4335334B2/en
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3261Flexible containers having several compartments
    • B65D81/3266Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Package Specialized In Special Use (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Description

【0001】
【発明の属する技術分野】
本発明は点滴注射等に用いられる薬剤混合輸液容器に関する。更に詳しくは希釈用または溶解用の液体(本発明においては「液体状の薬剤」という。)とこれとは別の他の薬剤(本発明においては、液体状の薬剤に混合または溶解して使用する薬剤を「他の薬剤」という。)が密封状態で隔離収納されており、輸送、貯蔵の間はこれらの薬剤を分離した状態に保ち、点滴用輸液容器として使用するに際して簡単な操作でこれら双方の薬剤を容易に溶解または混合することができる薬剤混合輸液容器に関する。
【0002】
【従来の技術】
医療分野において、点滴注射は広く用いられており、点滴に用いる輸液の中には使用する直前に2種類またはそれ以上の薬剤を混合して輸液をする場合がある。例えばバイアル等の容器に入った粉末薬剤あるいは凍結乾燥薬剤を点滴する時は、これらを液体状の薬剤に溶解して輸液剤として点滴注射に用いるが、このような場合、通常混合作業は診察室または病室などの環境下で行われるため、異物の混入、雑菌の侵入等の可能性が危惧されている。
【0003】
かかる危険性を避ける目的で衛生防疫性を備えた各種の薬剤混合輸液容器が開発されている。これらの薬剤混合輸液容器はバイアル薬剤容器と可携性の液体状の薬剤の容器を外気から遮断された系内に密封してあるものであり、使用に際し密封系内においてこの封止を破り、連通させ二薬剤を混合するものである。かかる輸液容器が、特開平5−123377、特開平5−192377、特開平7−255820などに提案されている。
【0004】
しかしながら、これらの輸液容器においては雑菌の侵入の危険は回避されたが、前記のこれらの輸液容器は従来のバイアル容器を用いているために部品数が増え容器組み立ての工程が煩雑となること、嵩高による箱詰め等での収納量が少ないこと、廃棄時に容器本体を分解して、ゴム、ブラスチック、ガラスなどに分別しなければならないという問題があった。
【0005】
【発明が解決しようとする課題】
本発明は、このような問題に鑑みてなされたものて、組み立て工程が簡素化でき、且つ衛生防疫性、収納性及び易廃棄性に優れた複合輸液容器を提供することを目的とする。
【0006】
【課題を解決するための手段】
本発明は、
[1]内部に液体状の薬剤を収納し、端面がカバーフィルム6で閉栓された口部材2により密封された可撓性容器1と、前記液体状の薬剤と混合して使用する他の薬剤を収納し、端面がカバーフィルム11で閉栓された口部材8及び連通治具9を有する可撓性容器7とが前記両フィルム面間で連結接合され、前記連通治具9は可撓性容器7内に挿入されて該容器の下部で挟持され、栓12を有する口部材10に液体状薬剤と他の薬剤を溶解または混合し、調整した薬剤が通過可能な通路である孔13連通治具の可撓性容器内における底部に有し、かつ口部材10と反対側の先端が尖っていることを特徴とする薬剤混合輸液容器、
を開発することにより上記の目的を達成した。
【0007】
【発明の実施形態】
以下、本発明の内容を図面を用いて詳細に説明する。
液体状の薬剤としては生理食塩水、ぶどう糖液、注射用蒸留水、その他各種の電解質含有液などが挙げられる。また他の薬剤としては点滴注射などに用いられる粉末薬剤あるいは凍結乾燥薬剤または液状の薬剤などである。
本発明の薬剤混合輸液容器の一例を図1に示す。
図1において可撓性容器1は、液体状の薬剤を収納する可撓性の容器であり、内容物確認のための透明性及びレトルト殺菌のための耐熱性を有する材料からなる。好ましい材料としては、単一のポリオレフィンフィルム、2種類以上のポリオレフィンの積層フィルム、ポリオレフィンと他の合成樹脂との積層フィルム等が挙げられる。
可撓性容器1の製造方法は特に限定する必要はないが、例えばブラスチック成形加工において一般的なインフレーション成形により得られる筒状フィルムを切断し上下をシールして用いることが有利である。
【0008】
可撓性容器1の底部にはポリオレフィンを主材料とした充填及び取り出し用の口部材2が筒状フィルムのシール部3に接着されている。この際ヒートシールによりシールすることがコスト、性能的に有利である。可撓性容器1の上部周縁部4もヒートシールにより接着する。この場合、周縁部4には、点滴注射時に架台に吊り下げるための吊り下げ用の穴5を設けてもよい。
可撓性容器1は液体状の薬剤を口部材2より充填した後、口部材2の端面をポリオレフィンを主材質としたカバーフィルム6をヒートシールして密閉する。
【0009】
他の薬剤を収納するための容器7は可撓性容器であることが必要である。使用材料としては上記可撓性容器1と同じものが使用できる。また薬剤の変質を防止する必要がある場合には、酸素及び水蒸気に対するバリア性を有する材料を用いてもよい。バリア性材料の具体例としては最も内側をポリオレフィン層とし、その上にバリア層を配したラミネート材料が挙げられる。必要に応じてバリア層の上にポリオレフィンなどの保護層を設けてもよい。
好ましいバリア層の材料としてはエチレンービニルアルコール共重合体、ポリアミド、ポリ塩化ビニリデン、ポリエステル、アルミニウム箔あるいはケイ素酸化物、酸化アルミまたはアルミニウム等を蒸着した樹脂フィルム等が挙げられ、他の薬剤の性質に応じてこれらのバリア材料を選択してあるいは組み合わせて積層して用いる。
【0010】
他の薬剤のための可撓性容器7を製造するためには、プラスチックのフィルム成形加工において使用される一般的な多層インフレーション成形、多層Tダイ成形、ラミネート成形等により得られるフィルムを用いることができる。
可撓性容器7の上部に、可撓性容器1に使用した口部材2と同様の口部材8を挟持させる。口部材8の上部端面にはポリオレフィンを主材質としたカバーフィルム11を例えばヒートシールして閉栓する。可撓性容器7の底部には硬質のポリオレフィンを主材質とした先端が尖った形状の連通治具9を備えた薬剤充填及び取り出し用口部材10を図1に示す様に挟持させる。
該連通治具9を備えた口部材10の形態は、連通治具9と口部材10を一体で射出成形等により成形するのが好ましいが、別々に成形した後組み合わせ支持したり、別々に成形した後一体化してもよい。可撓性容器7には、他の薬剤を口部材10より充填した後ゴム栓12で密封する。
【0011】
該連通治具9は、中空針状が好ましいが、例えばカバーフィルム6、11を破った時に、可撓性容器1から液体状の薬剤を可撓性容器7に導入することができ、かつ他の薬剤を溶解または混合した調製した他の薬剤を可撓性容器7より口部材10に通過可能な通路、例えば孔13があればその形状は針状、尖棒状、板状等、カバーフィルムを破壊でき得るならばどんな形状でもよい。
連通治具9の先端は、確実にカバーフィルム6及び11を貫通できる様に、口部材8の中空部に挿入支持されている。
【0012】
上記のように可撓性容器1及び可撓性容器7はそれぞれカバーフィルムにより密閉されているので独立の形で取り扱うことができるため、それぞれの内容物の薬剤に応じた適切な殺菌条件を選ぶことができる。すなわち、液体状の薬剤を入れた可撓性容器1は高温の加熱殺菌であるレトルト殺菌を、一方他の薬剤を入れた可撓性容器7は加熱により変質の危険あるような時には放射線殺菌などにより殺菌を行った後、無菌室などにおいてこれら両者の口部材2及び8を溶着連結することにより一体化すれば良い。
可撓性容器1及び可撓性容器7は両カバーフィルム6及び11の面が重なるように、カバーフィルムを挟持して口部材2及び口部材8の周縁部同士の溶着により連結一体化されている。溶着の方法としては、バット溶着、熱板溶着、インパルス溶着、高周波溶着、超音波溶着等が挙げられるが、とりわけ生産性の観点からは高周波溶着が好ましい。
【0013】
薬剤等が充填された薬剤混合輸液容器は、貯蔵、輸送などにおいての封止部の安全性を確保するために口部材2及び口部材10の間を段ボールなどにより保護する程度で良く、安全に梱包、輸送、保存できる。
両可撓性容器間の連通方法の詳細を図2に示す。
段ボール等の保護材を除いた後、可撓性容器7を縦方向に圧縮することにより口部材8により誘導された連通治具9の先端がカバーフィルム6及び11を貫通破壊し、これにより液体状の薬剤の可撓性容器1と可撓性容器7が連通し、両薬剤が混合される。場合によっては可撓性容器1及び可撓性容器7を交互に押しつぶし、薬剤同士のより均一な混合を図ることが可能である。
十分に混合あるいは溶解が済んだ調製された薬剤は、口部材10を閉栓したゴム栓を貫通した中空針等に通して輸液などに使用する。
【0014】
【発明の効果】
本発明の複合輸液容器は、部品数が少なく、製造は容易であり、生産性の良好な構造を有しており、薬剤充填後においても使用するまではそれぞれの薬剤を確実に分離状態を維持し、使用に際しては簡単な操作で無菌状態を維持したまま混合できる。更に全体がプラスチックであって廃棄は容易であり、密閉した薬剤混合輸液容器内で混合できる衛生防疫性を備え、使用前の収納性及び使用後の廃棄性に優れた薬剤混合輸液容器である。
【図面の簡単な説明】
【図1】本発明の薬剤混合輸液容器の正面断面図。
【図2】本発明の薬剤混合輸液容器を連通させる時の状態を示す概略図。
【符号の説明】
1 可撓性容
2 口部
3 ヒートシール部
4 周縁部
5 吊り下げ用穴
6 カバーフィルム
7 可撓性容
8 口部
9 連通治具
10 口部
11 カバーフィルム
12 ゴム栓
13 連通治具に設けた孔
[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a drug mixed infusion container used for instillation injection and the like. More specifically, a liquid for dilution or dissolution (referred to as “liquid drug” in the present invention) and another drug (in the present invention, mixed or dissolved in a liquid drug) "Other drugs" are sealed and housed in a sealed state, and these drugs are kept separated during transportation and storage, and these can be easily operated when used as an infusion container for infusion. The present invention relates to a drug-mixed infusion container that can easily dissolve or mix both drugs.
[0002]
[Prior art]
In the medical field, instillation is widely used, and infusion used for infusion may be infused by mixing two or more kinds of drugs immediately before use. For example, when instilling a powdered drug or freeze-dried drug in a container such as a vial, these are dissolved in a liquid drug and used for infusion as an infusion. In such cases, the mixing operation is usually performed in the examination room. Or, since it is carried out in an environment such as a hospital room, there is a concern about the possibility of contamination by foreign substances and invasion of germs.
[0003]
In order to avoid such a risk, various drug-mixed infusion containers having sanitary and epidemiological properties have been developed. These drug-mixed infusion containers are those in which a vial drug container and a portable liquid drug container are sealed in a system that is shielded from the outside air, and when used, this seal is broken in the sealed system. Communicating and mixing two drugs. Such infusion containers have been proposed in JP-A-5-123377, JP-A-5-192377, JP-A-7-255820, and the like.
[0004]
However, in these infusion containers, the risk of invasion of various germs has been avoided, but these infusion containers use conventional vial containers, which increases the number of parts and complicates the container assembly process. There is a problem that the storage amount in the boxing due to bulkiness is small, and the container body must be disassembled at the time of disposal and separated into rubber, plastic, glass and the like.
[0005]
[Problems to be solved by the invention]
The present invention has been made in view of such problems, and an object of the present invention is to provide a composite infusion container that can simplify an assembling process and is excellent in hygiene prevention, storage, and easy disposal.
[0006]
[Means for Solving the Problems]
The present invention
[1] A flexible container 1 containing a liquid medicine inside and sealed by a mouth member 2 whose end face is closed with a cover film 6, and another medicine used by mixing with the liquid medicine The flexible container 7 having the mouth member 8 whose end face is closed with the cover film 11 and the communication jig 9 is connected and joined between the two film surfaces, and the communication jig 9 is a flexible container. is inserted into the 7 is sandwiched by the bottom of the vessel, the liquid medicine and other drugs dissolved or mixed in the mouth member 10 having a stopper 12, a hole 13 adjusted drug is passable passageway communicating Michiharu A drug-mixing infusion container characterized by having a sharp tip on the opposite side of the mouth member 10 at the bottom of the device in the flexible container;
The above objective was achieved by developing
[0007]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the contents of the present invention will be described in detail with reference to the drawings.
Examples of the liquid drug include physiological saline, glucose solution, distilled water for injection, and other various electrolyte-containing solutions. Other drugs include powder drugs, freeze-dried drugs, and liquid drugs used for instillation injections.
An example of the drug-mixed infusion container of the present invention is shown in FIG.
The flexible container 1 in Fig. 1 is a container of flexible for accommodating the liquid medicament, made of a material having a heat resistance for transparency and retort sterilization for the contents confirmation. Preferable materials include a single polyolefin film, a laminated film of two or more types of polyolefin, a laminated film of polyolefin and other synthetic resin, and the like.
Method of manufacturing a flexible container 1 need not be particularly limited, for example, by cutting the tubular film obtained by a general inflation molding advantageously be used to seal the top and bottom in brass tick molding.
[0008]
The bottom of the flexible container 1 neck member (2) for filling and removal and polyolefin as a main material is bonded to the sealing portion 3 of the tubular film. In this case, sealing by heat sealing is advantageous in terms of cost and performance. Upper peripheral edge portion 4 of the flexible container 1 is also bonded by heat-sealing. In this case, the peripheral edge 4 may be provided with a suspending hole 5 for suspending from the pedestal during drip injection.
After the flexible container 1 is filled from the mouth member 2 a liquid drug, an end surface of the mouth member 2 is sealed by heat-sealing the cover film 6 in which the polyolefin as a main material.
[0009]
Container for housing the other agent 7 is required to be a flexible container. Same as the flexible container 1 can be used as the material used. Further, when it is necessary to prevent the alteration of the drug, a material having a barrier property against oxygen and water vapor may be used. Specific examples of the barrier material include a laminate material in which the innermost layer is a polyolefin layer and a barrier layer is disposed thereon. If necessary, a protective layer such as polyolefin may be provided on the barrier layer.
Preferred barrier layer materials include ethylene-vinyl alcohol copolymer, polyamide, polyvinylidene chloride, polyester, aluminum foil or resin film deposited with silicon oxide, aluminum oxide or aluminum, etc. Properties of other drugs These barrier materials are selected according to the above or combined and used.
[0010]
To produce the flexible container 7 for other agents, general multilayer inflation molding to be used in the film molding of plastic, multi-layer T-die molding, the use of a film obtained by lamination molding, etc. Can do.
On top of the flexible container 7, thereby clamping the same mouth member 8 and the mouth member 2 used in the flexible container 1. The upper end surface of the mouth member 8 to plugging the cover film 11 in which the polyolefin as a main material for example by heat sealing. The bottom of the flexible container 7 to sandwich the drug loading and unloading mouth member 10 having a communication Michiharu device 9 shaped with a pointed tip in which the polyolefin rigid main material as shown in FIG.
Form of the mouth member 10 having a該連Michiharu tool 9 is preferably molded by injection molding or the like communicating Michiharu member 9 and the mouth member 10 integrally, or combinations supported after forming separately, separately It may be integrated after being molded. The flexible container 7 is sealed with a rubber stopper 12 after filling from the mouth member 10 other agents.
[0011]
該連Michiharu member 9 is a hollow needle is preferred, for example when broke cover film 6 and 11, the liquid agent can be introduced into the flexible container 7 from the flexible container 1, and other drugs dissolved or mixed with other agents prepared was passable to the mouth member 10 of a flexible container 7 passages, for example, holes 13, if any, with the shape of acicular, pointed rods, plate-like, etc. Any shape can be used as long as the cover film can be broken.
The tip of the communicating Michiharu device 9, as can be reliably penetrate the cover film 6 and 11, is inserted supported by the hollow portion of the mouth member 8.
[0012]
Since it can be handled in separate form because it is sealed by a respective flexible container 1 and the flexible container 7 cover film as described above, appropriate sterilization conditions in accordance with the drug each content Can be selected. That is, radiation when such flexible container 1 containing the liquid drug to retort sterilization at a high temperature heat sterilization, while the other flexible container 7 containing the drug is the danger of deterioration by heat after sterilization by such sterilization may be integrated by welding connecting the mouth member 2 and 8 of them in such a clean room.
The flexible container 1 and the flexible container 7 as the surface of both the cover film 6 and 11 overlap, connecting by welding the peripheral edge portions of the mouth member 2 and the mouth member 8 by holding the cover film It is integrated. Examples of the welding method include butt welding, hot plate welding, impulse welding, high frequency welding, ultrasonic welding, and the like, but high frequency welding is particularly preferable from the viewpoint of productivity.
[0013]
Agent such as a drug mixed infusion container is filled may extent to protect storage, transport by cardboard between the mouth member 2 and the mouth member 10 in order to ensure the safety of the sealing portion of the like, It can be safely packed, transported and stored.
Details of the communication method between the two flexible containers are shown in FIG.
After removing the protective material such as corrugated cardboard, the flexible container 7 is compressed in the longitudinal direction so that the tip of the communication jig 9 guided by the mouth member 8 penetrates and breaks the cover films 6 and 11, thereby liquid. The flexible drug container 1 and the flexible container 7 communicate with each other, and both drugs are mixed. In some cases, the flexible container 1 and the flexible container 7 can be crushed alternately to achieve more uniform mixing of the drugs.
Is well mixed or dissolved was prepared after completion medicament is to through the hollow needle or the like through the rubber stopper that plugging the mouth member 10 is used, such as an infusion.
[0014]
【The invention's effect】
The composite infusion container of the present invention has a small number of parts, is easy to manufacture, has a structure with good productivity, and reliably maintains each drug until it is used even after drug filling. However, it can be mixed while maintaining sterility by a simple operation when used. Furthermore, it is a plastic mixed infusion container which is plastic as a whole and is easy to dispose of, has a sanitary and epidemiological property that can be mixed in a sealed drug mixed infusion container, and is excellent in storage before use and disposal after use.
[Brief description of the drawings]
FIG. 1 is a front sectional view of a drug infusion container of the present invention.
FIG. 2 is a schematic view showing a state when the drug-mixed infusion container of the present invention is in communication.
[Explanation of symbols]
1 flexible container 2 mouth member 3 heat-sealed portion 4 periphery 5 hanging hole 6 cover film 7 flexible container 8 neck member 9 stations Michiharu instrument 10 neck member 11 cover film 12 rubber plug 13 Hole provided in the communication jig

Claims (1)

内部に液体状の薬剤を収納し、端面がカバーフィルム6で閉栓された口部材2により密封された可撓性容器1と、前記液体状の薬剤と混合して使用する他の薬剤を収納し、端面がカバーフィルム11で閉栓された口部材8及び連通治具9を有する可撓性容器7とが前記両フィルム面間で連結接合され、前記連通治具9は可撓性容器7内に挿入されて該容器の下部で挟持され、栓12を有する口部材10に液体状薬剤と他の薬剤を溶解または混合し、調整した薬剤が通過可能な通路である孔13連通治具の可撓性容器内における底部に有し、かつ口部材10と反対側の先端が尖っていることを特徴とする薬剤混合輸液容器。A liquid medicine is accommodated therein, and a flexible container 1 sealed with a mouth member 2 whose end face is closed with a cover film 6 and other medicines to be used by mixing with the liquid medicine are accommodated. The opening member 8 whose end face is closed with the cover film 11 and the flexible container 7 having the communication jig 9 are connected and joined between the two film surfaces, and the communication jig 9 is placed in the flexible container 7. The hole 13 which is a passage through which the liquid medicine and other chemicals are dissolved or mixed in the mouth member 10 which is inserted and clamped at the lower part of the container 12 and has the stopper 12 and through which the adjusted medicine can pass can be used as a communication jig. A drug-mixing infusion container characterized by having a tip at the bottom in a flexible container and having a sharp tip opposite to the mouth member 10.
JP28488998A 1998-10-07 1998-10-07 Drug infusion container Expired - Fee Related JP4335334B2 (en)

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AU2001286061A1 (en) * 2000-09-11 2002-03-26 Adrian James Gaunt Applicator
US7048724B2 (en) * 2002-12-17 2006-05-23 Denver Biomedicals, Inc. Device for withdrawing body fluids
US20070074980A1 (en) * 2005-09-02 2007-04-05 Bankoski Brian R Implant rehydration packages and methods of use
JP5024526B2 (en) * 2007-02-26 2012-09-12 味の素株式会社 Multi-chamber container
WO2010081174A2 (en) * 2009-01-12 2010-07-15 Aktivpak, Inc. Packaged products, inserts and compartments for aseptic mixing of substances, along with methods for use therewith
EP2665502B1 (en) * 2011-01-17 2020-03-25 AktiVax, Inc. Aseptic cartridge and dispenser arrangement
DE102013226706A1 (en) * 2013-12-19 2015-06-25 Beiersdorf Ag Lightweight packaging with dosing chamber

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JPH0257257A (en) * 1988-08-24 1990-02-27 Yamarura Glass Co Ltd Transfusion container
JPH04329953A (en) * 1991-04-30 1992-11-18 Takeda Chem Ind Ltd Gear free holding/mixing apparatus for two kinds of medicines held in individually sealed container
JPH05123377A (en) * 1991-05-29 1993-05-21 Fujisawa Pharmaceut Co Ltd Infusion device
JP2630185B2 (en) * 1991-10-25 1997-07-16 藤沢薬品工業株式会社 Infusion device
JP3483218B2 (en) * 1994-03-18 2004-01-06 扶桑薬品工業株式会社 Infusion container
JPH09248328A (en) * 1996-03-15 1997-09-22 Material Eng Tech Lab Inc Container for medical treatment and its production
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JPH10108893A (en) * 1996-10-07 1998-04-28 Nippon Kayaku Co Ltd Multi-chamber medical container for continuous mixing
JP2000084046A (en) * 1998-09-10 2000-03-28 Showa Denko Kk Composite infusion solution container

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