JP5376825B2 - Method of injecting chemical solution container, chemical formulation and medical solution into medical infusion bag - Google Patents

Method of injecting chemical solution container, chemical formulation and medical solution into medical infusion bag Download PDF

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JP5376825B2
JP5376825B2 JP2008097738A JP2008097738A JP5376825B2 JP 5376825 B2 JP5376825 B2 JP 5376825B2 JP 2008097738 A JP2008097738 A JP 2008097738A JP 2008097738 A JP2008097738 A JP 2008097738A JP 5376825 B2 JP5376825 B2 JP 5376825B2
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伝内 武田
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Ajinomoto Co Inc
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本発明は、複数の室を備える薬液容器、その薬液容器に複数種類の薬液を収容した薬液製剤及び薬液容器に収容した薬液を該医療用輸液バッグに注入する方法に関する。より詳細には、人体に点滴により供給される輸液製剤、例えば、高カロリー輸液、アミノ酸輸液、電解質輸液、糖類輸液、その他の医療用輸液に、反応を生じ易い薬液を使用前に注入するために好適な複数の室を備える薬液容器、その薬液容器に複数種類の薬液を収容した薬液製剤及び薬液容器に収容した第1、第2、第3の薬液を該医療用輸液バッグに注入する方法に関する。 The present invention relates to a chemical solution container having a plurality of chambers, a chemical preparation containing a plurality of types of chemical solutions in the chemical solution container, and a method for injecting the chemical solution stored in the chemical solution container into the medical infusion bag . More specifically, in order to inject a liquid solution that easily causes a reaction into an infusion preparation to be supplied to the human body by infusion, for example, a high calorie infusion, an amino acid infusion, an electrolyte infusion, a saccharide infusion, or other medical infusion before use. The present invention relates to a chemical solution container having a plurality of suitable chambers, a chemical preparation containing a plurality of types of chemical solutions in the chemical solution container, and a method for injecting the first, second and third chemical solutions stored in the chemical solution container into the medical infusion bag. .

従来、点滴により人体に供給される輸液成分、例えば、アミノ酸液、ブドウ糖液等は、混合すると変質するため、剥離可能な隔離手段により仕切られた輸液容器、特に輸液バッグ内の複数の個室へそれぞれ収容し、使用時に輸液バッグを外から押圧して隔離手段を剥離させて混合することが工夫されており、このような技術は、例えば、特開昭62−176451号公報、特開平8−182739号公報、特表平8−509631号公報等に開示されている。また点滴により患者に輸液を投与する場合、患者の病態により、アミノ酸液、ブドウ糖液等の輸液製剤に少量の各種薬液、例えば、トレースミネラル(微量元素)、ビタミン剤、鎮痛剤、脂肪輸液、抗生物質、ミネラル分、強心剤等を混合することが必要になる。通常、輸液製剤に少量の薬液を混合する作業(混注)は、病院内のクリーンブース内で行われ、混合すべき薬液を注射器を用いて輸液バッグ内の輸液へ注入する。この場合、薬液の細菌感染を起こさないように注意深く行われる。これらの混注操作は煩雑であり、簡便な操作で混注が行なえることが望まれている。   Conventionally, infusion components supplied to the human body by infusion, for example, amino acid solution, glucose solution, etc., are altered when mixed, so each of the infusion containers separated by a detachable isolating means, especially into a plurality of individual chambers in the infusion bag, respectively. It has been devised to house and press the infusion bag from the outside at the time of use to separate and separate the separating means, and such techniques are disclosed in, for example, JP-A-62-176451, JP-A-8-182739. No. 5, No. 8-509631, and the like. In addition, when infusion is administered to a patient by intravenous drip, depending on the patient's pathology, a small amount of various medicinal solutions such as amino acid solution and glucose solution, for example, trace mineral (trace element), vitamin, analgesic, fat infusion, antibiotics It is necessary to mix substances, minerals, cardiotonics, etc. Usually, a work (mixed injection) for mixing a small amount of liquid medicine with an infusion preparation is performed in a clean booth in a hospital, and the liquid medicine to be mixed is injected into the infusion liquid in an infusion bag using a syringe. In this case, it is performed carefully so as not to cause bacterial infection of the drug solution. These mixed injection operations are complicated, and it is desired that mixed injection can be performed with a simple operation.

他方、近年、在宅医療が好まれ増加する傾向にあり、家庭で患者に輸液を点滴により投与することが多くなっている。輸液は、1日の投与量が約1kgの輸液バッグ2個の場合が多く、比較的重量があり、また在宅医療用の輸液への薬液の混注が病院で行われる場合、混注後に変質しない間に患者に投与するため、病院から輸液を頻繁に運搬することが必要となり、在宅看護の負担を重くしている。   On the other hand, in recent years, home medical care has been favored and tends to increase, and infusions are frequently administered to patients at home. Infusions are often 2 infusion bags with a daily dose of about 1 kg, and they are relatively heavy. When a medical solution is mixed with a medical solution for home medical care, it does not change after the mixed injection. In order to administer it to patients, it is necessary to frequently transport infusions from hospitals, increasing the burden of home care.

特開平10−24088号は、無菌保証が成された状態で、薬剤封入バイアル等を少ない部品で簡易に接続した輸液容器を提供することを目的とした薬剤封入容器セットを開示する。この薬剤封入容器セットは、樹脂製容器であり複数の室を有し、室と室との隔離条部の少なくとも一部が外側から開放可能なピールシール部又は弱シール部で形成され、第1室に薬液が収容され、第2室に充填容器が接続され、充填容器は薬液に混合される薬剤を収容し、充填容器の開口を閉じる蓋体又は膜体が第2室の外側から押圧することにより充填容器内へ押し込むことが可能であり、蓋体又は膜体が充填容器内へ押し込まれることにより第2室内と充填容器内が連通される。高圧蒸気滅菌処理した樹脂製容器と薬剤を収容したバイアルは、無菌、無塵室内で接続され、その後第2室のみが電子照射滅菌され、第2室内の一旦外界に晒された充填容器の外面と共に滅菌処理される。   Japanese Patent Laid-Open No. 10-24088 discloses a drug-filled container set for the purpose of providing an infusion container in which a drug-filled vial or the like is simply connected with few parts in a state where sterility is guaranteed. This drug enclosure container set is a resin container and has a plurality of chambers, and at least a part of a separating strip portion between the chambers is formed by a peel seal portion or a weak seal portion that can be opened from the outside. A chemical solution is stored in the chamber, a filling container is connected to the second chamber, the filling container stores the drug mixed with the chemical solution, and a lid or a film body that closes the opening of the filling container presses from the outside of the second chamber. Thus, it can be pushed into the filling container, and the second chamber and the filling container are communicated with each other by pushing the lid or film into the filling container. The plastic container sterilized by high-pressure steam and the vial containing the drug are connected in a sterile, dust-free chamber, and then only the second chamber is sterilized by electron irradiation, and the outer surface of the filled container once exposed to the outside in the second chamber And sterilized together.

実公平6−42676号公報は、バイアル中の薬剤を、容易且つ安全にバッグ内の点滴用薬液に添加する目的の輸液バッグを開示する。この輸液バッグは、ゴム栓によって封止されたバイアルの口部を接続可能な口部材を有する。口部材は、外周面下部が合成樹脂製フィルムの一方の開口端に融着され、下端が封止膜により密閉され、上部外周に雄ネジを備える有底円筒状部品3、有底円筒状部品に挿入され、上端が閉塞され、この閉塞された部分を貫通して、先端が穿刺刃の中空針6が固定され、下端が穿刺刃である棒状部品4、有底円筒状部品の雄ネジに螺合する雌ネジを備える下部小径部及び小径部と区画部を介して一体成形されバイアルの口部が嵌合される大径部を有し区画部を中空針が刺通する第2部品5、並びに第2部品の大径部の開口端を閉塞するシール10を有する。先端が穿刺刃である代わりに棒状部品の端部に固定したゴム栓63を設けることができる。   Japanese Utility Model Publication No. 6-42676 discloses an infusion bag for the purpose of easily and safely adding a drug in a vial to an infusion drug solution in the bag. This infusion bag has a mouth member capable of connecting a mouth portion of a vial sealed with a rubber stopper. The mouth member has a bottomed cylindrical part 3 with a lower outer peripheral surface fused to one opening end of the synthetic resin film, a lower end sealed with a sealing film, and a male screw on the upper outer periphery. The hollow needle 6 having a puncture blade at the tip is fixed and the lower end is a stick-shaped part 4 having a puncture blade and a male screw of a bottomed cylindrical part. Second part 5 having a small diameter part having a female screw to be screwed together and a small diameter part and a large diameter part which is integrally formed through the partition part and into which the mouth of the vial is fitted, and through which the hollow needle pierces the partition part. And a seal 10 for closing the open end of the large diameter portion of the second part. Instead of the tip being a puncture blade, a rubber stopper 63 fixed to the end of the rod-shaped part can be provided.

輸液製剤に混注すべき、各種の少量の薬液を少ない操作で混注できる薬液容器を検討するにあたり、各薬液同志が混合によって汚濁が生じたり分解が促進されるものを考慮する必要がある。特に、ビタミン剤は、光や温度により品質劣化が促進されるばかりでなく、微量元素類と配合すると不溶性の析出物あるいは微粒子が生じたり、分解が促進される恐れがある。   When examining a chemical container that can be mixed and mixed with an infusion preparation with a small number of operations, it is necessary to consider what each chemical solution causes to be contaminated or promoted to decompose. In particular, vitamin agents are not only accelerated in quality deterioration due to light and temperature, but may contain insoluble precipitates or fine particles or may be decomposed when mixed with trace elements.

高カロリー輸液用糖・電解質・アミノ酸液には、ビタミンB2他のビタミン剤、及び鉄供給源他の複数の微量元素を含有する微量元素製剤を混注する例が多くみられる。ビタミン剤と微量元素製剤を混合した薬液は、短期間に品質劣化し、とくにビタミンB2と微量元素製剤に含まれる鉄供給源由来の析出物が確認できる。この析出物の生成には、温度、光、還元物質、酸素などの要因が関与するが、きわめて短時間に生成することから同一容器内に充填することは困難である。 In sugar, electrolytes, and amino acid solutions for high-calorie infusion, there are many cases where vitamin B 2 and other vitamin preparations, and trace element preparations containing a plurality of trace elements such as an iron source are mixed. The chemical solution in which the vitamin preparation and the trace element preparation are mixed deteriorates in a short time, and in particular, precipitates derived from vitamin B 2 and the iron supply source contained in the trace element preparation can be confirmed. Factors such as temperature, light, reducing substances, and oxygen are involved in the formation of this precipitate, but since it is generated in a very short time, it is difficult to fill the same container.

本発明は、高カロリー輸液、アミノ酸輸液、電解質輸液、糖類輸液その他の薬液収容する輸液バッグ内へ患者に必要な少量の薬液を混注する作業を、病院において安全に且つ容易に行うことができ、また在宅医療がなされる家庭において混注作業を可能にする薬液容器を提供することを目的とする。本発明は、また混注すべき異種の薬液間の品質劣化の原因となる相互作用を排除し選択的に隔壁手段で隔離された複数の室に薬液を分離収容することが可能な薬液容器を提供するとを目的とする。本発明のその他の目的は、以下の説明において明らかにされる。   The present invention can safely and easily perform the work of co-injecting a small amount of liquid medicine necessary for a patient into an infusion bag containing high-calorie infusion, amino acid infusion, electrolyte infusion, saccharide infusion, and other medicinal liquids in a hospital, Moreover, it aims at providing the chemical | medical solution container which enables mixed injection work in the home where home medical care is made. The present invention also provides a chemical container capable of separating and accommodating chemical liquids in a plurality of chambers that are selectively isolated by a partition means by eliminating an interaction that causes quality deterioration between different kinds of chemical liquids to be mixed. Then the purpose. Other objects of the present invention will be clarified in the following description.

本発明の薬液容器は、ビタミンB2を含有する薬液を収容する第1区画、鉄供給源を含有する薬液を収容する第2区画、及び両区画から薬液を輸液容器内へ送出可能な連通機構を備える。鉄供給源を含有する薬液は、亜鉛供給源、銅供給源、マンガン供給源又はヨウ素供給源を含有する。第1区画は第1室(A1)、第2室及び副室に分割され、第1室にビタミンB2を含有する薬液が収容され、第2室にビタミンA、ビタミンD、ビタミンE又はビタミンKを含有する薬液が収容され、ビタミンB12又は葉酸が第1室又は第2室の薬液に含有され、副室は連通機構を具備する。連通機構は、特願2000−321487号に記載の連通機構を用いることができる。 The medicinal solution container of the present invention includes a first compartment that contains a medicinal solution containing vitamin B 2 , a second compartment that contains a medicinal solution containing an iron supply source, and a communication mechanism capable of sending the medicinal solution from both compartments into the infusion container. Is provided. The chemical solution containing an iron source contains a zinc source, a copper source, a manganese source, or an iodine source. The first compartment is divided into a first chamber (A1), a second chamber, and a subchamber, a chemical solution containing vitamin B 2 is stored in the first chamber, and vitamin A, vitamin D, vitamin E, or vitamins are stored in the second chamber. A chemical solution containing K is accommodated, vitamin B 12 or folic acid is contained in the chemical solution in the first chamber or the second chamber, and the subchamber has a communication mechanism. As the communication mechanism, the communication mechanism described in Japanese Patent Application No. 2000-32487 can be used.

第1室と副室との間が第1隔離手段により区画され、第2室と副室との間にが第2隔離手段により区画され、第1隔離手段及び第2隔離手段は第1室又は第2室の薬液を外部から押圧することにより開放される。第1室が第1小室及び第2小室に区画され、第1小室がビタミンB1を含有する薬液を収容し、第2小室がビタミンCを含有する薬液を収容し、ビタミンB2が第1小室又は第2小室に収容される薬液に含有される。ビタミンB6、ニコチン酸類、パントテン酸類又はビオチンが第1小室及び第2小室のいずれかの薬液に含有される。 The first chamber and the sub chamber are partitioned by the first isolating means, and the second chamber and the sub chamber are partitioned by the second isolating means, and the first isolating means and the second isolating means are the first chamber. Or it opens by pressing the chemical | medical solution of a 2nd chamber from the outside. The first chamber is divided into a first chamber and a second chamber, the first chamber contains a chemical solution containing vitamin B 1 , the second chamber contains a chemical solution containing vitamin C, and vitamin B 2 is the first It is contained in the chemical solution stored in the small chamber or the second small chamber. Vitamin B 6 , nicotinic acids, pantothenic acids, or biotin is contained in the chemical solution in either the first chamber or the second chamber.

連通機構は、輸液容器内部と薬液容器のいずれかの区画又は室を連通する通路、通路を閉鎖する閉鎖体、及び閉鎖体を移動させるか又は閉鎖体に貫通路を形成し通路を開通させる手段を含む。   The communication mechanism includes a passage that connects the inside of the infusion container and any compartment or chamber of the chemical container, a closing body that closes the passage, and a means for moving the closing body or forming a through passage in the closing body to open the passage including.

本発明の薬液容器は、ビタミンを含有する薬液を収容する第1区画、鉄供給源を含有する薬液を収容する第2区画、及び両区画から薬液を輸液容器内へ送出可能な連通機構を備える。第1区画及び第2区画は、可撓性樹脂フイルムの周縁部を相互に強固に接着して形成される袋状空間を強固な密封部により仕切ることにより形成され、連通機構は第1区画及び第2区画にそれぞれ配置される。好適には、第1区画は第1室、第2室及び副室に分割され、第2室と副室との間にが第2隔離手段により区画され、第1隔離手段及び第2隔離手段は第1室又は第2室の薬液を外部から押圧することにより開放される。第1隔離手段及び第2隔離手段は樹脂フィルムが弱接着されることにより形成される。   The medicinal solution container of the present invention includes a first compartment that contains a medicinal solution containing vitamins, a second compartment that contains a medicinal solution containing an iron supply source, and a communication mechanism capable of sending the medicinal solution from both compartments into the infusion container. . The first compartment and the second compartment are formed by partitioning a bag-like space formed by firmly adhering the peripheral portions of the flexible resin film to each other by a strong sealing portion. Arranged in the second section. Preferably, the first section is divided into a first chamber, a second chamber, and a sub chamber, and the second chamber and the sub chamber are partitioned by the second isolating means, and the first isolating means and the second isolating means. Is opened by pressing the chemical solution in the first chamber or the second chamber from the outside. The first separating means and the second separating means are formed by weakly bonding the resin film.

本発明の薬液容器は、2枚重ねた可撓性樹脂フイルムの2つの側縁部、上縁部、下縁部を強固に接着し袋状空間を形成し、該袋状空間を3つの弱シール(72、73、74)により仕切って形成される4つの室(E、V1、V2、V3)を含む。室内の薬液を輸液容器内へ送出可能な連通機構が下縁に配置され、3つの弱シール(75、73、74)は、連通機構52から遠いものほど強く接着し、遠いものほど開放するために大きな押圧力が必要であるように構成される。   The liquid chemical container of the present invention forms a bag-like space by firmly bonding two side edges, an upper edge, and a lower edge of a two-layered flexible resin film. It includes four chambers (E, V1, V2, V3) that are partitioned by seals (72, 73, 74). A communication mechanism capable of delivering the chemical solution in the room to the infusion container is disposed at the lower edge, and the three weak seals (75, 73, 74) are more strongly bonded to the one farther from the communication mechanism 52 and open to the farther one. Is configured so that a large pressing force is required.

本発明の薬液容器は、ガラスやポリエチレン、ポリプロピレン、ポリ4−メチルペンテンやシクロオレフィンポリマー(Cyclo Olefine Polymer(COP)、商品名 ゼオノア、日本ゼオン社製)等の熱可塑性樹脂で製することができる。本発明の薬液容器として、成形性や柔軟性に富む熱可塑性樹脂が好適に使用されるが、ビタミン剤のうち特に脂溶性ビタミン類(ビタミンA、ビタミンD、ビタミンE及びビタミンK)が吸着しにくい熱可塑性樹脂を用いることが好ましく、緒特性に優れた前記シクロオレフィンポリマー(商品名 ゼオノア、日本ゼオン社製)が特に好ましい。また、シクロオレフィンポリマーとポリエチレンとをTダイ押出機あるいはインフレーション成形機により2層あるいは3層に積層した多層フィルムを形成し薬液容器として使用することが好ましい。また、ポリエチレンに替えて、ポリプロピレンあるいはポリエチレンとポリプロピレンの混合組成の樹脂との多層フィルムを形成してもよい。   The chemical solution container of the present invention can be made of a thermoplastic resin such as glass, polyethylene, polypropylene, poly-4-methylpentene, or cycloolefin polymer (Cyclo Olefine Polymer (COP), trade name: ZEONOR, manufactured by ZEON Corporation). . As the chemical solution container of the present invention, a thermoplastic resin rich in moldability and flexibility is preferably used, but particularly fat-soluble vitamins (vitamin A, vitamin D, vitamin E and vitamin K) among the vitamin agents are adsorbed. It is preferable to use a difficult thermoplastic resin, and the cycloolefin polymer (trade name: ZEONOR, manufactured by Nippon Zeon Co., Ltd.) having excellent cord characteristics is particularly preferable. Further, it is preferable to form a multilayer film in which a cycloolefin polymer and polyethylene are laminated in two or three layers by a T-die extruder or an inflation molding machine, and use the resultant as a chemical container. Further, in place of polyethylene, a multilayer film of polypropylene or a resin having a mixed composition of polyethylene and polypropylene may be formed.

本発明の連通機構としては、金属あるいは熱可塑性樹脂性の先端が鋭利な針体や、混注操作時の針刺し事故を防止するため先端が鈍角となった連通針を好適に利用できる。また、隔離手段で区画された薬液容器の各室をガラスあるいは剛性、あるいは準剛性の熱可塑性樹脂で製した場合の連通機構としては、特願2000−321487号公報記載の操作ロッドにより可動する栓体を閉鎖体として使用してもよい。更に、長さの異なる2つの菅が隣接するか、菅内部に細径の内菅を備えた2重筒形状の針体を連通機構として利用してもよい。   As the communication mechanism of the present invention, a needle body having a sharp tip made of metal or thermoplastic resin, or a communication needle having a blunt tip to prevent a needle stick accident during mixed injection operation can be suitably used. Further, as a communication mechanism when each chamber of the chemical container partitioned by the isolating means is made of glass or a rigid or quasi-rigid thermoplastic resin, a plug movable by an operating rod described in Japanese Patent Application No. 2000-32487 The body may be used as a closure. Furthermore, a double cylinder-shaped needle body in which two ridges having different lengths are adjacent to each other or a small-diameter inner heel is provided inside the ridge may be used as the communication mechanism.

本発明の薬液容器を用いて輸液容器に各薬液を混注する際、連通機構を輸液容器側の連通口部に容易に接合でき、迅速に混注操作を行なうために、連通機構が備わった薬液容器低部の剛性度を高めることが好ましい。特に、薬液を収容する各室を可撓性樹脂で構成する場合は前記低部の剛性度を薬液収容室より高く設定すると好ましい混注操作性が得られる。また、可撓性の樹脂フィルムにて複数の室を区画するにあたり、下面に針体、上面に溶着用リブが具備され、且つ内部に薬液通路を有する熱可塑性樹脂製の低部部材に前記フィルムを接着することが好ましい。この低部材が変形し難いようにその剛性が調整されていると、可撓性フィイルムの接着精度、接着スピードがあがり、また混注操作性も向上し特に好ましい態様といえる。   When mixing each chemical solution into the infusion container using the chemical solution container of the present invention, the communication mechanism can be easily joined to the communication port on the infusion container side, and the chemical solution container equipped with the communication mechanism can be quickly used for the mixed injection operation. It is preferable to increase the rigidity of the low part. In particular, when each chamber for storing a chemical solution is formed of a flexible resin, a preferable mixed operability can be obtained by setting the rigidity of the low portion higher than that of the chemical solution storage chamber. Further, when the plurality of chambers are partitioned by the flexible resin film, the film is formed on the lower member made of a thermoplastic resin having a needle body on the lower surface, a welding rib on the upper surface, and a chemical passage inside. Is preferably adhered. When the rigidity of the low member is adjusted so as not to be easily deformed, the bonding accuracy and bonding speed of the flexible film are increased, and the mixed injection operability is improved.

本発明の薬液容器において、一つのみ連通機構を設ける場合は、連通機構に隣接する室に微量元素を含有する薬液を収容し、その室の上層に微量元素と配合変化し難いビタミンA、ビタミンD、ビタミンE及びビタミンKを含有する薬液を収容した室を弱接着した隔壁を介して設け、更に前記ビタミンA他を含有する室の上層にビタミンA、ビタミンD、ビタミンE及びビタミンK以外のビタミンB2をはじめとする水溶性ビタミン群を収容する室を弱接着した隔壁を介して設けることが好ましい。この際、弱接着された隔壁の接着強度を、上層に比べ下層側のほうが弱い押圧力で連通するように調整することにより、混注操作を開始し最初に微量元素を収容した室が輸液容器に注入され、その後にビタミンA、ビタミンD、ビタミンE及びビタミンKを含有する薬液が微量元素を洗い出し、最後に微量元素と配合変化しやすいビタミンB2等をを含む薬液が注入されるよう区画することが好ましい。弱接着部の接着強度の調整は、隔壁幅や、その形状により調整可能であり、またシール時の温度、圧力、加圧時間を調整することにより制御可能である。 When only one communication mechanism is provided in the chemical solution container of the present invention, a chemical solution containing a trace element is accommodated in a chamber adjacent to the communication mechanism, and vitamin A and vitamin which are difficult to change in combination with the trace element in the upper layer of the chamber. A chamber containing a drug solution containing D, vitamin E, and vitamin K is provided through a weakly bonded partition wall, and the upper layer of the chamber containing vitamin A, etc., is provided with vitamins other than vitamin A, vitamin D, vitamin E, and vitamin K. It is preferable to provide a chamber containing a water-soluble vitamin group including vitamin B2 through a weakly bonded partition wall. At this time, by adjusting the adhesive strength of the weakly bonded partition wall so that the lower layer side communicates with a lower pressing force than the upper layer, the mixed injection operation is started and the chamber containing the trace elements first becomes the infusion container. After the injection, the chemical solution containing vitamin A, vitamin D, vitamin E, and vitamin K is used to wash out trace elements, and finally, the chemical solution containing vitamin B 2 and the like that are easily mixed with trace elements is injected. It is preferable. The adjustment of the adhesive strength of the weakly bonded portion can be adjusted by the width of the partition wall and its shape, and can be controlled by adjusting the temperature, pressure, and pressurizing time at the time of sealing.

本発明の薬液容器の連通機構は、混注操作前に取り外しもしくは連通機構例えば針体により開封可能な密封手段が備えられていることが好ましい。更に、本発明の隔離手段で区画された薬液容器において、各室を液密状態で分離可能ように、機械的、人為的に切断できる隔離手段としてもよい。これにより、例えば滅菌工程を終えた本発明の薬液容器を微量元素を含有する薬液を収容した室部分と、ビタミン剤を収容した室部分とをそれぞれ独立して包装することができ、輸液容器にビタミン剤のみを混注すべき場合あるいは微量元素のみを混注すべき場合の薬液容器として利用できる。本発明の薬液容器は、脱酸素剤と共に着色遮光フィルムもしくはアルミラミネートフィルムからなる酸素難透過性の外装袋に封入され最終製品とすることが好ましい。   The communication mechanism of the chemical solution container of the present invention is preferably provided with a sealing means that can be removed or opened by a communication mechanism such as a needle body before the mixed injection operation. Furthermore, in the chemical container partitioned by the isolating means of the present invention, the isolating means may be mechanically or artificially cut so that each chamber can be separated in a liquid-tight state. Thereby, for example, the chamber part containing the chemical solution containing the trace element and the chamber part containing the vitamin agent can be individually packaged in the drug container of the present invention after the sterilization process, It can be used as a chemical container when only vitamins should be mixed or only trace elements should be mixed. The chemical container of the present invention is preferably enclosed in an oxygen poorly permeable outer bag made of a colored light-shielding film or an aluminum laminate film together with an oxygen scavenger to form a final product.

高カロリー輸液に混注されるべきビタミン剤としては、ビタミンA、B1、B6、B12、C、D、E、K、パントテン酸、ビオチン、ニコチン酸及び葉酸の13種類の必須ビタミンを挙げることができる。13種類のビタミンはそれぞれ薬液に調整する際、至適なpHが存在し、また同一薬液に配合するとビタミン間で配合変化することがあるので、適切な群に分離して各室に充填、収容することが好ましい。また、ビタミン剤を含有する薬液の量としては1〜5mlが好ましいが、各室には薬液とともに窒素ガス、二酸化炭素ガス等の不活性ガスを充填し操作性の良い薬液容器容量に調整することが好ましい。薬液容器の薬液収容部の容量が5ml以下と小さすぎると混注操作が困難となり、また200ml以上の容量とすると片手で混注することが困難となりかつ容器材料のコストがかさみ好ましくない。 Vitamin preparations to be mixed with high-calorie infusion include 13 essential vitamins: vitamin A, B 1 , B 6 , B 12 , C, D, E, K, pantothenic acid, biotin, nicotinic acid and folic acid be able to. Each of the 13 types of vitamins has an optimum pH when adjusted to a chemical solution, and when mixed in the same chemical solution, the composition may change between vitamins, so it is separated into appropriate groups and filled in each chamber. It is preferable to do. In addition, the amount of the chemical solution containing the vitamin is preferably 1 to 5 ml, but each chamber is filled with an inert gas such as nitrogen gas and carbon dioxide gas together with the chemical solution to adjust the chemical solution container volume to have good operability. Is preferred. If the capacity of the chemical container of the chemical container is too small, such as 5 ml or less, the mixed injection operation becomes difficult, and if the capacity is 200 ml or more, it is difficult to mix with one hand and the cost of the container material is undesirably high.

微量元素を含む薬液に配合される鉄供給源としては、硫酸鉄、塩化第一鉄、塩化第二鉄及びグルコン酸鉄を挙げることが出きる。亜鉛供給源としては硫酸亜鉛、塩化亜鉛、グルコン酸亜鉛、乳酸亜鉛、酢酸亜鉛を挙げることができる。マンガン供給源としては硫酸マンガン、銅供給源としては硫酸銅を挙げることができる。微量元素製剤の好ましい各供給源の組合せについては、特願2001−54370号に記載の表1記載の塩化第二鉄(六水和物)、塩化マンガン(四水和物)、硫酸亜鉛(七水和物)、硫酸銅(五水和物)及びヨウ化カリウムを含有することが好ましい。なお、特願2000−394260号記載の微量元素配合製剤は、肝機能障害患者用に混注する微量元素製剤としてマンガンを含有しないので薬液として好適に使用される。   Examples of the iron supply source blended in the chemical solution containing trace elements include iron sulfate, ferrous chloride, ferric chloride and iron gluconate. Examples of the zinc supply source include zinc sulfate, zinc chloride, zinc gluconate, zinc lactate, and zinc acetate. Examples of the manganese supply source include manganese sulfate, and examples of the copper supply source include copper sulfate. Regarding combinations of preferable sources of the trace element preparation, ferric chloride (hexahydrate), manganese chloride (tetrahydrate), zinc sulfate (seven) described in Table 1 of Japanese Patent Application No. 2001-54370 are used. Hydrate), copper sulfate (pentahydrate) and potassium iodide are preferably contained. The trace element-containing preparation described in Japanese Patent Application No. 2000-394260 is suitably used as a chemical solution because it does not contain manganese as a trace element preparation mixed for patients with hepatic dysfunction.

本発明の薬液容器は、総合ビタミン剤及び微量元素製剤が好適に充填、収容されるが、それに加え注射液として上市されている各種の薬剤も収容することができる。患者の状態に応じて輸液組成を変化させることができる無機質塩類剤、アルギニンやグルタミンの投与量を増加することができるアルギニンとグルタミンが配合された注射用アミノ酸製剤、大豆油などの脂肪配合注射剤及びヘパリンナトリウム注射剤などの血液凝固防止剤も収容することができる。   The medicinal solution container of the present invention is suitably filled and accommodated with a multivitamin and a trace element preparation, but in addition, can also contain various drugs marketed as injection solutions. Inorganic salt preparations that can change the infusion composition according to the patient's condition, amino acid preparations for injection containing arginine and glutamine that can increase the dosage of arginine and glutamine, and fat-containing injections such as soybean oil And anticoagulants such as sodium heparin injection can also be accommodated.

ビタミン剤として配合されるビタミンCは、ビタミンCそのものであってもよく、その誘導体及びその塩であってもよい。具体的には、ビタミンC(アスコルビン酸)、アスコルビン酸ナトリウム、アスコルビン酸パルミテート、アスコルビン酸ジパルミテート、アスコルビン酸リン酸エステルマグネシウム塩などがあげられる。ビタミンB1としては、従来から使用されているものは何れも使用可能であり、たとえばチアミンであってもよく、その誘導体、具体的には、プロスルチアミン、アクトチアミン、チアミンジスルフィド、フルスルチアミンなどや、それらの塩、たとえば塩酸チアミン、硝酸チアミンなどであってもよい。ビタミンB1としては、従来から使用されているものは何れも使用可能であり、たとえばチアミンであってもよく、その誘導体、具体的には、プロスルチアミン、アクトチアミン、チアミンジスルフィド、フルスルチアミンなどや、それらの塩、たとえば塩酸チアミン、硝酸チアミンなどであってもよい。   Vitamin C blended as a vitamin preparation may be vitamin C itself, or a derivative or salt thereof. Specific examples include vitamin C (ascorbic acid), sodium ascorbate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbic acid phosphate magnesium salt, and the like. As vitamin B1, any conventionally used one can be used. For example, thiamine may be used, and derivatives thereof, specifically, prosultiamine, actiamine, thiamine disulfide, fullsultiamine and the like. Or a salt thereof such as thiamine hydrochloride, thiamine nitrate and the like. As vitamin B1, any conventionally used one can be used. For example, thiamine may be used, and derivatives thereof, specifically, prosultiamine, actiamine, thiamine disulfide, fullsultiamine and the like. Or a salt thereof such as thiamine hydrochloride, thiamine nitrate and the like.

ビタミンA、ビタミンD、ビタミンE及びビタミンKは、そのものであってもよく、その誘導体の形で用いてもよい。具体的には、ビタミンA及びその誘導体としては、ビタミンA1(レチノール)、ビタミンA2(3−デヒドロレチノール)、ビタミンA3(サブビタミンA)、レチネン(ビタミンAアルデヒド)、ビタミンA酸、パルミチン酸レチノール、酢酸レチノールなどをあげることができる。ビタミンD及びその誘導体としてはビタミンD2(エルゴカルシフェロール)、ビタミンD3(コレカルシフェロール)、ビタミンD4、プロビタミンD2(エルゴステリン)、プロビタミンD3(デヒドロコレステリン)などをあげることができる。ビタミンE及びその誘導体としてはα−トコフェロール、酢酸トコフェロール、β−トコフェロール、γ−トコフェロール、δ−トコフェロールなどをあげることができる。ビタミンK及びその誘導体としてはビタミンK1(フィロキノン、フィトナジオン)、ビタミンK2(ファルノキノン)、ビタミンK3(メナジオン)、ビタミンK4、ビタミンK5、ビタミンK6、ビタミンK7などをあげることができる。 Vitamin A, vitamin D, vitamin E and vitamin K may be per se or may be used in the form of their derivatives. Specifically, vitamin A and its derivatives include vitamin A 1 (retinol), vitamin A 2 (3-dehydroretinol), vitamin A 3 (subvitamin A), retinene (vitamin A aldehyde), vitamin A acid, Examples thereof include retinol palmitate and retinol acetate. Vitamin D and its derivatives include vitamin D 2 (ergocalciferol), vitamin D 3 (cholecalciferol), vitamin D 4 , provitamin D 2 (ergosterin), provitamin D 3 (dehydrocholesterin), etc. Can do. Examples of vitamin E and derivatives thereof include α-tocopherol, tocopherol acetate, β-tocopherol, γ-tocopherol, and δ-tocopherol. Vitamin K and a derivative thereof vitamin K1 (phylloquinone, phytonadione), vitamin K 2 (Farunokinon), vitamin K 3 (menadione), vitamin K 4, vitamin K 5, vitamin K 6, and the like vitamins K 7 .

図1乃至図6は、本発明の薬液容器の第1乃至第6実施例の薬液容器を示す概略平面図であり、同様の部分又は部品には同一の符号を付し、重複する説明を省略する。図1の本発明の第1実施例の薬液容器10は、ビタミンB2を含有する薬液を収容する第1区画A、鉄供給源を含有する薬液を収容する第2区画B、並びに両区画から薬液を送出するための連通機構52、53を備える。薬液容器10の第1区画A、第2区画Bは、2つの側縁部12、12、上縁部14、下縁部18、連結縁部16を備える柔軟な樹脂フィルムにより形成される。薬液容器10の連通機構52、53は、中空針、図9を参照し後述する連通具等により構成される。連通機構52、53の外表面は、使用直前まで保護カバー53で覆って無菌状態に維持される。第2区画B内の鉄供給源を含有する薬液は、亜鉛供給源、銅供給源、マンガン供給源又はヨウ素供給源を含有する。 FIGS. 1 to 6 are schematic plan views showing chemical liquid containers according to first to sixth embodiments of the chemical liquid container of the present invention. The same reference numerals are given to the same parts or components, and duplicated descriptions are omitted. To do. The chemical solution container 10 according to the first embodiment of the present invention shown in FIG. 1 includes a first compartment A that contains a chemical solution containing vitamin B 2 , a second compartment B that contains a chemical solution containing an iron supply source, and both compartments. Communication mechanisms 52 and 53 are provided for delivering the chemical solution. The first compartment A and the second compartment B of the chemical solution container 10 are formed of a flexible resin film including two side edges 12, 12, an upper edge 14, a lower edge 18, and a connecting edge 16. The communication mechanisms 52 and 53 of the chemical solution container 10 are constituted by a hollow needle, a communication tool described later with reference to FIG. The outer surfaces of the communication mechanisms 52 and 53 are covered with the protective cover 53 and maintained in a sterile state until just before use. The chemical | medical solution containing the iron supply source in the 2nd division B contains a zinc supply source, a copper supply source, a manganese supply source, or an iodine supply source.

図2の第2実施例の薬液容器20において、図1の第1区画Aに相当する部分が、隔離手段22により、第1室A1、第2室A2及び副室28に区画されている。第1室A1と副室28の間が第1弱シール24により仕切られ、第2室A2と副室28の間が第2弱シール25により仕切られる。第1弱シール24、第225は、それぞれ第1室A1又は第2室A2内の薬液を外部から押圧することにより剥離させ、各室内の薬液を副室28及び連通機構52を介し図示しない輸液容器内へ送出し輸液と混合させることができる。第2区画Bは、鉄供給源を含有する薬液を収容する。第2区画Bの薬液は、亜鉛供給源、銅供給源、マンガン供給源又はヨウ素供給源を含有させることができる。薬液容器20の第1室A1は、ビタミンB2を含有する薬液を収容する。第2室A2は、ビタミンA、ビタミンD、ビタミンE又はビタミンKを含有する薬液を収容する。ビタミンB12又は葉酸が、第1室又は第2室内の薬液に含有される。 In the chemical solution container 20 of the second embodiment of FIG. 2, a portion corresponding to the first compartment A of FIG. 1 is partitioned into a first chamber A 1, a second chamber A 2, and a sub chamber 28 by the separating means 22. The first chamber A1 and the sub chamber 28 are partitioned by the first weak seal 24, and the second chamber A2 and the sub chamber 28 are partitioned by the second weak seal 25. The first weak seal 24 and the second seal 225 are separated by pressing the chemical solution in the first chamber A1 or the second chamber A2 from the outside, respectively, and the chemical solution in each chamber is not shown via the sub chamber 28 and the communication mechanism 52. It can be delivered into the container and mixed with the infusion solution. 2nd division B accommodates the chemical | medical solution containing an iron supply source. The chemical | medical solution of 2nd division B can contain a zinc supply source, a copper supply source, a manganese supply source, or an iodine supply source. The first chamber A1 of the chemical solution container 20 stores a chemical solution containing vitamin B 2 . The second chamber A2 contains a chemical solution containing vitamin A, vitamin D, vitamin E, or vitamin K. Vitamin B 12 or folic acid is contained in the first chamber or the second chamber of the chemical solution.

図3の第3実施例の薬液容器30において、図2の第1室A1に相当する部分が、隔離手段23により、第1小室A11、第2小室A12に区画される。第1小室A11と副室28の間が第3弱シール241により仕切られ、第2小室A12と副室28の間が第4弱シール242により仕切られる。第3弱シール241、第4弱シール242は、それぞれ第1小室A11又は第2小室A12内の薬液を外部から押圧することにより剥離可能であり、各室内の薬液を副室28及び連通機構52を介し図示しない輸液容器内へ送出し輸液と混合させることができる。第2区画Bは、鉄供給源を含有する薬液を収容する。第2区画Bの薬液は、亜鉛供給源、銅供給源、マンガン供給源又はヨウ素供給源を含有させる。   In the chemical solution container 30 of the third embodiment of FIG. 3, a portion corresponding to the first chamber A <b> 1 of FIG. 2 is partitioned into a first small chamber A <b> 11 and a second small chamber A <b> 12 by the separating means 23. The first small chamber A11 and the sub chamber 28 are partitioned by the third weak seal 241 and the second small chamber A12 and the sub chamber 28 are partitioned by the fourth weak seal 242. The third weak seal 241 and the fourth weak seal 242 can be peeled by pressing the chemical solution in the first small chamber A11 or the second small chamber A12 from the outside, respectively, and the chemical solution in each chamber is separated from the sub chamber 28 and the communication mechanism 52. It can be sent into an infusion container (not shown) via the, and mixed with the infusion solution. 2nd division B accommodates the chemical | medical solution containing an iron supply source. The chemical solution in the second zone B contains a zinc source, a copper source, a manganese source, or an iodine source.

第1小室A11はビタミンB1を含有する薬液を収容し、第2小室A12はビタミンCを含有する薬液を収容する。ビタミンB2が第1小室A11又は第2小室A12に収容される薬液に含有される。第2室A2は、ビタミンA、ビタミンD、ビタミンE又はビタミンKを含有する薬液を収容する。第2区画B内の鉄供給源を含有する薬液は、亜鉛供給源、銅供給源、マンガン供給源又はヨウ素供給源を含有する。 The first chamber A11 containing a chemical solution containing vitamin B 1, the second chamber A12 houses the drug solution containing the vitamin C. Vitamin B2 is contained in the chemical solution contained in the first chamber A11 or the second chamber A12. The second chamber A2 contains a chemical solution containing vitamin A, vitamin D, vitamin E, or vitamin K. The chemical | medical solution containing the iron supply source in the 2nd division B contains a zinc supply source, a copper supply source, a manganese supply source, or an iodine supply source.

図4の本発明の第4実施例の薬液容器60は、2枚重ねた可撓性樹脂フイルムの2つの側縁部12、12、上縁部14、下縁部18、連結縁部16を強固に接着して袋状空間を形成し、その袋状空間を3つの弱シール72、73、74により仕切って形成される4つの室E、V1、V2、V3を有する。室Eは、鉄供給源を含有する薬液を収容すると共に、連通機構52を備える。連通機構52の外表面は、使用直前まで保護カバー53で覆われ無菌状態に維持される。室V1は、図3の第1小室A11と同様の薬液を収容し、室V2は、図3の第2小室A12と同様の薬液を収容し、室V3は、第2室A2と同様の薬液を収容する。   The chemical solution container 60 according to the fourth embodiment of the present invention shown in FIG. 4 includes two side edges 12, 12, an upper edge 14, a lower edge 18, and a connecting edge 16 of a flexible resin film stacked on each other. A bag-shaped space is formed by firmly bonding, and the bag-shaped space is divided into three chambers E, V1, V2, and V3 formed by three weak seals 72, 73, and 74. The chamber E accommodates a chemical solution containing an iron supply source and includes a communication mechanism 52. The outer surface of the communication mechanism 52 is covered with a protective cover 53 and maintained in a sterile state until just before use. The chamber V1 contains the same chemical solution as the first small chamber A11 in FIG. 3, the chamber V2 contains the same chemical solution as the second small chamber A12 in FIG. 3, and the chamber V3 has the same chemical solution as the second chamber A2. To accommodate.

図4の本発明の第4実施例の薬液容器60において、3つの弱シール72、73、74は、連通機構52から遠いものほど強く接着し、遠いものほど開放するために大きな押圧力が必要であるようにされる。弱シール72、73、74のこのような構成により、連通機構52を介し薬液容器60内の薬液を図示しない輸液容器内へ送出するとき、薬液容器60に外部から圧力を加えることにより、連通機構52に近い方の室から薬液が順次送出される。それ故、薬液容器60内における異なる室内の薬液の混合量が最少になり、混合による変化が最少となる。   In the chemical container 60 of the fourth embodiment of the present invention shown in FIG. 4, the three weak seals 72, 73, 74 are strongly bonded to the one farther from the communication mechanism 52, and require a large pressing force to open the farther one. Be made to be. With such a configuration of the weak seals 72, 73, 74, when the chemical solution in the chemical solution container 60 is sent into the infusion container (not shown) via the communication mechanism 52, the communication mechanism is applied by applying pressure to the chemical solution container 60 from the outside. The chemicals are sequentially delivered from the chamber closer to 52. Therefore, the mixing amount of the chemical solutions in different chambers in the chemical solution container 60 is minimized, and the change due to the mixing is minimized.

図5の第5実施例の薬液容器70は、2枚重ねた可撓性樹脂フイルムの2つの側縁部12、12、上縁部14、下縁部18、連結縁部16を強固に接着して袋状空間を形成し、その袋状空間を1つの強シール16及び2つの弱シール73、74により仕切って形成される4つの室E、V1、V2、V3を有する。室Eは、鉄供給源を含有する薬液を収容すると共に連通機構54を備える。室V1は、連通機構52を備える。連通機構52、54のそれぞれ室V1側及び室E側の端部は、弱シール75、76で覆われる。室E、V1、V2、V3は、それぞれ図4の第4実施例の薬液容器60の室E、V1、V2、V3と同様の薬液を収容する。また3つの弱シール75、73、74は、連通機構52から遠いものほど強く接着し、遠いものほど開放するために大きな押圧力が必要であるようにする。連通機構52の端部を覆う弱シール75の剥離強度は弱シール76より大とし、室E内の薬液を他の室の薬液より先に送出可能とする。   The chemical solution container 70 of the fifth embodiment of FIG. 5 firmly bonds two side edges 12, 12, an upper edge 14, a lower edge 18, and a connecting edge 16 of a flexible resin film stacked in two sheets. Thus, a bag-like space is formed, and the bag-like space has four chambers E, V1, V2, and V3 formed by partitioning the bag-like space with one strong seal 16 and two weak seals 73 and 74. The chamber E stores a chemical solution containing an iron supply source and includes a communication mechanism 54. The chamber V1 includes a communication mechanism 52. The ends of the communication mechanisms 52 and 54 on the chamber V1 side and the chamber E side are covered with weak seals 75 and 76, respectively. The chambers E, V1, V2, and V3 contain chemical solutions similar to the chambers E, V1, V2, and V3 of the chemical solution container 60 of the fourth embodiment shown in FIG. Further, the three weak seals 75, 73, and 74 are more strongly bonded to the one farther from the communication mechanism 52, and require a larger pressing force to open the farther one. The peel strength of the weak seal 75 that covers the end of the communication mechanism 52 is greater than that of the weak seal 76, so that the chemical solution in the chamber E can be delivered before the chemical solution in the other chambers.

図6の第6実施例の薬液容器80は、図5の第5実施例の薬液容器70を一部変更したものであり、副室88を設けると共に、2つの連通機構に代え、1つの連通機構52を設けている。副室88は、空室とするか又は適当な液体又は薬剤を収容する。副室88と室Eの間は、弱シール76により区画され、副室88と室Eの間は弱シール76により区画される。その他の構造及び各室に収容する薬液は、図5の第5実施例と同様とすることができる。   The chemical solution container 80 of the sixth embodiment of FIG. 6 is a partial modification of the chemical solution container 70 of the fifth embodiment of FIG. 5, is provided with a sub chamber 88 and is replaced with two communication mechanisms. A mechanism 52 is provided. The subchamber 88 is vacant or contains a suitable liquid or medicament. The sub chamber 88 and the chamber E are partitioned by a weak seal 76, and the sub chamber 88 and the chamber E are partitioned by a weak seal 76. The other structure and the chemical solution stored in each chamber can be the same as in the fifth embodiment of FIG.

図7は、本発明の薬液容器から薬剤を注入可能な輸液バッグ(輸液容器)100を示す概略平面図であり、図8は、図7の輸液バッグに組込まれる注入口本体90を示す斜視図である。輸液バッグ100は、2枚重ねた可撓性樹脂フイルムの2つの側縁部112、112、上縁部114、及び下縁部118を強固に接着して袋状空間を形成し、その袋状空間を1つの弱シール107により仕切って形成される2つの室101、102を有する。室101、102は、周知のように輸液成分の混合変化を避けるため、アミノ酸液とブドウ糖液をそれぞれ収容する。輸液バッグの上縁114は、注入口本体90及び吊下げ穴104、105、106を備える。輸液バッグの下縁128は、保護キャップで覆われたポート112を備える。輸液バッグ内の輸液は、ポート112中の栓体を中空針で刺通し、中空針及びチューブ等を介し患者に投与される。   FIG. 7 is a schematic plan view showing an infusion bag (infusion container) 100 capable of injecting a drug from the drug solution container of the present invention, and FIG. 8 is a perspective view showing an injection port body 90 incorporated in the infusion bag of FIG. It is. The infusion bag 100 forms a bag-like space by firmly bonding two side edge portions 112, 112, an upper edge portion 114, and a lower edge portion 118 of a two-layered flexible resin film. It has two chambers 101 and 102 formed by partitioning the space with one weak seal 107. The chambers 101 and 102 contain an amino acid solution and a glucose solution, respectively, in order to avoid mixing changes of the infusion components as is well known. The upper edge 114 of the infusion bag includes an inlet main body 90 and suspension holes 104, 105, 106. The lower edge 128 of the infusion bag comprises a port 112 covered with a protective cap. The infusion solution in the infusion bag is pierced through the plug in the port 112 with a hollow needle, and is administered to the patient via the hollow needle and the tube.

注入口本体90は、4個の注入口91〜94を有する。注入口91、92は、スリットの入った栓体を備え、先端が鋭利でない一対の連通機構を受け入れることができる。注入口93、94は、スリットなしの栓体を備え、中空針のような鋭利な一対の連通機構を受け入れることができる。注入口91〜94は、汚染を防ぐため使用直前まで図示しない保護キャップにより覆われる。   The inlet body 90 has four inlets 91 to 94. The inlets 91 and 92 include a stopper with a slit, and can receive a pair of communication mechanisms whose tips are not sharp. The inlets 93 and 94 are provided with plugs without slits and can receive a pair of sharp communication mechanisms such as hollow needles. The inlets 91 to 94 are covered with a protective cap (not shown) until just before use in order to prevent contamination.

図9は、薬剤容器10の連通機構52が連通状態にされた状態の概略断面図である。図9の実施例においては、薬剤容器10側に配置される栓体151を中空の連通具144により刺通することにより連通具144内の通路142を経て薬剤容器10の内部と輸液バッグ100の第1室101とを連通する連通路が形成される。連通具144は、支持体156内を伸長し薬剤容器10内に端部141を有し、連通具144内の通路142が端部141において輸液バッグ内部と連通する。連通具144は可撓性輸液バッグの外側から手動で薬剤容器10の方へ押圧することにより、鋭利な先端145が薬剤容器10の筒状口部を閉鎖する栓体151を刺通し、連通具144の先端開口143が薬剤容器10内に位置され、薬剤容器10内と輸液バッグ100内が、開口143及び通路142を介し液体連通状態にされる。連通具144は、その外周部で支持孔114に係合し、栓体151を刺通する前後の連通具144の位置を維持するための複数のリブ146を備える。   FIG. 9 is a schematic cross-sectional view of the state in which the communication mechanism 52 of the medicine container 10 is in a communication state. In the embodiment of FIG. 9, the stopper 151 arranged on the side of the medicine container 10 is pierced by the hollow communication tool 144, thereby passing through the passage 142 in the communication tool 144 and the inside of the drug container 10 and the infusion bag 100. A communication path that communicates with the first chamber 101 is formed. The communication tool 144 extends in the support 156 and has an end portion 141 in the drug container 10, and the passage 142 in the communication tool 144 communicates with the inside of the infusion bag at the end portion 141. The communication tool 144 is manually pressed from the outside of the flexible infusion bag toward the drug container 10 so that the sharp tip 145 pierces the plug 151 that closes the cylindrical mouth of the drug container 10, and the communication tool 144. The distal end opening 143 is positioned in the medicine container 10, and the inside of the medicine container 10 and the infusion bag 100 are brought into a liquid communication state through the opening 143 and the passage 142. The communication tool 144 includes a plurality of ribs 146 that engage with the support hole 114 at the outer peripheral portion thereof and maintain the position of the communication tool 144 before and after the plug body 151 is pierced.

図9に示す薬剤容器及び輸液バッグの組立の手順を説明する。まず柔軟な輸液バッグ100の注入口本体90の注入口91へ連通機構52の幾分膨大化された端部141を挿入する。次に連通具144の鋭利な先端145を隔壁140及び栓体151を貫通して進め、先端145に隣接する先端開口143を薬剤容器10内部と連通させ、それにより、輸液バッグ100内と薬剤容器10内を、先端開口143、通路142を介し連通させる。この連通路を介し薬剤容器10内の薬剤を輸液バッグ100内へ流入させ、混合液を薬液バッグ100内に形成する。次に吊下げ用穴104〜106を利用し薬液バッグ100を点滴用架台(図示しない)に係合し薬液排出口112の栓体を中空針で穿刺し中空針及び中空針に連通されるチューブ等を介し混合薬液を患者に点滴投与する。   A procedure for assembling the drug container and the infusion bag shown in FIG. 9 will be described. First, the somewhat enlarged end portion 141 of the communication mechanism 52 is inserted into the inlet 91 of the inlet body 90 of the flexible infusion bag 100. Next, the sharp tip 145 of the communication tool 144 is advanced through the partition wall 140 and the plug 151, and the tip opening 143 adjacent to the tip 145 is communicated with the inside of the drug container 10, thereby the inside of the infusion bag 100 and the drug container. 10 is communicated through a tip opening 143 and a passage 142. The drug in the drug container 10 is caused to flow into the infusion bag 100 through this communication path, and a mixed solution is formed in the drug solution bag 100. Next, the drug solution bag 100 is engaged with an infusion stand (not shown) using the suspension holes 104 to 106, the stopper of the drug solution discharge port 112 is punctured with a hollow needle, and the tube communicated with the hollow needle and the hollow needle. The drug solution is instilled into the patient via the above.

図10は、本発明の第7実施例の薬液容器170を示す概略平面図である。この薬液容器は、図5の薬液容器70とほぼ同様の構造を備え、連通機構が変更されている。薬液容器170の連通機構52は、図11及び図12に90度異なる角度から見た側面図で示すように、円板状部分51、板状突起55、二重中空針121を含む。図13は、二重中空針121の内外の中空部を偏心させたものを示す側断面面、図14は、図13の2重中空針の下方から見た平面図である。   FIG. 10 is a schematic plan view showing a chemical solution container 170 according to a seventh embodiment of the present invention. This chemical solution container has substantially the same structure as the chemical solution container 70 of FIG. 5, and the communication mechanism is changed. The communication mechanism 52 of the chemical solution container 170 includes a disk-shaped portion 51, a plate-shaped protrusion 55, and a double hollow needle 121 as shown in side views viewed from an angle different from 90 degrees in FIGS. FIG. 13 is a side cross-sectional view showing the inner and outer hollow parts of the double hollow needle 121 eccentric, and FIG. 14 is a plan view seen from below the double hollow needle of FIG.

連通機構52の円周部分は、下縁部28を形成する樹脂フィルムの内側面に強固に接着され、板状突起55の端縁56は、連結縁部16を形成する樹脂フィルムの内側面に強固に接着される。   The circumferential portion of the communication mechanism 52 is firmly bonded to the inner surface of the resin film forming the lower edge portion 28, and the edge 56 of the plate-like protrusion 55 is attached to the inner surface of the resin film forming the connecting edge portion 16. Bonded firmly.

本発明の薬液容器は、高カロリー輸液、アミノ酸輸液、電解質輸液、糖類輸液その他の薬液収容する輸液バッグ内へ患者に必要な少量の薬液を混注する作業を、病院において安全に且つ容易に行うことができ、また在宅医療がなされる家庭において混注作業を可能にする。本発明の薬液容器は、また混注すべき異種の薬液間の品質劣化の原因となる相互作用を排除し選択的に隔壁手段で隔離された複数の室に薬液を分離収容することができる。   The medical solution container of the present invention performs a safe and easy operation in a hospital for co-injecting a small amount of medical solution necessary for a patient into an infusion bag containing high-calorie infusion, amino acid infusion, electrolyte infusion, saccharide infusion, or other medicinal solution. It is possible to perform co-infusion work at home where home medical care is performed. The chemical solution container of the present invention can separate and accommodate the chemical solution in a plurality of chambers that are selectively separated by the partition means by eliminating an interaction that causes quality deterioration between different types of chemical solutions to be mixed.

本発明の第1実施例の薬液容器を示す概略平面図。The schematic plan view which shows the chemical | medical solution container of 1st Example of this invention. 本発明の第2実施例の薬液容器を示す概略平面図。The schematic plan view which shows the chemical | medical solution container of 2nd Example of this invention. 本発明の第3実施例の薬液容器を示す概略平面図。The schematic plan view which shows the chemical | medical solution container of 3rd Example of this invention. 本発明の第4実施例の薬液容器を示す概略平面図。The schematic plan view which shows the chemical | medical solution container of 4th Example of this invention. 本発明の第5実施例の薬液容器を示す概略平面図。The schematic plan view which shows the chemical | medical solution container of 5th Example of this invention. 本発明の第6実施例の薬液容器を示す概略平面図。The schematic plan view which shows the chemical | medical solution container of 6th Example of this invention. 本発明の薬液容器から薬剤を注入可能な輸液バッグを示す概略平面図。The schematic plan view which shows the infusion bag which can inject | pour a chemical | medical agent from the chemical | medical solution container of this invention. 図7の輸液バッグに組込まれる注入口本体を示す斜視図。The perspective view which shows the injection inlet main body integrated in the infusion bag of FIG. 本発明の薬剤容器に適用可能な連通具を輸液バッグの注入口本体に取付けて示す断面図である。It is sectional drawing which attaches the communication tool applicable to the chemical | medical agent container of this invention to the inlet main body of an infusion bag, and shows it. 本発明の第7実施例の薬液容器を示す概略平面図。The schematic plan view which shows the chemical | medical solution container of 7th Example of this invention. 図10の連通機構の側面図。The side view of the communication mechanism of FIG. 図10の連通機構の側面図であり、図11と90度回転させた側面図。FIG. 11 is a side view of the communication mechanism of FIG. 10, and is a side view rotated 90 degrees with respect to FIG. 11. 図10の2重中空針の側断面図。FIG. 11 is a side sectional view of the double hollow needle of FIG. 10. 図13の2重中空針の下方から見た平面図である。It is the top view seen from the downward direction of the double hollow needle of FIG.

符号の説明Explanation of symbols

10、20、30、40:薬液容器、12:側縁部羽、14:上縁部、18:下縁部、23:隔離手段、28:副室、52:連通機構、53:保護カバー、72〜74:弱シール、A:第1区画、B:第2区画、A11:第1小室、A12:第2小室、A2:第2小室 10, 20, 30, 40: Chemical solution container, 12: Side edge wing, 14: Upper edge, 18: Lower edge, 23: Isolation means, 28: Sub chamber, 52: Communication mechanism, 53: Protective cover, 72-74: Weak seal, A: 1st division, B: 2nd division, A11: 1st small chamber, A12: 2nd small chamber, A2: 2nd small chamber

Claims (6)

医療用輸液バッグ100に使用前に薬液を注入するための薬液容器60、70、80であって、
前記薬液を前記薬液容器60、70、80から前記医療用輸液バッグ100に送出するため、前記薬液容器60、70、80と前記医療用輸液バッグ100とを連通する連通機構52を有し、
前記薬液容器は、前記連通機構52に連通可能な第1の室V1と、前記第1の室V1を介して前記連通機構52に連通する第2の室V2と、前記第2の室V2を介して前記第1の室V1に連通する第3の室V3とを備え、
前記連通機構52と前記第1の室V1との間に、最も接着強度の弱い第1の弱シール部72、75を設け、
前記第1の室V1と前記第2の室V2との間に、前記第1の弱シール部72、75より接着強度の強い第2の弱シール部73を設け、
前記第2の室V2と前記第3の室V3との間に、前記第2の弱シール部73より接着強度の強い第3の弱シール部74を設け、
前記第1、第2、第3の室V1、V2、V3に、それぞれ、第1、第2、第3の薬液を収容したことを特徴とする薬液容器。
A medical solution container 60, 70, 80 for injecting a medical solution into the medical infusion bag 100 before use,
In order to send the chemical solution from the chemical solution containers 60, 70, 80 to the medical infusion bag 100, the medical solution container 60, 70, 80 and the medical infusion bag 100 are communicated with each other, and a communication mechanism 52 is provided.
The chemical solution container includes a first chamber V1 that can communicate with the communication mechanism 52, a second chamber V2 that communicates with the communication mechanism 52 via the first chamber V1, and the second chamber V2. And a third chamber V3 communicating with the first chamber V1 through
Between the communication mechanism 52 and the first chamber V1, first weak seal portions 72 and 75 having the weakest adhesive strength are provided,
Between the first chamber V1 and the second chamber V2, a second weak seal portion 73 having stronger adhesive strength than the first weak seal portions 72 and 75 is provided,
Between the second chamber V2 and the third chamber V3, a third weak seal portion 74 having stronger adhesive strength than the second weak seal portion 73 is provided,
A chemical solution container, wherein the first, second, and third chambers V1, V2, and V3 contain first, second, and third chemical solutions, respectively.
請求項1に記載の薬液容器に複数種類の薬液を収容した薬液製剤であって、
前記第1の室V1に収容した前記第1の薬液が、微量元素を含有する薬液であり、
前記第2の室V2に収容した前記第2の薬液が、前記微量元素と配合変化し難い薬液であり、
前記第3の室V3に収容した前記第3の薬液が、前記微量元素と配合変化しやすい薬液であることを特徴とする薬液製剤。
A chemical preparation containing a plurality of types of chemical solutions in the chemical solution container according to claim 1,
The first chemical solution contained in the first chamber V1 is a chemical solution containing a trace element;
The second chemical liquid stored in the second chamber V2 is a chemical liquid that hardly mixes with the trace element,
The drug solution formulation, wherein the third drug solution stored in the third chamber V3 is a drug solution that is easily mixed with the trace element.
前記微量元素を含有する薬液が、鉄供給源を含有する薬液であり、前記配合変化しやすい薬液が、ビタミンB2を含有する薬液であることを特徴とする請求項2に記載の薬液製剤。 The chemical solution containing trace elements, a chemical solution containing iron sources, chemical formulation according to claim 2, wherein the formulation labile chemical solution, characterized in that it is a chemical liquid containing vitamin B 2. 前記配合変化し難い薬液が、脂溶性ビタミン類を含有する薬液であることを特徴とする請求項3に記載の薬液製剤。   The medicinal solution preparation according to claim 3, wherein the medicinal solution which is difficult to change is a medicinal solution containing fat-soluble vitamins. 前記鉄供給源を含有する薬液が、亜鉛供給源、銅供給源、マンガン供給源又はヨウ素供給源を含有するものであることを特徴とする請求項3または4に記載の薬液製剤。   The drug solution preparation according to claim 3 or 4, wherein the drug solution containing the iron supply source contains a zinc supply source, a copper supply source, a manganese supply source, or an iodine supply source. 医療用輸液バッグの使用前に、請求項1に記載の薬液容器に収容した前記第1、第2、第3の薬液を該医療用輸液バッグに注入する方法であって、
最初に前記第1の室V1を押圧して前記第1の弱シール部72、75を開放し、前記連通機構52を介して前記第1の薬液を前記医療用輸液バッグに注入し、
次に前記第2の室V2を押圧して前記第2の弱シール部73を開放し、前記第2の薬液によって、前記第1の室V1に残留する前記第1の薬液を洗い出しながら、前記連通機構52を介して前記第2の薬液を前記医療用輸液バッグに注入し、
次に前記第3の室V3を押圧して前記第3の弱シール部74を開放し、前記第2の室V2、前記第1の室V1及び前記連通機構52を介して、前記第3の薬液を前記医療用輸液バッグに注入することを特徴とする医療用輸液バッグに薬液を注入する方法。
Before using the medical infusion bag, the first, second and third chemical liquids contained in the chemical liquid container according to claim 1 are injected into the medical infusion bag,
First, the first chamber V1 is pressed to open the first weak seal portions 72 and 75, and the first drug solution is injected into the medical infusion bag through the communication mechanism 52,
Next, the second chamber V2 is pressed to open the second weak seal portion 73, and the second chemical solution is used to wash out the first chemical solution remaining in the first chamber V1, while Injecting the second drug solution into the medical infusion bag via the communication mechanism 52;
Next, the third chamber V3 is pressed to open the third weak seal portion 74, and the third chamber V3, the first chamber V1, and the communication mechanism 52 are used to connect the third chamber V3. A method for injecting a chemical solution into a medical infusion bag, characterized by injecting the chemical solution into the medical infusion bag.
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