JP2000157607A - Medical container - Google Patents
Medical containerInfo
- Publication number
- JP2000157607A JP2000157607A JP10333876A JP33387698A JP2000157607A JP 2000157607 A JP2000157607 A JP 2000157607A JP 10333876 A JP10333876 A JP 10333876A JP 33387698 A JP33387698 A JP 33387698A JP 2000157607 A JP2000157607 A JP 2000157607A
- Authority
- JP
- Japan
- Prior art keywords
- moisture
- permeable
- container
- chamber
- medical container
- 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.)
- Pending
Links
- 229920005989 resin Polymers 0.000 claims abstract description 40
- 239000011347 resin Substances 0.000 claims abstract description 40
- 239000002274 desiccant Substances 0.000 claims abstract description 39
- 239000003814 drug Substances 0.000 claims abstract description 33
- 239000000463 material Substances 0.000 claims abstract description 19
- 230000035699 permeability Effects 0.000 claims abstract description 15
- 238000010521 absorption reaction Methods 0.000 claims abstract description 6
- 239000012528 membrane Substances 0.000 claims description 54
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- 239000002245 particle Substances 0.000 claims description 10
- 239000002994 raw material Substances 0.000 abstract 2
- 238000005192 partition Methods 0.000 abstract 1
- 239000010410 layer Substances 0.000 description 33
- 229940079593 drug Drugs 0.000 description 18
- -1 polyethylene Polymers 0.000 description 15
- 238000004891 communication Methods 0.000 description 14
- 239000000243 solution Substances 0.000 description 11
- 239000005022 packaging material Substances 0.000 description 10
- 230000001954 sterilising effect Effects 0.000 description 8
- 238000004659 sterilization and disinfection Methods 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 7
- 238000007789 sealing Methods 0.000 description 7
- 239000004698 Polyethylene Substances 0.000 description 6
- 239000004743 Polypropylene Substances 0.000 description 6
- 230000004888 barrier function Effects 0.000 description 6
- 230000003115 biocidal effect Effects 0.000 description 6
- 229920000573 polyethylene Polymers 0.000 description 6
- 229920001155 polypropylene Polymers 0.000 description 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 238000003860 storage Methods 0.000 description 5
- 238000003466 welding Methods 0.000 description 5
- 230000036425 denaturation Effects 0.000 description 4
- 238000004925 denaturation Methods 0.000 description 4
- 238000001035 drying Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000000465 moulding Methods 0.000 description 4
- 229920005672 polyolefin resin Polymers 0.000 description 4
- 229920005992 thermoplastic resin Polymers 0.000 description 4
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 239000003242 anti bacterial agent Substances 0.000 description 3
- 229940088710 antibiotic agent Drugs 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 238000000151 deposition Methods 0.000 description 3
- 229920001971 elastomer Polymers 0.000 description 3
- 239000010419 fine particle Substances 0.000 description 3
- 238000002955 isolation Methods 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 229920000098 polyolefin Polymers 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 239000005060 rubber Substances 0.000 description 3
- 229910052814 silicon oxide Inorganic materials 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 2
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 238000000071 blow moulding Methods 0.000 description 2
- 238000005520 cutting process Methods 0.000 description 2
- 230000009089 cytolysis Effects 0.000 description 2
- 230000008021 deposition Effects 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 230000002209 hydrophobic effect Effects 0.000 description 2
- 238000001746 injection moulding Methods 0.000 description 2
- 229920000092 linear low density polyethylene Polymers 0.000 description 2
- 239000004707 linear low-density polyethylene Substances 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 239000012466 permeate Substances 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 229910002027 silica gel Inorganic materials 0.000 description 2
- 239000000741 silica gel Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000009423 ventilation Methods 0.000 description 2
- OEPOKWHJYJXUGD-UHFFFAOYSA-N 2-(3-phenylmethoxyphenyl)-1,3-thiazole-4-carbaldehyde Chemical compound O=CC1=CSC(C=2C=C(OCC=3C=CC=CC=3)C=CC=2)=N1 OEPOKWHJYJXUGD-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- 229920001328 Polyvinylidene chloride Polymers 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
- 229920002125 Sokalan® Polymers 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 239000004775 Tyvek Substances 0.000 description 1
- 229920000690 Tyvek Polymers 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 239000012461 cellulose resin Substances 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 125000004122 cyclic group Chemical group 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 238000002845 discoloration Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000005038 ethylene vinyl acetate Substances 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
- 239000011737 fluorine Substances 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 239000011344 liquid material Substances 0.000 description 1
- 229920001684 low density polyethylene Polymers 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 239000002808 molecular sieve Substances 0.000 description 1
- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 description 1
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 1
- 239000004584 polyacrylic acid Substances 0.000 description 1
- 229920006350 polyacrylonitrile resin Polymers 0.000 description 1
- 229920006122 polyamide resin Polymers 0.000 description 1
- 229920001225 polyester resin Polymers 0.000 description 1
- 239000004645 polyester resin Substances 0.000 description 1
- 229920013716 polyethylene resin Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 239000005033 polyvinylidene chloride Substances 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 229910052709 silver Inorganic materials 0.000 description 1
- 239000004332 silver Substances 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- URGAHOPLAPQHLN-UHFFFAOYSA-N sodium aluminosilicate Chemical compound [Na+].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O URGAHOPLAPQHLN-UHFFFAOYSA-N 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
Landscapes
- Bag Frames (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は水分を吸湿することによ
って変質あるいは変性する薬剤を樹脂容器内に無菌的に
簡単に充填することができると共に変性することなく安
全に保存することができる医療容器に関するものであ
る。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container which can easily and aseptically fill a resin container with a drug which is degraded or denatured by absorbing moisture and which can be safely stored without denaturation. It is about.
【０００２】[0002]
【従来の技術】医療容器はガラス容器から樹脂容器に代
わりつつある。樹脂容器は柔軟な容器であるため、使用
時、エア針等を必要としないため医療容器に好ましい。
その廃棄処理もガラス容器より簡単である。その容器に
用いる樹脂はポリ塩化ビニル、エチレン−酢酸ビニル共
重合体、ポリエチレン等である。容器の廃棄問題の点、
及び内容物に悪影響を与えない点で特にポリエチレンの
樹脂容器が頻繁に用いられている。最近、可撓性の樹脂
容器を二室に分け、一の室に凍結乾燥した抗生物質を収
容させ、他の室にその抗生物質の溶解液を収容した複室
容器が医療容器として提供されている（特開平４−３６
４８５０号公報）。室と室との間は容器の内壁同士を剥
離可能に熱シールした隔離手段で構成され、使用時に隔
離手段が開封されて室同士が連通され、抗生物質と溶解
液とが混合される。前記凍結乾燥した抗生物質は一般に
水分を吸湿すると急激な変質、或いは変性を起こし易
い。このため、前記複室容器の抗生物質を収容した室の
外側のみが難透湿性包材で気密に覆われている。包材内
には乾燥剤、又は乾燥剤と共に脱酸素剤が収容されてい
る。乾燥剤は包材を透湿してくる水分及び室内の抗生物
質に残存している微量な水分を吸収している。2. Description of the Related Art Medical containers are replacing glass containers with resin containers. Since the resin container is a flexible container, it does not require an air needle or the like at the time of use, and thus is preferable for a medical container.
Its disposal is also easier than glass containers. The resin used for the container is polyvinyl chloride, ethylene-vinyl acetate copolymer, polyethylene or the like. The issue of container disposal,
In particular, polyethylene resin containers are frequently used because they do not adversely affect the contents. Recently, a multi-compartment container in which a flexible resin container is divided into two compartments, one containing freeze-dried antibiotics, and the other containing a solution of the antibiotics, has been provided as a medical container. (JP-A-4-36
No. 4850). The space between the chambers is constituted by isolation means in which the inner walls of the container are heat-sealed so that the inner walls of the container can be peeled off. When used, the isolation means is opened, the chambers are communicated with each other, and the antibiotic and the solution are mixed. Generally, the freeze-dried antibiotic is apt to undergo rapid deterioration or denaturation when it absorbs moisture. For this reason, only the outside of the multi-chamber container containing the antibiotic is airtightly covered with the moisture-impermeable packaging material. The packaging material contains a desiccant or a deoxidizer together with the desiccant. The desiccant absorbs the moisture permeating the packaging material and the trace moisture remaining in the antibiotic in the room.
【０００３】[0003]
【発明が解決しようとする課題】しかしながら、複室容
器の一部の室を難透過性包材で覆う場合は、抗生物質の
充填が煩雑であり、包材の取り付けにも手間がかかる。
特に、抗生物質の凍結乾燥物をクリーンルーム内で無菌
的に充填する場合は簡単な充填方法が望ましい。従っ
て、本発明は水分を吸湿することによって変質あるいは
変性する薬剤を樹脂容器内に無菌的に簡単に充填するこ
とができると共にそれを変性させることなく安全に保存
することができる医療容器を提供するものである。However, in the case where a part of the chamber of the multi-chamber container is covered with the impervious packaging material, the filling of the antibiotic is complicated, and the installation of the packaging material is troublesome.
In particular, when a freeze-dried antibiotic is filled aseptically in a clean room, a simple filling method is desirable. Therefore, the present invention provides a medical container that can easily and aseptically fill a resin container with a drug that changes or denatures by absorbing moisture, and that can safely store it without denaturing it. Things.
【０００４】[0004]
【課題を解決するための手段】本発明は、互いに対向す
る可撓性容器壁同士が剥離可能に熱接着されて該容器内
が複数の室に形成される樹脂容器であって、前記室の少
なくとも一の室には水分の吸湿により変質する薬剤が収
容され、前記一の室壁は難透湿性素材で形成され、前記
一の室壁に通気透湿性膜が設られると共に、前記通気吸
湿性膜を介して前記一の室内の水分を吸湿する乾燥剤が
設けられ、前記通気透過性膜及び前記乾燥剤は非透湿性
又は難透湿性材料で覆われていることを特徴とする医療
容器を提供するものである。SUMMARY OF THE INVENTION The present invention is a resin container in which a plurality of flexible container walls opposed to each other are heat-bonded releasably from each other and formed in a plurality of chambers. At least one chamber contains a drug that is degraded due to moisture absorption, the one chamber wall is formed of a hardly permeable material, and the one chamber wall is provided with a gas permeable membrane, A medical container characterized by being provided with a desiccant that absorbs moisture in the one room through a membrane, wherein the air-permeable membrane and the desiccant are covered with a non-moisture-permeable or slightly moisture-permeable material. To provide.
【０００５】本発明の医療容器は可撓性壁を有した樹脂
容器であり、樹脂容器は複数の室に分けられている。各
室には異なる固体或いは液体の薬剤が無菌的或いは滅菌
されて収容されている。前記樹脂容器はブロー成形、圧
空成形、真空成形、射出成形したもの、或いはフィルム
或いはシートを適宜に裁断して周縁を熱溶着シールして
成形したものである。また、前記樹脂容器には必要によ
り内容物を充填或いは排出するための排出口が形成或い
は取り付けられる。The medical container of the present invention is a resin container having a flexible wall, and the resin container is divided into a plurality of chambers. Each chamber contains a different solid or liquid drug aseptically or sterile. The resin container is formed by blow molding, air pressure molding, vacuum molding, or injection molding, or is formed by cutting a film or sheet appropriately and sealing the periphery by heat welding. In addition, a discharge port for filling or discharging the contents is formed or attached to the resin container as needed.
【０００６】前記容器の壁を樹脂の多層構造とする場
合、ブロー成形、圧空成形、真空成形、或いは射出成形
等のときは各樹脂の共押出によって形成される。フィル
ム或いはシートを使用するときは、そのフィルム或いは
シートを共押出しによって形成するか、各樹脂フィルム
を個々に形成した後、これらをラミネートして製造す
る。前記樹脂容器の素材は、ポリオレフィン系樹脂、塩
化ビニル、塩化ビニリデン系樹脂、ポリエステル系樹
脂、ポリビニルアルコール系樹脂、ポリアクリルニトリ
ル系樹脂、ポリアクリル酸系樹脂、ポリアミド系樹脂等
の汎用樹脂である。また樹脂容器は単層又は多層で形成
されていても良い。容器内の薬剤と接触する最内層は、
薬剤に影響を与えない、また溶出物が生じない樹脂層で
あることが望ましい。このような樹脂としては、ポリオ
レフィン系樹脂が望ましく、例えば、低、中、高−密度
ポリエチレン、ポリプロピレン等の低級オレフィン樹脂
等が挙げられる。[0006] When the wall of the container has a multilayer structure of resin, it is formed by co-extrusion of each resin at the time of blow molding, pressure molding, vacuum molding or injection molding. When a film or sheet is used, the film or sheet is formed by co-extrusion, or each resin film is individually formed and then laminated. The material of the resin container is a general-purpose resin such as polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin, polyvinyl alcohol resin, polyacrylonitrile resin, polyacrylic acid resin, and polyamide resin. Further, the resin container may be formed in a single layer or a multilayer. The innermost layer that comes into contact with the drug in the container,
It is desirable that the resin layer does not affect the drug and does not generate elutes. As such a resin, a polyolefin-based resin is desirable, and examples thereof include low-, middle-, and high-density lower-grade olefin resins such as polyethylene and polypropylene.
【０００７】前記容器壁の内の後述する薬剤が収容さら
れる一の室壁は内容物の確認ができる程度に透明性を有
する難透湿性素材からなる。容器壁の透湿度は１０〜
０．１ｇ／ｍ２・ｄａｙ（温度：４０℃：０−９０％Ｒ
Ｈ）の範囲にあることが望ましい。特に、２．０〜０．
１ｇ／ｍ２・ｄａｙ（温度：４０℃：０−９０％ＲＨ）
の範囲にあることが望ましい。このような容器壁は、通
常、湿度に対するバリアー層が積層されている。バリア
ー層の素材は、ポリ塩化ビニリデン、ポリテトラフロロ
エチレン、ポリ３フッ化エチレン、塩酸ゴム、ポリエチ
レン、ポリプロピレン、環状ポリオレフィン等を挙げる
ことができる。また樹脂層にアルミニウム、珪素、マグ
ネシウム、チタン、銀、金等の土類金属若しくは金属、
又はそれらの酸化物を蒸着させた蒸着層である。前記バ
リアー層には全く水分を透過させない非透湿性のものが
ある。非透湿性バリアー層は金属層を有するものが殆ど
であり、その透湿度は０．１ｇ／ｍ２・ｄａｙ（温度：
４０℃：０−９０％ＲＨ）未満で実質的に水蒸気を透過
させないものである。しかし、非透湿性バリアー層は通
常透明性がないため、前記容器壁には一部の使用のみが
可能である。[0007] One chamber wall of the container wall in which a medicine to be described later is accommodated is made of a moisture-impermeable material having transparency so that the contents can be checked. The moisture permeability of the container wall is 10
0.1 g / m 2 · day (temperature: 40 ° C .: 0-90% R)
It is desirable to be in the range of H). In particular, 2.0-0.
1 g / m 2 · day (temperature: 40 ° C .: 0-90% RH)
Is desirably within the range. Such a container wall is usually laminated with a barrier layer against humidity. Examples of the material for the barrier layer include polyvinylidene chloride, polytetrafluoroethylene, polytrifluoroethylene, hydrochloric acid rubber, polyethylene, polypropylene, and cyclic polyolefin. In addition, an earth metal or metal such as aluminum, silicon, magnesium, titanium, silver, gold, etc.
Alternatively, it is a deposition layer obtained by depositing these oxides. The barrier layer includes a non-moisture-permeable layer that does not allow moisture to pass at all. Most of the moisture-impermeable barrier layers have a metal layer, and the moisture permeability of the barrier layer is 0.1 g / m 2 · day (temperature:
(40 ° C .: 0-90% RH) and substantially does not transmit water vapor. However, since the impermeable barrier layer is usually not transparent, only a part of the container wall can be used.
【０００８】前記樹脂容器は互いに対向する可撓性容器
壁同士が剥離可能に熱接着されて前記容器内が複数の室
に形成されるものである。前記容器壁同士が剥離可能に
熱接着されていることにより、互いに反応しやすい内容
物を別々の室に保存することができる。使用時には容器
壁同士の熱接着部を容器の外側から剥離開封することに
より内容物同士を無菌的に混合させることができる。外
側からの剥離開封は容器室を外側から押圧するか、容器
壁を両側から引っ張ることによって行うことができる。[0008] The resin container is formed such that the walls of the flexible containers facing each other are thermally bonded so as to be peelable, and the inside of the container is formed into a plurality of chambers. Since the container walls are heat-bonded so that they can be separated from each other, contents that easily react with each other can be stored in separate chambers. At the time of use, the contents can be aseptically mixed by peeling and opening the heat bonded portion between the container walls from the outside of the container. Peeling and opening from the outside can be performed by pressing the container chamber from the outside or by pulling the container wall from both sides.
【０００９】前記剥離可能な熱接着シール部は通常ピー
ルシール部或いは弱シール部と称される。前記熱接着シ
ール部の剥離強度は、室内の圧が０．０１〜１．０Ｋｇ
ｆ／ｃｍ２、特に、０．０５〜０．５Ｋｇｆ／ｃｍ２の
昇圧で剥離する強度が望ましい。上記範囲を下回る強度
であれば、製造、運搬、保存時等の隔離状態を保つため
の安全性に欠ける。上記範囲を上回る強度であれば、用
時に連通操作を容易にすることができなくなるおそれが
ある。剥離可能なシール部を熱溶着で形成する場合、容
器等の最内壁層が異なる樹脂ブレンド物であることが望
ましい。特に、異なる樹脂は熱溶融開始温度、或いはビ
カッド軟化点温度が異なり、相溶性のあまりない樹脂ブ
レンド物からなることが望ましい。かかるブレンド物層
を有することより、ピールシール接着のシール温度条件
設定が簡単にできる。ピールシール接着に求められるシ
ール強度、即ち、使用時の外力による易剥離性と、保存
時に剥離が生じないシール強度との関係を厳密に設定す
ることができる。内層に相溶性の異なる樹脂を溶融混合
しこれをシート状に成形すると、ミクロ的に熱接着性の
異なる部分に分離した内層表面とすることができる。そ
して、任意の温度におけるそのシートの表面相互のミク
ロ的な部分の熱溶融性を決めることにより、シール強度
の強弱を正確に付け、前記効果を容易に達成するもので
ある。[0009] The peelable thermal adhesive seal is usually called a peel seal or a weak seal. The peel strength of the thermal adhesive seal portion is such that the indoor pressure is 0.01 to 1.0 kg.
f / cm 2 , in particular, peeling strength at a pressure increase of 0.05 to 0.5 kgf / cm 2 is desirable. If the strength is lower than the above range, the safety for maintaining an isolated state during production, transportation, storage, etc. is lacking. If the strength exceeds the above range, the communication operation may not be easily performed at the time of use. When the peelable seal portion is formed by thermal welding, it is desirable that the innermost wall layer of the container or the like be a different resin blend. In particular, it is desirable that the different resins have different melting start temperatures or biquad softening points, and are made of a resin blend having little compatibility. By having such a blended material layer, it is possible to easily set the sealing temperature conditions for peel seal bonding. The relationship between the seal strength required for peel seal adhesion, that is, the easy peelability due to external force during use, and the seal strength that does not cause peeling during storage can be strictly set. When a resin having different compatibility is melt-mixed in the inner layer and formed into a sheet, the inner layer surface can be microscopically separated into portions having different thermal adhesiveness. Then, by determining the thermal fusibility of the microscopic portion between the surfaces of the sheet at an arbitrary temperature, the strength of the sealing strength is accurately provided, and the above-mentioned effect is easily achieved.
【００１０】前記一の室には水分によって変質或いは変
性する薬剤が収容される。また、本発明の医療容器にお
いて、前記一の室壁を開孔して取付口を形成し、取付口
にカップ部材を取り付けても良い。カップ部材を実質的
な薬剤の収容室としても良い。前記取付口にカップ部材
を取り付けるようにすれば、カップ部材に予め変質し易
い薬剤を収容して、前記一の室に取り付ける直前まで十
分に無菌状態を維持することができる。[0010] The one chamber contains a drug which is altered or denatured by moisture. Further, in the medical container of the present invention, the one chamber wall may be opened to form an attachment port, and a cup member may be attached to the attachment port. The cup member may be a substantial medicine chamber. If the cup member is attached to the attachment port, the easily perturbable medicine is stored in the cup member in advance, and a sufficiently sterile state can be maintained until immediately before attachment to the one chamber.
【００１１】前記易変質性薬剤としては、水分を吸収す
ることによって数日以内で変色、変性などを起こすもの
であり、例えば、凍結乾燥した抗生物質やその他の合成
薬剤などを挙げることができる。The easily degradable drug is one that causes discoloration or denaturation within several days by absorbing water, and examples thereof include freeze-dried antibiotics and other synthetic drugs.
【００１２】前記一の室の容器壁には通気透湿性膜が設
けられる。前記通気透湿性膜は、微細な多孔質の樹脂膜
からなり、ガス又は蒸気を容易に通気させるものであ
る。前記通気透湿性膜は、熱可塑性樹脂を繊維状にして
繊維同士を加熱プレスしてシート状に形成したもの（商
標名「タイベック」）、熱可塑性樹脂を微粒子に分散さ
せて分散粒子を互いに接着させてシート状に形成したも
の（商標名「ミリポアメンブレンフィルタ」）、及び熱
可塑性樹脂の溶解物中に不溶性の微粒子を混ぜてこの混
合物をシート状に形成した後に延伸して微粒子を取り除
いたもの等を挙げることができる。前記熱可塑性樹脂は
セルロース系樹脂、ポリオレフィン系樹脂、フッ素系樹
脂、塩化ビニル系樹脂などを挙げることができる。A gas-permeable and breathable membrane is provided on the container wall of the one chamber. The gas-permeable and moisture-permeable film is made of a fine porous resin film, and allows gas or steam to easily pass therethrough. The breathable and breathable membrane is formed by forming a thermoplastic resin into a fibrous shape and heating and pressing the fibers together to form a sheet (trade name “Tyvek”). The thermoplastic resin is dispersed in fine particles and the dispersed particles are adhered to each other. (Millipore Membrane Filter) trade name, insoluble fine particles mixed in a melt of thermoplastic resin, this mixture is formed into a sheet, and then stretched to remove fine particles And the like. Examples of the thermoplastic resin include a cellulose resin, a polyolefin resin, a fluorine resin, and a vinyl chloride resin.
【００１３】前記通気透湿性膜は前記一の室の容器壁に
設けられる。前記通気透湿性膜で覆われる容器壁には複
数の連通孔又は１つの大きな連通孔が形成されるが、そ
の連通孔は水蒸気などを十分に通過させる程度の大きさ
に形成されている。前記通気透過性膜は取付部材を介し
て容器壁に取り付けても良く、また容器壁に直接熱溶着
しても良い。特に、前記通気透過性膜を直接熱溶着する
ことが簡単で望ましい。前記通気透湿性膜を介して前記
一の室内の水分を吸湿するための乾燥剤が設けられる。
乾燥剤としては、それ自身吸湿性の強い物質であって化
学的乾燥剤でも物理的乾燥剤でも良い。好ましい乾燥剤
としてはシリカゲル、活性アルミナ、塩化カルシウム、
モレキュラーシーブス等の多孔質構造物等がある。乾燥
剤の能力は特に、空気１Ｌ中に残存する水分が５×１０
−３ｍｇ以下まで乾燥させるものが望ましい。かかる乾
燥剤であれば絶対湿度を上記範囲まで下げることができ
る。The air-permeable and moisture-permeable membrane is provided on a container wall of the one chamber. A plurality of communication holes or one large communication hole is formed in the container wall covered with the gas-permeable and moisture-permeable membrane, and the communication hole is formed in such a size as to allow sufficient passage of water vapor or the like. The gas-permeable membrane may be attached to the container wall via an attachment member, or may be directly heat-sealed to the container wall. In particular, it is simple and desirable to directly heat-weld the air-permeable membrane. A desiccant is provided for absorbing moisture in the one room through the breathable and permeable membrane.
The desiccant itself is a substance having a strong hygroscopic property, and may be a chemical desiccant or a physical desiccant. Preferred drying agents are silica gel, activated alumina, calcium chloride,
There are porous structures such as molecular sieves. In particular, the capacity of the desiccant is such that the moisture remaining in 1 L of air is 5 × 10 5
It is desirable to dry to -3 mg or less. With such a desiccant, the absolute humidity can be reduced to the above range.
【００１４】本発明の医療容器は前記通気透湿性及び乾
燥剤を非透湿性又は難透湿性材料で気密に覆われる。前
記非透湿性又は難透湿性材料は上述した一の室壁を構成
するものと同様なものである。前記材料は前記通気透湿
性膜及び乾燥剤のみを気密に覆っても良いし、前記一の
室全体を覆っても良い。前記材料で乾燥剤を覆うことに
より、乾燥剤は長期間その吸湿機能が維持される。[0014] In the medical container of the present invention, the above-mentioned air-permeable and moisture-permeable and desiccant is air-tightly covered with a moisture-impermeable or slightly moisture-permeable material. The non-moisture-permeable or poorly moisture-permeable material is the same as that constituting the above-mentioned one chamber wall. The material may airtightly cover only the breathable moisture-permeable membrane and the desiccant, or may cover the entirety of the one chamber. By covering the desiccant with the material, the desiccant maintains its moisture absorbing function for a long time.
【００１５】本発明の医療容器を製造する場合、先ず樹
脂容器を成形する。次に、剥離可能な熱接着シールを行
った複数の室を形成する。前記一の室に連通孔を形成
し、前記通気透湿性膜でその連通孔を覆う。前記樹脂容
器の他の室に液剤を充填してこれを密封する。次に、樹
脂容器及び液剤を温度１００℃〜１４０℃の範囲で高圧
蒸気滅菌処理して前記液剤、前記一の室内、及び前記通
気透湿性膜の取り付け面を滅菌する。次に、前記一の室
を温度３０〜１００℃の範囲で加熱し、高圧蒸気滅菌時
に貯留した前記一の室内の水分を前記通気透湿性膜を介
して外に除去する。前記一の室内を速やかに乾燥させた
後、樹脂容器をクリーンルーム内に搬入する。前記一の
室を一部開放して、前記水分の吸湿により変質する薬剤
を収容する。前記一の室を密封した後、クリーンルーム
から取り出して前記乾燥剤を前記通気透湿性膜に設けて
医療容器とする。When manufacturing the medical container of the present invention, first, a resin container is molded. Next, a plurality of chambers in which a peelable thermal adhesive seal is formed are formed. A communication hole is formed in the one chamber, and the communication hole is covered with the gas permeable membrane. A liquid material is filled in another chamber of the resin container and sealed. Next, the resin container and the liquid agent are subjected to high-pressure steam sterilization at a temperature in the range of 100 ° C. to 140 ° C. to sterilize the liquid agent, the one room, and the mounting surface of the breathable and permeable membrane. Next, the one chamber is heated at a temperature in the range of 30 to 100 ° C., and moisture stored in the one chamber during the high-pressure steam sterilization is removed to the outside through the gas-permeable and moisture-permeable membrane. After quickly drying the one room, the resin container is carried into the clean room. The one chamber is partially opened to accommodate a drug that is degraded by the absorption of the water. After sealing the one chamber, it is taken out of the clean room and the desiccant is provided on the ventilated moisture-permeable membrane to form a medical container.
【００１６】本発明の医療容器は前記一の室を滅菌する
ことが簡単にでき、また高圧蒸気滅菌したときに貯まる
前記一の室内の蒸気水分を前記通気透湿性膜を介して速
やかに取り除くことができる。前記一の室は難透湿性素
材で形成されるため、保存時に外気の水蒸気が前記一の
室内に透湿し難い。また、乾燥剤は前記通気透湿性膜を
介して前記一の室内から水分を取り除く。従って、前記
一の室内の薬剤が水分などによって変質することはな
い。According to the medical container of the present invention, the one chamber can be easily sterilized, and steam moisture in the one chamber which accumulates during the high-pressure steam sterilization can be quickly removed through the gas permeable membrane. Can be. Since the one chamber is made of a moisture-impermeable material, it is difficult for external water vapor to permeate into the one chamber during storage. In addition, the desiccant removes moisture from the one room through the gas permeable membrane. Therefore, the medicine in the one room does not deteriorate due to moisture or the like.
【００１７】本発明の医療容器における前記通気透湿性
膜の透湿度は５００g/m ２・24hr（JIS P20208）以上、
特に１０００g/m２・24hr(JIS P20208)であることが望
ましい。前記通気透湿性膜の透湿度が前記範囲未満であ
ると、乾燥剤が前記一の室から迅速に水分を取り除くこ
とができないおそれがある。本発明の医療容器における
前記通気透湿性膜は粒子直径０．５〜０．７の粒子を９
９％以上阻止してなることが望ましい。前記通気透湿性
膜の粒子阻止率が前記範囲であれば、細菌などの侵入を
十分に防止できる。In the medical container of the present invention, the air permeability and the moisture permeability
The moisture permeability of the membrane is 500g / m 2・ 24hr (JIS P20208) or more
Especially 1000g / m2・ It is expected to be 24hr (JIS P20208)
Good. The moisture permeability of the breathable moisture-permeable membrane is less than the above range.
The desiccant quickly removes water from the chamber.
May not be possible. In the medical container of the present invention
The gas-permeable and breathable membrane comprises 9 particles having a particle diameter of 0.5 to 0.7.
It is desirable to prevent it by 9% or more. Breathable and breathable
If the particle rejection of the membrane is within the above range, bacteria and the like can be prevented from entering.
Can be sufficiently prevented.
【００１８】本発明の医療容器において、前記通気透湿
性膜の耐水圧が０．５Kg/cm２以上、特に０．８Kg/cm２
以上であることが望ましい。前記通気透湿性膜の耐水圧
が前記範囲以上であれば、使用時に剥離可能な熱溶着部
分を開封して各室同士を連通させる操作時に前記通気透
湿性膜に圧力が加わっても液剤等が前記通気透過性膜を
透過するおそれがない。操作時に前記容器内に加わる圧
力は０．４kg/cm２を超えることが殆どない。[0018] In the medical container of the present invention, the water-resistant pressure of the gas permeable membrane is 0.5 kg / cm 2 or more, particularly 0.8 kg / cm 2.
It is desirable that this is the case. If the water-resistant pressure of the gas-permeable moisture-permeable membrane is equal to or more than the above range, even when pressure is applied to the gas-permeable moisture-permeable membrane at the time of opening the heat-sealable portion that can be peeled off during use and communicating the chambers with each other, the liquid agent etc. There is no risk of permeation through the gas permeable membrane. The pressure applied in the vessel during operation rarely exceeds 0.4 kg / cm 2 .
【００１９】[0019]
【実施例】以下、本発明の医療容器に関する実施例を詳
述する。図１は本発明の医療容器の第１実施例に関する
概略側面図である。図２（Ａ）及び（Ｂ）は第１実施例
の医療容器の下部部分の正面図及び裏面図である。図３
は第１実施例の医療容器の使用時に関する概略側面図で
ある。図４は本発明の医療容器の第２実施例に関する概
略側面図である。図５は第２実施例の医療容器の下部部
分の裏面図である。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the medical container of the present invention will be described in detail. FIG. 1 is a schematic side view relating to a first embodiment of the medical container of the present invention. FIGS. 2A and 2B are a front view and a rear view of a lower portion of the medical container of the first embodiment. FIG.
FIG. 3 is a schematic side view of the medical container according to the first embodiment when used. FIG. 4 is a schematic side view relating to a second embodiment of the medical container of the present invention. FIG. 5 is a back view of the lower part of the medical container of the second embodiment.
【００２０】図１〜図３に示す如く、第１実施例の医療
容器１０は、互いに対向する可撓性容器壁８Ａ、８Ｂ同
士が剥離可能に熱接着されて該容器１０内が複数の室１
２，１４に形成される。医療容器１０は樹脂容器であ
り、前記一の室１４にはカップ部材１６が取り付けられ
る。カップ部材１６は実質的に室としての役割を果た
し、カップ部材１６内には水分の吸湿により変質する薬
剤１８が収容される。前記カップ部材１６壁は難透湿性
素材で形成される。前記一の室１４壁に通気透湿性膜２
０が設られ、通気吸湿性膜２０を介して一の室１４内及
びカップ部材１６内の水分を吸湿する乾燥剤２２が設け
られている。As shown in FIGS. 1 to 3, the medical container 10 according to the first embodiment has a plurality of chambers inside the container 10 in such a manner that flexible container walls 8A and 8B facing each other are thermally bonded so as to be peelable from each other. 1
2, 14 are formed. The medical container 10 is a resin container, and a cup member 16 is attached to the one chamber 14. The cup member 16 substantially functions as a chamber, and the cup member 16 accommodates a drug 18 that is degraded by absorbing moisture. The wall of the cup member 16 is formed of a hardly permeable material. The ventilation and permeable membrane 2 is provided on the wall of the one chamber 14.
0 is provided, and a desiccant 22 that absorbs moisture in the one chamber 14 and the cup member 16 through the gas-permeable and moisture-absorbing film 20 is provided.
【００２１】第１実施例の医療容器１０を更に詳しく説
明すると、医療容器１０はポリオレフィン製のインフレ
ーションフィルム（厚み：２００μｍ）を所定の長さに
裁断して、裁断端部の開口を固着シールして成形され
る。裁断端部の熱溶着の際に点滴口用の排出ポート２４
が取り付けられる。裁断端部の下端の固着シール部２６
には吊り孔２８が形成され、医療容器１０の本体が形成
される。医療容器１０の下部には可撓性容器壁８Ａ、８
Ｂ同士を剥離可能に熱接着させた剥離シール部３０が形
成される。The medical container 10 of the first embodiment will be described in more detail. The medical container 10 is obtained by cutting a polyolefin blown film (thickness: 200 μm) to a predetermined length and firmly sealing the opening at the cut end. Molded. A discharge port 24 for a drip port during thermal welding of the cut end
Is attached. Fixed sealing portion 26 at the lower end of the cut end
Is formed with a hanging hole 28, and the main body of the medical container 10 is formed. Flexible container walls 8A, 8
A peel seal portion 30 in which B is thermally bonded to be peelable is formed.
【００２２】前記ポリオレフィン製のインフレションフ
ィルムは共押出しされた二層フィルムで形成される。内
層は線状低密度ポリエチレン６０重量％とポリプロピレ
ン４０重量％とのブレンド樹脂層である。外層は単一の
低密度ポリエチレン層である。内層の厚みは５０μｍに
形成され、外層の厚みは１５０μｍに形成される。内層
の線状低密度ポリエチレンのビカッド軟化点温度（JI
S：K6758法）とポリプロピレンのビカッド軟化点温度
（JIS:K6760法）とは２０℃以上の差が見られる。前記
固着シール部２６は温度１７０℃のヒートシールバーで
熱溶着して形成され、前記剥離シール部３０は温度１３
０℃のヒートシールバーで熱溶着して形成される。The polyolefin inflation film is formed of a co-extruded two-layer film. The inner layer is a blend resin layer of 60% by weight of linear low density polyethylene and 40% by weight of polypropylene. The outer layer is a single low density polyethylene layer. The thickness of the inner layer is formed to be 50 μm, and the thickness of the outer layer is formed to be 150 μm. Bicad softening point temperature of linear low density polyethylene in inner layer (JI
A difference of 20 ° C. or more is observed between S: K6758 method) and the biquad softening point temperature of polypropylene (JIS: K6760 method). The fixed seal portion 26 is formed by heat welding with a heat seal bar at a temperature of 170 ° C.
It is formed by heat welding with a 0 ° C. heat seal bar.
【００２３】前記医療容器１０の上部の他の室１２には
排出ポート２４から溶解液３８が充填され、排出ポート
２４はゴム栓で密封される。密封後、溶解液３８は容器
１０共に温度１１５℃で高圧蒸気滅菌処理される。前記
剥離シール部３０には一の室１４が形成される。前記剥
離シール部３０の容器壁８Ａには取付口３２が開孔さ
れ、前記剥離シール部３０の容器壁８Ｂには連通口３４
が開孔される。取付口３２にはカップ部材１６が取り付
けられ、カップ部材１６には凍結乾燥物である薬剤１８
が無菌的に収容される。連通口３４には通気透湿性膜２
０が取り付けられ、通気透湿性膜２０の外側には乾燥剤
２２が配せられる。乾燥剤２２は包材３６で気密に覆わ
れ、包材３６は剥離シール部３０の容器壁８Ｂに熱溶着
される。The other chamber 12 above the medical container 10 is filled with a lysis solution 38 through a discharge port 24, and the discharge port 24 is sealed with a rubber stopper. After sealing, the solution 38 is subjected to high-pressure steam sterilization at a temperature of 115 ° C. for both the container 10 and the container 10. One chamber 14 is formed in the peel seal portion 30. A mounting port 32 is opened in the container wall 8A of the peel seal portion 30, and a communication port 34 is formed in the container wall 8B of the peel seal portion 30.
Is opened. The cup member 16 is attached to the attachment opening 32, and the medicine 18, which is a lyophilized product, is attached to the cup member 16.
Are aseptically contained. The communication port 34 has a breathable moisture-permeable membrane 2
0 is attached, and a desiccant 22 is provided outside the gas permeable membrane 20. The desiccant 22 is air-tightly covered with a packaging material 36, and the packaging material 36 is thermally welded to the container wall 8 </ b> B of the peel seal portion 30.
【００２４】前記通気透湿性膜２０はポリフロロエチレ
ン系のメンブランフィルタにポリエチレンメッシュを重
ね合わせたものからなる。前記通気透湿性膜２０はポリ
エチレンメッシュを介して容器壁８Ｂ面に熱溶着され
る。前記通気透湿性膜２０の透湿度は４０００g/m２・24
hr（JIS P20208）以上であり、通気透湿性膜２０は粒
子直径０．２〜０．７の粒子を９９％以上阻止してな
る。通気透湿性膜２０は疎水性フィルタであり、水に対
する耐水性は４．３Kg/cm２である。The air-permeable and moisture-permeable membrane 20 is formed by laminating a polyethylene mesh on a polyfluoroethylene-based membrane filter. The gas-permeable and moisture-permeable membrane 20 is thermally welded to the surface of the container wall 8B via a polyethylene mesh. The moisture permeability of the gas permeable membrane 20 is 4000 g / m 2 · 24.
hr (JIS P20208) or more, and the gas permeable membrane 20 blocks 99% or more of particles having a particle diameter of 0.2 to 0.7. The gas-permeable and moisture-permeable membrane 20 is a hydrophobic filter, and has a water resistance of 4.3 kg / cm 2 .
【００２５】前記カップ部材１６は樹脂成形物であり、
エチレン−環状オレフィン系共重合体が用いられる。カ
ップ部材１６壁は難透湿性であり、そのカップ部材１６
の透湿度は１．０g/m２・24hr（温度４０℃：０−９０
％RH）以下である。前記カップ部材１６にはフランジが
形成され、カップ部材１６はフランジを介して容器壁８
Ａ面に液密に熱溶着されている。前記乾燥剤２２は５ｇ
のモレキュラーシブスからなり、約０．４g程度の水分
吸収が可能である。前記包材３６は中間層にナイロン層
を有し、ナイロン層には酸化珪素の蒸着処理がなされて
いる。The cup member 16 is a resin molded product.
An ethylene-cyclic olefin-based copolymer is used. The wall of the cup member 16 is impervious to moisture,
The moisture permeability 1.0g / m 2 · 24hr (temperature 40 ℃: 0-90
% RH). The cup member 16 is formed with a flange, and the cup member 16 is connected to the container wall 8 via the flange.
It is liquid-tight and heat-welded to the A surface. 5 g of the desiccant 22
, And can absorb about 0.4 g of water. The packaging material 36 has a nylon layer as an intermediate layer, and the nylon layer has been subjected to silicon oxide deposition.
【００２６】次に、第１実施例の医療容器１０の製造方
法を簡単に説明すると、先ず、医療容器１０の本体をイ
ンフレーションフィルムから製造する。次に、医療容器
１０の本体の下部に剥離可能なシール部３０を形成し、
シール部３０の所定位置に貫通孔を開ける。これによ
り、取付口３２及び連通口３４を容器壁８Ａ、８Ｂのそ
れぞれに形成する。次に、連通口３４を通気透湿性膜２
０で覆い、通気透湿性膜２０はシール部３０の容器壁８
Ｂに液密に熱溶着される。一方、取付口３２には無菌維
持シールが剥離可能に取り付けられる。尚、製造工程段
階であるので無菌維持シールは図には記載されていな
い。次に、医療容器１０の排出ポート２４から除菌フィ
ルタを通した溶解液３８を所定量充填する。排出ポート
２４をゴム線で液密に密封した後に、医療容器１０を温
度１１５℃で高圧蒸気滅菌処理する。これにより、医療
容器１０の室内１２、１４及び溶解液３８が滅菌処理さ
れる。Next, the method of manufacturing the medical container 10 of the first embodiment will be briefly described. First, the main body of the medical container 10 is manufactured from a blown film. Next, a peelable seal portion 30 is formed at the lower portion of the main body of the medical container 10,
A through hole is opened at a predetermined position of the seal portion 30. Thereby, the attachment port 32 and the communication port 34 are formed in each of the container walls 8A and 8B. Next, the communication port 34 is connected to the gas permeable membrane 2.
0, and the gas-permeable and breathable membrane 20 is
B is heat-sealed liquid-tight. On the other hand, a sterility maintaining seal is detachably attached to the attachment port 32. Note that the aseptic maintenance seal is not shown in the drawing because it is in the manufacturing process stage. Next, a predetermined amount of the lysis solution 38 that has passed through the sterilization filter is filled from the discharge port 24 of the medical container 10. After the discharge port 24 is liquid-tightly sealed with a rubber wire, the medical container 10 is subjected to high-pressure steam sterilization at a temperature of 115 ° C. Thereby, the chambers 12 and 14 of the medical container 10 and the solution 38 are sterilized.
【００２７】次に、高圧蒸気滅菌中に一の室１４内に貯
まった水又は水蒸気を温度６０℃エアで乾燥する。乾燥
後、医療容器１０をクリーンルーム内に搬入する。一
方、カップ部材１６には予め薬剤１８が乾燥状態かつ無
菌的状態で収容され、カップ部材１６もクリーンルーム
内に搬入される。次に、クリーンルーム内で医療容器１
０から無菌維持シールが取付口３２から剥がされ、取付
口３２にカップ部材１６が液密に取り付けられる。次
に、クリーンルームから湿度３０％以下の乾燥ルームに
医療容器１０が搬入され、乾燥ルーム内で乾燥剤２２が
通気透湿性膜２０に配せられる。そして、包材３６で乾
燥剤２２及び通気透湿性膜２０を液密に覆う。これによ
り、医療容器１０を製品とする。Next, the water or steam stored in one chamber 14 during the high-pressure steam sterilization is dried with air at a temperature of 60 ° C. After drying, the medical container 10 is carried into a clean room. On the other hand, the medicine 18 is previously stored in the cup member 16 in a dry state and an aseptic state, and the cup member 16 is also carried into the clean room. Next, the medical container 1 in the clean room
From 0, the aseptic maintenance seal is peeled off from the attachment port 32, and the cup member 16 is attached to the attachment port 32 in a liquid-tight manner. Next, the medical container 10 is transported from the clean room to a drying room having a humidity of 30% or less, and the desiccant 22 is disposed on the ventilation and moisture permeable membrane 20 in the drying room. Then, the desiccant 22 and the gas permeable film 20 are covered with the packaging material 36 in a liquid-tight manner. Thereby, the medical container 10 is made into a product.
【００２８】このように構成された医療容器１０にあっ
ては、保存時にカップ部材１６内の水分は通気透湿性膜
２０を介して乾燥剤２２によって速やかに吸湿される。
このため、難透湿性のカップ部材１６壁から水蒸気が透
湿してカップ部材１６内に入ったとしても乾燥剤２２が
これを速やかに吸湿する。医療容器１０の使用に際して
は、容器１０の室１２を外側から圧迫する。これによ
り、剥離可能なシール部３０が剥離して室１２と室１４
及びカップ部材１４内が連通する。このため、図３に示
す如く溶解液３８に薬剤１８が溶解する。従って、医療
容器１０はその製造時にあっては一の室１４内に簡単に
薬剤１８を収容することができる。医療容器１０はその
保存時に薬剤１８が十分な乾燥状態におかれ、薬剤１８
は変質、変性することなく安全に保存される。医療容器
１０はその使用時に溶解液３８に薬剤１８を無菌的かつ
簡単に溶解させることができる。In the medical container 10 configured as described above, the moisture in the cup member 16 is quickly absorbed by the desiccant 22 through the gas permeable membrane 20 during storage.
For this reason, even if water vapor permeates from the wall of the cup member 16 having poor moisture permeability and enters the cup member 16, the desiccant 22 quickly absorbs the moisture. When using the medical container 10, the chamber 12 of the container 10 is pressed from the outside. As a result, the peelable seal portion 30 is peeled, and the chambers 12 and 14 are separated.
And the inside of the cup member 14 communicates. Therefore, the drug 18 is dissolved in the solution 38 as shown in FIG. Therefore, the medical container 10 can easily contain the medicine 18 in the one chamber 14 at the time of manufacture. When the medical container 10 is stored, the medicine 18 is placed in a sufficiently dry state.
Is safely stored without alteration or denaturation. The medical container 10 can aseptically and easily dissolve the drug 18 in the dissolving solution 38 at the time of use.
【００２９】次に、本発明の第２実施例に係る医療容器
５０につて図４及び図５に基づいて説明する。図４及び
図５に示すごと、医療容器５０の本体は第１実施例の医
療容器１０の本体と同様にインフレーションフィルムか
ら成形される。医療容器５０の本体が第１実施例のもの
と異なるのは、剥離シール条部５２が容器５０の胴部を
横断して形成されている。そして、剥離シール条部５２
によって容器５０内は室５４と５６に区分されている。
医療容器５０の本体に使用されるインフレーションフィ
ルムは中間層にポリプロピレン層を有し、ポリプロピレ
ン層には酸化珪素の蒸着層が設けられる。このため、中
間層は難透湿性層として機能し、医療容器５０の容器壁
４６、４８の透湿度は０．８g/m２・24hr（温度４０
℃：０−９０％RH）である。Next, a medical container 50 according to a second embodiment of the present invention will be described with reference to FIGS. As shown in FIGS. 4 and 5, the main body of the medical container 50 is formed from a blown film, similarly to the main body of the medical container 10 of the first embodiment. The main body of the medical container 50 is different from that of the first embodiment in that the peeling seal strip 52 is formed across the body of the container 50. Then, the peel seal strip 52
The interior of the container 50 is divided into chambers 54 and 56.
The blown film used for the main body of the medical container 50 has a polypropylene layer as an intermediate layer, and a vapor-deposited layer of silicon oxide is provided on the polypropylene layer. Therefore, the intermediate layer functions as a moisture-impermeable layer, and the moisture permeability of the container walls 46 and 48 of the medical container 50 is 0.8 g / m 2 · 24 hr (temperature 40
° C: 0-90% RH).
【００３０】医療容器５４の室５４には溶解液５８が収
容され、室５６には乾燥薬剤６０が収容される。室５６
の容器壁４８には細かな複数の連通孔６２が形成され、
連通孔６２が存在する容器壁４８はポリエチレン繊維性
多孔質膜である通気透湿性膜６４で液密に覆われてい
る。通気透湿性膜６４は５０００g/m２・24hr（JIS P20
208）以上であり、通気透湿性膜６４は粒子直径０．２
〜０．７の粒子を９９％以上阻止してなる。通気透湿性
膜６４は疎水性多孔質膜であり、水の透過に対する耐水
圧は０．８Kg/cm２である。The solution 54 is contained in the chamber 54 of the medical container 54, and the dry medicine 60 is contained in the chamber 56. Room 56
A plurality of fine communication holes 62 are formed in the container wall 48 of
The container wall 48 in which the communication hole 62 exists is liquid-tightly covered with a gas-permeable and moisture-permeable membrane 64 that is a polyethylene fibrous porous membrane. Breathable moisture permeability film 64 is 5000g / m 2 · 24hr (JIS P20
208) or more, and the gas permeable membrane 64 has a particle diameter of 0.2
０．７0.7 particles are blocked by 99% or more. The gas-permeable and moisture-permeable membrane 64 is a hydrophobic porous membrane, and has a water pressure resistance to water permeation of 0.8 kg / cm 2 .
【００３１】医療容器５０の室５６全体は難透湿性シー
ト６６と非透湿性シート６８とで気密に覆われている。
難透湿性シート６６は酸化珪素が蒸着された透明シート
であり、その透湿度は１．０g/m２・24hr（温度４０
℃：０−９０％RH）である。非透湿性シート６８はアル
ミニウム箔層が設けられ、不透明シートとなっている。
前記難透湿性シート６６と非透湿性シート６８とで形成
された包材７０内には乾燥剤７２が配される。乾燥剤７
２は６ｇのシリカゲルからなる。The entire chamber 56 of the medical container 50 is hermetically covered with a moisture-impermeable sheet 66 and a moisture-impermeable sheet 68.
The low moisture-permeable sheet 66 is a transparent sheet on which silicon oxide is deposited, and has a moisture permeability of 1.0 g / m 2 · 24 hr (temperature 40
° C: 0-90% RH). The impermeable sheet 68 is provided with an aluminum foil layer and is an opaque sheet.
A desiccant 72 is disposed in a packaging material 70 formed of the hardly moisture-permeable sheet 66 and the non-permeable sheet 68. Desiccant 7
2 consists of 6 g of silica gel.
【００３２】次に、第２実施例の医療容器５０の製造方
法を簡単に説明する。医療容器５０は本体の胴部に剥離
シール条部５２を形成し、室５６に複数の連通孔６２を
形成する。連通孔６２に熱溶着により通気透湿性膜６４
を液密に張り付けた後、溶解液５８を室５４に液密に収
容して、容器５０共に溶解液５８及び室５６内を高圧蒸
気滅菌する。室５４を温度６０℃のエアで処理して内部
に貯まった水分を通気透湿性膜６４を介して取り除き乾
燥する。医療容器５０をクリーンルーム内に搬入し、医
療容器５０の端部を切断した一旦、室５４を開口し、そ
の開口端から乾燥薬剤６０を室５４内に充填する。充填
後、再び医療容器の端部を熱溶着シールして室５４を密
封する。医療容器５０をクリーンルームから取り出し、
乾燥剤７２を医療容器１０の端部の両側に配すると共
に、シート６６とシート６８とが剥離シール条部５２を
挟んだ状態で、室５４を気密に覆う。Next, a method of manufacturing the medical container 50 according to the second embodiment will be briefly described. The medical container 50 has a peel seal strip 52 formed in the body of the main body, and a plurality of communication holes 62 formed in the chamber 56. The gas-permeable and air-permeable membrane 64 is thermally welded to the communication hole 62.
Then, the dissolving solution 58 is housed in the chamber 54 in a liquid-tight manner, and the dissolving solution 58 and the inside of the chamber 56 together with the container 50 are subjected to high-pressure steam sterilization. The chamber 54 is treated with air at a temperature of 60 ° C. to remove moisture stored therein through the gas-permeable and moisture-permeable membrane 64 and to dry it. The medical container 50 is carried into the clean room, and once the end of the medical container 50 is cut, the chamber 54 is opened, and the dry medicine 60 is filled into the chamber 54 from the opening end. After filling, the end of the medical container is heat-sealed again to seal the chamber 54. Take out the medical container 50 from the clean room,
The desiccant 72 is disposed on both sides of the end of the medical container 10, and the chamber 54 is airtightly covered with the sheet 66 and the sheet 68 sandwiching the peeling seal strip 52.
【００３３】このような構成の医療容器１０にあって
も、その製造時、薬剤を無菌的に簡単に収容することが
できる。また、保存時にあっては室５６内の水分を乾燥
剤７２が十分に除去することができる。使用時にあって
は、隔離シール条部５２を剥離することによって、無菌
的に且つ簡単に薬剤６０を溶解液５８に溶解することが
できる。[0033] Even in the medical container 10 having such a configuration, the medicine can be easily aseptically accommodated at the time of manufacture. In addition, the desiccant 72 can sufficiently remove the water in the chamber 56 during storage. At the time of use, the drug 60 can be dissolved in the dissolving liquid 58 aseptically and easily by peeling off the isolation seal strip 52.
【００３４】[0034]
【発明の効果】以上説明したように本発明に係る医療容
器では、前記室の少なくとも一の室には水分の吸湿によ
り変質する薬剤が収容され、前記一の室壁は難透湿性素
材で形成され、前記一の室壁に通気透湿性膜が設られる
と共に、前記通気吸湿性膜を介して前記一の室内の水分
を吸湿する乾燥剤が設けられ、前記通気透過性膜及び前
記乾燥剤は非透湿性又は難透湿性材料で覆われているの
で、水分を吸湿することによって変質あるいは変性する
薬剤を樹脂容器内に無菌的に簡単に充填することができ
ると共にそれを変性させることなく安全に保存すること
ができる。As described above, in the medical container according to the present invention, at least one of the chambers contains a drug that is degraded by the absorption of moisture, and the wall of the one chamber is formed of a material having poor moisture permeability. A ventilating and permeable membrane is provided on the wall of the one room, and a desiccant that absorbs moisture in the one room is provided through the ventilating and absorbing membrane, and the breathable and permeable membrane and the desiccant are As it is covered with a non-permeable or non-permeable material, it can be easily and aseptically filled into a resin container with a drug that changes or denatures by absorbing moisture, and safely without denaturing it. Can be saved.
【図１】図１は本発明の医療容器の第１実施例に関する
概略側面図である。FIG. 1 is a schematic side view of a first embodiment of the medical container of the present invention.
【図２】図２（Ａ）及び（Ｂ）は第１実施例の医療容器
の下部部分の正面図及び裏面図である。FIGS. 2A and 2B are a front view and a back view of a lower portion of the medical container of the first embodiment.
【図３】図３は第１実施例の医療容器の使用時に関する
概略側面図である。FIG. 3 is a schematic side view when the medical container of the first embodiment is used.
【図４】図４は本発明の医療容器の第２実施例に関する
概略側面図である。FIG. 4 is a schematic side view relating to a second embodiment of the medical container of the present invention.
【図５】図５は第２実施例の医療容器の下部部分の裏面
図である。FIG. 5 is a rear view of a lower portion of the medical container according to the second embodiment.
１０ 医療容器 １２、１４ 室 １６ カップ部材 １８ 薬剤 ２０ 通気透湿性膜 ２２ 乾燥剤 ２４ 排出口 DESCRIPTION OF SYMBOLS 10 Medical container 12, 14 room 16 Cup member 18 Drug | drug 20 Breathable air-permeable membrane 22 Desiccant 24 Outlet
Claims (5)
能に熱接着されて該容器内が複数の室に形成される樹脂
容器であって、前記室の少なくとも一の室には水分の吸
湿により変質する薬剤が収容され、前記一の室壁は難透
湿性素材で形成され、前記一の室壁に通気透湿性膜が設
られると共に、前記通気吸湿性膜を介して前記一の室内
の水分を吸湿する乾燥剤が設けられ、前記通気透過性膜
及び前記乾燥剤は非透湿性又は難透湿性材料で覆われて
いることを特徴とする医療容器。1. A resin container in which flexible container walls facing each other are heat-bonded to each other so as to be peelable, and the inside of the container is formed into a plurality of chambers, and at least one of the chambers has a water-containing property. A medicine which is deteriorated by moisture absorption is stored therein, the one chamber wall is formed of a moisture-impermeable material, and the one chamber wall is provided with a gas-permeable moisture-permeable film, and the one room wall is provided via the gas-permeable moisture-absorbing film. 1. A medical container, comprising: a desiccant that absorbs moisture of the air; and wherein the air-permeable membrane and the desiccant are covered with a moisture-impermeable or slightly moisture-permeable material.
24hr（JIS P20208）以上であることを特徴とする請求
項１記載の医療容器。2. The moisture-permeable vapor-permeable membrane has a moisture permeability of 500 g / m 2.
The medical container according to claim 1, wherein the medical container is at least 24 hours (JIS P20208).
７の粒子を９９％以上阻止してなることを特徴とする請
求項２記載の医療容器。3. The air-permeable and moisture-permeable membrane has a particle diameter of 0.5 to 0.5.
3. The medical container according to claim 2, wherein 99% or more of the particles are blocked.
２以上であることを特徴とする請求項３記載の医療容
器。4. The water-permeable moisture-permeable membrane has a water resistance of 0.5 kg / cm.
4. The medical container according to claim 3, wherein the number is two or more.
壁を開口して形成される取付口に取り付けられるカップ
部材であることを特徴とする請求項４記載の医療容器。5. The medical container according to claim 4, wherein the one chamber for accommodating the medicine is a cup member attached to a mounting opening formed by opening the one chamber wall.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10333876A JP2000157607A (en) | 1998-11-25 | 1998-11-25 | Medical container |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10333876A JP2000157607A (en) | 1998-11-25 | 1998-11-25 | Medical container |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2000157607A true JP2000157607A (en) | 2000-06-13 |
Family
ID=18270949
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10333876A Pending JP2000157607A (en) | 1998-11-25 | 1998-11-25 | Medical container |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2000157607A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005063216A1 (en) * | 2003-12-26 | 2005-07-14 | Hisamitsu Pharmaceutical Co., Inc. | Use-activated plaster |
| JP2008525277A (en) * | 2004-12-23 | 2008-07-17 | クリニカル・デザインズ・リミテッド | Drug container |
-
1998
- 1998-11-25 JP JP10333876A patent/JP2000157607A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005063216A1 (en) * | 2003-12-26 | 2005-07-14 | Hisamitsu Pharmaceutical Co., Inc. | Use-activated plaster |
| JPWO2005063216A1 (en) * | 2003-12-26 | 2007-07-19 | 久光製薬株式会社 | Active-use patch |
| JP4861702B2 (en) * | 2003-12-26 | 2012-01-25 | 久光製薬株式会社 | Active-use patch |
| JP2008525277A (en) * | 2004-12-23 | 2008-07-17 | クリニカル・デザインズ・リミテッド | Drug container |
| JP2011201601A (en) * | 2004-12-23 | 2011-10-13 | Clinical Designs Ltd | Medicament container |
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