JP3604280B2

JP3604280B2 - Pharmaceutical container with seal

Info

Publication number: JP3604280B2
Application number: JP13646398A
Authority: JP
Inventors: 茂杉原
Original assignee: Daikyo Seiko Ltd
Current assignee: Daikyo Seiko Ltd
Priority date: 1997-07-10
Filing date: 1998-05-19
Publication date: 2004-12-22
Anticipated expiration: 2018-05-19
Also published as: JPH1179227A

Description

【０００１】
【発明の属する技術分野】
本発明は、医薬品等を充填した医薬品容器（以下、単に「容器」と総称する場合もある）の口部を高い密封性で封止してその内部に保持する医薬品等の品質を長期間安定に保持できると共に、当該医薬品を使用する際には簡単に封止を解除できる封止具付きの医薬品容器に関するものである。
【０００２】
【従来の技術】
医薬品容器の封止に関しては日本薬局方に、ゴム栓又はゴム板で容器開口部を封止し、更に外側からアルミニウム板を包み被せることによりアルミキャップを施し、環境変化や運搬・輸送時の振動その他の外的要因によってもその密封状態が変化しない封止器具の使用が定められている。従来は上記アルミニウムが主体であったが、近年はアルミニウムに代えて合成樹脂又は可撓性を有する素材を成形したキャップを用いる技術が、例えば特開昭５６−６４９６１、実開昭６３−１８０５５６、特開平５−２７０５６０、特開平７−１６５２５２、特開平７−１８７２１６、特開平７−３３０００７、特開平８−３４４６６及び特開平８−２７６９５２各号公報等に提案されている。
【０００３】
【発明が解決しようとする課題】
本発明は上記従来技術を改良し、封止器具として必須の要件である密封性が高く、当初の密封状態を長期間安定に保持できることに加え、使用の際の封止の解除が非常に簡単な操作で且つ衛生的に行える実用性の高い封止具付き医薬品用容器の提供を目的としている。また、本発明は使用の後の廃棄処理が容易である封止具付き医薬品用容器を提供することも目的としている。
【０００４】
【課題を解決するための手段】
上記課題を解決する手段として本発明は、 [1] 1)医薬品を充填する容器、2)板状又は栓状のゴム弾性体からなり該容器口部を密着して封止する直接封止体、3)中央部分に窓部を有する天面と該天面外縁から円筒状に下垂するスカート部を有し、該直接封止体及び該容器口部の外側に密接して被さり該直接封止体を該容器口部に密着固定する合成樹脂製のキャップ及び4)合成樹脂製薄膜からなり少なくとも該キャップの窓部及び天面を覆い剥離可能に形成されたカバー、を有してなり、前記スカート部は略中央の位置においてその外壁面又は内壁面に円環状溝を有することによりキャップ上部とキャップ下部が該円環状溝の底部をなす薄い壁面で連繋されており、かつ該キャップ下部の内壁面と容器口部外壁面の該キャップ下部の内壁面に対応する位置に両者が嵌合又は係合により固着する手段及び該キャップ下部の回転又は移動防止手段を有しており、〔１〕前記カバーを剥離することにより前記容器口部から前記キャップを分離することなく前記容器口部に密着して封止している前記直接封止体の上面を露出させ、及び／又は、〔２〕前記キャップに前記容器口部の外周に沿って左右いづれかの方向への回転力を加えることにより該円環状溝の部分が破断して、前記キャプ上部及び前記直接封止体を前記容器口部から分離して該容器口部を露出させ得て、前記〔１〕及び／又は〔２〕の状態を適宜選択し得るようにされていることを特徴とする封止具付きの医薬品容器、
[2] 上記直接封止体が容器口部内に嵌挿できる脚部を有するものであることを特徴とする上記[1] 記載の封止具付きの医薬品容器、
[3] 上記固着手段は該キャップ下部の下端の内壁面に沿って設けられた断面鉤爪状の係止突起が、容器口部上端に設けられた鍔状突起の下部傾斜面と係合してキャップを容器口部に密着固定するものであり、かつ上記回転又は移動防止手段はキャップ下部下端から天面方向に向い前記係止突起を越えて設けられた切り欠きと、前記鍔状突起の下面の該切り欠きに対応した位置に設けられた移動防止突起との係合からなり、キャップに回転力を加えてもキャップ下部の容器口部円周方向への回転又は移動は妨げられて上記円環状溝の部分が破断するようにされていることを特徴とする上記 [1]又は[2] 記載の封止具付きの医薬品容器、
[4] 上記固着手段並びに回転又は移動防止手段が、上記容器口部の外周面に設けられた傾斜環状突起と、上記スカート部下部の内壁面に該傾斜環状突起に嵌合するように設けられた傾斜環状溝との嵌合からなり、上記キャップに回転力を加えても該嵌合によりキャップ下部は移動を妨げられることにより上記円環状溝の部分が破断するようにされていることを特徴とする上記 [1]又は[2] 記載の封止具付きの医薬品容器、及び
[5] 上記直接封止体が直接封止体天面下面から突出して容器口部内に嵌入できる脚部を有する栓体であり、該脚部はその外周に突起を有するとともに先端側から天面側に向かう切れ込みを有し、該脚部の先端側を容器口部内に嵌入して該突起を該容器口部上縁に係止することにより半打栓状態を維持するときには該切れ込みの一部は容器口部外にあって容器内部と外部の通気路を形成し、完全打栓すると該脚部全体が容器口部内に嵌挿されると共に天面下面の周縁部は開口部上縁に密着して容器口部を密着封止するようにされており、上記キャップのスカート部には上記半打栓状態において上記通気路と連通する通気孔を穿たれており、且つ上記カバーは少なくとも上記窓部及び通気孔を覆う略円筒形状であることを特徴とする上記[1] ないし[4] のいずれかに記載の封止具付きの医薬品容器、を提供するものである。
本発明においては上記キャップの外周及び上記容器の外周に、両者の係合もしくは嵌合位置を示す標識、又は係合もしくは嵌合位置を示す標識とキャップを回転させる方向を示す標識を設けることが、製造工程上さらには使用上特に好ましい。
また、本発明においてはキャップに回転力を与えることによる円環状溝の部分の破断が破断力３〜３０kgf で起こるようにされていることが特に好ましく、さらに本発明の前記キャップは熱可塑性樹脂又は熱可塑性樹脂組成物からなるものが特に好ましい。
【０００５】
【発明の実施の形態】
本発明の特徴を図１及び図２を参照してまず簡単に説明する。逆有底円筒状の合成樹脂製キャップ（以下「キャップ」という）１は、医薬品容器（以下、「容器」と略称する）２の開口部５を直接封止している直接封止体（ゴム板又はゴム栓）６に被さり、該直接封止体６を医薬品容器２に強固に固着している。キャップ１の天面９には窓部７を設けてあり、合成樹脂製の薄板又はシールからなるカバー８を天面９の上表面に取り付けて該窓部７を覆ってある。該カバー８を剥がすことにより窓部７の下部に位置する直接封止体６の上表面を露出することができる。キャップ１のスカート部１０は図２の（ａ）に示す容器口部４の外周に沿う筒壁をなしており、該スカート部１０の略中央又は若干下側の位置において、その外周面又は内周面に円環状溝１１を設けることにより、キャップ１は円環状溝１１より上部となるキャップ上部１２と円環状溝１１より下部となる部分であるキャップ下部１３が、円環状溝１１の底部である薄い壁１４で繋がった構造となっている。一方、該キャップ下部１３は容器口部４と嵌合、係合又は螺合する固着手段（図１の例では係止爪１５と鍔状突起４１と傾斜した下面４２）及び容器口部４の外周に沿う方向への回転移動防止手段（切欠き１６及び係止用突起２０による係合）を有することにより、容器口部４に固着するとともに、直接封止体６及びキャップ１を容器口部４に固定して容器の密封性を保証し、キャップ１に容器口部４の外周に沿って回転力を加えてもキャップ下部１３は回転移動を妨げられ、さらに小さな回転力を加えるとキャップ上部のみが回転移動できるので、円環状溝１１位置に破断力が働き、円環状溝１１の位置で簡単に破断されて、キャップ上部１２が離れ、直接封止体６さらには開口部５を露出することができる。
【０００６】
また、本発明の特徴を図６に示す他の実施態様により説明すると、医薬品容器２２の開口部分５は直接封止体（図示の例では脚付ゴム栓）２６で密着封止し、これを内包するように逆有底円筒状の合成樹脂製のキャップ１′で覆い、該直接封止体２６を医薬品容器２２に強固に固着する。キャップ１′の天面２９には窓部２７を設けてあり、合成樹脂製の薄板又はシールからなるカバー３８を天面２９の上表面に取り付けて該窓部２７を覆ってある。使用時には該カバー３８を剥がすことにより窓部２７の下部に位置する直接封止体２６の上表面を露出することができる。キャップ１′のスカート部３０は容器口部４′の外周に沿う筒壁状をなし、該スカート部３０の略中央又は若干下側の位置において、その外周面又は内周面（図示の例では内周面）に円環状溝３１を設けることにより、スカート部３０の円環状溝３１の位置においてキャップ１′は円環状溝３１より上の部分であるキャップ上部３２と円環状溝３１より下となる部分であるキャップ下部３３が、円環状溝３１の底部をなす薄い壁３４で繋がった構造となっている。一方、容器口部４′の外周壁に傾斜環状突起２３を設け、キャップ下部３３の内壁面には該傾斜環状突起２３を雄型とする雌型となるように傾斜環状溝２８を設けて、対応する位置を合わせて両者を嵌合、係止できる構造とすることにより、直接封止体２６及びキャップ１′全体を容器口部４′に固定し、開口部５を密封している。この構造により、容器２を固定してキャップ１′に容器口部４′の外周に沿った方向に回転力を加えると、傾斜環状突起２３と傾斜環状溝の強い嵌合は外れずキャップ下部３３は容器口部４′に固着され回転できず、さらに回転力を加えるとキャップ上部３２のみが回転移動して、円環状溝３１の位置に破断力が働き、円環状溝３１の位置で簡単に破断されて、キャップ上部３２が離れ、直接封止体２６、さらには開口部５を露出することができる。
【０００７】
本発明のキャップを容器口に装着するには、図４の概略説明図に示すようにキャップ１の切欠き１６の位置を示す標識１８と、容器２の係止用突起２０の位置を示す標識１９を合印としてキャップを容器口部に打ち込むことにより、キャップ１の係止爪１５が鍔状突起の傾斜した下面４２に強く嵌合して、キャップ１が容器口部４に固定される。図３（ｂ）のように２個の切欠き１６，１６′を設けた場合には当然係止用突起２０も対称する位置に２個設ける。
【０００８】
本発明において円環状溝は３〜３０ｋｇｆの破断力で破断するように設計する。また、このような破断をもたらすキャップの破断回転力は４〜５０ｋｇｆ、好ましくは４〜３２ｋｇｆとなるように設計する。具体的な値はキャップに用いる合成樹脂材質によるが、本発明では溝の底部の薄い壁１４の部分の厚さは０．０１〜０．５ｍｍが好適であった。また溝の断面形状は横Ｕ字形、横Ｖ字形、角形のいずれでもよく、溝の幅（スカート部の壁における高さ方向の長さ）は０．１〜０．７ｍｍ程度、溝深さは溝底部の壁厚さにより決まる。前記のように円環状溝はスカート部の外周面，内周面のいずれに設けてもよいが、外周面に設けた場合には、カバー（シール）が円環状溝を覆う構造とすれば、溝内へのゴミ等の付着を防止できる。
【０００９】
以上のような構成の本発明の封止具付き医薬品容器は、その目的に応じて、〔１〕カバーを剥離して直接封止体の上面を露出し、この露出部分に注射針等を刺通する、又は／及び〔２〕キャップに回転力を与え、円環状溝の位置で破断してカバー、キャップ上部及び直接封止体を外す、という〔１〕と〔２〕の用い方が可能である。
上記〔１〕の用い方は、具体的には例えば容器内に充填された医薬品が凍結乾燥された注射用薬品等の場合、まずカバーを剥離し、露出した直接封止体の天面に注射針を差し込んで、注射器内の注射用蒸留水等の液剤を容器内に注入し、医薬品を溶解させ注射液とする。次いで、該注射針により溶解された注射液を注射器内に戻し、直接封止体から注射針を抜き取り、注射液を投与する。
上記〔２〕の用い方は、具体的には例えば直接封止体を除いて医薬品を速やかに使用する或いは、容器２の容器口を速やかに他の医薬品使用装置に取り付けて使用するような場合が挙げられ、カバーを剥離した後に容器を手で保持するか又は固定手段で固定しておき、キャップ上部を左右どちらかに回転力を加え、円環状溝の底部の薄い壁の位置で破断して、キャップ上部、直接封止体を容器口部から分離する。このように容器の開口部が迅速に露出でき、医療現場での緊急操作が安全、確実かつ衛生的に行える。
上記〔１〕のように用いた後、使用済みの容器、キャップ等の廃棄処理にあたり、上記〔２〕のようにキャップを破断すると、弾性体からなる直接封止体も簡単に開口部５から分離されるので、分別して処理することが容易になる。
【００１０】
本発明の更なる実施の態様であって、容器内に濃縮製剤、特に凍結乾燥製剤操作ができる封止具付き容器について図１１の概略説明図を参照して説明する。直接封止体４６は直接封止体天面４３から容器口部４０側に突出する大きな切れ込み４８（４８′）付きの脚部４４（４４′）を有する脚付き栓であり、脚部４４（４４′）外周の突起４５（４５′）により半打栓状態で開口部５の上縁に係止できて、このとき切れ込み４８（４８′）が容器内と外部との通気路を形成する。スカート部１０には該通気路に対応する位置に通気孔５０を穿孔してあるので、キャップ５１を取り付けた状態で容器２内と外部は連通しており、滅菌環境下での濃縮或いは真空乾燥工程において容器２内からの医薬品の蒸気４９が排気できる。通気孔５０の数は切れ込み４８の数（通気路数）と同じにすればよく、図示の例では２個を対称な位置に設けてある。濃縮或いは真空乾燥が終了した時点で直ちにキャップ５１及び直接封止体４６を完全に打栓して図９に示すように開口部５を密封することができる。カバー８は完全に打栓した状態において通気孔５０を密封するように略円筒形状とする。キャップ５１と容器口部４０の固着手段、回転又は移動防止手段、キャップに回転力を加えたときに円環状溝部分で破断する構成等はすでに説明したものと同様である。
【００１１】
このように通気孔付きキャップを有する本発明の医薬品容器は、前記〔１〕又は〔２〕の用い方に加え、キッャプに直接封止体を取り付けた状態で、濃縮装置或いは凍結乾燥装置の槽内で製剤できて、製剤後に同じ槽内で直ちに打栓、キャップ締めして密封できるので非常に衛生的且つ高効率に製品とすることができる。
【００１２】
本発明のキャップの素材としては合成樹脂又は合成樹脂組成物が挙げられ、特に好ましくは熱可塑性樹脂又は熱可塑性樹脂組成物が挙げられる。具体的には、ポリプロピレン（ＰＰ）：例えば三井ポリプロＪ９００〔商品名、三井石油化学（株）製〕，三菱ポリプロＪＦ４０Ｍ〔商品名、三菱化学（株）製〕，高級ＰＰ＃９１１９〔商品名、アコモケミカル（株）製〕等、超高分子量ポリエチレンやポリエチレンホモポリマー等の高軟化温度ポリエチレン、ポリエチレンテレフタレート（ＰＥＴ）等の飽和ポリエステル及び飽和ポリエステル系ポリマーアロイ類：例えばパイロアロイＡＡ〔ＰＥＴ、商品名、東洋紡績（株）〕、ＴＰＸ＃ＤＸ８１０〔ポリメチルペンテン、商品名、三井石油化学（株）製〕、スミプロイ〔商品名、住友化学工業（株）製〕〕等、ポリスチレン、ポリエーテルエーテルケトン及びポリエーテルケトン類：例えばＫＡＤＥＬＥ−１０００〔商品名、帝人（株）製〕等、アクリル樹脂、ポリスチレン、ポリアミド、ポリフェニレン・サルファイド、エポキシ樹脂、ポリカーボネート（ＰＣ）などの合成樹脂及びこれらに配合剤を加えた合成樹脂組成物が挙げられる。成形法についても特に限定さるところはなく、公知技術に従い行なうが、例えば原料の合成樹脂又は合成樹脂組成物を混練し、金型内に射出成形するなどして本発明に係るキャップを製造することができる。
【００１３】
キャップのスカート部の円環状溝部分以外の厚さについては特に限定されるところはないが、通常０．６〜２．０ｍｍ程度である。窓部のサイズ、形状についても特に限定されるところはないが、通常円形の窓を天面の中央部分に設け、天面の上表面には窓部を囲むような環状突起を設けておくと、シール材を弱く圧着してカバーを設ける場合に有利である。また直接封止体がゴム板の場合、天面の内表面に窓部を囲むように環状突起を設けて密封性を向上させることができる。
【００１４】
本発明の直接封止体としては、この種分野で公知のゴム弾性体からなる板状又は栓状のものを使用できる。容器口部内に嵌入して容器口部内壁に密着する脚付タイプのものを用いると、より高い密封性が得られる。また、医薬品に接触する可能性のある表面は、フッ素系樹脂、ポリエチレン等の医薬品を汚染しない合成樹脂フィルムで被覆することは特に好ましい実施態様である。
ゴム弾性体の素材として例えば、ブチルゴム系、イソプレンゴム系等の合成ゴム類、スチレン・ブタジエンブロック共重合体及びその水素添加物等の熱可塑性エラストマー類、ポリエチレン等のポリオレフィン系樹脂とゴム成分との共架橋樹脂等が挙げられ、公知技術に従い成形することができる。
【００１５】
本発明のカバーは、少なくともキャップ窓部を完全に覆って天面に圧着できるサイズが必要であるが、通常はキャップの天面に例えば高周波加熱等により弱く圧着される平板状シール又は、キャップ上部に密着して被さる逆有底円筒形状である。またキャップに通気孔を有するものの場合は、窓部と通気孔を完全に覆える形状とする。その材質としてはこの種用途に用いることのできる公知の合成樹脂薄膜が挙げられ、具体的には前記したキャップの材質として例示した合成樹脂、特に好ましくは熱可塑性樹脂が挙げられる。カバーを高周波溶着又は超音波溶着する場合には、キャップの材質と同じものを用いることが好ましい。
【００１６】
本発明の容器としては、この種分野の公知の各種材質を用いることができるが、特に医薬品が直接接触するものであるため、汚染等の危険がなく安全性の高いものを選択する必要がある。特に好ましい材質として、環状オレフィン系共重合樹脂：例えばＺＥＯＮＥＸ２８０〔商品名、日本ゼオン（株）製〕，ＣＯＣ（アベル）〔商品名、三井石油化学（株）製〕等、を挙げることができる。
【００１７】
【実施例】
本発明においては、キャップの窓部の構造、カバーの構造、キャップ下部と容器口部の固着手段、さらにキャップ下部の回転防止手段は任意に採用できるし、またキャップと容器口部との間の直接封止体の形状についても特に限定されるところはないが、以下に本発明の実施例について更に具体的に説明する。
【００１８】
〔実施例１〕
容器として環状オレフィン系共重合樹脂、直接封止体として合成ゴム、キャップ及びカバーとしてはポリプロピレンを材料として用い、本発明品を製造した。図１は本実施例の概略断面図、図２は図１の構成を各部分に分離した状態を示した概略断面図であり、（ａ）には医薬品容器の容器口部４及び開口部５を、（ｂ）には直接封止体６を、（ｃ）にはキャップ１を、そして（ｄ）にはカバー８を、それぞれ示している。医薬品３を医薬品容器２の内部に充填した後、弾性体からなる板状の直接封止体６を医薬品容器２の開口部５の上縁に載置して封止し、さらにキャップ１を直接封止体６及び容器口部２に被せる。キャップ１は中央部に貫通穴として設けた窓部８を有する天面９及び該天面９の外周から容器口部４の外周面に密着して被さる円筒形状のスカート部１０を有し、スカート部１０の下端の内壁面に内周に沿って環状に突出する断面鉤爪状の係止爪１５を固定手段として容器口部４の上縁外周の鍔状突起４１の下面４２に係止することにより該直接封止体６を容器口部４の上縁面に強固に密着固定している。
【００１９】
図３の（ａ）に示すように、係止爪１５はキャップ１の断面において内周壁に対する角度θが７２〜９５°の角度で設けられている。この角度の範囲にすると一度キャップ止めすると、容器口部４からは分離し難い程度に強固に固着できる。また、容器２の鍔状突起４１の下面４２も係止爪１５の角度に合わせて設計する。さらに係止爪１５の長さＭはキャップサイズにもよるが０．８〜２．０ｍｍさらには２．５ｍｍ程度が好ましく、長いほうが強固に固着できる。Ｍに対して図３のＬが長いほどキャップ打ち込み操作が容易になるが、キャップを容器口部に打ち込む難易は使用する合成樹脂の表面カタサ、圧縮歪等に関係する。
【００２０】
図３の（ｂ）は図２の（ｃ）のキャップ１を矢印Ａ方向に俯瞰した概略図であり、図４の（ａ）は容器２、直接封止体６、キャップ及びカバーを分離した状態で示す概略斜視図、同図の（ｂ）は容器口部周辺の概略説明図である。係止爪１５はキャップ１の下端の内壁面に沿って設けられているが、完全な環状ではなく、内周の直径に対して対称な位置（２ケ所）において切り欠き１６及び１６′が設けられている。一方、図４に示すように、容器口部４の鍔状突起４１の下面４２には該切り欠き１６及び１６′に対応した係止用突起２０及び２０′を設けて、キャップ下部１３の回転移動を防止している。キャップ１と容器２のそれぞれに該切欠き１６及び１６′、係止用突起２０及び２０′の位置を示す標識１８，１９を印刷又は刻印等により設け、キャップ締め作業を容易にしてある。
【００２１】
また図２において、スカート部１０の外壁には外壁全周にわたる円環状溝１１が設けられ、上記のようにキャップ上部１２とキャップ下部１３は円環状溝１１の底部の薄い壁１４で繋がった状態となっている。本実施例では円環状溝１１の断面は横Ｕ字であるが、横Ｖ字或いは角溝のいずれでもよい。本実施例では薄い壁１４の厚さは０．０１〜０．５ｍｍ、円環状溝１１の高さ０．１〜０．７ｍｍである。この溝は破断力が３〜３０ｋｇｆとなるように設計されている。
【００２２】
キャップ１の天面９の窓部７からキャップ１のスカート部１０の円環状溝１１を越えてキャップ下部１３に至るまで連続して、合成樹脂薄膜からなるカバー８で覆い、直接封止体６の天面及び円環状溝１１への汚染を防止するとともに、容器２の密封性を向上させている。医薬品充填後、容器口部４に直接封止体６及びキャップ１を打栓し、この種分野で公知の手段により簡単にカバーを剥離自在に取り付けることができる。カバーには剥離用の突出片又は切れ目を入れることもできる。
【００２３】
以上のように構成された本実施例では、例えば医薬品３が凍結乾燥された注射用薬品等の場合、まずカバー８を剥離し、露出した直接封止体６の天面に注射針を差し込んで、注射器内の注射用蒸留水等の液剤を容器内に注入し、医薬品３を溶解させ注射液とする。次いで、該注射針により溶解された注射液を注射器内に戻し、容器から注射針を抜き取り、注射液を投与する。
また、容器２を手で保持するか固定手段で固定しておき、キャップ上部１２に左右どちらかに回転力を加えると、キャップ下部１３も回転しようとするが、切り欠き１６の両側の断面鉤爪状突起の端面１７ａ又は１７ｂ、及び切り欠き１６′の両側の断面鉤爪状突起の端面１７′ａ又は１７′ｂが容器２の係止用突起２０及び２０′に当たり、それ以上の回転を止められる。さらに回転力を加えると、キャップ上部１２はそのまま回転力を受けるので、薄い壁１４の部分に破断力が働きこの円環状溝１１の位置で破断され、キャップ上部１２が簡単に分離できる。これにより開口部５が迅速に露出できる。医療現場での緊急操作が安全、確実かつ衛生的に行える。また、前記したように使用済みの容器、キャップ等の廃棄処理にあたり、キャップ上部１２を分離すると、弾性体からなる直接封止体も簡単に開口部５から分離されるので、分別処理が容易になる。
【００２４】
〔実施例２〕
容器として環状オレフィン系共重合樹脂、直接封止体として熱可塑性エラストマー、キャップ及びカバーとしては飽和ポリエステル系ポリマーアロイを材料として用いて、本発明品を製造した。本例は実施例１の構造とほぼ同様であるが、係止用突起の形状が異なったものであるので、図５の（ａ）及び（ｂ）に容器開口部近傍の部分斜視図及び部分断面図を示し、その他の部分の図示は省略する。係止用突起２１は鍔状突起４１から下面４２の側に三角柱の形状で突出している。キャップ上部に回転力を与えると、実施例１の場合と同様に切り欠き１６の両側の断面鉤爪状突起の端面１７ａ又は１７ｂ、及び切り欠き１６′の両側の断面鉤爪状突起の端面１７′ａ又は１７′ｂが容器２の係止用突起２１及び図示は省略した２１′に当たり、それ以上の回転を止められる。一方キャップ上部は回転しようとするので、薄い壁の部分に破断力が働き、円環状溝の位置で破断され、キャップ上部が簡単に分離できる。これにより容器２の開口部５が迅速に露出できる。本実施例では円環状溝は破断力が３〜５０ｋｇｆとなるように設計されている。
【００２５】
〔実施例３〕
容器として環状オレフィン系共重合樹脂、直接封止体としてポリオレフィン系樹脂とゴム成分との共架橋樹脂、キャップ及びカバーとしてはポリエーテルケトンを材料として用い、本発明品を製造した。図６の（ａ）に示すように、容器２２は本体より外径、内径が小さくなった容器口部４が略円筒状に形成されており、鍔状突起は設けられていない。容器口部４の長さＨの約半分以下の位置より下に、すなち開口部５の上縁から深さｈ_１からｈ_２の位置に、開口部５の全周にわたる環状の突起が開口部５の上端面に対し一定の傾斜（傾斜の高さｈ＝ｈ_２−ｈ_１）をつけて設けられている。この傾斜環状突起２３の断面は本例では山型（三角形）であり、該三角形は底辺長さより高さが長い形状にしてあるためキャップの打ち込み操作が容易である。ただし、角状等その他の断面形状を採用することもできる。
【００２６】
開口部５には図６の（ｂ）に示す直接封止体天面６′の下面（開口部５に対面する側）に突出した環状の脚部２４を嵌入するが、該脚部２４の外周には環状の突起２５が設けてあり、容器口部４の内壁面にに密着して封止することができる。図示は省略したが脚部２４及び直接封止体天面６′の下面の薬液接触可能な面をすべて非汚染性、耐薬品性の合成樹脂フィルムで積層することは特に好ましい実施態様である。
【００２７】
図６の（ｃ）及び図７に示すようにキャップ１′は天面２９に窓部２７を有し、天面２９の外周円縁から下垂する円筒形状のスカート部３０を有する点では実施例１と同じであるが、本実施例ではスカート部３０の内壁面に円環状溝３１を設けることにより、キャップ上部３２とキャップ下部３３を該円環状溝３１の底部である薄い壁３４で繋いでいる。円環状溝３１を内壁面に設けたことによりスカート部３０が均一な表面となる。また表面全体に浅い凹凸３７を設けてキャップに回転力を与えるときの指滑りを防止している。スカート部３０の下端外縁には外側に向かう環状突起部３５を設け操作する際の指掛けの便を図ってある。
【００２８】
キャップ下部３３の内壁には、容器口部４′の傾斜環状突起２３を雄型とした雌型として嵌合する形状で傾斜環状溝２８が設けてある。また、容器口部４′の傾斜環状突起２３とキャップの傾斜環状溝２８の位置を合わせてキャップを取り付けるために、キャップ天面２９の外表面及び容器口部外周壁面に締め位置を示す標識１８′及び１９′をそれぞれつけてある。また、キャップ１′の天面２９の上面にはキャップ１′を捻じる際の方向を示す標識３８が設けてある。
【００２９】
キャップ１′の天面２９にはカバーとして合成樹脂製の薄板からなるシール３７が接着される。シールのサイズは窓部及び天面を覆う大きさであり、キャップ内部へのゴミ、細菌等の侵入を防止する。また、振動や環境変化によりキャップ上面より剥離することのないようにキャップ天面の全面に接着する。
【００３０】
容器２２内に医薬品を充填した後、直接封止体２６の脚部２４を容器口部内に嵌入し天面６の外縁下面を開口部５の上縁に密接させて開口部５を封止し、さらにキャップ１′の標識１８′を容器の標識１９′に合わせて被せ、カバー（シール）３８を圧着する。キャップ１′の天面２９の内面には環状突起３６が設けてある。シール３８を圧着して密封する際に該環状突起３６は直接封止体天面６′を押しつけるので、密封性をさらに向上できる。あるいはカバー３８，キャップ１′及び直接封止体２６を組み合わせておいて、標識１８′と標識１９′を合わせて打栓と同時にキャップ締め及びカバー圧着を行なうようにしてもよい。
【００３１】
本実施例の容器２２内の医薬品を使用するには、カバー３８の末端に設けた図示を省略した突出片をつまんで引くことにより、剥離する。この状態で窓部２７において直接封止体天面６′の上面が露出するので、キャップ１′を嵌めたままで、直接封止体を貫通して注射針を容器内部に刺し通すことができる。以下、実施例１の場合と同様に医薬品を溶解して注射液とし、該注射液を注射器内に吸引することにより、衛生的にかつ簡単に注射液を投与することができる。
【００３２】
本実施例において、キャップ１′を円環状溝３１の部分で破断して容器２２の開口部を露出する方法は、実施例１の場合と同様にキャップ１′の上面の標識に示す方向にキャップ１′を回転するように力を加える。キャップ下部３３は傾斜環状溝２８で容器口部５の傾斜環状突起２３に嵌合、固着しているので回転移動できず、円環状溝３１の薄い壁部３４で破断される。本発明において、薄い壁の厚さ０．０１〜０．５ｍｍ、高さ０．１〜０．７ｍｍである。
【００３３】
本実施例において、キャップ１′の内壁面に設けた傾斜環状溝の傾斜の長さｈ（ｈ＝ｈ_２−ｈ_１）は２〜１２ｍｍとした。本発明において長さｈは、キャップを構成する合成樹脂素材の物理的性質に関係しており、ゴム弾性体のように切断伸び（％）の大きい合成樹脂ではｈを大きくすることは好ましくない。従って、切断伸び（％）の小さい合成樹脂を選択するか、あるいは合成樹脂に微粉末の充填剤を０．１〜２５重量％配合することにより伸びを小さくすることが好ましい手段として挙げられる。
【００３４】
さらに、キャップ材質としてポリエチレンテレフタレート、ポリメチルペンテンを用いて実施例１〜３のキャップを製造した。各実施例で得られた医薬品容器封止体はいずれも破断回転力４〜３２ｋｇｆを与えることにより円環状溝位置で破断され、キャップ上部を容易に分離することができた。なお、実施例１のものは既製品の容器であっても、その口部が係止爪で強固に係止、固着できる構造を有するものであれば、封止具部分のみを適用して同様の効果を得ることができる。
【００３５】
〔実施例４〕
容器として環状オレフィン系共重合樹脂、直接封止体として合成ゴム、直接封止体の脚部積層フィルムとしてはフッ素樹脂、キャップ及びカバーとしてはポリプロピレンを材料として用い、直接封止体が切れ込みを有する脚部付き栓であり、半打栓状態で該切れ込み部分とキャップの通気孔が通気路を形成できる本発明品を製造した。
図９は本実施例の概略断面図、図１０は図９の構成を各部分に分離して示した概略説明図、図１１は本実施例のものを半打栓状態にして製剤工程に付している場合を説明する図、図１２は溝部分で破断された状態を示す概略図であり、図９〜図１２において図１〜図８と共通符号の部分は同じ意味を表す。図９乃至及び図１０に示すように、本実施例においては容器口部４０は図１のものより高さ方向長さの長い、すなわち幅広の鍔状突起４１が設けられているが、キャップ５１と容器口部４０の固着手段は実施例１のものと同様である。本例では直接封止体４６が封止体天面４３の下面に突出して設けられた脚部４４及び４４′を有するいわゆる脚付き栓であり、脚部４４及び４４′の外周には突起４５及び４５′が設けられ、また脚部４４及び４４′には先端側から封止体天面５３に向かう大きな切れ込み４８及び４８′が設けられており、脚部先端を基準とする該切れ込み４８（４８′）の高さは突起４５（４５′）の下端の位置する高さよりも高くしてある。また、脚部外周は突起４５（４５′）の下端までは弾性体の素面のままにしてあるが、突起４５（４５′）の下端から脚部先端及び切れ込み表面は連続して合成樹脂フィルム４７を積層し、容器内の医薬品等への汚染を防止している。キャップ５１はスカート部１０に通気孔５０及び５０′を穿ってあり、その他の構成は実施例１の場合と同様である。カバー８は略円筒形状であってキャップ５１に密着内包して覆うときに、少なくとも窓部７及び通気孔５０及び５０′を覆うサイズにしてある。
【００３６】
本発明品を用いた製剤工程を説明する。医薬品３の原液を容器２内に充填した後、図１１に示すように直接封止体４６の脚部４４（４４′）の先端側を開口部５内に嵌挿し突起４５（４５′）の下端を容器口部４０の上縁に係止させ、半打栓状態とし、滅菌した減圧装置槽又は凍結乾燥装置槽内で真空乾燥又は凍結乾燥する。このとき切れ込み４８（４８′）の高さは突起４５（４５′）下端の高さより高いので切れ込み上部４９（４９′）は容器口部４０の上縁より上に位置して、容器内部と外部を連通する通気路を形成できる。また、キャップ５１の通気孔５０（５０′）は半打栓状態でその上端が少なくとも容器口部より上方にあってしかも切れ込み上部４９（４９′）により形成された通気路と連通した通気路を形成するように穿孔されているので、この通気路から容器２内の医薬品の蒸気５２を外部に排出できる。真空乾燥又は凍結乾燥が終了した時点でキャップ、直接封止体を一度に完全打栓することにより、切れ込み４８（４８′）は容器口部４０内に入り切れ込みの上部である脚部４４（４４′）の基部及び直接封止体天面４３が容器口部４０の内壁及び上縁に密着封止し、またキャップ５１の通気孔５０（５０′）は容器口部の鍔状突起４１の外周部で塞がれ、容器内部と外部は完全に遮断される。キャップ５１の係止爪１５が鍔状突起４１の傾斜を有する下面４２に食い込んでキャップを容器口部４０に固着し、また切欠き１６（１６′）と係止用突起２０（２０′）が係合する。なお、製剤を開始する際にキャップ及び容器の外周につけておいた標識（図示は省略）で両者の係合位置を合わせておくことができる。
【００３７】
上記のように製剤された医薬品からキャップ５１を外すには、まずカバー８を外し、実施例１の場合と同様にキャップ５１に回転力を加えると、キャップ下部１３は係止爪１５で下面４２に固着しており、一方切欠き１６（１６′）と係止用突起２０（２０′）が係合しているためキャップ下部１３は回転又は移動できず、円環状溝１１の底の薄い壁１４部分が破断する。図１２に破断されたキャップ１２と直接封止体４６を示す。
【００３８】
【発明の効果】
本発明の医薬品容器封止体は、キャップの上に接着したフィルム、シールを剥離して簡単に直接封止体を露出できるので、直接封止体への注射針刺しが非常に簡単、迅速、確実にしかも衛生的に行える。しかも、容器口部を当該医薬品使用装置に組み合わせて使用する場合には、キャップに小さな回転力を与えるだけで円環状溝において破断することによりキャップ上部を容易に分離できて、衛生的にしかも迅速に上記使用装置に取り付けることができる、という二つの使用法に対応できる。さらに通気孔を有するキャップと切れ込みを有する脚部付き栓を直接封止体として組み合わせた本発明品は濃縮乾燥、凍結乾燥の槽内で製剤後直ちに完全打栓、キャップ打ち込みが可能であり、極めて衛生的に且つ高効率に製品を得られる。また、本発明品は容器口部と直接封止体、キャップはいずれも強度に固着し容器内を密封できるので、内部に充填した医薬品を長期、高品質に保存できる。さらに、本発明品は材質として金属を用いることなく、しかも各構成部分に分離することが容易であるため、廃棄処理も簡単、容易、かつ安全である。
【図面の簡単な説明】
【図１】本発明の一実施態様を示す部分断面図である。
【図２】図１の封止具付き医薬品用容器を各構成部分に分けた状態を示した説明図である。
【図３】図２の（ｃ）部分の部分拡大断面及びを矢印Ａの方向から見た状態を示す図である。
【図４】本発明の図１及び図２の容器口部の構造を説明するための概略斜視図及び部分断面図である。
【図５】本発明の他の実施態様における容器口部近傍の斜視図及び部分断面図である。
【図６】本発明の他の実施態様を各構成部分に分けた状態を示した説明図である。
【図７】本発明の図６の（ｃ）のキャップ部分を拡大して示した一部切欠き断面図である。
【図８】本発明の図６の（ｃ）部分を矢印Ｂ方向から見た状態を示す説明図である。
【図９】本発明のさらに他の実施態様を示す部分断面図である。
【図１０】図９の封止具付き医薬品用容器を各構成部分に分けた状態を示した説明図である。
【図１１】図９及び図１０の本発明品を用いた製剤工程の説明図である。
【図１２】図９ないし図１１のキャップを円環状溝部分で破断した状態を示す説明図である。
【符号の説明】
１，１′及び５１キャップ、２及び２２容器、
３医薬品、４，４′及び４０容器口部、
５開口部、６，２６及び４６直接封止体、
６′及び４３直接封止体天面、７及び２７窓部、
８及び３８カバー、９及び２９天面、
１０及び３０スカート部、１１及び３１円環状溝、
１２及び３２キャップ上部、１３及び３３キャップ下部、
１４及び３４薄い壁、１５係止爪、
１６及び１６′ 切り欠き、１７ａ及び１７ｂ端面
１８，１８′，１９，１９′及び３８標識、
２０，２０′及び２１係止用突起、
２３傾斜環状突起、２４，４４及び４４′ 脚部、
２５突起、２８傾斜環状溝、
３５環状突起部、３６突起
３７凹凸、３９小突起
４１鍔状突起、４２下面、
４５及び４５′ 突起、４７合成樹脂フィルム、
４８及び４８′ 切れ込み、４９及び４９′ 切れ込み上部、
５０及び５０′ 通気孔、５２蒸気。[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention seals the mouth of a pharmaceutical container filled with pharmaceuticals and the like (hereinafter, sometimes simply referred to as "container") with high hermeticity and stabilizes the quality of pharmaceuticals and the like held therein for a long time. The present invention relates to a medicine container provided with a closure which can be held in a container and can easily release the seal when the medicine is used.
[0002]
[Prior art]
Regarding the sealing of pharmaceutical containers, the Japanese Pharmacopoeia seals the container opening with a rubber stopper or rubber plate, and further covers the aluminum plate from the outside with an aluminum cap to cover environmental changes and vibration during transportation and transportation. The use of a sealing device whose sealing state does not change due to other external factors is specified. Conventionally, the above-mentioned aluminum was mainly used, but in recent years, a technique using a cap formed of a synthetic resin or a flexible material instead of aluminum has been disclosed in, for example, JP-A-56-64961, JP-A-63-180556, It is proposed in JP-A-5-270560, JP-A-7-165252, JP-A-7-187216, JP-A-7-330007, JP-A-8-34466 and JP-A-8-276952.
[0003]
[Problems to be solved by the invention]
The present invention is an improvement over the above-mentioned conventional technology. In addition to having a high sealing property, which is an essential requirement as a sealing device, and being able to stably maintain the initial sealing state for a long period of time, it is very easy to release the sealing during use. It is an object of the present invention to provide a highly practical container for medical supplies with a closure that can be performed in a sanitary manner with a simple operation. Another object of the present invention is to provide a pharmaceutical container with a closure that is easy to dispose after use.
[0004]
[Means for Solving the Problems]
As a means for solving the above-mentioned problems, the present invention provides: [1] 1) a container for filling a medicine, 2) a direct sealing body made of a plate-like or plug-like rubber elastic body and tightly sealing the mouth of the container. , 3) a top surface having a window at the center portion, and a skirt portion hanging down cylindrically from an outer edge of the top surface, and closely covering the outside of the direct sealing body and the container opening, and directly sealing A cap made of a synthetic resin for tightly fixing the body to the container mouth and 4) a cover made of a thin film made of a synthetic resin and formed at least at a window portion and a top surface of the cap so as to be peelable, and The skirt portion has an annular groove at its outer wall surface or inner wall surface at a substantially central position, so that the upper portion of the cap and the lower portion of the cap are connected by a thin wall surface forming the bottom of the annular groove. Corresponds to the inner wall surface under the cap on the wall surface and the outer wall surface of the container mouth A means for fixing the two to each other by fitting or engaging and a means for preventing rotation or movement of the lower portion of the cap, [1] By peeling off the cover, the upper surface of the directly sealed body that is tightly sealed to the container opening without separating the cap from the container opening is exposed, and / or [2]. Said On the cap In the left or right direction along the outer circumference of the container mouth The annular groove is broken by applying rotational force Then, the cap upper part and the direct sealing body can be separated from the container mouth to expose the container mouth, and the state of [1] and / or [2] can be appropriately selected. A pharmaceutical container with a seal, characterized by being
[2] The pharmaceutical container with the sealing device according to [1], wherein the directly sealed body has a leg portion that can be inserted into a container mouth.
[3] The fixing means is such that a claw-shaped locking projection provided along an inner wall surface at a lower end of the lower portion of the cap is engaged with a lower inclined surface of a flange-shaped projection provided at an upper end of a container mouth. A cap provided in close contact with the cap of the container, and the rotation or movement preventing means is provided with a notch provided from the lower end of the cap toward the top surface and beyond the locking projection, and a lower surface of the flange-shaped projection. And engagement with a movement preventing projection provided at a position corresponding to the notch, and even if a rotational force is applied to the cap, rotation or movement of the lower portion of the cap in the circumferential direction of the container opening is hindered, and The pharmaceutical container with the sealing device according to the above [1] or [2], wherein a portion of the annular groove is broken.
[4] The fixing means and the rotation or movement preventing means are provided on the inner peripheral wall of the lower portion of the skirt portion so as to be fitted to the inclined annular projection provided on the outer peripheral surface of the container mouth. Characterized in that, even when a rotational force is applied to the cap, the lower portion of the cap is prevented from moving by applying the rotational force, so that the portion of the annular groove is broken. A pharmaceutical container with a closure according to the above [1] or [2], and
[5] A plug having a leg in which the direct sealing body projects directly from the lower surface of the top surface of the sealing body and can be fitted into the container mouth. A part of the notch when the half-plugged state is maintained by fitting the distal end of the leg into the container mouth and locking the projection to the upper edge of the container mouth. Is outside of the container mouth to form an air passage between the inside and the outside of the container, and when completely stoppered, the entire leg is inserted into the container mouth and the peripheral edge of the lower surface of the top surface is in close contact with the upper edge of the opening. The skirt portion of the cap is provided with a ventilation hole communicating with the ventilation path in the half-plugged state, and the cover has at least the window portion. [1] to [4] characterized by having a substantially cylindrical shape covering the vent hole. ] The pharmaceutical container provided with the sealing device according to any one of [1] to [10].
In the present invention, a sign indicating the engagement or fitting position of the two or a sign indicating the engagement or fitting position and a sign indicating the direction of rotating the cap may be provided on the outer periphery of the cap and the outer periphery of the container. It is particularly preferable in the production process and further in use.
Further, in the present invention, it is particularly preferable that breakage of the portion of the annular groove by applying a rotational force to the cap occurs at a breakage force of 3 to 30 kgf, and the cap of the present invention is preferably made of thermoplastic resin or Those comprising a thermoplastic resin composition are particularly preferred.
[0005]
BEST MODE FOR CARRYING OUT THE INVENTION
First, the features of the present invention will be briefly described with reference to FIGS. An inverted bottomed cylindrical synthetic resin cap (hereinafter, referred to as a “cap”) 1 is a direct sealing body (rubber) that directly seals an opening 5 of a pharmaceutical container (hereinafter, abbreviated as “container”) 2. (A plate or a rubber stopper) 6, and the directly sealed body 6 is firmly fixed to the medicine container 2. A window 7 is provided on the top surface 9 of the cap 1, and a cover 8 made of a thin plate or a seal made of a synthetic resin is attached to the upper surface of the top surface 9 to cover the window 7. By peeling off the cover 8, the upper surface of the sealing body 6 directly below the window 7 can be exposed. The skirt portion 10 of the cap 1 forms a cylindrical wall along the outer periphery of the container mouth portion 4 shown in FIG. 2 (a). By providing the annular groove 11 on the peripheral surface, the cap 1 has a cap upper part 12 above the annular groove 11 and a cap lower part 13 below the annular groove 11 at the bottom of the annular groove 11. It has a structure connected by a certain thin wall 14. On the other hand, the cap lower portion 13 is fitted with, engaged with, or screwed into the container opening 4 (in the example of FIG. 1, the locking claw 15, the flange-shaped projection 41 and the inclined lower surface 42) and the container opening 4. By having means for preventing rotation and movement in the direction along the outer periphery (engagement by the notch 16 and the locking projection 20), it is fixed to the container opening 4 and the sealing body 6 and the cap 1 are directly connected to the container opening. 4 to ensure the tightness of the container. Even if a rotational force is applied to the cap 1 along the outer periphery of the container opening 4, the lower cap portion 13 is prevented from rotating and moving. Since only one of them can be rotated, a breaking force acts on the position of the annular groove 11, which is easily broken at the position of the annular groove 11, the cap upper part 12 is separated, and the sealing body 6 and the opening 5 are directly exposed. be able to.
[0006]
Further, the features of the present invention will be described with reference to another embodiment shown in FIG. 6. The opening portion 5 of the medicine container 22 is tightly sealed with a direct sealing body (rubber stopper with legs in the illustrated example) 26, and this is sealed. It is covered with an inverted bottomed cylindrical synthetic resin cap 1 ′ so as to be enclosed, and the direct sealing body 26 is firmly fixed to the medicine container 22. A window 27 is provided on the top surface 29 of the cap 1 ′, and a cover 38 made of a thin plate or a seal made of synthetic resin is attached to the upper surface of the top surface 29 to cover the window 27. At the time of use, by peeling off the cover 38, the upper surface of the direct sealing body 26 located below the window 27 can be exposed. The skirt portion 30 of the cap 1 ′ has a cylindrical wall shape along the outer periphery of the container opening 4 ′, and at an approximate center or slightly below the skirt portion 30, its outer peripheral surface or inner peripheral surface (in the illustrated example, By providing the annular groove 31 on the inner peripheral surface), the cap 1 ′ is positioned above the annular groove 31 at the position of the annular groove 31 of the skirt portion 30, and the cap upper part 32 is located below the annular groove 31. The lower part 33 of the cap is connected by a thin wall 34 forming the bottom of the annular groove 31. On the other hand, the inclined annular projection 23 is provided on the outer peripheral wall of the container opening 4 ′, and the inclined annular groove 28 is provided on the inner wall surface of the cap lower part 33 so as to be a female type having the inclined annular projection 23 as a male type. By adopting a structure in which both can be fitted and locked by matching the corresponding positions, the entire sealing body 26 and the cap 1 'are directly fixed to the container mouth 4', and the opening 5 is sealed. With this structure, when the container 2 is fixed and a rotational force is applied to the cap 1 ′ in a direction along the outer periphery of the container opening 4 ′, the strong engagement between the inclined annular projection 23 and the inclined annular groove does not come off, and the lower cap portion 33 does not come off. Is fixed to the container opening 4 ′ and cannot be rotated. When a rotational force is further applied, only the cap upper portion 32 rotates and a breaking force acts on the position of the annular groove 31. By breaking, the cap upper part 32 separates, and the sealing body 26 and the opening 5 can be directly exposed.
[0007]
In order to attach the cap of the present invention to the container mouth, a marker 18 indicating the position of the notch 16 of the cap 1 and a marker indicating the position of the locking projection 20 of the container 2 as shown in the schematic explanatory view of FIG. By hitting the cap into the container mouth with 19 as a mark, the locking claw 15 of the cap 1 is fitted tightly to the inclined lower surface 42 of the flange-like projection, and the cap 1 is fixed to the container mouth 4. When two notches 16 and 16 'are provided as shown in FIG. 3B, two locking projections 20 are naturally provided at symmetrical positions.
[0008]
In the present invention, the annular groove is designed to break with a breaking force of 3 to 30 kgf. The cap is designed so that the breaking rotational force of the cap that causes such breaking is 4 to 50 kgf, preferably 4 to 32 kgf. The specific value depends on the synthetic resin material used for the cap, but in the present invention, the thickness of the thin wall 14 at the bottom of the groove is preferably 0.01 to 0.5 mm. The cross-sectional shape of the groove may be any of a horizontal U-shape, a horizontal V-shape, and a square. The width of the groove (length in the height direction of the skirt wall) is about 0.1 to 0.7 mm, and the groove depth is Determined by the wall thickness at the bottom of the groove. As described above, the annular groove may be provided on either the outer peripheral surface or the inner peripheral surface of the skirt portion. However, when provided on the outer peripheral surface, if the cover (seal) has a structure covering the annular groove, Adhesion of dust and the like into the groove can be prevented.
[0009]
The pharmaceutical container with a sealing device of the present invention having the above-described configuration is, depending on the purpose, [1] Peel off the cover to directly expose the upper surface of the sealed body, and pierce the exposed portion with an injection needle or the like, and / or [2] Applying rotational force to the cap, breaking at the position of the annular groove, and removing the cover, the top of the cap and the direct sealing body [1] When [2] Is possible.
the above [1] Specifically, for example, in the case of a medicament filled in a container is a freeze-dried injectable drug or the like, first, the cover is peeled off, and the injection needle is inserted into the exposed top surface of the directly sealed body. Then, a solution such as distilled water for injection in a syringe is injected into the container, and the drug is dissolved to prepare an injection solution. Next, the injection solution dissolved by the injection needle is returned into the syringe, the injection needle is directly removed from the sealed body, and the injection solution is administered.
the above [2] Specifically, for example, there is a case where a medicine is used immediately without a direct sealing body, or a case where the container opening of the container 2 is quickly attached to another medicine using device and used. After peeling off the cover, hold the container by hand or fix it with fixing means, apply a rotational force to the upper part of the cap to the left or right, break at the position of the thin wall at the bottom of the annular groove, and Then, the sealed body is directly separated from the container mouth. In this way, the opening of the container can be quickly exposed, and emergency operation at a medical site can be performed safely, reliably and hygienically.
the above [1] After disposing of used containers, caps, etc. [2] When the cap is broken as described above, the direct sealing body made of an elastic body is easily separated from the opening 5, so that it is easy to separate and process.
[0010]
A further embodiment of the present invention will be described with reference to the schematic explanatory view of FIG. 11, in which a concentrated preparation, particularly a lyophilized preparation can be operated in a container. The direct sealing body 46 is a legged plug having a leg 44 (44 ') with a large cutout 48 (48') projecting from the top surface 43 of the direct sealing body toward the container opening 40, and the leg 44 ( 44 ') The protrusion 45 (45') on the outer periphery can be locked to the upper edge of the opening 5 in a half-plugged state, and at this time, the cut 48 (48 ') forms an air passage between the inside and the outside of the container. Since the skirt portion 10 is provided with a vent hole 50 at a position corresponding to the ventilation path, the inside and the outside of the container 2 communicate with each other with the cap 51 attached. In the process, the vapor 49 of the medicine from the container 2 can be exhausted. The number of the ventilation holes 50 may be the same as the number of the cuts 48 (the number of ventilation paths). In the illustrated example, two are provided at symmetric positions. Immediately after the concentration or vacuum drying is completed, the cap 51 and the direct sealing body 46 can be completely stoppered to seal the opening 5 as shown in FIG. The cover 8 has a substantially cylindrical shape so as to seal the vent hole 50 in a completely stoppered state. The means for fixing the cap 51 to the container opening 40, the means for preventing rotation or movement, the structure for breaking at the annular groove when a rotational force is applied to the cap, and the like are the same as those already described.
[0011]
The pharmaceutical container of the present invention having a cap with a vent as described above, [1] Or [2] In addition to the method of use, the product can be prepared in a tank of a concentrator or lyophilizer with the sealer directly attached to the cap, and can be sealed immediately by stoppering and capping in the same tank after the preparation. The product can be made hygienic and highly efficient.
[0012]
Examples of the material for the cap of the present invention include a synthetic resin or a synthetic resin composition, and particularly preferably a thermoplastic resin or a thermoplastic resin composition. Specifically, polypropylene (PP): For example, Mitsui Polypro J900 [trade name, manufactured by Mitsui Petrochemical Co., Ltd.], Mitsubishi Polypro JF40M [trade name, manufactured by Mitsubishi Chemical Corporation], high-grade PP # 9119 [trade name, Acomo Chemical Co., Ltd.], high softening temperature polyethylene such as ultra-high molecular weight polyethylene and polyethylene homopolymer, and saturated polyesters such as polyethylene terephthalate (PET) and saturated polyester polymer alloys: Pyroalloy AA [PET, trade name, Toyobo Co., Ltd.], TPX # DX810 [polymethylpentene, trade name, manufactured by Mitsui Petrochemical Co., Ltd.], Sumiploy [trade name, manufactured by Sumitomo Chemical Co., Ltd.]], polystyrene, polyether ether ketone, and the like. Polyetherketones: For example, KADEL E-1000 [trade name, Teijin ( ) Ltd.] or the like, an acrylic resin, polystyrene, polyamide, polyphenylene sulfide, epoxy resin, polycarbonate (PC) synthetic resins and synthetic resin composition obtained by adding compounding agents in these and the like. There is no particular limitation on the molding method, and the molding is performed according to a known technique.For example, kneading a synthetic resin or a synthetic resin composition as a raw material and manufacturing the cap according to the present invention by injection molding in a mold or the like. Can be.
[0013]
The thickness of the cap other than the annular groove portion of the skirt portion is not particularly limited, but is usually about 0.6 to 2.0 mm. There is no particular limitation on the size and shape of the window, but a circular window is usually provided at the center of the top surface, and an annular projection surrounding the window portion is provided on the upper surface of the top surface. This is advantageous when the cover is provided by weakly pressing the sealing material. In the case where the directly sealed body is a rubber plate, an annular projection is provided on the inner surface of the top surface so as to surround the window, so that the sealing performance can be improved.
[0014]
As the direct sealing body of the present invention, a plate-shaped or plug-shaped one made of a rubber elastic body known in this field can be used. Use of a leg-attached type that fits into the container mouth and adheres tightly to the inner wall of the container mouth provides higher sealing performance. In addition, it is a particularly preferred embodiment that the surface which may come into contact with the medicine is covered with a synthetic resin film which does not contaminate the medicine such as a fluororesin or polyethylene.
As rubber elastic material, for example, butyl rubber, synthetic rubbers such as isoprene rubber, thermoplastic elastomers such as styrene-butadiene block copolymer and hydrogenated product thereof, and polyolefin resin such as polyethylene and rubber component Examples thereof include a co-crosslinked resin and the like, which can be molded according to a known technique.
[0015]
The cover of the present invention needs to have a size that can completely cover at least the cap window and can be pressure-bonded to the top surface. It has an inverted bottomed cylindrical shape that is tightly covered with. If the cap has a vent, the shape is such that the window and the vent can be completely covered. Examples of the material include a known synthetic resin thin film that can be used for this kind of application, and specific examples include the synthetic resin exemplified as the material of the cap described above, and particularly preferably a thermoplastic resin. When the cover is subjected to high frequency welding or ultrasonic welding, it is preferable to use the same material as the material of the cap.
[0016]
As the container of the present invention, various materials known in this field can be used. Particularly, since the medicine is in direct contact with the container, it is necessary to select a highly safe container without risk of contamination or the like. . Particularly preferred materials include cyclic olefin copolymer resins: for example, ZEONEX 280 (trade name, manufactured by Nippon Zeon Co., Ltd.) and COC (Abel) (trade name, manufactured by Mitsui Petrochemical Co., Ltd.). .
[0017]
【Example】
In the present invention, the structure of the window of the cap, the structure of the cover, the means for fixing the lower part of the cap to the container opening, and the means for preventing rotation of the lower part of the cap can be arbitrarily adopted. Although the shape of the direct sealing body is not particularly limited, examples of the present invention will be described more specifically below.
[0018]
[Example 1]
The product of the present invention was manufactured using a cyclic olefin copolymer resin as the container, synthetic rubber as the direct sealing body, and polypropylene as the cap and cover. 1 is a schematic cross-sectional view of the present embodiment, and FIG. 2 is a schematic cross-sectional view showing a state in which the configuration of FIG. 1 is separated into parts. FIG. 1 (a) shows a container opening 4 and an opening 5 of a pharmaceutical container. (B) shows the direct sealing body 6, (c) shows the cap 1, and (d) shows the cover 8. After filling the medicine 3 into the inside of the medicine container 2, a plate-like direct sealing body 6 made of an elastic body is placed on the upper edge of the opening 5 of the medicine container 2 to seal it, and the cap 1 is directly put on. It covers the sealing body 6 and the container opening 2. The cap 1 has a top surface 9 having a window 8 provided as a through hole in the center portion, and a cylindrical skirt portion 10 which is in close contact with the outer periphery of the container opening 4 from the outer periphery of the top surface 9. Locking the lower surface 42 of the flange-shaped projection 41 on the outer periphery of the upper edge of the container opening 4 by using a hook 15 having a hook-like cross section projecting annularly along the inner circumference on the inner wall surface at the lower end of the portion 10 as a fixing means. As a result, the direct sealing body 6 is firmly fixed to the upper edge surface of the container opening 4.
[0019]
As shown in FIG. 3A, the locking claw 15 is provided at an angle θ of 72 to 95 ° with respect to the inner peripheral wall in the cross section of the cap 1. If the angle is set within this range, once the cap is closed, it can be firmly fixed to the extent that it is difficult to separate from the container opening 4. Further, the lower surface 42 of the flange-shaped protrusion 41 of the container 2 is also designed according to the angle of the locking claw 15. Further, the length M of the locking claw 15 is preferably about 0.8 to 2.0 mm, and more preferably about 2.5 mm, though it depends on the size of the cap. The longer the length of L in FIG. 3 with respect to M, the easier the cap driving operation is. However, the difficulty of driving the cap into the mouth of the container is related to the surface roughness of the synthetic resin used, compressive strain, and the like.
[0020]
3 (b) is a schematic view of the cap 1 of FIG. 2 (c) as viewed in the direction of arrow A, and FIG. 4 (a) is a view in which the container 2, the direct sealing body 6, the cap and the cover are separated. FIG. 3B is a schematic perspective view showing the state, and FIG. The locking claws 15 are provided along the inner wall surface at the lower end of the cap 1, but are not completely annular, but are provided with notches 16 and 16 'at positions (two places) symmetrical with respect to the diameter of the inner circumference. Have been. On the other hand, as shown in FIG. 4, locking projections 20 and 20 ′ corresponding to the notches 16 and 16 ′ are provided on the lower surface 42 of the flange-shaped projection 41 of the container mouth 4, and the rotation of the cap lower part 13 is performed. Movement is prevented. Marks 18 and 19 indicating the positions of the notches 16 and 16 'and the locking projections 20 and 20' are provided on the cap 1 and the container 2 by printing or engraving to facilitate the cap tightening operation.
[0021]
In FIG. 2, an annular groove 11 is provided on the outer wall of the skirt portion 10 over the entire outer wall, and the cap upper portion 12 and the cap lower portion 13 are connected by the thin wall 14 at the bottom of the annular groove 11 as described above. It has become. In this embodiment, the cross section of the annular groove 11 is a horizontal U-shape, but may be any of a horizontal V-shape or a square groove. In this embodiment, the thickness of the thin wall 14 is 0.01 to 0.5 mm, and the height of the annular groove 11 is 0.1 to 0.7 mm. This groove is designed to have a breaking force of 3 to 30 kgf.
[0022]
From the window 7 of the top surface 9 of the cap 1 to the cap lower portion 13 through the annular groove 11 of the skirt 10 of the cap 1, it is continuously covered with a cover 8 made of a synthetic resin thin film. This prevents contamination of the top surface and the annular groove 11 and also improves the hermeticity of the container 2. After filling the medicine, the sealing body 6 and the cap 1 are directly plugged into the container opening 4, and the cover can be easily detachably attached by means known in this field. The cover can also have protruding pieces or cuts for peeling.
[0023]
In the present embodiment configured as described above, for example, when the medicine 3 is a freeze-dried injection medicine or the like, first, the cover 8 is peeled off, and the injection needle is inserted into the exposed top surface of the directly sealed body 6. Then, a liquid agent such as distilled water for injection in a syringe is injected into the container, and the drug 3 is dissolved to prepare an injection solution. Next, the injection solution dissolved by the injection needle is returned into the syringe, the injection needle is withdrawn from the container, and the injection solution is administered.
When the container 2 is held by hand or fixed by a fixing means, and a rotational force is applied to the upper part 12 of the cap to the left or right, the lower part 13 of the cap also tries to rotate. The end faces 17a or 17b of the protruding projections and the end faces 17'a or 17'b of the claw-shaped projections on both sides of the notch 16 'hit the locking projections 20 and 20' of the container 2, and further rotation is stopped. . When a rotational force is further applied, the cap upper portion 12 receives the rotational force as it is, so that a breaking force acts on the thin wall portion 14 and the position of the annular groove 11 is changed. Break in The cap upper part 12 can be easily separated. Thus, the opening 5 can be quickly exposed. Emergency operation at medical sites can be performed safely, reliably and hygienically. Further, as described above, when the used container, the cap, and the like are discarded, when the cap upper portion 12 is separated, the direct sealing body made of an elastic body is also easily separated from the opening 5, so that the separation processing can be easily performed. Become.
[0024]
[Example 2]
The product of the present invention was produced using a cyclic olefin copolymer resin as a container, a thermoplastic elastomer as a direct sealing body, and a saturated polyester polymer alloy as a cap and cover. This embodiment is almost the same as the structure of the first embodiment, but the shapes of the locking projections are different. Therefore, FIGS. 5A and 5B show a partial perspective view and a partial view near the container opening. A cross-sectional view is shown, and illustration of other parts is omitted. The locking projection 21 projects from the flange-shaped projection 41 toward the lower surface 42 in the shape of a triangular prism. When a rotational force is applied to the upper portion of the cap, similarly to the first embodiment, the end faces 17a or 17b of the claw-shaped projections on both sides of the notch 16 and the end faces 17'a of the claw-shaped projections on both sides of the notch 16 '. Alternatively, 17'b corresponds to the locking projection 21 of the container 2 and 21 '(not shown), and further rotation is stopped. On the other hand, since the upper portion of the cap is about to rotate, a breaking force acts on the thin wall portion, the portion is broken at the position of the annular groove, and the upper portion of the cap can be easily separated. Thereby, the opening 5 of the container 2 can be quickly exposed. In this embodiment, the annular groove is designed to have a breaking force of 3 to 50 kgf.
[0025]
[Example 3]
The product of the present invention was manufactured using a cyclic olefin copolymer resin as a container, a co-crosslinked resin of a polyolefin resin and a rubber component as a direct sealing body, and polyether ketone as a cap and cover as materials. As shown in FIG. 6 (a), the container 22 has a substantially cylindrical cylindrical opening 4 having an outer diameter and an inner diameter smaller than that of the main body, and has no flange-like projection. A depth h from the upper edge of the opening 5 below a position which is about half or less of the length H of the container opening 4. ₁ To h ₂ At a position, an annular projection extending over the entire circumference of the opening 5 has a constant inclination (inclination height h = h) with respect to the upper end surface of the opening 5. ₂ -H ₁ ) Is provided. In this embodiment, the cross section of the inclined annular projection 23 is mountain-shaped (triangular). The triangular shape is longer than the base length, so that the cap can be easily driven. However, other cross-sectional shapes such as a square shape can be adopted.
[0026]
An annular leg 24 projecting from the lower surface (the side facing the opening 5) of the direct sealing body top surface 6 'shown in FIG. An annular projection 25 is provided on the outer circumference, and can be tightly sealed to the inner wall surface of the container opening 4 to be sealed. Although not shown in the drawings, it is a particularly preferred embodiment to laminate all the surfaces of the leg portion 24 and the lower surface of the top surface 6 'of the directly sealed body which can be contacted with a chemical liquid with a non-staining and chemically resistant synthetic resin film.
[0027]
As shown in FIG. 6 (c) and FIG. 7, the cap 1 'has an embodiment in that it has a window 27 on the top surface 29 and a cylindrical skirt portion 30 hanging down from the outer periphery of the top surface 29. In the present embodiment, the cap upper portion 32 and the cap lower portion 33 are connected by a thin wall 34 which is the bottom of the annular groove 31 by providing the annular groove 31 on the inner wall surface of the skirt portion 30 in this embodiment. I have. By providing the annular groove 31 on the inner wall surface, the skirt portion 30 has a uniform surface. Also, shallow irregularities 37 are provided on the entire surface to prevent finger slippage when applying a rotational force to the cap. An outwardly projecting annular projection 35 is provided on the outer edge of the lower end of the skirt portion 30 to facilitate finger-holding when operating.
[0028]
On the inner wall of the cap lower portion 33, an inclined annular groove 28 is provided in a shape to be fitted as a female type with the inclined annular projection 23 of the container mouth 4 'being a male type. Further, in order to align the position of the inclined annular projection 23 of the container opening 4 ′ with the position of the inclined annular groove 28 of the cap and attach the cap, the sign 18 indicating the fastening position on the outer surface of the cap top surface 29 and the outer peripheral wall surface of the container opening. 'And 19' respectively. In addition, on the upper surface of the top surface 29 of the cap 1 ', there is provided a mark 38 indicating the direction in which the cap 1' is twisted.
[0029]
A seal 37 made of a synthetic resin thin plate is adhered to the top surface 29 of the cap 1 'as a cover. The size of the seal is large enough to cover the window and the top surface, thereby preventing dust, bacteria, and the like from entering the inside of the cap. In addition, the adhesive is adhered to the entire top surface of the cap so as not to be separated from the upper surface of the cap due to vibration or environmental change.
[0030]
After filling the container 22 with the medicine, the leg portion 24 of the sealing body 26 is directly fitted into the opening of the container, and the lower surface of the outer edge of the top surface 6 is brought into close contact with the upper edge of the opening 5 to seal the opening 5. Then, the mark 18 'of the cap 1' is put on the container in accordance with the mark 19 'of the container, and the cover (seal) 38 is crimped. An annular projection 36 is provided on the inner surface of the top surface 29 of the cap 1 '. When the seal 38 is pressed and sealed, the annular projection 36 directly presses the top surface 6 'of the sealing body, so that the sealing performance can be further improved. Alternatively, the cover 38, the cap 1 ', and the direct sealing body 26 may be combined, and the cap 18 and the mark 19' may be combined with each other so that capping and cover crimping are performed simultaneously with stoppering.
[0031]
In order to use the medicine in the container 22 of this embodiment, the medicine is peeled by pinching and pulling a not-shown protrusion provided at the end of the cover 38. In this state, the upper surface of the top surface 6 'of the sealed body is directly exposed at the window 27, so that the injection needle can be pierced directly into the container through the sealed body while the cap 1' is fitted. Hereinafter, as in the case of Example 1, the pharmaceutical solution is dissolved to form an injection solution, and the injection solution can be administered sanitarily and easily by sucking the injection solution into the syringe.
[0032]
In the present embodiment, the method of exposing the opening of the container 22 by breaking the cap 1 'at the annular groove 31 is the same as that of the first embodiment in the direction indicated by the sign on the upper surface of the cap 1'. Apply force to rotate 1 '. Since the cap lower portion 33 is fitted and fixed to the inclined annular projection 23 of the container mouth 5 by the inclined annular groove 28, the cap lower portion 33 cannot be rotated and is broken by the thin wall portion 34 of the annular groove 31. In the present invention, the thin wall has a thickness of 0.01 to 0.5 mm and a height of 0.1 to 0.7 mm.
[0033]
In this embodiment, the length h (h = h) of the inclination of the inclined annular groove provided on the inner wall surface of the cap 1 '. ₂ -H ₁ ) Is 2 to 12 mm. In the present invention, the length h is related to the physical properties of the synthetic resin material constituting the cap, and it is not preferable to increase h in a synthetic resin having a large cutting elongation (%) such as a rubber elastic body. Therefore, it is preferable to select a synthetic resin having a small breaking elongation (%) or to reduce the elongation by adding a fine powder filler to the synthetic resin in an amount of 0.1 to 25% by weight.
[0034]
Furthermore, the caps of Examples 1 to 3 were manufactured using polyethylene terephthalate and polymethylpentene as cap materials. Each of the sealed medical container obtained in each example was broken at the annular groove position by applying a breaking rotational force of 4 to 32 kgf, and the upper part of the cap could be easily separated. In addition, even if the thing of Example 1 is a ready-made container, if the mouth part has the structure which can be firmly locked and fixed with the locking claw, the same applies by applying only the sealing part. The effect of can be obtained.
[0035]
[Example 4]
Cyclic olefin copolymer resin as the container, synthetic rubber as the direct sealing body, fluorine resin as the leg laminated film of the direct sealing body, and polypropylene as the cap and cover, and the direct sealing body has cuts. The product of the present invention, which is a stopper with a leg, in which the cut portion and the vent of the cap can form a ventilation path in a half-plugged state, was manufactured.
9 is a schematic cross-sectional view of the present embodiment, FIG. 10 is a schematic explanatory view showing the configuration of FIG. 9 separated into parts, and FIG. FIG. 12 is a schematic view showing a state in which the groove portion is broken. In FIGS. 9 to 12, the portions denoted by the same reference numerals as those in FIGS. 1 to 8 have the same meaning. As shown in FIGS. 9 and 10, in the present embodiment, the container mouth portion 40 is provided with a longer flange-shaped projection 41 than in FIG. The means for fixing the container and the container mouth 40 is the same as that in the first embodiment. In this example, the direct sealing body 46 is a so-called leg plug having legs 44 and 44 ′ protrudingly provided on the lower surface of the sealing body top surface 43, and a projection 45 is provided on the outer periphery of the legs 44 and 44 ′. And 45 'are provided, and the legs 44 and 44' are provided with large cuts 48 and 48 'extending from the distal end side toward the top surface 53 of the sealing body. 48 ') is higher than the height at which the lower end of the projection 45 (45') is located. In addition, the outer periphery of the leg remains the same as the elastic body until the lower end of the projection 45 (45 '), but the tip of the leg and the cut surface are continuously formed from the lower end of the projection 45 (45'). To prevent contamination of medicines in containers. The cap 51 has ventilation holes 50 and 50 ′ formed in the skirt portion 10, and the other configuration is the same as that of the first embodiment. The cover 8 has a substantially cylindrical shape, and is sized to cover at least the window 7 and the ventilation holes 50 and 50 ′ when the cover 8 is tightly enclosed in the cap 51.
[0036]
The formulation process using the product of the present invention will be described. After filling the undiluted solution of the medicine 3 into the container 2, the distal end side of the leg 44 (44 ') of the sealing body 46 is directly inserted into the opening 5 as shown in FIG. The lower end is engaged with the upper edge of the container opening 40 to form a half stoppered state, and is vacuum-dried or freeze-dried in a sterilized decompression device tank or freeze-drying device tank. At this time, since the height of the notch 48 (48 ') is higher than the height of the lower end of the projection 45 (45'), the notch upper portion 49 (49 ') is located above the upper edge of the container opening 40, and the inside and outside of the container are provided. Can be formed. Further, the vent hole 50 (50 ') of the cap 51 is in a half-plugged state, and its upper end is at least above the container mouth, and further communicates with the vent passage formed by the cut upper portion 49 (49'). Since it is perforated so as to form, the vapor 52 of the drug in the container 2 can be discharged to the outside from this ventilation path. When the vacuum drying or freeze-drying is completed, the cap and the directly sealed body are completely stoppered at once, so that the cut 48 (48 ') enters the container mouth 40 and the leg 44 (44) which is the upper part of the cut. ′) And the top surface 43 of the directly sealed body are tightly sealed to the inner wall and the upper edge of the container opening 40, and the vent hole 50 (50 ′) of the cap 51 is formed on the outer periphery of the flange 41 of the container opening. The inside and outside of the container are completely shut off. The locking claw 15 of the cap 51 cuts into the inclined lower surface 42 of the flange-shaped projection 41 to fix the cap to the container mouth 40, and the notch 16 (16 ') and the locking projection 20 (20') are formed. Engage. When the preparation is started, the engagement position between the cap and the outer periphery of the container can be matched with a mark (not shown) attached to the outer periphery of the container.
[0037]
In order to remove the cap 51 from the medicine prepared as described above, the cover 8 is first removed, and a rotational force is applied to the cap 51 in the same manner as in the first embodiment. On the other hand, since the notch 16 (16 ') and the locking projection 20 (20') are engaged, the cap lower portion 13 cannot rotate or move, and the bottom wall of the annular groove 11 has a thin wall. 14 parts break. FIG. 12 shows the broken cap 12 and the direct sealing body 46.
[0038]
【The invention's effect】
Since the sealed medical container of the present invention can easily directly expose the sealed body by peeling off the film and the seal adhered on the cap, it is very easy, quick and reliable to pierce the sealed body directly with the injection needle. And hygiene. In addition, when the container mouth is used in combination with the drug-using device, the upper portion of the cap can be easily separated by applying a small rotating force to the cap and breaking it in the annular groove, so that it is hygienic and quick. Can be attached to the above-mentioned use device. Further, the product of the present invention in which a cap having a vent hole and a stopper with a notch having a notch are directly combined as a sealed body is capable of completely stoppering and capping immediately after preparation in a concentration-drying and freeze-drying tank. Sanitary and highly efficient products can be obtained. Further, in the product of the present invention, the container mouth portion, the directly sealed body, and the cap are all firmly fixed and the inside of the container can be sealed, so that the medicine filled therein can be stored for a long time and with high quality. Furthermore, since the product of the present invention does not use metal as a material and can be easily separated into its constituent parts, disposal is simple, easy and safe.
[Brief description of the drawings]
FIG. 1 is a partial sectional view showing one embodiment of the present invention.
FIG. 2 is an explanatory view showing a state in which the medical container with a seal of FIG. 1 is divided into components.
3 is a view showing a partially enlarged cross section of a portion (c) of FIG.
FIG. 4 is a schematic perspective view and a partial cross-sectional view for explaining the structure of the container mouth portion in FIGS. 1 and 2 of the present invention.
FIG. 5 is a perspective view and a partial cross-sectional view of the vicinity of a container mouth in another embodiment of the present invention.
FIG. 6 is an explanatory diagram showing a state in which another embodiment of the present invention is divided into components.
7 is a partially cutaway cross-sectional view showing an enlarged cap portion of FIG. 6C of the present invention.
FIG. 8 is an explanatory view showing a state of FIG. 6 (c) of the present invention viewed from the direction of arrow B.
FIG. 9 is a partial sectional view showing still another embodiment of the present invention.
FIG. 10 is an explanatory view showing a state in which the pharmaceutical container with a sealing device of FIG. 9 is divided into components.
FIG. 11 is an explanatory view of a preparation process using the product of the present invention shown in FIGS. 9 and 10.
FIG. 12 is an explanatory view showing a state in which the cap of FIGS. 9 to 11 is broken at an annular groove portion.
[Explanation of symbols]
1, 1 'and 51 caps, 2 and 22 containers,
3 pharmaceuticals, 4, 4 'and 40 container mouths,
5 openings, 6, 26 and 46 direct seals,
6 'and 43 direct sealing body top surface, 7 and 27 window part,
8 and 38 covers, 9 and 29 top,
10 and 30 skirt part, 11 and 31 annular groove,
12 and 32 Upper cap, 13 and 33 Lower cap,
14 and 34 thin walls, 15 locking claws,
16 and 16 'notches, 17a and 17b end faces
18, 18 ', 19, 19' and 38 signs,
20, 20 'and 21 locking projections,
23 slanted annular projections, 24, 44 and 44 'legs,
25 projections, 28 inclined annular grooves,
35 annular projection, 36 projection
37 irregularities, 39 small protrusions
41 flange-shaped protrusion, 42 lower surface,
45 and 45 'projections, 47 synthetic resin film,
48 and 48 'notch, 49 and 49' notch top,
50 and 50 'vents, 52 steam.

Claims

1) a container for filling medicines, 2) a direct sealing body made of a plate-like or plug-like rubber elastic body and tightly sealing the mouth of the container, 3) a top surface having a window at the center and It has a skirt portion that hangs cylindrically from the outer edge of the top surface, and is made of a synthetic resin that covers the direct sealing body and the outside of the container mouth in close contact and tightly fixes the direct sealing body to the container mouth. A cap and 4) a cover made of a synthetic resin thin film and covering at least a window portion and a top surface of the cap so as to be releasable, wherein the skirt portion has an outer wall surface or an inner wall surface at a substantially central position. The upper portion of the cap and the lower portion of the cap are connected to each other by a thin wall forming the bottom of the annular groove, and the inner wall surface of the lower portion of the cap and the inner wall surface of the lower portion of the outer wall of the container opening are provided. Hands that are fixed to each other by fitting or engaging And has a rotating or moving prevention means lower the cap, sealed in close contact with the container mouth portion without separating the cap from the container mouth part by peeling off the (1) the cover And / or [2] applying a rotating force to the cap along the outer periphery of the container opening in either the left or right direction, thereby forming a portion of the annular groove. By breaking , the upper part of the cap and the directly sealed body can be separated from the mouth of the container to expose the mouth of the container, and the state of [1] and / or [2] can be appropriately selected. pharmaceutical container with sealing device, characterized in that it is in.

2. The pharmaceutical container with a closure according to claim 1, wherein the directly sealed body has a leg portion that can be inserted into the container mouth.

In the fixing means, the locking projection having a hook-shaped cross section provided along the inner wall surface at the lower end of the lower portion of the cap engages with the lower inclined surface of the flange-shaped projection provided at the upper end of the container opening to hold the cap to the container. A notch provided from the lower end of the lower part of the cap toward the top surface and beyond the locking projection; and a notch provided on the lower surface of the flange-shaped projection. It consists of engagement with a movement prevention projection provided at a position corresponding to the notch, and even if a rotational force is applied to the cap, rotation or movement in the circumferential direction of the container opening at the lower part of the cap is prevented, and The pharmaceutical container with a closure according to claim 1 or 2, wherein the portion is configured to be broken.

The fixing means and the rotation or movement preventing means are provided with an inclined annular projection provided on an outer peripheral surface of the container mouth, and an inclined annular provided on an inner wall surface below the skirt portion so as to be fitted to the inclined annular projection. A groove is fitted, and even if a rotational force is applied to the cap, the fitting prevents the lower portion of the cap from moving, so that the annular groove portion is broken. The pharmaceutical container with the closure according to claim 1 or 2.

The direct sealing body is a plug body having a leg portion that protrudes directly from the lower surface of the top surface of the sealing body and can fit into the mouth of the container, and the leg portion has a projection on the outer periphery thereof and extends from the tip side to the top side. When the half-plugged state is maintained by fitting the distal end side of the leg portion into the container mouth and locking the projection to the upper edge of the container mouth, a part of the cut is formed in the container. When the vent is formed outside the mouth and the inside and outside of the container are completely plugged, the entire leg is fitted into the mouth of the container, and the peripheral edge of the lower surface of the top surface is in close contact with the upper edge of the opening. The mouth portion is tightly sealed, and the skirt portion of the cap is provided with a ventilation hole communicating with the ventilation path in the half-plugged state, and the cover has at least the window portion and the ventilation hole. 3. A substantially cylindrical shape covering the pores. Closures with a pharmaceutical container according to any one of Motomeko 4.

Claims are provided on the outer periphery of the cap and the outer periphery of the container, a sign indicating an engagement or fitting position of the two, or a sign indicating the engagement or fitting position and a sign indicating a direction in which the cap is rotated. A pharmaceutical container with a closure according to any one of claims 1 to 5.

7. The sealing device according to claim 1, wherein the annular groove is broken by applying a rotational force to the cap at a breaking force of 3 to 30 kgf. Pharmaceutical container with a label.

The pharmaceutical container with a closure according to any one of claims 1 to 7, wherein the cap is made of a thermoplastic resin or a thermoplastic resin composition.