JPH1179227A - Medicine container with sealer - Google Patents
Medicine container with sealerInfo
- Publication number
- JPH1179227A JPH1179227A JP10136463A JP13646398A JPH1179227A JP H1179227 A JPH1179227 A JP H1179227A JP 10136463 A JP10136463 A JP 10136463A JP 13646398 A JP13646398 A JP 13646398A JP H1179227 A JPH1179227 A JP H1179227A
- Authority
- JP
- Japan
- Prior art keywords
- cap
- container
- annular groove
- top surface
- mouth
- 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.)
- Granted
Links
Abstract
Description
【０００１】[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。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a pharmaceutical product in which the mouth of a pharmaceutical container filled with pharmaceuticals and the like (hereinafter, sometimes simply referred to as "container") is sealed with high hermeticity and held therein. The present invention relates to a pharmaceutical container equipped with a seal that can stably maintain the quality of the pharmaceutical for a long period of time and can easily release the seal when using the pharmaceutical.
【０００２】[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６３−１８
０５５６、特開平５−２７０５６０、特開平７−１６５
２５２、特開平７−１８７２１６、特開平７−３３００
０７、特開平８−３４４６６及び特開平８−２７６９５
２各号公報等に提案されている。2. Description of the Related Art Pharmaceutical containers are sealed by the Japanese Pharmacopoeia by sealing the container opening with a rubber stopper or rubber plate, and further covering the aluminum plate from the outside with an aluminum cap to provide environmental changes and transportation. -The use of a sealing device whose sealing state does not change due to vibration during transportation and other external factors is specified. Conventionally, the above-described aluminum was mainly used. 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 and JP-A-63-18.
0556, JP-A-5-270560, JP-A-7-165
252, JP-A-7-187216, JP-A-7-3300
07, JP-A-8-34466 and JP-A-8-27695
No. 2 has been proposed.
【０００３】[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。SUMMARY OF THE INVENTION The present invention is an improvement over the prior art described above, in which the sealing property, which is an essential requirement for a sealing device, is high, and the initial sealing state can be stably maintained for a long period of time. It is an object of the present invention to provide a highly practical container for medical supplies with a sealing device, which can release the sealing of the product with a very simple operation and in a hygienic manner. Another object of the present invention is to provide a pharmaceutical container with a closure that is easy to dispose after use.
【０００４】[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、キャ
ップに回転力を加えることにより該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。Means for Solving the Problems As means for solving the above-mentioned problems, the present invention provides: [1] 1) a container for filling a medicine, 2) a plate-like or plug-like rubber elastic body, which is closely attached to the mouth of the container. 3) having 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 being outside the direct sealing body and the container opening And a cap made of a synthetic resin for covering and sealing the direct sealing body to the opening of the container, and 4) formed of a synthetic resin thin film and formed at least to cover the window and the top surface of the cap and to be peelable. cover,
The skirt portion has an annular groove on its outer wall surface or inner wall surface at a substantially central position, so that the cap upper portion and the cap lower portion are connected by a thin wall surface forming the bottom of the annular groove. And means for fixing the inner wall surface of the lower part of the cap and the outer wall surface of the container mouth corresponding to the inner wall surface of the lower part of the cap by fitting or engaging, and means for preventing rotation or movement of the lower part of the cap. A pharmaceutical container with a closure, wherein the portion of the annular groove is broken by applying a rotational force to the cap, [2] wherein the direct sealed body is Characterized by having legs that can be inserted into the
[1] The pharmaceutical container with the closure according to [1], [3] wherein the fixing means has a hook-shaped locking projection provided along the inner wall surface at the lower end of the lower portion of the cap at the upper end of the container mouth. The cap is tightly fixed to the container mouth by engaging with the lower inclined surface of the flange-shaped projection, and the rotation or movement preventing means is directed from the lower end of the cap toward the top surface and beyond the locking projection. The notch provided includes an engagement between a notch provided and a movement preventing protrusion provided at a position corresponding to the notch on the lower surface of the flange-shaped protrusion. Even when a rotational force is applied to the cap, the container opening circle at the lower portion of the cap. The pharmaceutical container with the closure according to the above [1] or [2], wherein rotation or movement in the circumferential direction is hindered so that the annular groove portion is broken. The fixing means and the rotation or movement preventing means are provided on the outer peripheral surface of the container mouth. An inclined annular projection which is made from the mating of the inclined annular groove provided to fit into the inclined annular projection on the inner wall surface of the skirt subordinate unit,
The above-mentioned [1], wherein even if a rotational force is applied to the cap, the lower portion of the cap is prevented from moving by the fitting, so that the annular groove portion is broken.
Or a pharmaceutical container with the closure according to [2], and [5] a stopper body having a leg portion, wherein 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, The leg has a projection on its outer periphery and has a notch extending from the distal end to the top surface, and the distal end of the leg is fitted into the container opening to lock the projection on the upper edge of the container opening. Thus, when maintaining the half-plugged state, a part of the cut is outside the container mouth to form a ventilation path between the inside and the outside of the container, and when completely plugged, the entire leg is inserted into the container mouth. At the same time, the peripheral edge of the lower surface of the top surface is in close contact with the upper edge of the opening to tightly seal the container mouth, and the skirt portion of the cap communicates with the air passage in the half-plugged state. The cover is perforated, and the cover is a substantially circle covering at least the window and the vent. The above items [1], which is a shape there is provided a pharmaceutical container, with the sealing tool according to any one of [4]. 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. 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 is performed with a breaking 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】[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。DESCRIPTION OF THE PREFERRED EMBODIMENTS The features of the present invention will first be briefly described with reference to FIGS. An inverted bottomed cylindrical synthetic resin cap (hereinafter referred to as “cap”) 1 is a direct sealing body (rubber) that directly seals an opening 5 of a pharmaceutical container (hereinafter abbreviated as “container”) 2. Plate or rubber stopper) 6
The direct sealing 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 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. The structure is 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 circumference (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 if a smaller rotational force is applied, the upper cap portion 13 is closed. Since only the rotary movement can be performed, a breaking force acts on the position of the annular groove 11, and 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】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２
２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２
７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３
１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２
３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２
６、さらには開口部５を露出することができる。The features of the present invention will be described with reference to another embodiment shown in FIG. 6. The opening 5 of the medicine container 22 is tightly sealed with a direct sealing body (rubber stopper with legs in the illustrated example) 26. Is covered with an inverted bottomed cylindrical cap 1 'made of synthetic resin, and the directly sealed body 26 is sealed with the medicine container 2.
2 is firmly fixed. A window 27 is provided on the top surface 29 of the cap 1 ′. 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, and the window 2 is provided.
7 is covered. 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 is located at the approximate center or slightly below the skirt portion 30 at its outer peripheral surface or inner peripheral surface (in the illustrated example, Annular groove 3 on the inner peripheral surface)
1, the annular groove 31 of the skirt 30 is provided.
In the position 1, the cap 1 ′ has a cap upper portion 32, which is a portion above the annular groove 31, and a cap lower portion 33, which is a portion below the annular groove 31, connected by a thin wall 34 forming the bottom of the annular groove 31. Structure. 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 opening 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 inclined annular projection 2
3 and the inclined annular groove cannot be disengaged, and the cap lower part 33 is fixed to the container mouth part 4 'and cannot be rotated. When a rotational force is further applied, only the cap upper part 32 rotates and the position of the annular groove 31 is changed. A break force is applied to the cap, the cap is easily broken at the position of the annular groove 31, the cap upper part 32 is separated, and the sealing body 2 is directly
6, and further the opening 5 can be exposed.
【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。In order to attach the cap of the present invention to the container mouth, as shown in a schematic explanatory view of FIG. 4, a marker 18 indicating the position of the notch 16 of the cap 1 and a locking projection 20 of the container 2 are provided.
By inserting the cap into the container opening with the mark 19 indicating the position of the cap as a mark, the locking claw 15 of the cap 1 is strongly fitted to the inclined lower surface 42 of the flange-like projection, and the cap 1 is Fixed to When two notches 16, 16 'are provided as shown in FIG.
Are also provided at symmetrical positions.
【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４〜５０ｋｇ
ｆ、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０．０
１〜０．５ｍｍ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。In the present invention, the annular groove is 3 to 30 kgf.
Designed to break with the breaking force of In addition, the breaking rotational force of the cap that causes such breaking is 4 to 50 kg.
f, preferably 4 to 32 kgf.
The specific value depends on the synthetic resin material used for the cap,
In the present invention, the thickness of the portion of the thin wall 14 at the bottom of the groove is 0.0
1-0.5 mm was preferred. The cross-sectional shape of the groove may be any of a horizontal U-shape, a horizontal V-shape, and a square shape, and the width of the groove (the length of the skirt wall in the height direction) is 0.1 to 0.1 mm.
About 7 mm, the groove depth is determined by the wall thickness of the groove bottom. 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】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、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、というとの用い方が可能である。上記
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。[0009] In the pharmaceutical container with the closure of the present invention having the above-described structure, the cover is peeled off to directly expose the upper surface of the sealed body, and an injection needle or the like is inserted into the exposed portion, according to the purpose. It can be used to pass through or / and apply a rotational force to the cap to break at the location of the annular groove to remove the cover, the top of the cap and the direct seal. In the above-mentioned usage, specifically, for example, in the case of a medicament filled in a container being a freeze-dried injectable medicine 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 liquid agent such as distilled water for injection in the syringe is injected into the container, and the drug is dissolved to form 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. Specifically, the above-mentioned usage is, for example, a case where the medicine is used immediately without the direct sealing body, or a case where the container port of the container 2 is quickly attached to another medicine use device and used. After peeling off the cover, hold the container by hand or fix it with fixing means, apply a rotating force to the upper part of the cap left or right, break at the position of the thin wall at the bottom of the annular groove, Separate the upper, direct seal from the container mouth. In this way, the opening of the container can be quickly exposed, and emergency operation at the medical site can be performed safely, reliably and hygienically. After disposing of the used containers and caps after use as described above, when the caps are broken as described above, the direct sealing body made of the elastic body is easily separated from the opening 5. Separate processing becomes easier.
【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４
９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。[0010] In a further embodiment of the present invention, a container with a closure that allows a concentrated preparation, particularly a freeze-dried preparation, to be operated in the container will be described with reference to the schematic explanatory view of FIG. 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 projection 45 (45') on the outer periphery can be locked to the upper edge of the opening 5 in a half-plugged state.
(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, and the skirt portion 10 is concentrated or vacuum dried under a sterile environment. Pharmaceutical vapor 4 from inside the container 2 in the process
9 can exhaust. 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. Cap 51
The fixing means of the container and the container opening 40, the means for preventing rotation or movement, the structure of breaking at the annular groove portion when a rotational force is applied to the cap, and the like are the same as those already described.
【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、前記又はの用い方に加え、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。[0011] The pharmaceutical container of the present invention having a cap with a vent as described above can be used in addition to the above-mentioned method or the method described above, in a state where the sealed body is directly attached to the cap in a tank of a concentration device or a freeze-drying device. The product can be plugged and sealed immediately after the preparation in the same tank by capping and capping, so that the product can be made very hygienic and highly efficient.
【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Ｊ９
００〔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〔ＰＥ
Ｔ、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ＫＡＤＥＬ Ｅ-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。The material of the cap of the present invention includes 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 J9
00 [trade name, manufactured by Mitsui Petrochemical Co., Ltd.], Mitsubishi Polypro JF40M [trade name, manufactured by Mitsubishi Chemical Co., Ltd.], high-grade PP #
9119 (trade name, manufactured by Acomo Chemical Co., Ltd.); high softening temperature polyethylene such as ultra-high molecular weight polyethylene and polyethylene homopolymer; saturated polyester such as polyethylene terephthalate (PET); and saturated polyester polymer alloys: for example, pyroalloy AA [ PE
T, trade name, Toyobo Co., Ltd.], TPX # DX810
[Polymethylpentene, trade name, Mitsui Petrochemical Co., Ltd.
Sumiploy [trade name, manufactured by Sumitomo Chemical Co., Ltd.]]
Polystyrene, polyether ether ketone and polyether ketones: for example, KADEL E-1000 (trade name, manufactured by Teijin Limited), acrylic resin, polystyrene, polyamide, polyphenylene sulfide, epoxy resin, polycarbonate (PC), etc. And synthetic resin compositions obtained by adding a compounding agent thereto. The molding method is not particularly limited, and is performed according to a known technique.For example, the cap according to the present invention is manufactured by kneading a synthetic resin or a synthetic resin composition as a raw material and injection molding in a mold. Can be.
【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。The thickness of the cap skirt other than the annular groove is not particularly limited, but is usually about 0.6 to 2.0 mm. Although there is no particular limitation on the size and shape of the window portion, it is preferable to provide a circular window in the center portion of the top surface and provide an annular projection on the upper surface of the top surface so as to surround the window portion. This is advantageous when the cover is provided by weakly pressing the sealing material. When the direct sealing 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】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。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 closely adheres 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 type, synthetic rubbers such as isoprene rubber type, thermoplastic elastomers such as styrene / butadiene block copolymer and hydrogenated product thereof, and polyolefin resin such as polyethylene and rubber component Co-crosslinked resins and the like can be mentioned, and can be molded according to known techniques.
【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。The cover of the present invention is required to have a size capable of completely covering at least the cap window portion and being capable of being pressure-bonded to the top surface. , And has an inverted bottomed cylindrical shape that is closely attached to the upper portion of the cap. 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 use, 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】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ZEONEX 280
〔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。As the container of the present invention, various known materials in this field can be used. Particularly, since the medicine is in direct contact with the container, a container having high safety without danger of contamination is selected. There is a need. As a particularly preferred material, a cyclic olefin copolymer resin: for example, ZEONEX 280
[Trade name, manufactured by Nippon Zeon Co., Ltd.], COC (Abel) [trade name, manufactured by Mitsui Petrochemical Co., Ltd.], and the like.
【００１７】[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。DESCRIPTION OF THE PREFERRED EMBODIMENTS In the present invention, the structure of a window portion of a cap,
The structure of the cover, the means for fixing the lower part of the cap and the mouth of the container, and the means for preventing rotation of the lower part of the cap can be arbitrarily adopted, and the shape of the direct sealing body between the cap and the mouth of the container is also particularly limited. However, there is no specific description about the embodiment of the present invention.
【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。Example 1 A product of the present invention was produced using a cyclic olefin copolymer resin as a container, synthetic rubber as a direct sealing body, and polypropylene as a cap and cover. FIG. 1 is a schematic sectional view of the present embodiment, and FIG. 2 is a schematic 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) the direct sealing body 6, (c) the cap 1,
(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 be sealed, 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 covers the outer surface of the container opening 4 from the outer periphery of the top surface 9 in close contact. 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 adhered and fixed to the upper edge surface of the container opening 4.
【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４
１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。As shown in FIG. 3A, the angle of the locking claw 15 with respect to the inner peripheral wall in the cross section of the cap 1 is 72 to 72.
It is provided at an angle of 95 °. 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 mouth 4. In addition, the collar-shaped protrusion 4 of the container 2
The lower surface 42 of the first member is also designed according to the angle of the locking claw 15.
Further, although the length M of the locking claw 15 depends on the cap size, it is preferably about 0.8 to 2.0 mm, and more preferably about 2.5 mm. L in FIG. 3 for M
The longer the is, the easier the cap driving operation is, but the difficulty in driving the cap into the mouth of the container is related to the surface roughness, compression strain, etc. of the synthetic resin used.
【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１
６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１
８，１９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。FIG. 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 the container 2, the direct sealing body 6, the cap and the cover. FIG. 2 is a schematic perspective view showing the container in a separated state, and FIG. The locking claw 15 is provided along the inner wall surface at the lower end of the cap 1, but is not completely annular, but is notched at two positions symmetrical with respect to the diameter of the inner circumference.
6 and 16 'are provided. 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.
Is provided to prevent the cap lower portion 13 from rotating. Marks 1 indicating the positions of the notches 16 and 16 'and the locking projections 20 and 20' on the cap 1 and the container 2, respectively.
8 and 19 are provided by printing or engraving or the like to facilitate the cap tightening operation.
【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３〜３
０ｋｇｆとなるように設計されている。In FIG. 2, the outer wall of the skirt portion 10 is provided with an annular groove 11 over the entire outer wall, and the cap upper portion 12 and the cap lower portion 13 are thin walls 14 at the bottom of the annular groove 11 as described above. It is in a connected state.
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 has a breaking force of 3 to 3
It is designed to be 0 kgf.
【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。The cap 1 is continuously covered with the cover 8 made of a synthetic resin thin film from the window 7 on the top surface 9 of the cap 1 to the cap lower part 13 through the annular groove 11 of the skirt 10 of the cap 1 and directly sealed. The contamination of the top surface of the stopper 6 and the annular groove 11 is prevented, and the sealing performance of the container 2 is improved. After filling the medicine, the sealing body 6 and the cap 1 are directly plugged into the container mouth 4, and the cover can be easily detachably attached by means known in this field. The cover may also have a protruding piece or cut for peeling.
【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。In this embodiment configured as described above, for example, in the case where the drug 3 is a freeze-dried injection drug or the like, the cover 8 is first peeled off, and the injection needle is placed on the exposed top surface of the direct seal 6. And the liquid medicine such as distilled water for injection in the syringe is injected into the container, and the medicine 3 is dissolved to prepare an injection liquid. 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. In addition, the container 2 is held by hand or fixed by fixing means,
When a rotational force is applied to the cap upper part 12 on either side,
The cap lower part 13 also tries to rotate, but the notch 16
End faces 17a or 17b of the claw-shaped projections on both sides of the notch 16 'and end faces 17'a of the claw-shaped projections on both sides of the notch 16'
Or 17'b hits the locking projections 20 and 20 'of the container 2 and further rotation is stopped. When a further rotational force is applied, the upper portion 12 of the cap receives the rotational force as it is, so that a breaking force acts on the thin wall portion 14 and this annular groove 11
And 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, cap, etc. are disposed of, when the cap upper part 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 is facilitated. Become.
【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１
７ａ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。Example 2 Cyclic olefin copolymer resin as a container, thermoplastic elastomer as a direct sealing body,
The product of the present invention was manufactured using a saturated polyester polymer alloy as a material for the cap and the cover. This embodiment is almost the same as the structure of the first embodiment, but the shape of the locking projection is different. Therefore, FIGS. 5 (a) and 5 (b) 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 part of the cap, the end faces 1 of the claw-shaped projections on both sides of the notch 16 are formed in the same manner as in the first embodiment.
7a or 17b and the end faces 17'a or 17'b of the claw-like projections on both sides of the notch 16 'hit 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】〔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ｈ1 からｈ2 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＝ｈ2 −ｈ1）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。Example 3 The present invention uses 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. Was manufactured. As shown in FIG. 6 (a), the container 22 has a substantially cylindrical container opening 4 having an outer diameter and an inner diameter smaller than the main body, and has no flange-like projection. Below about less than half of the position of the length H of the container mouth portion 4, the position of h 2 from the depth h 1 from the upper edge of the sand opening 5, an annular projection over the entire circumference of the opening 5 The upper end surface of the opening 5 is provided with a certain inclination (height of inclination h = h 2 −h 1 ). In this example, the cross section of the inclined annular projection 23 is mountain-shaped (triangular), and since the triangle is longer than the length of the base, the cap can be easily driven. However, other cross-sectional shapes such as a square shape can be adopted.
【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。An annular leg 24 projecting from the lower surface (the side facing the opening 5) of the top surface 6 'of the direct sealing body shown in FIG. 6B is fitted into the opening 5. An annular projection 25 is provided on the outer periphery of the portion 24, and can be tightly sealed to the inner wall surface of the container mouth portion 4 for sealing. Although not shown, the legs 24
It is a particularly preferred embodiment that all surfaces of the lower surface of the top surface 6 'of the directly sealed body that can be contacted with the chemical liquid are laminated with a non-staining and chemically resistant synthetic resin film.
【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。As shown in FIGS. 6C and 7, the cap 1 ′ has a window 27 on the top surface 29 and a cylindrical skirt portion 30 that hangs down from the outer periphery of the top surface 29. In this embodiment, the skirt portion 30
The cap upper part 32 and the cap lower part 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 annular groove 31. 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. Skirt part 30
An outwardly protruding annular projection 35 is provided on the outer edge of the lower end of the device, so that it is easy for the user to hook the finger when operating.
【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。On the inner wall of the cap lower part 33, there is provided a slanted annular groove 28 having a shape to be fitted as a female type in which the slanted annular projection 23 of the container mouth 4 'is male. 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. Also,
On the upper surface of the top surface 29 of the cap 1 ', a mark 38 indicating the direction in which the cap 1' is twisted is provided.
【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。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, and prevents entry of dust, bacteria, etc. into the cap. Further, the adhesive is adhered to the entire top surface of the cap so as not to be peeled off from the upper surface of the cap due to vibration or environmental change.
【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。After filling the container 22 with the medicine, the leg 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 close the opening 5. Sealed,
Further, 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 crimped and sealed,
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】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。In order to use the medicine in the container 22 of the present embodiment, the medicine is peeled off by pinching and pulling a projection (not shown) 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 drug is dissolved to prepare an injection solution, and the injection solution can be sanitarily and easily administered by sucking the injection solution into the syringe.
【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。In this embodiment, the method of exposing the opening of the container 22 by breaking the cap 1 'at the annular groove 31 is indicated by the sign on the upper surface of the cap 1' as in the case of the first embodiment. A force is applied to rotate the cap 1 'in the direction. 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, it cannot be rotated and 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】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＝ｈ2 −ｈ1 ）
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。In this embodiment, the inclined length h (h = h 2 -h 1 ) of the inclined annular groove provided on the inner wall surface of the cap 1 ′.
Was 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 for a synthetic resin having a large cutting elongation (%) such as a rubber elastic body. Therefore, it is preferable to reduce the elongation by selecting a synthetic resin having a small breaking elongation (%) or by adding a fine powder filler to the synthetic resin in an amount of 0.1 to 25% by weight.
【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。Further, in Example 1 using polyethylene terephthalate and polymethylpentene as cap materials.
~ 3 caps were produced. Each of the sealed medical container containers obtained in each of the examples was broken at the annular groove position by applying a breaking rotational force of 4 to 32 kgf, and the upper portion 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】〔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４
４′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（４
５′）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。Example 4 A cyclic olefin copolymer resin was used as the container, synthetic rubber was used as the direct sealing body, a fluororesin was used as the leg laminated film of the direct sealing body, and polypropylene was used as the cap and cover. The product of the present invention was manufactured in which the directly sealed body was a stopper with a cut having a cut, and the cut and the vent of the cap could form a ventilation path in a half-plugged state. 9 is a schematic cross-sectional view of the present embodiment, FIG. 10 is a schematic explanatory view showing the structure of FIG. 9 separated into parts, and FIG. FIG. 12 is a schematic view showing a state in which the groove portion is broken, and portions having the same reference numerals in FIGS. 9 to 12 as those in FIGS. 1 to 8 have the same meaning.
As shown in FIGS. 9 and 10, in this embodiment, the container opening 40 is provided with a longer flange-shaped projection 41 than that of 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 'projecting from the lower surface of the top surface 43 of the sealing body, and a projection 45 is provided on the outer periphery of the legs 44 and 44'. And 45 'are provided, and legs 44 and 4 are provided.
4 'are provided with large cuts 48 and 48' extending from the front end side toward the top surface 53 of the sealing body.
5 ') is higher than the height at which the lower end is located. In addition, the outer periphery of the leg remains the same as that of the elastic body up to 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】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。The preparation 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 make it into 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, the height of the cut 48 (48 ') is
(45 ') The cut upper part 49 because it is higher than the lower end height
(49 ') is located above the upper edge of the container opening 40, and can form an air passage communicating between the inside and the outside of the container. Further, the vent hole 50 (50 ') of the cap 51 is in a half-plugged state, and the upper end thereof 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 is
The cap is fixed to the container opening 40 by cutting into the inclined lower surface 42, and the notch 16 (16 ') and the locking projection 20 (20') are engaged. 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】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。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. And the notch 16 (16 ') is engaged with the locking projection 20 (20'), so that the cap lower part 13 cannot rotate or move. Of the thin wall 14 is broken. FIG. 12 shows the broken cap 12 and the direct sealing body 46.
【００３８】[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。According to the present invention, since the sealed body of the pharmaceutical container of the present invention can easily expose the sealed body by peeling off the film and the seal adhered on the cap, the injection needle can be pierced directly into the sealed body. Simple, fast, reliable and hygienic. 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 rotational force to the cap and breaking it in the annular groove, thereby improving hygiene and speed. Can be attached to the above-mentioned use device. Further, the present invention product in which a cap having a vent hole and a stopper with a leg having a notch are directly combined as a sealing body is completely stoppered immediately after preparation in a concentration-drying and freeze-drying tank,
Caps can be driven, and products can be obtained extremely hygienically and with high efficiency. 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 hermetically sealed, so that the medicine filled therein can be stored for a long time and with high quality. Further, since the product of the present invention does not use metal as a material and can be easily separated into each component, disposal is simple, easy, and safe.
【図１】 本発明の一実施態様を示す部分断面図であ
る。FIG. 1 is a partial sectional view showing one embodiment of the present invention.
【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。FIG. 2 is an explanatory view showing a state in which the pharmaceutical container with a seal of FIG. 1 is divided into components.
【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。FIG. 3 is a partially enlarged sectional view of a portion (c) of FIG.
FIG. 4 is a diagram showing a state viewed from the direction of FIG.
【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。FIG. 4 is a schematic perspective view and a partial cross-sectional view for explaining the structure of the container mouth part in FIGS. 1 and 2 of the present invention.
【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。FIG. 5 is a perspective view and a partial cross-sectional view near a container mouth in another embodiment of the present invention.
【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。FIG. 6 is an explanatory diagram showing a state in which another embodiment of the present invention is divided into components.
【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。7 is a partially cutaway cross-sectional view showing an enlarged cap portion of FIG. 6C of the present invention.
【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。FIG. 8 is an explanatory diagram showing a state of FIG. 6C of the present invention viewed from the direction of arrow B.
【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。FIG. 9 is a partial sectional view showing still another embodiment of the present invention.
【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。FIG. 10 is an explanatory view showing a state in which the pharmaceutical container with a seal of FIG. 9 is divided into components.
【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。FIG. 11 is an explanatory diagram of a preparation process using the product of the present invention shown in FIGS. 9 and 10.
【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。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.
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３
３ 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′，１９，１
９′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、４
５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。1, 1 'and 51 caps, 2 and 22 containers, 3 pharmaceuticals, 4, 4' and 40 container mouths, 5 openings,
6, 26 and 46 Direct seal, 6 'and 43 Direct seal top, 7 and 27 Window, 8 and 38
Cover, 9 and 29 Top surface, 10 and 30 Skirt part, 11 and 31 Annular groove, 12 and 32 Cap upper part, 13 and 3
3 cap bottom, 14 and 34 thin wall,
15 locking claw, 16 and 16 'notch,
17a and 17b End faces 18, 18 ', 19, 1
9 'and 38 signs, 20, 20' and 21 locking projections, 23 inclined annular projections, 24, 44
And 44 'legs, 25 protrusions,
28 inclined annular groove, 35 annular protrusion,
36 protrusion 37 unevenness, 39 small protrusion 41 flange-shaped protrusion, 42 lower surface, 4
5 and 45 'projections, 47 synthetic resin films, 48 and 48' cuts, 49 and 49 'cut tops, 50 and 50' vents,
52 steam.
Claims (8)
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、キャップに回
転力を加えることにより該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封止具付きの医薬品容
器。1. A container for filling a medicine, 2) a plate-shaped or plug-shaped rubber elastic body, which is a direct sealing body for tightly sealing the mouth of the container, and 3) a window at the center. A top surface having a top surface and a skirt portion which hangs cylindrically from an outer edge of the top surface, covers the direct sealing body and the outside of the container opening closely, and tightly fixes the direct sealing body to the container opening. Synthetic resin cap and
4) a cover formed of a synthetic resin thin film and covering at least the window portion and the top surface of the cap so as to be peelable, and the skirt portion has a circular shape on its outer wall surface or inner wall surface at a substantially central position. By having an annular groove, 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, and correspond to the inner wall surface of the lower portion of the cap and the inner wall surface of the lower portion of the outer wall surface of the container opening. And a means for preventing the rotation or movement of the lower portion of the cap at a position where the two are fixed by engagement or engagement, and a portion of the annular groove is broken by applying a rotating force to the cap. A pharmaceutical container with a sealing device.
る脚部を有するものであることを特徴とする請求項１記
載の封止具付きの医薬品容器。2. The pharmaceutical container with a closure according to claim 1, wherein the directly sealed body has a leg that can be inserted into the container mouth.
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請求項１又は請求
項２記載の封止具付きの医薬品容器。3. The fixing means according to claim 1, wherein a hook-shaped engaging projection provided along an inner wall surface at a lower end of the lower portion of the cap engages with a lower inclined surface of a flange-shaped projection provided at an upper end of a container mouth. The cap is tightly fixed to the container mouth, and the rotation or movement preventing means is provided with a notch provided from the lower end of the lower part of the cap toward the top surface and beyond the locking projection; The lower surface of the cap is engaged with a movement preventing projection provided at a position corresponding to the notch, so that rotation or movement of the cap lower portion in the circumferential direction of the container opening is prevented even if a rotational force is applied to the cap. The pharmaceutical container with a closure according to claim 1 or 2, wherein a portion of the annular groove is broken.
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請求項１
又は請求項２記載の封止具付きの医薬品容器。4. The container according to claim 1, wherein the fixing means and the rotation or movement preventing means are fitted on the inclined annular projection provided on the outer peripheral surface of the container mouth and the inclined annular projection on the inner wall surface below the skirt. It consists of fitting with the provided inclined annular groove,
2. A portion of the annular groove being broken by preventing the lower portion of the cap from moving even if a rotational force is applied to the cap.
Or the pharmaceutical container provided with the closure according to claim 2.
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
ことを特徴とする請求項１ないし請求項４のいずれかに
記載の封止具付きの医薬品容器。5. A plug body having a leg which projects directly from the lower surface of the top surface of the sealing body and has a leg which can be fitted into the mouth of the container. From the top to the top surface side, the tip of the leg is inserted into the container mouth, and the projection is engaged with the upper edge of the container mouth to maintain the half stoppered state. Is partially outside the container mouth to form an air passage between the inside and the outside of the container. 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 the upper edge of the opening. The container opening is tightly sealed to the container, 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 is at least A substantially cylindrical shape covering the window and the ventilation hole; A pharmaceutical container with a closure according to any one of claims 1 to 4.
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
を示す標識を設けたことを特徴とする請求項１ないし請
求項５のいずれかに記載の封止具付きの医薬品容器。6. A sign indicating the engagement or fitting position of the two or a sign indicating the engaging or fitting position and a sign indicating the direction of rotating the cap are provided on the outer periphery of the cap and the outer periphery of the container. The pharmaceutical container with a closure according to any one of claims 1 to 5, characterized in that:
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を特徴とする請求項１ないし請求
項６のいずれかに記載の封止具付きの医薬品容器。7. A method according to claim 1, wherein a breakage of said annular groove by applying a rotational force to said cap occurs at a breaking force of 3 to 30 kgf. A pharmaceutical container provided with the closure according to the above.
性樹脂組成物からなることを特徴とする請求項１ないし
請求項７のいずれかに記載の封止具付きの医薬品容器。8. The pharmaceutical container with a closure according to claim 1, wherein the cap is made of a thermoplastic resin or a thermoplastic resin composition.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP13646398A JP3604280B2 (en) | 1997-07-10 | 1998-05-19 | Pharmaceutical container with seal |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP9-185222 | 1997-07-10 | ||
| JP18522297 | 1997-07-10 | ||
| JP13646398A JP3604280B2 (en) | 1997-07-10 | 1998-05-19 | Pharmaceutical container with seal |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH1179227A true JPH1179227A (en) | 1999-03-23 |
| JP3604280B2 JP3604280B2 (en) | 2004-12-22 |
Family
ID=26470036
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP13646398A Expired - Lifetime JP3604280B2 (en) | 1997-07-10 | 1998-05-19 | Pharmaceutical container with seal |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3604280B2 (en) |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002172161A (en) * | 2000-12-08 | 2002-06-18 | Asahi Medical Co Ltd | Sealing structure of liquid port for medical care implement and medical care implement having the sealing structure |
| JP2004067098A (en) * | 2002-05-31 | 2004-03-04 | Jutekku Kk | Container, cap and their combination |
| JP2005319323A (en) * | 2005-07-20 | 2005-11-17 | Asahi Kasei Medical Co Ltd | Sealing structure of cylindrical liquid port for medical instrument, medical instrument with the sealing structure, and sealing method |
| JP2009045140A (en) * | 2007-08-16 | 2009-03-05 | Ajinomoto Co Inc | Connecting structure of medicine vial and prefilled syringe, method for connecting medicine vial and prefilled syringe, medicine vial and combined kit formulation |
| US9637251B2 (en) | 2000-02-11 | 2017-05-02 | Medinstill Development Llc | Sealed containers and methods of filling and resealing same |
| EP2111795A4 (en) * | 2006-12-27 | 2017-12-27 | Kaneka Corporation | Vacuum blood collection tube |
| CN108190071A (en) * | 2018-01-31 | 2018-06-22 | 苏州江天包装彩印有限公司 | For the Sealing piece and its moulding process of cosmetic product |
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| WO2019111938A1 (en) | 2017-12-07 | 2019-06-13 | 藤森工業株式会社 | Port-equipped bag and cap-equipped bag |
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|---|---|---|---|---|
| CN106860026A (en) * | 2017-03-03 | 2017-06-20 | 浙江简成医疗科技有限公司 | A kind of multi-functional connector of Nasal gastrointestinal tube |
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1998
- 1998-05-19 JP JP13646398A patent/JP3604280B2/en not_active Expired - Lifetime
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9637251B2 (en) | 2000-02-11 | 2017-05-02 | Medinstill Development Llc | Sealed containers and methods of filling and resealing same |
| JP2002172161A (en) * | 2000-12-08 | 2002-06-18 | Asahi Medical Co Ltd | Sealing structure of liquid port for medical care implement and medical care implement having the sealing structure |
| JP2004067098A (en) * | 2002-05-31 | 2004-03-04 | Jutekku Kk | Container, cap and their combination |
| JP2005319323A (en) * | 2005-07-20 | 2005-11-17 | Asahi Kasei Medical Co Ltd | Sealing structure of cylindrical liquid port for medical instrument, medical instrument with the sealing structure, and sealing method |
| EP2111795A4 (en) * | 2006-12-27 | 2017-12-27 | Kaneka Corporation | Vacuum blood collection tube |
| JP2009045140A (en) * | 2007-08-16 | 2009-03-05 | Ajinomoto Co Inc | Connecting structure of medicine vial and prefilled syringe, method for connecting medicine vial and prefilled syringe, medicine vial and combined kit formulation |
| JP2018111545A (en) * | 2017-01-06 | 2018-07-19 | 新輝合成株式会社 | Pedal openable garbage box |
| WO2019111938A1 (en) | 2017-12-07 | 2019-06-13 | 藤森工業株式会社 | Port-equipped bag and cap-equipped bag |
| CN111447910A (en) * | 2017-12-07 | 2020-07-24 | 藤森工业株式会社 | Bag with opening and bag with cover |
| JPWO2019111938A1 (en) * | 2017-12-07 | 2020-11-26 | 藤森工業株式会社 | Bag with port and bag with cap |
| CN108190071A (en) * | 2018-01-31 | 2018-06-22 | 苏州江天包装彩印有限公司 | For the Sealing piece and its moulding process of cosmetic product |
Also Published As
| Publication number | Publication date |
|---|---|
| JP3604280B2 (en) | 2004-12-22 |
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