JPH11104213A - Cap for medicine container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To take a medicine into a syringe through aseptic operation by making a cap, which is to be attached to the mouth part of a medicine container, of resins, forming the cap with a freely stretchable cylinder part and a piercing part and air-tightly connecting the opening end of the cylinder part at the fitting end of the piercing part. SOLUTION: A cap 1 to be attached to a mouth part 3 formed for taking out a medicine 2 sealed and stored in a medicine container 4 is composed of a freely stretchable cylinder part 1A made of resins and a tube-shaped piercing part 1B piercing the mouth part 3. This piercing part 1B has a piercing end 5 for piercing the mouth part 3 connectable in the medicine container 4 and a fitting end 6 to fit the mouth part of the syringe. Then, this piercing part 1B is air-tightly connected to an opening end 7 of the cylinder part 1A at the fitting end 6 and inserted axially movably from the opening end 7 into the cylinder part 1A. Besides, another opening end 8 of the cylinder part 1A is air-tightly connected at the mouth part 3 and at an opening 6A of the fitting end 6 of the piercing part 1B, a lid seal material 9 is provided for sealing the opening 6A.

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【０００１】[0001]

【産業上の利用分野】本発明は、上記薬剤容器の口部に
取り付けられるキャップに関するものであり、より詳細
には、上記薬剤容器から無菌的に且つ簡単に薬剤を注射
筒等に充填することのできる薬剤容器のキャップに関す
るものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a cap attached to the mouth of a medicine container, and more particularly, to a method for aseptically and easily filling a medicine into an injection cylinder or the like from the medicine container. The present invention relates to a drug container cap that can be used.

【０００２】[0002]

【従来の技術】一般にバイアルやアンプル等から薬剤を
取り出す操作には注射器が使用される。例えば、バイア
ルの場合、注射器に針を取付け、注射器内に溶解液を取
り込み、この状態で注射針をバイアルゴム栓に刺通し、
一旦、溶解液をバイアル内に注入する。バイアル内の薬
剤を溶解液に溶解した後、再び注射器内に混合溶液を戻
す。そして、ゴム栓の刺通で汚染された注射針を取り換
えた後に患者に投与を行う。かかる操作はできる限り無
菌的に行われる。また、アンプルの場合、アンプルの首
部をカットして開口し、その開口から注射針を差し込ん
で注射器に薬剤を充填した後に、これを患者に投与す
る。2. Description of the Related Art In general, a syringe is used for an operation of taking out a medicine from a vial, an ampule or the like. For example, in the case of a vial, a needle is attached to the syringe, the solution is taken into the syringe, and the syringe needle is pierced in the vial rubber stopper in this state,
Once the lysate is injected into the vial. After dissolving the drug in the vial into the dissolving solution, the mixed solution is returned to the syringe again. Then, the administration is performed to the patient after replacing the injection needle contaminated by the penetration of the rubber stopper. Such an operation is performed aseptically as possible. In the case of an ampoule, the neck of the ampoule is cut and opened, and a syringe is inserted through the opening to fill a syringe with a drug, which is then administered to a patient.

【０００３】[0003]

【発明が解決しようとする課題】しかしながら、バイア
ルから薬剤を取り出す操作では、注射器の針を取り替え
る等の煩雑な操作を必要とし、操作が煩雑になればなる
ほど、無菌的操作が困難となる。また、アンプルからの
薬剤の取り出す操作では注射針を狭い開口に差し込む等
の手間がかかり、また開放された開口から薬剤が外界の
汚染空気に晒される危険性がある。従って、本発明は、
薬剤の取り出し操作及び投与操作が簡単で、出来る限り
の無菌的操作による薬剤の注射器内への取り込みができ
る薬剤容器のキャップを提供することを目的としてい
る。However, the operation of removing the medicine from the vial requires a complicated operation such as replacement of the needle of the syringe, and the more complicated the operation, the more difficult the aseptic operation becomes. In addition, in the operation of removing the medicine from the ampule, it takes time and effort to insert the injection needle into a narrow opening, and there is a risk that the medicine is exposed to contaminated air from the outside through the opened opening. Therefore, the present invention
It is an object of the present invention to provide a cap of a medicine container in which a medicine taking out operation and a dosing operation are simple and a medicine can be taken into a syringe by aseptic operation as much as possible.

【０００４】[0004]

【課題を解決するための手段】本発明は、薬剤が密封収
容され、且つ密封された該薬剤を取り出すための排出用
の口部が形成されてなる薬剤容器の該口部に取り付けら
れるキャップにおいて、上記キャップは樹脂製で伸縮自
在な筒部と管状で上記薬剤容器の口部に刺通する刺通部
とからなり、上記刺通部は上記容器口部に刺通して該薬
剤容器内に連通可能な刺通端と注射器の口部が嵌合され
る嵌合端とを有し、上記刺通部は上記嵌合端で上記筒部
の一の開口端に気密に接続される一方、該一の開口端か
ら上記筒部内に軸方向に移動可能に挿入されており、上
記筒部の他の開口端は上記容器口部と気密に接続され、
上記刺通部の嵌合端の開口には該開口を密封する蓋材が
設けられていることを特徴とする薬剤容器のキャップを
提供することにより、上記目的を達成したものである。SUMMARY OF THE INVENTION The present invention relates to a cap attached to a mouth of a medicine container having a medicine container hermetically contained therein and having a discharge port for taking out the sealed medicine. The cap includes a resin-made elastic tube portion and a tubular piercing portion that pierces the mouth of the drug container, and the piercing portion pierces the mouth of the container and communicates with the inside of the drug container. A possible piercing end and a fitting end into which the mouth of the syringe is fitted, wherein the piercing portion is airtightly connected to one opening end of the cylindrical portion at the fitting end. It is inserted movably in the axial direction from the one open end into the cylindrical portion, the other open end of the cylindrical portion is airtightly connected to the container mouth,
The object has been achieved by providing a cap for a medicine container, characterized in that a lid member for sealing the opening is provided at an opening at a fitting end of the piercing portion.

【０００５】本発明に係る薬剤容器は、ゴム栓等が口部
に取り付けられたバイアル、或いは最近、特に使用され
てきている樹脂製のアンプルで口部等を有したもの等を
挙げることができる。薬剤容器はキャップを取り付ける
口部を有するものであればどのような形態、形状のもの
でも良い。また、容器はバイアル等のようにガラス製で
も良いが、好ましくは樹脂製容器であることが望まし
い。樹脂製容器であれば、樹脂製のキャップ等を熱溶着
や接着剤接着で口部に液密な或いは気密な状態で取り付
けることが容易にできる。また、樹脂製であれば破損の
危険性が少なく、その廃棄処理も簡単にできる。薬剤容
器に密封収容される薬剤は凍結乾燥等した固形物でも良
く、また無菌充填や高圧蒸気滅菌処理された無菌水、無
菌薬液等を挙げることができる。The drug container according to the present invention may be a vial having a rubber stopper or the like attached to the mouth, or a resin ampule having a mouth and the like which has recently been particularly used. . The medicine container may have any form and shape as long as it has an opening for attaching a cap. The container may be made of glass such as a vial or the like, but is preferably a resin container. In the case of a resin container, a resin cap or the like can be easily attached to the mouth in a liquid-tight or air-tight state by heat welding or adhesive bonding. In addition, if it is made of resin, there is little risk of breakage, and the disposal can be simplified. The medicine hermetically contained in the medicine container may be a solid substance such as freeze-dried or the like, and examples thereof include aseptic water and aseptic liquid which have been aseptically filled or subjected to high-pressure steam sterilization.

【０００６】本発明に係るキャップは樹脂製である。キ
ャップが樹脂成形物であれば、キャップ壁等に伸縮性、
可撓性等を容易に賦与することができる。また、樹脂製
容器等の口部に液密或いは気密に接続する場合でも簡単
に接続を行うことができる。キャップに使用される樹脂
としては通常、熱可塑性樹脂等であり、ポリオレフィン
系樹脂、塩化ビニル、塩化ビニリデン系樹脂、ポリエス
テル系樹脂、ポリビニルアルコール系樹脂、ポリアクリ
ルニトリル系樹脂、ポリアクリル酸系樹脂、ポリアミド
系樹脂等の汎用樹脂である。特に、薬剤に影響を与えな
い、また溶出物が生じない樹脂であることが望ましく、
このような樹脂としては、ポリオレフィン系樹脂が望ま
しく、例えば、低、中、高−密度ポリエチレン、ポリプ
ロピレン等の低級オレフィン樹脂等が挙げられる。The cap according to the present invention is made of resin. If the cap is a resin molded product, the cap wall etc. have elasticity,
Flexibility and the like can be easily provided. Further, even when the liquid-tight or air-tight connection is made to the mouth of a resin container or the like, the connection can be easily performed. The resin used for the cap is usually a thermoplastic resin or the like, a polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin, polyvinyl alcohol resin, polyacrylonitrile resin, polyacrylic acid resin, It is a general-purpose resin such as polyamide resin. In particular, it is desirable that the resin does not affect the drug and does not generate eluate,
As such a resin, a polyolefin-based resin is desirable, and examples thereof include low-, middle-, and high-density lower-grade olefin resins such as polyethylene and polypropylene.

【０００７】上記キャップは伸縮自在な筒部と管状で薬
剤容器の口部に刺通する刺通部とからなる。上記キャッ
プの筒部と刺通部とは別体或いは一体に成形されたもの
であり、押出成形、射出成形、又はブロー成形したもの
である。特に、上記キャップは射出形成パリソンをブロ
ー成形したものが望ましい。上記刺通部は薬剤容器の口
部に刺通して該薬剤容器内に連通可能な刺通端と注射器
の口部が嵌合される嵌合端とを有している。薬剤容器の
口部に刺通するとは、薬剤容器の口部に設けられるゴム
栓や密封用の薄膜等を刺通することであり、これにより
管状の刺通部内と薬剤容器内とが連通可能となる。従っ
て、刺通端は鋭角端に形成されていることが望ましい。
また、刺通部の嵌合端は注射器の口部を外装するもので
あれば特にその形状に制限はなく、ルアーアダプター形
式の口部を受け入れる形状であっても良い。[0007] The cap comprises a telescopic tube part and a tubular piercing part penetrating the mouth of the medicine container. The cylindrical portion and the piercing portion of the cap are formed separately or integrally, and are formed by extrusion molding, injection molding, or blow molding. In particular, the cap is preferably formed by blow molding an injection-formed parison. The piercing portion has a piercing end that can penetrate into the mouth of the medicine container and communicate with the medicine container, and a fitting end into which the mouth of the syringe is fitted. To penetrate the mouth of the medicine container means to penetrate a rubber stopper or a sealing thin film provided at the mouth of the medicine container, so that the inside of the tubular penetration portion and the inside of the medicine container can communicate with each other. Becomes Therefore, it is desirable that the piercing end is formed at an acute end.
The shape of the fitting end of the piercing portion is not particularly limited as long as it covers the mouth of the syringe, and the fitting end may be shaped to receive a luer adapter type mouth.

【０００８】上記筒部は筒部の軸方向に伸縮自在である
限り含まれる。例えば、単なる柔軟な屈曲自在な可撓性
の薄壁、或いは蛇腹壁や材質自体が伸縮自在に形成され
る伸縮壁等を挙げることができる。上記刺通部は上記嵌
合端で上記筒部の一の開口端に気密に接続される一方、
該一の開口端から上記筒部内に軸方向に移動可能に挿入
されている。即ち、上記筒部は上記嵌合端で接続される
が、その嵌合端の開口部分が覆われるのでなく刺通部の
ほぼ全体を覆うように接続される。これは、もし、上記
筒部と刺通部とが一体に成形されたものであれば、上記
筒部の一の開口端及び刺通部の嵌合端で上記筒部が裏返
しにされて上記刺通部全体を覆って筒部が設けられる。
もし、上記筒部と刺通部とが別体で形成されるならば、
筒部は該筒部の内壁面と刺通部の外壁面とが固着されて
接続された状態で刺通部が筒部で覆われる。The above-mentioned cylindrical portion is included as long as it can be expanded and contracted in the axial direction of the cylindrical portion. For example, a simple flexible bendable flexible thin wall, a bellows wall, or a stretchable wall in which the material itself is stretchable can be used. The piercing portion is airtightly connected to one opening end of the cylindrical portion at the fitting end,
From the one opening end, it is inserted movably in the axial direction into the cylindrical portion. That is, the cylindrical portion is connected at the fitting end, but is connected so as not to cover the opening of the fitting end but to cover substantially the entire piercing portion. This is because if the cylindrical portion and the piercing portion are integrally formed, the cylindrical portion is turned upside down at one opening end of the cylindrical portion and the fitting end of the piercing portion. A tubular portion is provided to cover the entire piercing portion.
If the cylindrical portion and the piercing portion are formed separately,
The piercing portion of the tubular portion is covered with the tubular portion in a state where the inner wall surface of the tubular portion and the outer wall surface of the piercing portion are fixedly connected.

【０００９】上記筒部の他の開口端は上記薬剤容器の口
部で気密に該容器と接続されている。上記筒部は口部に
嵌着されても良いが、好ましくは接着剤を介して気密に
密着或いは熱溶着シールして取り付けられることが望ま
しい。上記刺通部の嵌合端の開口には該開口を密封する
蓋材が設けられている。蓋材は単なるフィルム又はシー
ト状のシール材を剥離可能に熱溶着して取り付けても良
く、また完全に樹脂成形した密封部材であっても良い
が、使用時に取り外すことができるものである。The other open end of the cylindrical portion is airtightly connected to the medicine container at the mouth of the medicine container. The above-mentioned cylindrical portion may be fitted to the mouth portion, but it is preferable that the tubular portion is attached in an airtight manner with an adhesive or by heat sealing. A lid material for sealing the opening is provided at the opening at the fitting end of the piercing portion. The lid material may be attached by simply peeling and attaching a simple film or sheet-shaped sealing material, or may be a completely resin-molded sealing member, but can be removed at the time of use.

【００１０】このように構成された薬剤容器のキャップ
によれば、注射器の口部を刺通部の嵌合端に嵌合し、注
射器を容器口部に向けて押し込めば、刺通端が容器口部
に簡単に刺通し、注射器内と薬剤容器内とが連通する。
そして、注射器内に薬液等を取り込み、注射器の口部を
嵌合端から外して、代わりに注射針を取り付ければ、直
ぐに投与が可能となる。この場合、薬剤容器の口部及び
刺通部の刺通端を筒部で無菌状態に容易にしておくこと
ができる。即ち、嵌合端の開口を蓋材等で密封し、薬剤
容器と共に密封包装しておけば、上記部分が簡単に無菌
維持しておくことができる。従って、薬剤の取り出し操
作及び投与操作が簡単で、無菌的操作による薬剤の注射
器内への取り込みができる。According to the cap of the medicine container thus constituted, the mouth of the syringe is fitted to the fitting end of the piercing portion, and the syringe is pushed toward the mouth of the container. The mouth is easily pierced, and the inside of the syringe and the inside of the medicine container communicate.
Then, a drug solution or the like is taken into the syringe, the mouth of the syringe is removed from the fitting end, and an injection needle is attached instead, so that administration becomes possible immediately. In this case, the mouth portion of the medicine container and the piercing end of the piercing portion can be easily sterilized by the cylindrical portion. That is, if the opening at the fitting end is sealed with a lid material or the like and hermetically sealed together with the medicine container, the above-mentioned portion can be easily maintained aseptically. Therefore, the operation of taking out and administering the medicine is simple, and the medicine can be taken into the syringe by aseptic operation.

【００１１】本発明に係る請求項２記載のキャップは、
請求項１記載のキャップにおいて、上記刺通部の外形断
面形状は上記容器の口部の開口断面形状と回転対称同形
或いは異形に形成され、上記刺通部は該刺通部の軸を中
心に一部回動させた位置で上記刺通部が上記容器口部内
への移動が可能となることを特徴とする。上記刺通部の
外形断面形状と上記容器口部の開口断面形状が回転する
ことにより同一となる或いは異形であれば、刺通部の嵌
合端に注射器をセットして押し込んだときに、刺通部は
容器口部によって一旦押し込みが阻止される。かかる阻
止の状態で注射器と容器とを相対的に押圧しあえば、注
射器の口部が刺通部の嵌合端に強固に嵌合される。注射
器と刺通部とが強固に嵌合されて押圧した状態で、注射
器を介して刺通部を一部回動させると、刺通部が容器口
部の開口内に挿入可能となって刺通部が口部に向けて再
び移動可能となる。そして、刺通部は上記容器口部への
刺通が可能となる。従って、このような刺通部の外形断
面形状と容器口部の開口断面形状との関係から、注射器
を操作する際に、先ず、注射器と刺通部とを強固にセッ
トしたのち、刺通部が口部の刺通を可能にするため、注
射器と刺通部との接続部分で薬液等の液だれ等を生じさ
せるおそれがなく、注射器と容器との接続が確実にでき
る。[0011] The cap according to claim 2 of the present invention,
2. The cap according to claim 1, wherein the outer cross-sectional shape of the piercing portion is formed to have the same or different shape as the opening cross-sectional shape of the mouth of the container in rotational symmetry, and the piercing portion is centered on the axis of the piercing portion. The piercing portion can be moved into the container mouth at a position where the piercing portion is partially rotated. If the outer cross-sectional shape of the piercing portion and the opening cross-sectional shape of the container mouth are the same or different by rotation, when the syringe is set and pushed into the fitting end of the piercing portion, The passage portion is once prevented from being pushed in by the container mouth. If the syringe and the container are pressed relatively to each other in this blocking state, the mouth of the syringe is firmly fitted to the fitting end of the piercing portion. When the piercing portion is partially rotated through the syringe in a state where the syringe and the piercing portion are firmly fitted and pressed, the piercing portion can be inserted into the opening of the container opening, and the piercing portion can be inserted. The passage is again movable towards the mouth. Then, the piercing portion can pierce the container opening. Therefore, based on the relationship between the outer cross-sectional shape of the piercing portion and the opening cross-sectional shape of the container mouth, when operating the syringe, first, the syringe and the piercing portion are firmly set, and then the piercing portion is set. Since the mouth can be pierced, there is no danger of dripping of a drug solution or the like at the connection portion between the syringe and the piercing portion, and the connection between the syringe and the container can be reliably performed.

【００１２】本発明に係る請求項３記載のキャップは、
請求項１又は２記載のキャップにおいて、上記刺通部が
上記容器口部に挿入された時に、該刺通部を上記容器口
部から脱抜不能にする係合部が上記刺通部と上記容器口
部との間に形成されていることを特徴とする。薬液等を
注射器内に注入した後に、刺通部から注射器を引き抜く
ときに、容器口部が刺通部と係合しているため、強固に
接続された注射器の口部と刺通部の嵌合端とを離すこと
ができ操作が簡単になる。The cap according to claim 3 of the present invention is
3. The cap according to claim 1, wherein when the piercing portion is inserted into the container mouth, the engaging portion that makes the piercing portion unable to be detached from the container mouth is formed with the piercing portion. 4. It is characterized by being formed between the container mouth. When the syringe is withdrawn from the piercing portion after injecting a drug solution or the like into the syringe, the mouth of the container is engaged with the piercing portion, so that the mouth of the strongly connected syringe and the piercing portion are fitted. The end can be separated and the operation is simplified.

【００１３】本発明に係る請求項４記載のキャップは、
請求項３記載のキャップにおいて、上記筒部と刺通部と
は一体形成され、上記筒部の一の開口端で上記筒部が裏
返されて上記刺通部を覆っていることを特徴とする。上
記筒部と刺通部とが一体形成されていれば、製造が容易
であるだけでなく、筒部と刺通部との気密性が確実に保
たれ、ピンホール等がない。このため、刺通部の嵌合端
に蓋材等をして高圧蒸気滅菌処理したときなど、筒部内
は確実に無菌が維持され、注射器の無菌的な接続が確実
にできる。[0013] The cap according to claim 4 of the present invention,
4. The cap according to claim 3, wherein the tubular portion and the piercing portion are integrally formed, and the tubular portion is turned upside down at one opening end of the tubular portion to cover the piercing portion. . If the cylindrical portion and the piercing portion are integrally formed, not only is manufacturing easy, but also the airtightness between the cylindrical portion and the piercing portion is reliably maintained, and there is no pinhole or the like. For this reason, for example, when the fitting end of the piercing portion is covered with a lid or the like and subjected to high-pressure steam sterilization, the inside of the cylindrical portion is reliably maintained aseptic, and the aseptic connection of the syringe can be reliably performed.

【００１４】本発明に係る請求項５記載のキャップは、
請求項３又は４記載のキャップにおいて、上記蓋材が水
蒸気透過性材料であることを特徴とする。蓋材が水蒸気
透過性材料であれば、キャップを薬剤容器と共に、高圧
蒸気滅菌処理したとき、筒部内に十分に水蒸気が浸透し
て滅菌される一方、滅菌処理後、筒部から速やかに水分
を取り除くことができる。このような水蒸気透過性材料
としては微多孔性フィルム等であり、ガーレー式通気度
が０．０１〜１０００秒／１００ｍｌで常圧で水や細菌
を通さず水蒸気は透過するものである。微多孔性フィル
ムとして市販されているものは、ジュラガード（セラニ
ーズ社）、ＦＰ−２（旭化成工業製）、ＮＦシート（徳
山曹達製）、セルポアＮＷ０１（積水化学工業製）等が
ある。[0014] The cap according to claim 5 of the present invention,
The cap according to claim 3 or 4, wherein the lid member is a water vapor permeable material. If the lid is made of a water vapor permeable material, when the cap and the drug container are subjected to high-pressure steam sterilization, sufficient water vapor penetrates into the cylinder to be sterilized. Can be removed. Such a water vapor permeable material is a microporous film or the like, which has a Gurley-type air permeability of 0.01 to 1000 seconds / 100 ml and is permeable to water and bacteria at normal pressure without passing water or bacteria. Commercially available microporous films include Juraguard (Celanese), FP-2 (Asahi Kasei Kogyo), NF sheet (Tokuyama Soda), Cellpore NW01 (Sekisui Chemical) and the like.

【００１５】[0015]

【実施例】以下、本発明に係る薬剤容器のキャップの好
ましい実施例を添付図面を参照しながら詳述する。図１
は第一実施例に係る薬剤容器のキャップの断面図であ
る。図２（Ａ）及び（Ｂ）は第一実施例に係る薬剤容器
のキャップの一体成形された筒部と刺通部の断面図であ
る。図３は第一実施例に係る薬剤容器のキャップが取り
付けられる薬剤容器の口部の開口断面図である。図４は
第一実施例に係る薬剤容器のキャップに注射器の口部を
取り付けた要部断面図である。図５は第一実施例に係る
薬剤容器のキャップの刺通部を容器口部に刺通した時の
要部断面図である。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the cap for a medicine container according to the present invention will be described below in detail with reference to the accompanying drawings. FIG.
FIG. 2 is a cross-sectional view of the cap of the medicine container according to the first embodiment. FIGS. 2A and 2B are cross-sectional views of the integrally formed cylindrical portion and the piercing portion of the cap of the medicine container according to the first embodiment. FIG. 3 is an opening cross-sectional view of the mouth of the medicine container to which the cap of the medicine container according to the first embodiment is attached. FIG. 4 is a cross-sectional view of a main part in which the mouth of the syringe is attached to the cap of the medicine container according to the first embodiment. FIG. 5 is a cross-sectional view of main parts when the piercing portion of the cap of the medicine container according to the first embodiment is pierced into the container mouth.

【００１６】第一実施例に係る薬剤容器のキャップ１
は、図１〜図５に示す如く薬剤２が密封収容され、且つ
密封された該薬剤２を取り出すための排出用の口部３が
形成されてなる薬剤容器４の口部３に取り付けられる薬
剤容器のキャップである。上記キャップ１は樹脂製で伸
縮自在な筒部１Ａと管状で薬剤容器４の口部３に刺通す
る刺通部１Ｂとからなり、刺通部１Ｂは容器口部３に刺
通して薬剤容器４内に連通可能な刺通端５と注射器１０
０の口部１０１が嵌合される嵌合端６とを有し、刺通部
１Ｂは嵌合端６で筒部１Ａの一の開口端７に気密に接続
される一方、一の開口端７から筒部１Ａ内に軸方向に移
動可能に挿入されており、筒部１Ａの他の開口端８は容
器口部３で気密に接続され、刺通部１Ｂの嵌合端６の開
口６Ａには開口６Ａを密封する蓋用シール材９が設けら
れている。A cap 1 for a medicine container according to the first embodiment.
As shown in FIGS. 1 to 5, a medicine 2 is hermetically sealed and accommodated, and a medicine attached to an opening 3 of a medicine container 4 having a discharge opening 3 for taking out the sealed medicine 2. Container cap. The cap 1 is made of a resin-made elastic tube portion 1A and a tubular piercing portion 1B that pierces the mouth portion 3 of the medicine container 4. The piercing portion 1B pierces the container mouth portion 3 and inserts the medicine container 4A. Piercing end 5 and syringe 10 which can communicate with each other
And a piercing portion 1B is airtightly connected to one opening end 7 of the cylindrical portion 1A at the fitting end 6 while one piercing portion is fitted thereto. 7 is inserted into the cylindrical portion 1A so as to be movable in the axial direction. The other open end 8 of the cylindrical portion 1A is airtightly connected to the container opening 3 and the opening 6A of the fitting end 6 of the piercing portion 1B. Is provided with a lid sealing material 9 for sealing the opening 6A.

【００１７】上記刺通部１Ｂの外形断面形状Ａは容器口
部３の開口断面形状Ｂとは同形に形成されるが互いに回
転対称関係に配されている。上記刺通部１Ｂは刺通部１
Ｂの軸を中心に一部回動させた位置で刺通部１Ｂが容器
口部３内へ移動可能となる。上記刺通部１Ｂが容器口部
３に挿入された時に、刺通部１Ｂを容器口部３から脱抜
不能にする係合部１０が刺通部１Ｂと容器口部３とに形
成されている。上記筒部１Ａと刺通部１Ｂとは一体形成
され、筒部１Ａの一の開口端７で筒部１Ａが裏返されて
刺通部１Ｂを覆っている。上記蓋用シール材９が水蒸気
ガス透過性である。The outer cross-sectional shape A of the piercing portion 1B is formed in the same shape as the cross-sectional shape B of the opening 3 of the container mouth portion 3, but they are arranged in a rotationally symmetric relationship with each other. The piercing portion 1B is the piercing portion 1
The piercing portion 1B can move into the container opening 3 at a position where the piercing portion 1B is partially rotated about the axis of B. When the piercing portion 1B is inserted into the container opening 3, an engaging portion 10 for preventing the piercing portion 1B from being detached from the container opening 3 is formed in the piercing portion 1B and the container opening 3. I have. The tubular portion 1A and the piercing portion 1B are integrally formed, and the tubular portion 1A is turned over at one opening end 7 of the tubular portion 1A to cover the piercing portion 1B. The lid sealing material 9 is permeable to water vapor gas.

【００１８】本実施例に係る薬剤容器のキャップ１を更
に詳しく説明すると、実施例に接続される薬剤容器４は
口部３が射出成形物であり、胴部が押出し成形物であ
る。容器口部３が所定の長さに裁断された押出成形管の
一端にスリーブ成形された状態で熱溶着され、他端に熱
溶着シール部１１を設けて薬剤容器４が成形される。容
器口部３には開口を密封する薄膜３Ａが形成され、かか
る薄膜３Ａはキャップ１の刺通部１Ｂの刺通端５による
刺通可能になっている。容器口部３の開口内壁の所定位
置には刺通部１Ｂとの係合部１０用の係合穴が形成さ
れ、刺通部１Ｂの外壁面に形成された係合突起がかかる
係合穴に係合したとき、容器口部３と刺通部１Ｂは互い
に脱抜不能となる。容器口部３及び胴部４Ａの樹脂素材
は直鎖状低密度ポリエチレンから形成されている。薬剤
容器４内には注射用薬液２が収容され、薬液２は薬剤容
器４と一緒に高圧蒸気滅菌処理されている。The cap 1 of the medicine container according to the present embodiment will be described in more detail. In the medicine container 4 connected to the embodiment, the mouth 3 is an injection-molded product and the body is an extruded product. The container opening 3 is heat-welded in a state where it is sleeve-formed at one end of an extruded tube cut to a predetermined length, and a heat-sealing seal portion 11 is provided at the other end to form the medicine container 4. A thin film 3A for sealing the opening is formed in the container opening 3, and the thin film 3A can be pierced by the piercing end 5 of the piercing portion 1B of the cap 1. An engagement hole for the engagement portion 10 with the piercing portion 1B is formed at a predetermined position on the inner wall of the opening of the container mouth portion 3, and an engagement hole formed by an engaging projection formed on the outer wall surface of the piercing portion 1B. , The container mouth portion 3 and the piercing portion 1B cannot be removed from each other. The resin material of the container opening 3 and the body 4A is made of linear low-density polyethylene. The drug container 4 contains the drug solution 2 for injection, and the drug solution 2 is subjected to high-pressure steam sterilization together with the drug container 4.

【００１９】図２（Ａ）に示す如く、キャップ１の本体
は筒部１Ａと刺通部１Ｂとが一体成形され、筒部１Ａは
ブロー延伸されて形成され、刺通部１Ｂは射出成形のパ
リソンを原形として形成される。筒部１Ａは薄肉で可撓
性壁に形成され、図２（Ｂ）に示す如く裏返されて刺通
部１Ｂのほぼ全体を覆っている。刺通部１Ｂは保形性を
維持して、容器口部３の薄膜３Ａに刺通可能な鋭角刺通
端５及び注射器１００の口部１０１と嵌合する嵌合端６
が設けられる。従って、筒部１Ａの一の開口端７と刺通
部１Ｂの嵌合端６とは継ぎ目のない連続する接続部とな
っている。嵌合端６の開口６Ａは蓋用シート材９で密封
され、シート材９は剥離可能に嵌合端６に熱溶着シール
されている。シート材９はポリエチレン製の微多孔性フ
ィルムを有し、水蒸気透過性で、水及び細菌の不透過性
機能を有している。そして、そのガーレー式通気度が
５．００秒／１００ｍｌ程度になっている。図３に示す
如く、刺通部１Ｂの外形断面形状Ａと容器口部３の開口
断面形状Ｂとは共に矩形状で同形に形成される。しか
し、キャップ１の容器口部３の取付け状態にあっては互
いに９０度回転して異ならせた位置で配されている。従
って、刺通部１Ｂを容器口部３の開口に対して９０度回
転すれば、容器口部３内に挿入可能となる。このように
刺通部１Ｂを９０度異ならせて配するように、筒部１Ｂ
の他の開口端部８が容器口部３の外壁面に熱溶着され、
これらの接着面は完全に密封シールされる。As shown in FIG. 2A, the main body of the cap 1 is formed by integrally molding a cylindrical portion 1A and a piercing portion 1B, the cylindrical portion 1A is formed by blow-extending, and the piercing portion 1B is formed by injection molding. Formed in parison form. The cylindrical portion 1A is formed of a thin and flexible wall, and is turned over as shown in FIG. 2 (B) to cover substantially the entire piercing portion 1B. The piercing portion 1B maintains shape retention, and has an acute piercing end 5 that can penetrate the thin film 3A of the container mouth portion 3 and a fitting end 6 that fits with the mouth portion 101 of the syringe 100.
Is provided. Therefore, one open end 7 of the cylindrical portion 1A and the fitting end 6 of the piercing portion 1B are a continuous connection portion without a seam. The opening 6A of the fitting end 6 is sealed with a lid sheet material 9, and the sheet material 9 is heat-sealed and sealed to the fitting end 6 in a peelable manner. The sheet material 9 has a microporous film made of polyethylene, is water vapor permeable, and has a function of impermeable water and bacteria. The Gurley type air permeability is about 5.00 seconds / 100 ml. As shown in FIG. 3, the outer cross-sectional shape A of the piercing portion 1B and the opening cross-sectional shape B of the container mouth 3 are both rectangular and formed in the same shape. However, in the state where the container opening 3 of the cap 1 is attached, the caps 1 are arranged at positions different from each other by rotating by 90 degrees. Therefore, if the piercing portion 1B is rotated by 90 degrees with respect to the opening of the container mouth portion 3, it can be inserted into the container mouth portion 3. As described above, the tubular portion 1B is arranged so that the piercing portions 1B are different from each other by 90 degrees.
The other open end 8 is heat-welded to the outer wall surface of the container mouth 3,
These adhesive surfaces are completely hermetically sealed.

【００２０】次に、薬剤容器のキャップの製造方法を簡
単に説明すると、まず、図２（Ａ）に示すキャップ１の
本体を射出成形とブロー成形とを組み合わせて成形し、
筒部１Ａを裏返して筒部１Ａで刺通部１Ｂを覆う。次
に、刺通部１Ｂの嵌合端６に蓋用シート材９を剥離可能
に熱溶着シールする。一方、押出成形チューブを所定の
長さに裁断して胴部とし、胴部の一端に射出成形した容
器口部３を取り付ける。胴部の他端から薬液２を充填
し、他端を熱溶着シールしてシール部１１を形成する。
上記薬剤容器４の容器口部３を筒部１Ａの他の開口端８
内に挿入して液密に熱溶着シールして固着する。次に、
キャップ１、薬剤容器４と共に薬液２を温度１１０℃で
高圧蒸気滅菌処理する。その後、キャップ１内を乾燥し
て、薬剤容器４の全体をガス及び水蒸気バリアー性の包
装材で包装して製品とする。Next, the method of manufacturing the cap of the medicine container will be briefly described. First, the main body of the cap 1 shown in FIG. 2A is formed by combining injection molding and blow molding.
The tubular portion 1A is turned over and the piercing portion 1B is covered with the tubular portion 1A. Next, the lid sheet material 9 is heat-sealed to the fitting end 6 of the piercing portion 1B so as to be peelable. On the other hand, the extruded tube is cut into a predetermined length to form a body, and an injection-molded container opening 3 is attached to one end of the body. The liquid medicine 2 is filled from the other end of the body, and the other end is heat-sealed to form a seal portion 11.
The container opening 3 of the medicine container 4 is connected to the other open end 8 of the cylindrical portion 1A.
And heat-sealed in a liquid-tight manner for sealing. next,
The medical solution 2 is subjected to high-pressure steam sterilization at 110 ° C. together with the cap 1 and the drug container 4. After that, the inside of the cap 1 is dried, and the entire medicine container 4 is wrapped with a gas and water vapor barrier wrapping material to obtain a product.

【００２１】次に、薬剤容器のキャップ１の使用方法を
簡単に説明すると、先ず、シール材９をキャップ１から
剥がし、図４に示す如く刺通部１Ｂの嵌合端６の開口６
Ａに滅菌された空の注射器１００の口部１０１を差し込
む。一定の力で注射器１００を薬剤容器４に向けて押圧
し、口部１０１を嵌合端６に確実に嵌合させる。かかる
押圧の際、刺通部１Ｂは容器口部３の開口に規制を受
け、口部１０１の開口６Ａの十分な嵌着が期待できる。
次に、注射器１００を容器口部３に対して９０度回動
し、これに伴った筒部１Ａを捻りながら刺通部１Ｂも９
０度回動して、図５に示す如く刺通部１Ｂは容器口部３
内に挿入可能となり、刺通部１Ｂが更に挿入されると刺
通端５が口部３の薄膜３Ａを破封すると共に、刺通部１
Ｂと容器口部３との係合部１０の係合穴と係合突起とが
係合する。これにより、注射器１００内と薬剤容器４内
とが連通可能となると共に、刺通部１Ｂが容器口部３か
ら脱抜不能となる。そして、薬剤容器４内の薬液２及び
一部のエアを注射器１０１内に取り込み、取り込んだ後
に、注射器１００の口部１０１を刺通部１Ｂから取り外
し、代わりに注射針を取付けて投与を開始する。Next, the method of using the cap 1 of the medicine container will be briefly described. First, the sealing material 9 is peeled off from the cap 1 and the opening 6 of the fitting end 6 of the piercing portion 1B as shown in FIG.
Insert the mouth 101 of the sterile empty syringe 100 into A. The syringe 100 is pressed toward the medicine container 4 with a constant force, and the mouth 101 is securely fitted to the fitting end 6. At the time of such pressing, the piercing portion 1B is restricted by the opening of the container mouth portion 3, and it is expected that the opening 6A of the mouth portion 101 is sufficiently fitted.
Next, the syringe 100 is rotated by 90 degrees with respect to the container opening 3, and the piercing portion 1B is also rotated by 9 degrees while twisting the cylindrical portion 1A.
Rotating by 0 degrees, the piercing portion 1B is inserted into the container opening 3 as shown in FIG.
When the piercing portion 1B is further inserted, the piercing end 5 breaks the thin film 3A of the mouth portion 3 and the piercing portion 1B is opened.
The engagement hole of the engagement portion 10 between B and the container mouth 3 engages with the engagement protrusion. As a result, the inside of the syringe 100 and the inside of the medicine container 4 can communicate with each other, and the piercing portion 1B cannot be removed from the container opening 3. Then, the medicinal solution 2 and a part of the air in the medicament container 4 are taken into the syringe 101, and after being taken in, the mouth portion 101 of the syringe 100 is removed from the piercing portion 1B, and the injection needle is attached instead to start administration. .

【００２２】このように構成された薬剤容器のキャップ
１にあっては、樹脂成形物であり、その部材が極めて少
ないので製造が簡単にできる。特に、キャップ１の筒部
１Ａと刺通部１Ｂとが一体成形されていれば、製造だけ
でなく、その接続部１Ｂの気密或いは液密性の保証が高
く、薬剤容器のキャップ１の保存中も刺通部１Ｂを無菌
に維持できる。即ち、注射器１００の口部１０１が接続
される刺通部１Ｂの嵌合端６の開口６Ａ及び容器口部３
の薄膜３Ａ面は保存時に完全な無菌保証がなされること
が必要とされ、かかる目的のために筒部１Ａが刺通部１
Ｂと一体成形されているということは、それだけピンホ
ール等の危険性を減らすことができる。従って、使用時
に注射器１００の口部１０１を刺通部１Ｂの嵌合端６に
接続しても無菌的な接続が十分にできる。また刺通部１
Ｂを薄膜３に刺通するときも無菌的な操作が可能とな
る。またこのようなキャップ１の構成において、蓋用シ
ール材９は水蒸気透過性材料からなるため、キャップ１
を滅菌した際に筒部１Ａ内の水蒸気が浸透して十分な滅
菌処理ができる。使用に際しては、上述したように注射
器の口部１０１を確実に刺通部１Ｂの嵌合端６にセット
した後、刺通部１Ｂの刺通端５を容器口部３の薄膜３Ａ
に刺通させることができる。The cap 1 of the medicine container thus constructed is a resin molded product, and the number of its members is extremely small, so that the production can be simplified. In particular, if the cylindrical portion 1A and the piercing portion 1B of the cap 1 are integrally formed, not only the production but also the air-tightness or liquid-tightness of the connecting portion 1B is high, and the cap 1 of the medicine container is stored. The piercing portion 1B can also be maintained aseptically. That is, the opening 6A of the fitting end 6 of the piercing portion 1B to which the mouth portion 101 of the syringe 100 is connected, and the container mouth portion 3
It is necessary that the surface of the thin film 3A be completely aseptic assured at the time of storage.
Being integrally formed with B can reduce the risk of pinholes and the like. Therefore, even when the mouth portion 101 of the syringe 100 is connected to the fitting end 6 of the piercing portion 1B during use, aseptic connection can be sufficiently achieved. Piercing section 1
When piercing B into the thin film 3, an aseptic operation can be performed. Further, in such a configuration of the cap 1, since the lid sealing material 9 is made of a water vapor permeable material, the cap 1
When water is sterilized, the water vapor in the cylindrical portion 1A penetrates and sufficient sterilization can be performed. In use, the mouth 101 of the syringe is securely set at the fitting end 6 of the piercing portion 1B as described above, and then the piercing end 5 of the piercing portion 1B is attached to the thin film 3A of the container mouth 3.
Can be pierced.

【００２３】上記実施例ではキャップ１の筒部１Ａと刺
通部１Ｂとを一体形成したが別体で形成しても良い。ま
た上記実施例ではキャップ１を樹脂製のアンプル容器に
接続したが、固形薬剤を収容したガラス製のバイアルの
ゴム栓口に取り付けたものでも良い。上記刺通部１Ｂの
外形断面形状Ａと上記容器口部の開口断面形状とを回転
対称同形としたが、形が異なる異形形成をして、刺通部
と容器口部とを相対的に回動したときに刺通部１Ｂが容
器口部に挿入可能となるものであれば良い。In the above embodiment, the cylindrical portion 1A and the piercing portion 1B of the cap 1 are formed integrally, but they may be formed separately. In the above embodiment, the cap 1 is connected to a resin ampoule container. However, the cap 1 may be attached to a rubber stopper of a glass vial containing a solid drug. Although the outer cross-sectional shape A of the piercing portion 1B and the opening cross-sectional shape of the container mouth portion are rotationally symmetrical and identical, different shapes are formed so that the piercing portion and the container mouth portion are relatively rotated. What is necessary is just to be able to insert the piercing portion 1B into the container mouth when moved.

【００２４】[0024]

【発明の効果】以上説明したように本発明に係る薬剤容
器のキャップによれば、上記キャップは樹脂製で伸縮自
在な筒部と管状で上記薬剤容器の口部に刺通する刺通部
とからなり、上記刺通部は上記容器口部に刺通して該薬
剤容器内に連通可能な刺通端と注射器の口部が嵌合され
る嵌合端とを有し、上記刺通部は上記嵌合端で上記筒部
の一の開口端に気密に接続される一方、該一の開口端か
ら上記筒部内に軸方向に移動可能に挿入されており、上
記筒部の他の開口端は上記容器口部で気密に接続され、
上記刺通部の嵌合端の開口には該開口を密封する蓋材が
設けられているので、薬剤の取り出し操作及び投与操作
が簡単で、出来る限りの無菌的操作による薬剤の注射器
内への取り込みができる。As described above, according to the cap for a medicine container according to the present invention, the cap is made of a resin-made elastic tubular part and a tubular piercing part which penetrates the mouth of the medicine container. Wherein the piercing portion has a piercing end which can pierce the container mouth and communicate with the medicine container, and a fitting end into which the mouth of the syringe is fitted. The fitting end is airtightly connected to one opening end of the cylindrical portion, and is inserted movably in the axial direction from the one opening end into the cylindrical portion, and the other opening end of the cylindrical portion is Airtightly connected at the container mouth,
Since the lid at the fitting end of the piercing portion is provided with a lid material for sealing the opening, the operation of taking out and administering the drug is easy, and the drug is injected into the syringe by aseptic operation as much as possible. Can be imported.

【図面の簡単な説明】[Brief description of the drawings]

【図１】図１は第一実施例に係る薬剤容器のキャップの
断面図である。FIG. 1 is a sectional view of a cap of a medicine container according to a first embodiment.

【図２】図２（Ａ）及び（Ｂ）は第一実施例に係る薬剤
容器のキャップの一体成形された筒部と刺通部の断面図
である。FIGS. 2A and 2B are cross-sectional views of an integrally formed cylindrical portion and a piercing portion of a cap of a medicine container according to a first embodiment.

【図３】図３は第一実施例に係る薬剤容器のキャップが
取り付けられる薬剤容器の口部の開口断面図である。FIG. 3 is an opening cross-sectional view of a mouth portion of the medicine container to which the cap of the medicine container according to the first embodiment is attached.

【図４】図４は第一実施例に係る薬剤容器のキャップに
注射器の口部を取り付けた要部断面図である。FIG. 4 is a cross-sectional view of a main part in which the mouth of the syringe is attached to the cap of the medicine container according to the first embodiment.

【図５】図５は第一実施例に係る薬剤容器のキャップの
刺通部を容器口部に刺通した時の要部断面図である。FIG. 5 is a cross-sectional view of main parts when the piercing portion of the cap of the medicine container according to the first embodiment is pierced into the mouth of the container.

【符号の説明】[Explanation of symbols]

１ 薬剤容器のキャップ １Ａ 筒部 １Ｂ 刺通部 ２ 薬剤 ３ 容器口部 ４ 薬剤容器 ５ 刺通端 ６ 嵌合端 ７ 一の開口端 ８ 他の開口端 ９ 蓋用シート材 １０ 係合部 DESCRIPTION OF SYMBOLS 1 Cap of medicine container 1A cylindrical part 1B penetration part 2 medicine 3 container mouth part 4 medicine container 5 penetration end 6 fitting end 7 one opening end 8 other opening end 9 lid sheet material 10 engaging part

Claims (5)

【特許請求の範囲】[Claims] 【請求項１】 薬剤が密封収容され、且つ密封された該
薬剤を取り出すための排出用の口部が形成されてなる薬
剤容器の該口部に取り付けられるキャップにおいて、 上記キャップは樹脂製で伸縮自在な筒部と管状で上記薬
剤容器の口部に刺通する刺通部とからなり、上記刺通部
は上記容器口部に刺通して該薬剤容器内に連通可能な刺
通端と注射器の口部が嵌合される嵌合端とを有し、 上記刺通部は上記嵌合端で上記筒部の一の開口端に気密
に接続される一方、該一の開口端から上記筒部内に軸方
向に移動可能に挿入されており、 上記筒部の他の開口端は上記容器口部と気密に接続さ
れ、 上記刺通部の嵌合端の開口には該開口を密封する蓋材が
設けられていることを特徴とする薬剤容器のキャップ。1. A cap attached to a mouth of a medicine container in which a medicine is hermetically accommodated and a discharge port for taking out the sealed medicine is formed, wherein the cap is made of resin and expands and contracts. It comprises a flexible tubular portion and a tubular piercing portion penetrating the mouth of the drug container, wherein the piercing portion pierces the container mouth and communicates with the drug container and a piercing end of the syringe. A piercing portion having a fitting end with which the piercing portion is fitted; and the piercing portion is air-tightly connected to one opening end of the cylindrical portion at the fitting end, and from the one opening end to the inside of the cylindrical portion. The other opening end of the cylindrical portion is air-tightly connected to the container mouth portion, and the opening at the fitting end of the piercing portion seals the opening. The cap of the medicine container characterized by being provided with. 【請求項２】 上記刺通部の外形断面形状は上記容器口
部の開口断面形状と回転対称同形或いは異形に形成さ
れ、上記刺通部は該刺通部の軸を中心に一部回動させた
位置で上記刺通部が上記容器口部内へ移動可能となるこ
とを特徴とする請求項１記載のキャップ。2. The outer cross-sectional shape of the piercing portion is formed to be rotationally symmetrical or different from the cross-sectional shape of the opening of the container mouth, and the piercing portion is partially rotated about the axis of the piercing portion. 2. The cap according to claim 1, wherein the piercing portion is movable into the container mouth at the position where the cap is made. 【請求項３】 上記刺通部が上記容器口部に挿入された
時に、該刺通部を上記容器口部から脱抜不能にする係合
部が上記刺通部と上記容器口部とに形成されていること
を特徴とする請求項１又は２記載のキャップ。3. When the piercing portion is inserted into the container mouth portion, an engaging portion for preventing the piercing portion from being detachable from the container mouth portion is provided between the piercing portion and the container mouth portion. The cap according to claim 1, wherein the cap is formed. 【請求項４】 上記筒部と刺通部とは一体形成され、上
記筒部の一の開口端で上記筒部が裏返されて上記刺通部
を覆っていることを特徴とする請求項３記載のキャッ
プ。4. The piercing portion is formed integrally with the tubular portion, and the tubular portion is turned over at one opening end of the tubular portion to cover the piercing portion. The cap described. 【請求項５】 上記蓋材が水蒸気ガス透過性であること
を特徴とする請求項３又は４記載のキャップ。5. The cap according to claim 3, wherein the lid is permeable to water vapor gas.