JPH05201456A - Rubber plug for medicine container - Google Patents
Rubber plug for medicine containerInfo
- Publication number
- JPH05201456A JPH05201456A JP4027142A JP2714292A JPH05201456A JP H05201456 A JPH05201456 A JP H05201456A JP 4027142 A JP4027142 A JP 4027142A JP 2714292 A JP2714292 A JP 2714292A JP H05201456 A JPH05201456 A JP H05201456A
- Authority
- JP
- Japan
- Prior art keywords
- rubber
- container
- rubber stopper
- rubber plug
- thermoplastic elastomer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は医薬品容器用ゴム栓に関
し、更に詳しくはゴム栓本体の脚部があるいはゴム栓本
体の脚部及び天面部が合成樹脂フイルムによりラミネー
トされ、また鍔部下面が熱可塑性エラストマーにより覆
われてなる医薬品容器用ゴム栓に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a rubber stopper for a pharmaceutical container, and more specifically, a leg portion of the rubber stopper body or a leg portion and a top portion of the rubber stopper body are laminated with a synthetic resin film, and a lower surface of the collar portion is The present invention relates to a rubber stopper for drug containers, which is covered with a thermoplastic elastomer.
【０００２】[0002]
【従来の技術】従来、特公昭５４−９１１９号公報や特
開昭５７−４７６３７号公報にみられるように、医薬品
容器用ゴム栓としてゴム中の加硫剤等の添加物、不純物
などが薬液中に浸出するのを防止するために、薬液に接
するゴム栓面を耐薬品性を有するプラスチツクシートで
ラミネートした医薬品容器用ゴム栓が知られている。2. Description of the Related Art Conventionally, as seen in JP-B-54-9119 and JP-A-57-47637, additives such as a vulcanizing agent and impurities in a rubber are used as a rubber stopper for a drug container in a chemical liquid. In order to prevent leaching into the inside, there is known a rubber stopper for drug containers in which a rubber stopper surface in contact with a drug solution is laminated with a plastic sheet having chemical resistance.
【０００３】また、特開昭６３−２９６７５６号公報に
みられるように、製剤工程でのゴム栓の搬送性を向上さ
せるために、ゴム栓本体の天面部を滑性のよいプラスチ
ツクシートでラミネートしたゴム栓も知られている。As disclosed in JP-A-63-296756, the top surface of the rubber stopper body is laminated with a plastic sheet having good lubricity in order to improve the transportability of the rubber stopper during the formulation process. Rubber stoppers are also known.
【０００４】[0004]
【発明が解決しようとする課題】従来提案されている医
薬品容器用ラミネートゴム栓は、容器口内面及び薬液に
接する部分は耐薬品性を有する合成樹脂フイルムでラミ
ネートされているが、容器口上面を接する面の大部分は
ゴムであり、医薬品容器口部の平面性が悪かったり、輸
送中の取扱いが悪かったりする場合には容器内の薬液成
分の一部がゴムと接触する可能性があり、ゴム中の加硫
剤等の添加剤や不純物が薬液中に浸出し、医薬品を汚染
する危険性があった。In the conventionally proposed laminated rubber stopper for drug containers, the inner surface of the container opening and the portion in contact with the chemical solution are laminated with a synthetic resin film having chemical resistance. Most of the contact surface is rubber, and if the flatness of the mouth of the drug container is poor, or if handling during transportation is poor, a part of the drug solution component in the container may contact the rubber, There is a risk that additives such as vulcanizing agents and impurities in the rubber will leach into the chemical liquid and contaminate the drug.
【０００５】またゴム栓の下面全面を合成樹脂フイルム
でラミネートされたゴム栓も提案されているが、この場
合には容器口上面とゴム栓の間の気密性が悪く、容器内
の医薬品が漏れたり、空気中の細菌等による汚染が起こ
る危険性があった。A rubber stopper in which the entire lower surface of the rubber stopper is laminated with a synthetic resin film has also been proposed, but in this case, the airtightness between the upper surface of the container mouth and the rubber stopper is poor and the drug in the container leaks. There was a risk of contamination by bacteria in the air.
【０００６】[0006]
【課題を解決するための手段】本発明者等はこれらの課
題を解決するために鋭意検討した結果、本発明に到達し
た。The inventors of the present invention have arrived at the present invention as a result of extensive studies to solve these problems.
【０００７】本発明はゴム栓本体の容器口内面及び薬剤
に接する箇所が、又はゴム栓本体の容器口内面、薬剤に
接する箇所及びゴム栓天面部が、耐薬品性をもつ合成樹
脂フイルムでラミネートされており、且つ該栓体の容器
口上面と接する部分の一部又は全部が熱可塑性エラスト
マーのシートで覆われてなることを特徴とする医薬品容
器用ゴム栓を要旨とする。According to the present invention, the inner surface of the rubber stopper main body and the portion in contact with the medicine or the inner surface of the rubber stopper main body, the portion in contact with the medicine and the top surface of the rubber stopper are laminated with a synthetic resin film having chemical resistance. A rubber stopper for a pharmaceutical container is characterized in that a part or all of a portion of the stopper that contacts the upper surface of the container mouth is covered with a sheet of a thermoplastic elastomer.
【０００８】本発明のゴム栓に使用するゴム材料として
は、ブチルゴム・ハロゲン化ブチルゴム・ポリブタジエ
ンゴム・ポリイソプレンゴム・エチレンプロピレンゴム
等の合成ゴム又は天然ゴムが使用され、且つ適宜、加硫
剤・加硫促進剤・充填剤等の配合物が添加された配合ゴ
ムであり、医薬品容器用ゴム栓に使用される一般的配合
のゴムが望ましい。As the rubber material used in the rubber stopper of the present invention, synthetic rubber or natural rubber such as butyl rubber, halogenated butyl rubber, polybutadiene rubber, polyisoprene rubber, ethylene propylene rubber, etc. is used, and a vulcanizing agent A compounded rubber to which a compound such as a vulcanization accelerator and a filler is added, and a commonly compounded rubber used for a rubber stopper for a pharmaceutical container is desirable.
【０００９】本発明のゴム栓の脚部のラミネートに使用
する合成樹脂フイルムは、医薬又は医療用薬品に耐える
フイルムであり、その素材が弗素樹脂・ナイロン・ポリ
エチレン・ポリプロピレン等であり、容器に充填される
薬品の種類により適宜選択される。これらのフイルムは
加硫操作でゴム及び熱可塑性エラストマーと接着するこ
とが必要であり、ゴム及び熱可塑性エラストマーとの接
着性を改善するためにフイルムの表面を化学処理・コロ
ナ放電処理・スパツタエツチング処理を必要に応じ行っ
てもよい。The synthetic resin film used for laminating the leg portion of the rubber stopper of the present invention is a film that can withstand pharmaceuticals or medical chemicals, and its material is fluororesin, nylon, polyethylene, polypropylene, etc., and is filled in a container. It is appropriately selected according to the type of chemicals used. It is necessary to bond these films with rubber and thermoplastic elastomer by vulcanization operation, and in order to improve the adhesion with rubber and thermoplastic elastomer, the surface of the film is chemically treated, corona discharge treated and sputtered. The treatment may be performed as needed.
【００１０】本発明の鍔部下面のラミネートに使用する
熱可塑性エラストマーは、耐薬品性・ゴム弾性を有し、
ＪＩＳ−Ａ硬度８０°以下の、厚さ１．５ｍｍ以下のシ
ートである。その素材としてはオレフイン系熱可塑性エ
ラストマー・スチレン系熱可塑性エラストマー・ウレタ
ン系熱可塑性エラストマー等が使用される。いずれの素
材を採用するかは脚部にラミネートされるフイルム材質
との組合せ又は容器に充填される薬品の種類等により適
宜選択される。The thermoplastic elastomer used for laminating the lower surface of the collar of the present invention has chemical resistance and rubber elasticity,
A sheet having a JIS-A hardness of 80 ° or less and a thickness of 1.5 mm or less. As the material, olefin-based thermoplastic elastomer, styrene-based thermoplastic elastomer, urethane-based thermoplastic elastomer and the like are used. Which material is used is appropriately selected depending on the combination with the film material to be laminated on the leg portion, the kind of the chemical filled in the container, and the like.
【００１１】[0011]
【作用】本発明はゴム栓本体の容器口上面と接する部分
の一部又は全部が熱可塑性エラストマーのシートで覆わ
れているため、（１）容器内の薬液成分の一部がゴムと
接触する可能性がなく、その結果ゴム中の加硫剤等の添
加剤や不純物が薬液中に浸出する心配がなく、（２）容
器口上面とゴム栓の間の気密性に優れ、容器内の医薬品
が漏れることがなく、空気中の細菌等による汚染が起こ
らない。In the present invention, since a part or all of the portion of the rubber stopper main body which is in contact with the upper surface of the container mouth is covered with the thermoplastic elastomer sheet, (1) a part of the chemical liquid component in the container comes into contact with the rubber. There is no possibility that as a result, additives such as vulcanizing agent and impurities in the rubber will not be leached into the chemical liquid. (2) Excellent airtightness between the top of the container mouth and the rubber stopper Does not leak, and contamination by bacteria in the air does not occur.
【００１２】[0012]
【実施例】本発明の実施例を図面に基づいて具体的に説
明する。Embodiments of the present invention will be specifically described with reference to the drawings.
【００１３】図１及び図２は本発明の実施例を説明する
工程図であり、図３は本発明の実施例を示すゴム栓の断
面図である。1 and 2 are process drawings for explaining an embodiment of the present invention, and FIG. 3 is a sectional view of a rubber plug showing the embodiment of the present invention.
【００１４】図１（ａ）に示すように、脚部長さ４．５
ｍｍ、脚径１２．７ｍｍ、天面部外径１９．０ｍｍのゴ
ム栓の寸法に合わせた上下金型Ａ、Ｂに平均分子量４５
０万、厚さ５０μの合成樹脂フイルム（本実施例ではポ
リエチレンフイルム）１と厚さ２．５ｍｍの未加硫ゴム
シート２（本実施例では日本合成ゴム社製ブチル３６５
を１００重量部、焼成クレーを６０重量部、活性亜鉛華
を３重量部、ジペンタメチレンチウラムテトラサルフア
イドを２重量部、酸化マグネシウムを５重量部をニーダ
ー及び２本のロールを使用して混練したもの）を重ね合
わせ、第１次成形として圧力５０ｋｇ／ｃｍ2 、温度１
６０℃、時間１０分で加熱加圧し、図１（ｂ）に示すよ
うに、バリ部分のついた第１次成形品３を得た。As shown in FIG. 1A, the leg length is 4.5.
mm, leg diameter 12.7 mm, top surface outer diameter 19.0 mm, and an average molecular weight of 45 for upper and lower molds A and B according to the dimensions of the rubber stopper.
Synthetic resin film (polyethylene film in this example) 1 having a thickness of 50,000 and unvulcanized rubber sheet 2 having a thickness of 2.5 mm (butyl 365 manufactured by Japan Synthetic Rubber Co., Ltd. in this example)
100 parts by weight, 60 parts by weight of calcined clay, 3 parts by weight of active zinc white, 2 parts by weight of dipentamethylene thiuram tetrasulfaide, and 5 parts by weight of magnesium oxide are kneaded using a kneader and two rolls. The first molding, pressure 50 kg / cm 2 , temperature 1
By heating and pressurizing at 60 ° C. for 10 minutes, a primary molded product 3 having a burr portion was obtained as shown in FIG.
【００１５】この第１次成形の際、未加硫ゴムシートの
みを使い若干の加硫（第一段の加硫）を行った後、金型
を開きポリエチレンフイルムを挟み再度加熱加圧して加
硫（第二段の加硫）を続行し第１次成形品を製造する方
法を用いてもよい。この場合第一段と第二段の全加硫時
間が本実施例の場合と同じとすればよい。At the time of this primary molding, after only a slight vulcanization (first-stage vulcanization) using only the unvulcanized rubber sheet, the mold is opened and the polyethylene film is sandwiched and heated and pressed again to apply. A method of continuing the vulcanization (second-stage vulcanization) to produce the primary molded article may be used. In this case, the total vulcanization time of the first stage and the second stage may be the same as that in this example.
【００１６】次に図２（ａ）に示すように、第１次成形
品の脚部にあらかじめ作製したゴム栓脚部と同じ径１
２．７ｍｍの孔を有し、厚さ０．８ｍｍの熱可塑性エラ
ストマーシート４（本実施例では住友化学工業製オレフ
イン系熱可塑性エラストマーでＪＩＳ−Ａ硬度６０°）
で覆わせた。Next, as shown in FIG. 2 (a), the diameter of the leg portion of the primary molded product is the same as that of the rubber plug leg portion previously prepared.
A thermoplastic elastomer sheet 4 having a hole of 2.7 mm and a thickness of 0.8 mm (in this embodiment, an olefin thermoplastic elastomer manufactured by Sumitomo Chemical Co., Ltd. JIS-A hardness 60 °).
Covered with.
【００１７】これを図１（ａ）のゴム栓脚部第１次成形
金型Ｂのみを最終製品形状に適合したゴム栓脚部第２次
成形金型Ｃに置き換えて、引続き、圧力５０ｋｇ／ｃｍ
2 、温度１６０℃、時間１分で加圧加熱し、図２（ｂ）
のように第２次成形品５を得た。ここで使用する熱可塑
性エラストマーは、ＪＩＳ−Ａ硬度で８０°を超えると
ゴム栓と容器口上面の間における気密性が悪くなり好ま
しくないし、また厚さ１．５ｍｍを超えると成形加工性
が悪くなり好ましくない。1A, only the rubber plug leg primary molding die B in FIG. 1A is replaced with a rubber plug leg secondary molding die C adapted to the shape of the final product, and the pressure is 50 kg / cm
2 、 Pressure and heating at 160 ℃ for 1 min.
The secondary molded product 5 was obtained as described above. If the thermoplastic elastomer used here exceeds 80 ° in JIS-A hardness, the airtightness between the rubber plug and the upper surface of the container mouth is deteriorated, which is not preferable, and if the thickness exceeds 1.5 mm, molding processability is deteriorated. It is not preferable.
【００１８】最後に第２次成形品５を金型Ａ及びＣより
取り出して、打抜き操作により周辺部のバリを除去して
図３（ａ）に示すような製品を得た。Finally, the secondary molded product 5 was taken out from the molds A and C, and the peripheral burrs were removed by a punching operation to obtain a product as shown in FIG. 3 (a).
【００１９】本発明では金型の形状を適宜変更して、図
３（ｂ）や図３（ｃ）に示すような形状の医薬品容器用
ゴム栓を製造してもよい。In the present invention, the shape of the mold may be appropriately changed to manufacture a rubber stopper for a drug container having a shape as shown in FIGS. 3 (b) and 3 (c).
【００２０】実施例で得られた図３（ａ）の形状のゴム
栓を医薬品容器に取り付け容器内を０．８ｋｇ／ｃｍ2
に加圧した場合の気密性試験を行った結果、５０個の試
料中漏れ（リークしたもの）はなかった。The rubber stopper having the shape shown in FIG. 3 (a) obtained in the example was attached to a drug container and the inside of the container was 0.8 kg / cm 2.
As a result of performing an airtightness test in the case of pressurizing to 50, there was no leakage (leakage) in 50 samples.
【００２１】また、上記容器内を０．５Ｔｏｒｒに減圧
した場合の気密性試験の結果も、５０個の試料中リーク
したものはなかった。The results of the airtightness test when the pressure inside the container was reduced to 0.5 Torr showed that none of the 50 samples leaked.
【００２２】比較例として、実施例の第１次成形品３を
打ち抜いたゴム栓について、実施例１と同様に加圧した
場合の気密性試験及び減圧した場合の気密性試験を行っ
た。As a comparative example, a rubber plug obtained by punching out the primary molded product 3 of the example was subjected to an airtightness test when pressurized and an airtightness test when depressurized as in the case of Example 1.
【００２３】比較例の加圧した場合の気密性試験は５０
個の試料中３２個がリークし、比較例の減圧した場合の
気密性試験は５０個の試料中４８個がリークした。The airtightness test under pressure of the comparative example is 50.
32 out of 50 samples leaked, and 48 out of 50 samples leaked in the airtightness test when the pressure was reduced in the comparative example.
【００２４】[0024]
【発明の効果】本発明の医薬品容器用ゴム栓は、ゴム栓
本体の容器口内面及び薬剤に接する箇所が、耐薬品性を
もつ合成樹脂フイルムでラミネートされており、且つ容
器口上面と接する部分が熱可塑性エラストマーで覆われ
ているため、薬液への汚染性が少なく容器との気密性に
優れている。In the rubber stopper for a pharmaceutical container of the present invention, the inner surface of the rubber stopper main body and the portion in contact with the drug are laminated with a synthetic resin film having chemical resistance and contact with the upper surface of the container mouth. Since it is covered with a thermoplastic elastomer, it is less contaminated by the chemical liquid and has excellent airtightness with the container.
【図１】本発明の実施例を説明する工程図である。FIG. 1 is a process diagram illustrating an example of the present invention.
【図２】本発明の実施例を説明する工程図である。FIG. 2 is a process chart illustrating an example of the present invention.
【図３】本発明の実施例を示すゴム栓の断面図である。FIG. 3 is a sectional view of a rubber plug showing an embodiment of the present invention.
１ 合成樹脂フイルム ２ 未加硫ゴムシート ３ 第１次成形品 ４ 熱可塑性エラストマー ５ 第２次成形品 Ａ ゴム栓天面部金型 Ｂ ゴム栓脚部第１次成形金型 Ｃ ゴム栓脚部第２次成形金型 1 Synthetic Resin Film 2 Unvulcanized Rubber Sheet 3 Primary Molded Product 4 Thermoplastic Elastomer 5 Secondary Molded Product A Rubber Plug Top Surface Mold B Rubber Plug Leg Primary Mold C C Rubber Plug Leg No. Secondary mold
Claims (2)
する箇所が、耐薬品性をもつ合成樹脂フイルムでラミネ
ートされており、且つ該栓体の容器口上面と接する部分
の一部又は全部が熱可塑性エラストマーのシートで覆わ
れてなる医薬品容器用ゴム栓。1. A part of or the whole of a portion of the rubber stopper main body which is in contact with the inner surface of the container and the medicine is laminated with a synthetic resin film having chemical resistance and which is in contact with the upper surface of the container mouth of the stopper. A rubber stopper for a pharmaceutical container, in which a sheet of thermoplastic elastomer is covered.
る箇所及びゴム栓天面部が、耐薬品性をもつ合成樹脂フ
イルムでラミネートされており、且つ該栓体の容器口上
面と接する部分の一部又は全部が熱可塑性エラストマー
のシートで覆われてなる医薬品容器用ゴム栓。2. A portion of the rubber stopper main body in which the inner surface of the container, the portion contacting the medicine and the top surface of the rubber stopper are laminated with a synthetic resin film having chemical resistance, and which is in contact with the upper surface of the container opening of the stopper. A rubber stopper for a pharmaceutical container in which a part or all of the above is covered with a sheet of thermoplastic elastomer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP4027142A JPH05201456A (en) | 1992-01-17 | 1992-01-17 | Rubber plug for medicine container |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP4027142A JPH05201456A (en) | 1992-01-17 | 1992-01-17 | Rubber plug for medicine container |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH05201456A true JPH05201456A (en) | 1993-08-10 |
Family
ID=12212805
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP4027142A Pending JPH05201456A (en) | 1992-01-17 | 1992-01-17 | Rubber plug for medicine container |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH05201456A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100398407C (en) * | 2005-10-19 | 2008-07-02 | 刘永红 | Compound film rubber cork and its preparation method |
| CN107697451A (en) * | 2017-09-13 | 2018-02-16 | 盛州医药包装材料科技（中国）有限公司 | A kind of combined type combines rubbery plug lid |
-
1992
- 1992-01-17 JP JP4027142A patent/JPH05201456A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100398407C (en) * | 2005-10-19 | 2008-07-02 | 刘永红 | Compound film rubber cork and its preparation method |
| CN107697451A (en) * | 2017-09-13 | 2018-02-16 | 盛州医药包装材料科技（中国）有限公司 | A kind of combined type combines rubbery plug lid |
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