JP5351480B2 - Water filled prefilled syringe for injection - Google Patents
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Description
本発明は、注射用水が充填されているプラスチック製の外筒を備えたプレフィルドシリンジに関するものである。更に詳しくは、注射用水がシクロオレフィンポリマーで形成されている外筒と、エラストマー製のガスケットからなるシリンジに充填され、シリンジ先端をキャップで密封されている日本薬局方注射用水充填プレフィルドシリンジに関する。 The present invention relates to a prefilled syringe provided with a plastic outer cylinder filled with water for injection. More specifically, the present invention relates to a prefilled syringe filled with water for injection in Japanese Pharmacopoeia in which water for injection is filled in a syringe composed of an outer cylinder formed of a cycloolefin polymer and an elastomer gasket, and the syringe tip is sealed with a cap.
注射用水は、注射剤の溶解・希釈用液として広く用いられている。予め薬剤とセットで添付されている添付溶解液は、小容量（２０ｍＬ未満）のものが多く、主にガラスアンプルに封入されて提供されている。
従来から、ガラスアンプル製剤は、アンプルカット時に発生する微細な破片の混入や細菌汚染の可能性、輸送・保管時の破損、使用後の廃棄の問題等が指摘されてきた。さらに移し変えの際の繁雑さや投薬過誤の可能性も医療現場では問題となっている。
したがって、これらの問題を全て解決できる機能を持った容器に充填された注射用水の開発が望まれていた。
Water for injection is widely used as a solution for dissolving and diluting injections. Many of the attached dissolution solutions that are attached in advance as a set with a drug have a small volume (less than 20 mL), and are mainly provided in a glass ampule.
Conventionally, it has been pointed out that glass ampoule preparations may contain fine debris generated during ampoule cutting, contamination with bacteria, damage during transportation and storage, and disposal problems after use. Furthermore, the complexity of transfer and the possibility of medication errors are also a problem in the medical field.
Therefore, the development of water for injection filled in a container having a function capable of solving all of these problems has been desired.
そこで、上記の問題点を解決するため小容量の注射用水について、プラスチック製のシリンジを用いてプレフィルドシリンジ化を試みた。注射用水を外筒がプラスチックからなるプレフィルドシリンジに充填し滅菌すると、日本薬局方注射用水の純度試験（５）亜硝酸性窒素の規格に不適合となることが判明した。
注射用水のプレフィルドシリンジ化にあたっては、充填される注射用水が日本薬局方注射用水の全ての規格に適合しているだけでなく、当該注射用水をプラスチック容器中に収納し、高圧蒸気滅菌により最終滅菌した場合、さらには長期の保管期間中においても、日本薬局方注射用水の全ての規格に適合する必要がある。
したがって、本発明は、従来の注射用水が抱えていた問題点を解決するとともに、日本薬局方注射用水が充填されているプラスチック製外筒からなるプレフィルドシリンジを提供することを目的とする。
Therefore, in order to solve the above problems, a small volume of water for injection was tried to be a prefilled syringe using a plastic syringe. It has been found that when water for injection is filled in a prefilled syringe whose outer cylinder is made of plastic and sterilized, the purity test for water for injection in Japanese Pharmacopoeia (5) is incompatible with the standard of nitrite nitrogen.
In making prefilled syringes for water for injection, not only is the water for injection filled compatible with all Japanese Pharmacopoeia water for injection, but the water for injection is stored in a plastic container and is sterilized by high-pressure steam sterilization. In this case, it is necessary to comply with all Japanese Pharmacopoeia water specifications even during a long storage period.
Accordingly, an object of the present invention is to provide a prefilled syringe comprising a plastic outer cylinder filled with Japanese Pharmacopoeia water for injection while solving the problems of conventional water for injection.
上記課題は以下の手段により解決される。
（１） プラスチック製の外筒と、前記外筒内を液密に摺動可能に設けられたガスケットと、前記外筒の先端開口を封止するキャップと、前記外筒と前記ガスケットとキャップで形成された空間内に充填された注射用水とからなるプレフィルドシリンジであって、前記外筒を構成する樹脂の材質は、シクロオレフィンポリマーであり、かつ、ノルボルネン、ノルボルネン誘導体を開環メタセシス重合して得られるシクロオレフィン系ポリマー類あるいはその水素添加物、又はこれらのシクロオレフィン系ポリマー類の混合物であり、ガラス転移温度が１００〜１５０℃の樹脂であり、前記ガスケットは、スチレン系エラストマーからなり、前記注射用水が、日本薬局方注射用水であり、前記外筒と前記ガスケットと前記キャップで形成された空間内に前記注射用水が充填された状態にて高圧蒸気滅菌されており、かつ第十五改正日本薬局方注射用水の純度試験（５）亜硝酸性窒素の規格に従い、滅菌後の注射用水１０ｍＬをネスラー管にとり、これにスルファニルアミドの希塩酸溶液（１→１００）１ｍＬ及びＮ，Ｎ−ジエチル−Ｎ'−１−ナフチルエチレンジアミンシュウ酸塩試液１ｍＬを加えたとき、注射用水は、微赤色を呈しないものであることを特徴とする日本薬局方注射用水が充填されてなるプレフィルドシリンジ。
（２） 前記注射用水の充填量が約０．５〜約２０ｍＬである（１）に記載の日本薬局方注射用水が充填されてなるプレフィルドシリンジ。
（３） 前記キャップの接液部分は、スチレン系エラストマーからなる（１）または（２）に記載のプレフィルドシリンジ。
The above problem is solved by the following means.
(1) and a plastic outer cylinder, said outer cylinder gasket slidably mounted liquid-tight, and a cap for sealing the end opening of said barrel, with the gasket and the cap and the outer cylinder A prefilled syringe comprising water for injection filled in the formed space, wherein the resin material constituting the outer cylinder is a cycloolefin polymer, and norbornene and norbornene derivatives are subjected to ring-opening metathesis polymerization. It is a cycloolefin polymer obtained or a hydrogenated product thereof, or a mixture of these cycloolefin polymers, a resin having a glass transition temperature of 100 to 150 ° C., and the gasket is made of a styrene elastomer, Water for injection is Japanese Pharmacopoeia water for injection, and is an empty space formed by the outer cylinder, the gasket, and the cap. Sterilized by high-pressure steam with the above-mentioned water for injection filled in between, and purity test of water for injection of the 15th revision Japanese Pharmacopoeia (5) 10 mL of water for injection after sterilization according to the standard of nitrite nitrogen Was added to a Nessler tube, and 1 mL of dilute hydrochloric acid solution (1 → 100) of sulfanilamide and 1 mL of N, N-diethyl-N′-1-naphthylethylenediamine oxalate test solution were added thereto. A prefilled syringe filled with Japanese Pharmacopoeia water for injection, which is not to be used.
( 2 ) A prefilled syringe filled with water for injection according to the Japanese Pharmacopoeia according to (1), wherein a filling amount of the water for injection is about 0.5 to about 20 mL.
(3) The prefilled syringe according to (1) or (2), wherein the liquid contact portion of the cap is made of a styrene elastomer.
本発明によれば、プラスチック製の外筒を備えたシリンジに注射用水が充填され、滅菌処理がされていて、使用に際して異物や細菌等による汚染の問題がなく、輸送・保管性にも優れ、使用後の廃棄も容易な日本薬局方注射用水充填プレフィルドシリンジを提供することができる。
更に、薬剤の溶解・希釈時の移し変えの繁雑さや投薬過誤の危険性のない日本薬局方注射用水充填プレフィルドシリンジを提供することができる。
According to the present invention, a syringe equipped with a plastic outer cylinder is filled with water for injection and sterilized, and there is no problem of contamination due to foreign matter or bacteria during use, and it is excellent in transportation and storage, A water-filled prefilled syringe for Japanese Pharmacopoeia that can be easily discarded after use can be provided.
Furthermore, it is possible to provide a water-filled prefilled syringe for Japanese Pharmacopoeia that does not involve the complexity of transfer during drug dissolution / dilution and the risk of medication errors.
本発明者らは、注射用水のプレフィルドシリンジ容器として種々の素材からなる外筒及びガスケットを作製し、鋭意検討を行い本発明を完成した。
本発明は、プラスチック製の外筒と、その外筒内を液密に移動可能に設置された弾性材料で形成されたガスケットと、その外筒の先端部分の開口を液密に封止するキャップと、それら外筒とガスケットとキャップで形成される密閉空間内に充填されている注射用水とからなるプラスチック製のプレフィルドシリンジで、前記プラスチック製の外筒をシクロオレフィン系ポリマーで形成し、ガスケットをエラストマーで形成したシリンジに日本薬局方注射用水が充填されているプレフィルドシリンジである。
The inventors of the present invention produced outer cylinders and gaskets made of various materials as prefilled syringe containers for water for injection, and intensively studied to complete the present invention.
The present invention relates to a plastic outer cylinder, a gasket formed of an elastic material installed so as to be movable in a liquid-tight manner in the outer cylinder, and a cap for liquid-tightly sealing the opening at the tip of the outer cylinder. And a plastic prefilled syringe made of water for injection filled in a sealed space formed by the outer cylinder, the gasket, and the cap, the plastic outer cylinder is formed of a cycloolefin polymer, and the gasket is This is a prefilled syringe in which a syringe made of elastomer is filled with water for injection into the Japanese Pharmacopoeia.
本発明のプレフィルドシリンジに充填されている注射用水は、第十五改正日本薬局方「注射用水」に定義されている「本品は、『常水』又は『精製水』の蒸留、または『精製水』の超ろ過（逆浸透膜、限外ろ過又はこれらの膜を組み合わせた製造システム）により製して注射剤の調製に用いるもの、又はこれを容器に入れて滅菌したものである。」、「本品を容器に入れて滅菌したものは、主として用時溶解又は懸濁して用いる注射剤の溶解剤に用いる。」及び純度試験に規定されている（１）酸又はアルカリ、（２）塩化物、（３）硫酸塩、（４）硝酸性窒素、（５）亜硝酸性窒素、（６）アンモニウム、（７）重金属、（８）過マンガン酸カリウム還元性物質、（９）蒸発残留物、の全ての項目に適合するものである。 The water for injection filled in the prefilled syringe of the present invention is defined by the 15th revision Japanese Pharmacopoeia “Water for Injection”. “This product is distilled of“ normal water ”or“ purified water ”or“ purified ” It is manufactured by ultrafiltration (reverse osmosis membrane, ultrafiltration or a combination system of these membranes) of “water” and used for preparing an injection, or sterilized by placing it in a container. ” "The product sterilized in a container is mainly used as an injectable solubilizer that is dissolved or suspended at the time of use." And (1) Acid or alkali specified in the purity test, (2) Chlorination (3) Sulfate, (4) Nitrate nitrogen, (5) Nitrite nitrogen, (6) Ammonium, (7) Heavy metal, (8) Potassium permanganate reducing substance, (9) Evaporation residue It is suitable for all items.
本発明のプラスチック製の外筒は、シクロオレフィン系ポリマーで形成されているのが好ましい。シクロオレフィン系ポリマーとしては、ノルボルネンやノルボルネン誘導体を開環メタセシス重合したシクロオレフィン系ポリマー類あるいはその水素添加物、又はこれらのシクロオレフィン系ポリマー類の混合物が好適に用いられる。シクロオレフィン系ポリマー類のガラス転移温度は、１００〜１５０℃の樹脂が好ましく、１２０〜１４０℃の樹脂が更に好適である。本発明において用いられるシクロオレフィン系ポリマーとしては、例えばゼオネックス６９０Ｒ等のゼオネックス（登録商標、日本ゼオン(株)製）、Daikyo Resin CZ（登録商標、大協精工(株)製）等が例示される。 The plastic outer cylinder of the present invention is preferably formed of a cycloolefin polymer. As the cycloolefin polymer, a cycloolefin polymer obtained by ring-opening metathesis polymerization of norbornene or a norbornene derivative, a hydrogenated product thereof, or a mixture of these cycloolefin polymers is preferably used. The glass transition temperature of the cycloolefin polymers is preferably a resin having a temperature of 100 to 150 ° C, and more preferably a resin having a temperature of 120 to 140 ° C. Examples of the cycloolefin-based polymer used in the present invention include ZEONEX (registered trademark, manufactured by Nippon Zeon Co., Ltd.) such as ZEONEX 690R, Daikyo Resin CZ (registered trademark, manufactured by Daikyo Seiko Co., Ltd.), and the like. .
本発明のガスケットは、エラストマーを原料として射出成形等の公知の手法で成形されたガスケットが使用される。エラストマーとしては、スチレン系エラストマーやオレフィン系エラストマーを主成分としたエラストマー組成物が好適に用いられる。スチレン系エラストマーとしてはＳＥＢＳ、ＳＢＲ、ＨＳＢＲ、ＳＩＳ等が、オレフィン系エラストマーとしては、エチレン−プロピレン共重合体エラストマーなどのエチレン−αオレフィン共重合体エラストマー等が例示される。
本発明のプレフィルドシリンジにおいて、キャップをはじめとして充填された注射用水の接液部分で外筒およびガスケット以外のものが接する場合、それらのものも上述したシクロオレフィン系ポリマー、あるいはエラストマーを用いることができる。
As the gasket of the present invention, a gasket formed by a known technique such as injection molding using an elastomer as a raw material is used. As the elastomer, an elastomer composition mainly composed of a styrene elastomer or an olefin elastomer is preferably used. Examples of the styrene elastomer include SEBS, SBR, HSBR, SIS, and the like, and examples of the olefin elastomer include ethylene-α olefin copolymer elastomer such as ethylene-propylene copolymer elastomer.
In the prefilled syringe of the present invention, when the parts other than the outer cylinder and the gasket come into contact with the water-injection part filled with water, including the cap, the above-mentioned cycloolefin polymer or elastomer can also be used. .
以下に実施例をあげて本発明を具体的に説明するが、これらにより本発明の範囲が限定されるものではない。
実験１ 表１に記載の各容器部材約６００ｃｍ２（厚み約１ｍｍ）を硬質ガラス製容器に入れ、蒸留水１００ｍLを加え、密栓した後、高圧蒸気滅菌器を用いて１２１℃で２０分間加熱した後、硬質ガラス製容器を取り出して室温になるまで放冷し、この内溶液を試験液とし、第十五改正日本薬局方「注射用水」に従って、純度試験の各項目について試験した。
その結果、いずれの容器部材も純度試験（５）亜硝酸性窒素以外の試験項目には適合していた。また、純度試験（５）亜硝酸性窒素については、表１に示すようにシクロオレフィンポリマーが適合していることが確認された（表１）。
なお、上記［純度試験（５）亜硝酸性窒素］は第十五改正日本薬局方に以下のとおり規定されている。
「本品１０ｍＬをネスラー管にとり、これにスルファニルアミドの希塩酸溶液（１→１００）１ｍＬ及びＮ，Ｎ−ジエチル−Ｎ'−１−ナフチルエチレンジアミンシュウ酸塩試液１ｍＬを加えるとき、液は微赤色を呈しない。」
EXAMPLES The present invention will be specifically described below with reference to examples, but the scope of the present invention is not limited by these examples.
Experiment 1 About 600 cm 2 (thickness: about 1 mm) of each container member described in Table 1 was put into a hard glass container, 100 mL of distilled water was added, and after sealing, heated at 121 ° C. for 20 minutes using a high-pressure steam sterilizer. Thereafter, the hard glass container was taken out and allowed to cool to room temperature. This solution was used as a test solution, and each item of the purity test was tested according to the 15th revision Japanese Pharmacopoeia “Water for Injection”.
As a result, all the container members were suitable for the test items other than the purity test (5) nitrite nitrogen. Moreover, about purity test (5) nitrite nitrogen, as shown in Table 1, it was confirmed that the cycloolefin polymer is suitable (Table 1).
The above [Purity Test (5) Nitrite Nitrogen] is defined as follows in the 15th revision Japanese Pharmacopoeia.
“When 10 mL of this product is placed in a Nessler tube, 1 mL of dilute hydrochloric acid solution of sulfanilamide (1 → 100) and 1 mL of N, N-diethyl-N′-1-naphthylethylenediamine oxalate reagent solution are added to the solution. Not present. "
実験２ 表２に記載の各容器部材約３０ｇを硬質ガラス製容器に入れ、蒸留水１００ｍLを加え、密栓した後、高圧蒸気滅菌器を用いて１２１℃で２０分間加熱した後、硬質ガラス製容器を取り出して室温になるまで放冷し、この内溶液を試験液とし、上記第十五改正日本薬局方「注射用水」に従って、純度試験の各項目について試験した。
その結果、いずれの容器部材も純度試験（５）亜硝酸性窒素以外の試験項目には適合していた。また、純度試験（５）亜硝酸性窒素については、表２に示すようにスチレン系エラストマーが適合していることが確認された。
Experiment 2 About 30 g of each container member shown in Table 2 was put in a hard glass container, 100 ml of distilled water was added, and after sealing, heated at 121 ° C. for 20 minutes using a high-pressure steam sterilizer, then a hard glass container The product was allowed to cool to room temperature, and this solution was used as a test solution, and tested for each item of the purity test in accordance with the 15th revised Japanese Pharmacopoeia “Water for Injection”.
As a result, all the container members were suitable for the test items other than the purity test (5) nitrite nitrogen. As for purity test (5) nitrite nitrogen, as shown in Table 2, it was confirmed that the styrene elastomer was suitable.
実施例１ 注射用水１ｍＬを１ｍL容の注射剤容器（外筒：シクロオレフィンポリマー（日本ゼオン(株):ゼオネックス690R）、ガスケットおよびキャップ：スチレン系エラストマー（三菱化学(株)製））に充填し、高圧蒸気滅菌（１２１℃、２０分）して、プレフィルドシリンジを製した。
比較例１ 注射用水１ｍＬを１mL容の注射剤容器（外筒：シクロオレフィンコポリマー（三井化学（株）:アペル APL6015）、ガスケットおよびキャップ：ブチルゴム）に充填し、高圧蒸気滅菌（１２１℃、２０分）して、プレフィルドシリンジを製した。
比較例２ 注射用水１ｍＬを注射剤容器（外筒：シクロオレフィンポリマー（日本ゼオン(株):ゼオネックス690R）、ガスケットおよびキャップ：ブチルゴム）に充填し、高圧蒸気滅菌（１２１℃、２０分間）して、プレフィルドシリンジを製した。
Example 1 1 mL of water for injection was filled into a 1 mL injection container (outer cylinder: cycloolefin polymer (Nippon Zeon Co., Ltd .: Zeonex 690R), gasket and cap: styrene elastomer (manufactured by Mitsubishi Chemical Corporation)). Then, high-pressure steam sterilization (121 ° C., 20 minutes) was performed to produce a prefilled syringe.
Comparative Example 1 1 mL of water for injection was filled in a 1 mL injection container (outer cylinder: cycloolefin copolymer (Mitsui Chemicals, Inc .: Apel APL6015), gasket and cap: butyl rubber), and autoclaved at 121 ° C for 20 minutes. ) To produce a prefilled syringe.
Comparative Example 2 1 mL of water for injection was filled in an injection container (outer cylinder: cycloolefin polymer (Nippon Zeon Co., Ltd .: Zeonex 690R), gasket and cap: butyl rubber), and autoclaved (121 ° C, 20 minutes). A prefilled syringe was made.
純度試験 実施例１及び比較例１，２で製した各プレフィルドシリンジに充填されている注射用水を試験液とし、第十五改正日本薬局方「注射用水」に従って、純度試験の各項目について試験した。
その結果、いずれのプレフィルドシリンジに充填されている注射用水も純度試験（５）亜硝酸性窒素以外の試験項目には適合していた。また、純度試験（５）亜硝酸性窒素については、表３に示すように、本発明の実施例１が適合していることが確認された。
Purity test Each pre-filled syringe manufactured in Example 1 and Comparative Examples 1 and 2 was tested for each item of the purity test according to the 15th revision Japanese Pharmacopoeia "Water for Injection" using the water for injection filled as a test solution. .
As a result, the water for injection filled in any prefilled syringe was suitable for the test items other than the purity test (5) nitrite nitrogen. Moreover, about purity test (5) nitrite nitrogen, as shown in Table 3, it was confirmed that Example 1 of this invention has adapted.
Claims (3)
前記外筒を構成する樹脂の材質は、シクロオレフィンポリマーであり、かつ、ノルボルネン、ノルボルネン誘導体を開環メタセシス重合して得られるシクロオレフィン系ポリマー類あるいはその水素添加物、又はこれらのシクロオレフィン系ポリマー類の混合物であり、ガラス転移温度が１００〜１５０℃の樹脂であり、
前記ガスケットは、スチレン系エラストマーからなり、前記注射用水が、日本薬局方注射用水であり、前記外筒と前記ガスケットと前記キャップで形成された空間内に前記注射用水が充填された状態にて高圧蒸気滅菌されており、かつ第十五改正日本薬局方注射用水の純度試験（５）亜硝酸性窒素の規格に従い、滅菌後の注射用水１０ｍＬをネスラー管にとり、これにスルファニルアミドの希塩酸溶液（１→１００）１ｍＬ及びＮ，Ｎ−ジエチル−Ｎ'−１−ナフチルエチレンジアミンシュウ酸塩試液１ｍＬを加えたとき、注射用水は、微赤色を呈しないものであることを特徴とする日本薬局方注射用水が充填されてなるプレフィルドシリンジ。 And plastic outer cylinder, said outer cylinder gasket slidably mounted liquid-tight, and a cap for sealing the end opening of the outer cylinder, are formed in said outer cylinder the gasket and the cap A prefilled syringe consisting of water for injection filled in the space,
The material of the resin constituting the outer cylinder is a cycloolefin polymer, and cycloolefin polymers obtained by ring-opening metathesis polymerization of norbornene and norbornene derivatives, or hydrogenated products thereof, or these cycloolefin polymers. A resin having a glass transition temperature of 100 to 150 ° C.
The gasket is made of a styrene-based elastomer, the injection water is Japanese Pharmacopoeia injection water, and the injection water is filled in a space formed by the outer cylinder, the gasket, and the cap. Purity test of steam sterilized and according to the 15th revised Japanese Pharmacopoeia water for injection (5) In accordance with nitrite nitrogen standards, 10 mL of water for injection after sterilization is placed in a Nessler tube, and diluted with sulfanilamide in dilute hydrochloric acid (1 → 100) When 1 mL of N, N-diethyl-N′-1-naphthylethylenediamine oxalate test solution is added, the water for injection does not exhibit a faint red color. Prefilled syringe filled with
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| JP3387775B2 (en) * | 1997-05-22 | 2003-03-17 | 株式会社大協精工 | Sealing stopper for syringe and prefilled syringe |
| JP3103535B2 (en) * | 1998-05-29 | 2000-10-30 | 大洋薬品工業株式会社 | Prefilled syringe preparation of calcitonin |
| JP4598484B2 (en) * | 2004-11-11 | 2010-12-15 | テルモ株式会社 | Ritodrine hydrochloride injection solution |
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