【０００１】[0001]
【発明の属する技術分野】本発明は薬物を吸着しない注
射剤容器に関する。さらに詳しくは、材質としてシクロ
ポリオレフィンを使用した、硝酸イソソルビド非吸着性
の注射剤容器に関する。TECHNICAL FIELD The present invention relates to an injection container which does not adsorb a drug. More specifically, the invention relates to an isosorbide dinitrate non-adsorptive injection container using cyclopolyolefin as a material.
【０００２】[0002]
【従来の技術】硝酸イソソルビド(Isosorbide Dinitrat
e)は、血管拡張作用を有し、狭心症・心筋梗塞等の虚血
性心疾患の予防・治療薬として長年に渡って用いられて
いる。2. Description of the Related Art Isosorbide dinitrate
e) has a vasodilatory action and has been used for many years as a preventive / therapeutic drug for ischemic heart diseases such as angina and myocardial infarction.
【０００３】狭心症の慢性期の治療・緩解や狭心症発作
の予防には、徐放剤またはテープ剤などが使用されてい
る。一方、狭心症発作を発症した時には、速やかな効果
発現が求められるため、注射剤、舌下錠または口腔内ス
プレーが用いられている。狭心症発作時には適切な治療
を行わないと生命に危険が及ぶため、硝酸イソソルビド
の注射剤の重要性は非常に高い。しかし注射剤を安全か
つ有効に作用させるためには、投与量を正確にコントロ
ールすることが極めて重要である。Sustained-release agents, tapes and the like are used for the treatment / remission of chronic phase angina and the prevention of angina attacks. On the other hand, injections, sublingual tablets or buccal sprays are used because rapid effect expression is required when an angina attack occurs. Injection of isosorbide dinitrate is of great importance because it can be life-threatening without proper treatment during an angina attack. However, in order for the injection to act safely and effectively, accurate control of the dose is extremely important.
【０００４】硝酸イソソルビドは、ポリエチレン、ポリ
プロピレンなどのポリオレフィン類や塩化ビニル等の材
質に吸着されることが知られている。現在、医療現場で
はポリエチレンやポリプロピレン製のディスポーザブル
・シリンジや塩化ビニル製の輸液セットが広く使用され
ているが、硝酸イソソルビドをこれらの材質の注射筒や
輸液セットに入れて保存すると、吸着により投与量を正
確にコントロールできない結果になってしまう。It is known that isosorbide dinitrate is adsorbed on materials such as polyolefins such as polyethylene and polypropylene and vinyl chloride. At present, disposable syringes made of polyethylene or polypropylene and infusion sets made of vinyl chloride are widely used in the medical field, but when isosorbide nitrate is stored in syringes or infusion sets made of these materials, the dose will be absorbed. The result is that you can't control it accurately.
【０００５】特開平5-139971号公報には、硝酸イソソル
ビドとともにセルロース誘導体、ゼラチン、ポリオキシ
エチレン硬化ヒマシ油、グリチルレチンおよびアルブミ
ンから選ばれた１種又はそれ以上を含有させてなること
を特徴とする注射剤が記載されている。しかし、これは
薬物濃度を0.05w/v％以上にしても析出しない注射剤の
提供を目的としたものであり、容器への吸着性に関して
は記載はない。Japanese Unexamined Patent Publication (Kokai) No. 5-139971 is characterized by containing, together with isosorbide dinitrate, one or more selected from cellulose derivatives, gelatin, polyoxyethylene hydrogenated castor oil, glycyrrhetin and albumin. Injectables are described. However, this is for the purpose of providing an injection that does not precipitate even when the drug concentration is 0.05 w / v% or more, and there is no description regarding the adsorptivity to the container.
【０００６】現在、硝酸イソソルビドを吸着しない注射
筒としては、ガラス製のものや表面をフッ素樹脂処理し
たものが知られている。At present, as an injection cylinder which does not adsorb isosorbide dinitrate, one made of glass or one having its surface treated with a fluororesin is known.
【０００７】しかし、ガラス製の注射筒は再生利用する
ことが原則であり、細菌等の２次感染を防ぐために、使
用のたびに滅菌処理したり、紫外線照射殺菌をしながら
保管したりしなければならない。そのため、医療現場で
はなるべくなら、ディスポーザブルタイプの注射筒を使
用したいという要望がある。[0007] However, it is a principle that the glass syringe is recycled, and in order to prevent secondary infection such as bacteria, it must be sterilized after each use or stored while being sterilized by ultraviolet irradiation. I have to. Therefore, there is a demand in the medical field to use disposable syringes as much as possible.
【０００８】また、フッ素樹脂処理した注射筒、輸液セ
ットは、硝酸イソソルビドを吸着しないことが知られて
いるが、フッ素樹脂は高価であるため、ディスポーザブ
ルタイプの注射筒としては普及していない。Further, it is known that the fluororesin-treated syringe and infusion set do not adsorb isosorbide nitrate, but since the fluororesin is expensive, it is not widely used as a disposable type syringe.
【０００９】したがって、現在、医療現場では、硝酸イ
ソソルビド注射液は、使用直前に注射筒に吸引したり、
輸液に添加したりすることで対応している。Therefore, at present, in medical practice, the isosorbide dinitrate injection solution is sucked into a syringe immediately before use,
It is handled by adding it to the infusion solution.
【００１０】[0010]
【発明が解決しようとする課題】しかし、近年の医療現
場では、薬物投与量を正確にコントロールするために、
予め定められた量の薬物を分取したプレフィルド・シリ
ンジ製剤や輸液バッグの提供が望まれている。上記のよ
うに、硝酸イソソルビドは通常、注射剤容器に使用され
る材質のものには吸着されてしまうため、保存しておく
ことができないという問題点があった。However, in the recent medical field, in order to accurately control the drug dose,
It is desired to provide a prefilled syringe preparation or an infusion bag in which a predetermined amount of drug is dispensed. As described above, since isosorbide dinitrate is usually adsorbed by the material used for the injection container, there is a problem that it cannot be stored.
【００１１】[0011]
【課題を解決するための手段】このような状況に鑑み、
本発明者らが鋭意研究を重ねた結果、シクロポリオレフ
ィンを材質として使用することにより、硝酸イソソルビ
ドが吸着されない注射剤容器の開発に成功し、本発明を
完成させた。[Means for Solving the Problems] In view of such a situation,
As a result of intensive studies by the present inventors, the inventors have succeeded in developing an injectable container in which isosorbide nitrate is not adsorbed by using cyclopolyolefin as a material, and completed the present invention.
【００１２】すなわち本発明は、シクロポリオレフィン
を材質とする硝酸イソソルビド非吸着性の注射剤容器で
ある。また、上記容器の容量が１〜500ml、または１〜2
00mlである上記注射剤容器である。That is, the present invention is an isosorbide dinitrate non-adsorptive injection container made of cyclopolyolefin. In addition, the capacity of the container is 1 to 500 ml, or 1 to 2
It is the said injection container which is 00 ml.
【００１３】また本発明は、プレフィルド・シリンジま
たは輸液用バッグである上記注射剤容器である。The present invention is also the above-mentioned injection container which is a prefilled syringe or an infusion bag.
【００１４】[0014]
【発明の実施の形態】本発明においてシクロポリオレフ
ィンとは、シクロオレフィンコポリマー（COC）または
シクロオレフィンポリマー（COP）を意味する。BEST MODE FOR CARRYING OUT THE INVENTION In the present invention, a cyclopolyolefin means a cycloolefin copolymer (COC) or a cycloolefin polymer (COP).
【００１５】これらシクロオレフィンコポリマーを素材
とした注射筒およびバイアルとしては、三井化学(株)製
のアペル(商品名)、大協精工(株)製のCZレジン(商品名)
が市販されている。また、シクロオレフィンポリマーと
しては、日本ゼオン(株)製のZEONOR(商品名)やZENONEX
(商品名)等が市販されており、容易に入手可能である。As an injection cylinder and a vial made of these cycloolefin copolymers, there are Apel (trade name) manufactured by Mitsui Chemicals, Inc. and CZ resin (trade name) manufactured by Daikyo Seiko Co., Ltd.
Is commercially available. As cycloolefin polymers, Zeonor (trade name) manufactured by Nippon Zeon Co., Ltd. and ZENONEX
(Trade name) and the like are commercially available, and are easily available.
【００１６】上記の様なシクロポリオレフィンを、注射
筒のような医療容器に応用したものが報告されている。
例えば、特開2000-334041号公報には、液密性および摺
動性の改善を目的とした、ピストン頭部が環状ポリオレ
フィン等の熱可塑性樹脂からなるシリンジが開示されて
いる。It has been reported that the cyclopolyolefin as described above is applied to a medical container such as a syringe.
For example, Japanese Patent Laid-Open No. 2000-334041 discloses a syringe whose piston head is made of a thermoplastic resin such as cyclic polyolefin for the purpose of improving liquid tightness and slidability.
【００１７】また、特開平10-137336号公報には、ルア
ーロック基部を強化した、バレル部分が環状ポリオレフ
ィンからなるプラスチックシリンジバレルが開示されて
いる。Further, Japanese Unexamined Patent Publication No. 10-137336 discloses a plastic syringe barrel having a reinforced luer lock base and a barrel portion made of a cyclic polyolefin.
【００１８】本発明に係る注射剤容器とは、注射用の液
剤の投与に使用するものであり、特に限定されない。好
ましくは、注射剤を投与する際に使用する注射筒、予め
液剤を充填したプレフィルド・シリンジ、バイアル、輸
液用バッグ等である。The injectable container according to the present invention is used for administration of a liquid agent for injection and is not particularly limited. Preferred are an injection cylinder used for administering an injection, a prefilled syringe prefilled with a liquid, a vial, an infusion bag, and the like.
【００１９】本発明において、硝酸イソソルビド溶液の
濃度は限定されないが、好ましくは0.001〜１w/v％であ
る。In the present invention, the concentration of the isosorbide dinitrate solution is not limited, but is preferably 0.001 to 1 w / v%.
【００２０】[0020]
【実施例】次に実施例を挙げて本発明をさらに詳細に説
明するが、本発明はこれらに限定されるわけではない。The present invention will be described in more detail with reference to examples, but the present invention is not limited thereto.
【００２１】実施例１硝酸イソソルビド 0.5g、等張化剤D-ソルビトール 25g
に注射用蒸留水 400mlを加え、加温溶解後、攪拌冷却し
て、さらに注射用蒸留水を適量加えて再攪拌し、500ml
の調製液を得た。この調製液を0.22μmの滅菌フィルタ
ーを使用してろ過滅菌処理し、0.1w/v％硝酸イソソルビ
ド溶液を製造した。この硝酸イソソルビド溶液50mlを、
シクロポリオレフィンを使用して製造した100mlのシリ
ンジ（商品名：Barrel 100mL、大協精工(株)製）に充填
し、プレフィルド・シリンジ製剤を製造したExample 1 0.5 g of isosorbide dinitrate and 25 g of isotonicity agent D-sorbitol
Add 400 ml of distilled water for injection to, dissolve by heating, stir and cool, then add an appropriate amount of distilled water for injection and re-stir to give 500 ml.
A preparation liquid of was obtained. The prepared solution was sterilized by filtration using a 0.22 μm sterilizing filter to produce a 0.1 w / v% isosorbide dinitrate solution. 50 ml of this isosorbide nitrate solution,
A prefilled syringe formulation was manufactured by filling a 100 ml syringe (trade name: Barrel 100 mL, manufactured by Daikyo Seiko Co., Ltd.) manufactured using cyclopolyolefin.
【００２２】実施例２硝酸イソソルビド 0.5g、等張化剤D-ソルビトール 25g
に注射用蒸留水 400mlを加え、加温溶解後、攪拌冷却し
て、さらに注射用蒸留水を適量加えて攪拌混合し、500m
lの調製液を得た。この調製液を0.22μmの滅菌フィルタ
ーでろ過滅菌処理し、0.1w/v％硝酸イソソルビド溶液を
製造した。シクロオレフィンポリマーを使用して製造し
たフィルム（商品名：ZEONOR1420、日本ゼオン(株)）を
用いて、輸液用のバッグを成型した。この容器に上記硝
酸イソソルビド溶液を50ml充填し、バッグ製剤を製造し
た。Example 2 Isosorbide dinitrate 0.5 g, tonicity agent D-sorbitol 25 g
400 ml of distilled water for injection was added to the above, dissolved by heating, stirred and cooled, and an appropriate amount of distilled water for injection was added and mixed with stirring to 500 m.
l of the preparation liquid was obtained. The prepared solution was sterilized by filtration with a 0.22 μm sterilizing filter to prepare a 0.1 w / v% isosorbide dinitrate solution. A bag for infusion was molded using a film (trade name: ZEONOR1420, Nippon Zeon Co., Ltd.) manufactured using cycloolefin polymer. This container was filled with 50 ml of the isosorbide dinitrate solution to prepare a bag preparation.
【００２３】[0023]
【試験例】次に本発明の効果を示すため、各種材質で製
造した注射剤容器に対する硝酸イソソルビドの吸着性を
検討した。[Test Example] Next, in order to show the effect of the present invention, the adsorptivity of isosorbide dinitrate to an injection container made of various materials was examined.
【００２４】試験例１注射剤容器の材質としてガラス、ポリエチレン、高密度
ポリエチレン、低密度ポリエチレン、ポリプロピレン、
シクロポリオレフィン（CZレジンBarrel 100ml、大協精
工(株)製）を使用して、0.1w/v％硝酸イソソルビド溶液
（5％のD-ソルビトールで等張化）50ml注射製剤を製造
した。これらを温度45℃、遮光の条件下で保存し、硝酸
イソソルビドの残存率（残存率＝保存後の含量／保存前
の含量×100）を測定した。Test Example 1 As the material of the injection container, glass, polyethylene, high density polyethylene, low density polyethylene, polypropylene,
Cyclopolyolefin (CZ resin Barrel 100 ml, manufactured by Daikyo Seiko Co., Ltd.) was used to prepare a 50 ml injection preparation of 0.1 w / v% isosorbide dinitrate solution (isotonicized with 5% D-sorbitol). These were stored at a temperature of 45 ° C. under light-shielding conditions, and the residual rate of isosorbide dinitrate (residual rate = content after storage / content before storage × 100) was measured.
【００２５】[0025]
【００２６】表１の結果から、ガラスとシクロオレフィ
ンコポリマーで製造した注射剤容器の材質の場合には、
６週間経過後でも、硝酸イソソルビドの残存率に変化は
みられなかった。一方、それ以外の材質を使用した時に
は、硝酸イソソルビドの残存率が経時的に低下し、注射
剤容器に吸着されたと考えられた。From the results shown in Table 1, in the case of the material of the injection container made of glass and cycloolefin copolymer,
Even after 6 weeks, there was no change in the residual rate of isosorbide dinitrate. On the other hand, when other materials were used, it was considered that the residual rate of isosorbide dinitrate decreased with time and was adsorbed to the injection container.
【００２７】試験例２試験例１とほぼ同様の方法で、各種材質の容器を使用し
て、0.05％硝酸イソソルビド水溶液を３カ月間保存し、
その残存率を測定した。保存条件は40℃、遮光下とし
た。材質として、ガラス、シクロオレフィンコポリマー
（CZレジンBarrel100ml、大協精工(株)製）、シクロオ
レフィンポリマー（ZEONOR1420、日本ゼオン(株)製)、
低密度ポリエチレンを使用し、バイアル、シリンジ、輸
液用バッグの形態に加工して試験を行った。Test Example 2 In the same manner as in Test Example 1, using a container of various materials, a 0.05% aqueous solution of isosorbide dinitrate was stored for 3 months,
The residual rate was measured. The storage conditions were 40 ° C and light shielding. As materials, glass, cycloolefin copolymer (CZ resin Barrel 100 ml, manufactured by Daikyo Seiko Co., Ltd.), cycloolefin polymer (ZEONOR1420, manufactured by Nippon Zeon Co., Ltd.),
The test was conducted by using low density polyethylene and processing it in the form of a vial, a syringe and an infusion bag.
【００２８】[0028]
【００２９】表２の結果から、ガラス、シクロオレフィ
ンコポリマー、シクロオレフィンポリマーで製造した容
器を使用した場合には、３カ月経過後でも、硝酸イソソ
ルビドの残存率に変化はみられなかった。一方、低密度
ポリエチレンを使用した注射剤容器では、硝酸イソソル
ビドの残存率が低下し、容器に吸着されたものと考えら
れた。From the results shown in Table 2, when the glass, the cycloolefin copolymer, and the container made of the cycloolefin polymer were used, there was no change in the residual ratio of isosorbide dinitrate even after 3 months. On the other hand, in the injection container using low density polyethylene, the residual rate of isosorbide dinitrate decreased, and it was considered that the container was adsorbed to the container.
【００３０】[0030]
【発明の効果】本発明により、硝酸イソソルビドを吸着
しない注射剤容器の提供が可能になった。そのため、投
与量を正確にコントロールすることができ、薬物の有効
性、安全性を保つことができる。また、長期間保存して
も薬物濃度に影響を与えないため、プレフィルド・シリ
ンジ製剤や輸液用バッグの製造も可能になり、医療現場
における投与量の分取ミスを防ぐことができる。INDUSTRIAL APPLICABILITY According to the present invention, it is possible to provide an injection container which does not adsorb isosorbide nitrate. Therefore, the dose can be accurately controlled, and the effectiveness and safety of the drug can be maintained. Further, since it does not affect the drug concentration even if it is stored for a long period of time, it becomes possible to manufacture a prefilled syringe preparation or an infusion bag, and it is possible to prevent the dosage mistakes in the medical field.
─────────────────────────────────────────────────────フロントページの続き Ｆターム(参考） 4C066 AA09 BB01 CC01 EE14 FF05 4C081 AC09 BB09 BC03 CA021 CC01 CE02 DA03 DB07 4C086 AA01 AA02 CA01 MA66 NA03 ZA40 ─────────────────────────────────────────────────── ───Continued front page F-term (reference) 4C066 AA09 BB01 CC01 EE14 FF05 4C081 AC09 BB09 BC03 CA021 CC01 CE02 DA03 DB07 4C086 AA01 AA02 CA01 MA66 NA03 ZA40
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2002135016AJP2003024415A (en) | 2001-05-10 | 2002-05-10 | Injectable solution vessel |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001-139705 | 2001-05-10 | ||
| JP2001139705 | 2001-05-10 | ||
| JP2002135016AJP2003024415A (en) | 2001-05-10 | 2002-05-10 | Injectable solution vessel |
| Publication Number | Publication Date |
|---|---|
| JP2003024415Atrue JP2003024415A (en) | 2003-01-28 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2002135016APendingJP2003024415A (en) | 2001-05-10 | 2002-05-10 | Injectable solution vessel |
| Country | Link |
|---|---|
| JP (1) | JP2003024415A (en) |
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| JP2005525952A (en)* | 2002-05-17 | 2005-09-02 | 株式会社大塚製薬工場 | Multilayer film and drug container using the same |
| US8029885B2 (en) | 2002-05-17 | 2011-10-04 | Otsuka Pharmaceutical Factory, Inc. | Multi-layer film and medicine container using the same |
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