JP7240374B2 - プラスチック容器 - Google Patents
プラスチック容器 Download PDFInfo
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- JP7240374B2 JP7240374B2 JP2020500519A JP2020500519A JP7240374B2 JP 7240374 B2 JP7240374 B2 JP 7240374B2 JP 2020500519 A JP2020500519 A JP 2020500519A JP 2020500519 A JP2020500519 A JP 2020500519A JP 7240374 B2 JP7240374 B2 JP 7240374B2
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Images
Classifications
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Description
本願は、2018年2月15日に、日本に出願された特願2018-024825号に基づき優先権を主張し、その内容をここに援用する。
例えば特許文献1には、最内層に環状ポリオレフィン樹脂層を配置し、中間層および最外層をPE系樹脂から形成する多層体が提案されている。特許文献1の実施例により得られるプラスチック容器は、医療容器を同発明の多層体からなる袋本体と、環状ポリオレフィン系樹脂からなる口部を接合している。しかし、医薬容器として汎用的な、PE系樹脂やPP系樹脂と比較して高価な環状ポリオレフィン系樹脂をポート部材の材質として用いることは、材料価格の観点のみならず、シート部材とポート部材を溶着するための時間が長くなり、相対的に低い生産性となるため、コスト面で好ましくない。また、口部をゴム栓等により封止した後、キャップにより密封性を保持する必要があるが、接合部で十分な強度を発現させるためには、キャップ部材も環状オレフィン系樹脂で構成しなければならず、この点でもコスト面の問題がある。
(式1) 0.01≦SP/SB≦0.15
前記非晶性ポリマーのガラス転移温度が、70℃以上であってもよい。
前記非晶性ポリマーのガラス転移温度が、100℃以上であってもよい。
前記プラスチック容器が輸液バッグまたはブロー成形容器の形態であってもよい。
前記医薬品が、ピラゾロン誘導体またはその薬学的に許容され得る塩を含有する水溶液であってもよい。
前記ピラゾロン誘導体が、3-メチル-1-フェニル-2-ピラゾリン-5-オンであってもよい。
本発明のプラスチック容器を、脱酸素剤とともに、ガスバリア性を有する包装体内に収容することも、薬液の保存安定性の点から、好ましい態様である。
本実施形態で述べる、プラスチックとの親和性が高い医薬品成分としては、代表的なものとしてピラゾロン誘導体を挙げることができる。ピラゾロン誘導体は、下記式(I)で表される化合物を用いることができる。
さらに、式(I)で示されるピラゾロン誘導体またはその薬学的に許容され得る塩のほか、それらの水和物若しくは溶媒和物を薬液の有効成分とすることもできる。
PP系樹脂は、プロピレンのホモポリマーのほか、エチレン、1-ブテン等のα-オレフィンを少量(好ましくは10重量%以下)共重合したコポリマーや、例えば特開2001-226435号公報に開示されるプロピレンとα-オレフィンとを多段重合により製造される共重合体等により構成される。また、これらホモポリマーや共重合体と他のポリオレフィンや樹脂とのコンパウンドを用いてもよい。中でも、環状ポリオレフィン層の剛直さを緩和し、多層フィルムの柔軟性を向上させるものとして、医療用容器用として汎用されている曲げ弾性率が400~600MPaの比較的柔軟なグレードのものを用いるのが好適である。また別の観点からはベース樹脂層を構成する樹脂のメルトフローレート(230℃、21.2N)値を1~4(g/10分)とするのが好適である。本実施形態で好適に使用できるベース樹脂層を構成する樹脂の具体例を例示すると、三菱ケミカル株式会社製の「ゼラス(登録商標)」(登録商標)を挙げることができる。特に、融解ピーク温度が160~170℃のPP系樹脂を用いることが好ましい。
シート部材の最内層を構成する材料には、容器外観の向上や品質の安定化、その他必要とされる性能を付与するために、安全衛生性を損なわない範囲で、酸化防止剤、紫外線吸収剤、帯電防止剤、滑剤、ブロッキング防止剤等の各種添加剤等を含有してもよい。
口部の溶着方法は、プラスチック容器が袋状容器である場合は、シート部材のシーラント層である最内層同士を重ね合わせて、その間に口部を挿入してヒートシールで溶着することができる。
(式1) 0.01≦SP/SB≦0.15
(式2) α<V/(SP+SB)<β
<シート部材の製膜>
Tダイ式多層製膜機を用いて、最内層の厚みが30(μm)、シート部材の総厚みが250(μm)となるよう、共押出工法によりシート部材を製膜した。ベース樹脂層がPE系樹脂である場合は、ベース樹脂層と最内層が隣接して配置された2層構成のシートとした。ベース樹脂層がPP系樹脂を主成分とする場合、ベース樹脂層と最内層との間に、接着性樹脂層を配置した3層の構成とした。ベース樹脂層、接着性樹脂層、および最内層として用いた樹脂組成は、表1および表2に一覧として示した。なお、表1において[ ]内の数値は各層の厚みであり、表2における( )の数値は混配の質量比を表す。
PP:ポリプロピレン系熱可塑性エラストマー(三菱ケミカル社製、ゼラス(登録商標)7025)
COP:シクロオレフィンポリマー(日本ゼオン社製、ZEONOR(登録商標)690R)
COC:シクロオレフィンコポリマー(ポリプラスチックス社製、TOPAS(登録商標)6013F04)
PP系接着樹脂:ポリプロピレン系接着性エラストマー(三菱ケミカル社製、ゼラス(登録商標)MC729)
ランダムPP:メタロセン触媒重合ポリプロピレン(日本ポリプロ社製、ウィンテック(登録商標)WFW4M)
LLDPE2:直鎖状低密度ポリエチレン(日本ポリエチレン社製、ハーモレックス(登録商標)NJ744N)
St(スチレン)系エラストマー:スチレン-エチレン-ブチレン-スチレンブロック共重合体(クレイトンポリマー社製、クレイトン(登録商標)G(スチレン含有率13質量%、比重0.90g/cm3、MFR=22g/10min(230℃、5kgf))
射出成形法により、円筒部内径が15mm、高さ38mm、円筒部肉厚が0.8mmのポート部材を得た。各試験例に用いた樹脂材料は、表1および表2に合わせて記載した。
上記により得られたシート部材とポート部材を用い、バッグ容器を製造した。バッグ容器は袋本体の内寸が約140(mm)×105(mm)となる寸法とした。袋本体を構成する2枚のシート間に、ポート部材を挟み込み、シート部材とポート部材を熱溶着してバッグ容器を形成した。出来上がったバッグ容器の袋本体の接液部(内容物接触部)の面積は250(cm2)であり、ポート部材の接液部(内容物接触部)の面積は20(cm2)であった。
上記により製袋した容器内には、下記表3に示す組成(エダラボンモデル製剤の組成)で、pH3.85に調製したエダラボン含有水溶液を製剤とし、容器内に105mLを充填して、接液面がETFE(テトラフルオロエチレン-エチレン共重合体)フィルムでラミネートされた、イソプレンゴム栓および各ポート部材と同一材質のキャップにより密封した。
カラム:内径4.6mm、長さ150mmのステンレス管に粒径5μmのオクタデシルシリル化シリカゲルを充填した液体クロマトグラフィー用カラム。
カラム温度:40℃付近の一定温度。
移動相:メタノール:水:酢酸=49.8:49.8:0.4
流速:1.0mL/min。
注入量:20μL
実験1の試験例1に用いたシート部材およびポート部材によりバッグ容器を製袋したが、ポート部材の接液部面積を大きく、接液部面積比率SP/SBを高くする目的で、円筒部高さ方向の寸法を延長し、接液部面積が30、40、50(cm2)となるポート部材を接合した。それ以外は実験1と同様の手法により、エダラボン残存率を求めた。実験2における試験結果を、実験1の試験例1の試験結果と共に表5に一覧として示した。
Claims (8)
- シート部材により袋状に形成され内部に収容部を有する袋本体と、前記袋本体に取り付けられ前記収容部に一端が連通し、他端の開口部が袋本体より外側に露出した筒状のポート部材とを有するプラスチック容器であって、
前記シート部材はベース樹脂層と最内層とを含む2層以上からなり、前記最内層は、少なくとも1種類または2種類以上のオレフィンモノマーを重合してなり、該オレフィンモノマーのうち少なくとも1種類は環状炭化水素骨格を有するモノマーである非晶性ポリマーが主成分としてなり、
かつ前記ポート部材は、環状炭化水素骨格を有さない結晶性ポリオレフィンを主成分とする樹脂により形成され、
前記袋本体の内容物接触部は、前記シート部材の前記最内層からなり、
前記ポート部材の内容物接触部は、前記結晶性ポリオレフィンを主成分とする樹脂からなり、
前記袋本体の内容物接触部面積S B (cm 2 )と、前記ポート部材の内容物接触部面積S P (cm 2 )との関係性が、下記(式1)を満足することを特徴とする、プラスチック容器。
(式1) 0.01≦S P /S B ≦0.15 - 前記結晶性ポリオレフィンが、ポリエチレン、ポリプロピレン、エチレン・α-オレフィン共重合体のいずれか1種類以上から選択されることを特徴とする、請求項1に記載のプラスチック容器。
- 前記非晶性ポリマーのガラス転移温度が、70℃以上であることを特徴とする、請求項1または2に記載のプラスチック容器。
- 前記非晶性ポリマーのガラス転移温度が、100℃以上であることを特徴とする、請求項1~3のいずれか1項に記載のプラスチック容器。
- 前記プラスチック容器が輸液バッグまたはブロー成形容器の形態である、請求項1~4のいずれか1項に記載のプラスチック容器。
- 前記プラスチック容器に収容される内容物が医薬品であることを特徴とする、請求項1~5のいずれか1項に記載のプラスチック容器。
- 前記医薬品が、ピラゾロン誘導体またはその薬学的に許容され得る塩を含有する水溶液であることを特徴とする、請求項6に記載のプラスチック容器。
- 前記ピラゾロン誘導体が、3-メチル-1-フェニル-2-ピラゾリン-5-オンであることを特徴とする、請求項7に記載のプラスチック容器。
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