JP7459620B2 - 医療用ゴム組成物、医療用ゴム部品、および、プレフィルドシリンジ - Google Patents
医療用ゴム組成物、医療用ゴム部品、および、プレフィルドシリンジ Download PDFInfo
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- JP7459620B2 JP7459620B2 JP2020063679A JP2020063679A JP7459620B2 JP 7459620 B2 JP7459620 B2 JP 7459620B2 JP 2020063679 A JP2020063679 A JP 2020063679A JP 2020063679 A JP2020063679 A JP 2020063679A JP 7459620 B2 JP7459620 B2 JP 7459620B2
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- rubber
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Description
表1に示した材料を混練して医療用ゴム組成物を調製した。混練は、オープンロールを用いて、20℃で約10分間行った。
ブチルゴム:エクソンモービル社製HT-1066(塩素化ブチルゴム)
ポリブタジエンゴム:日本ゼオン社製BR-1220
イソプレンゴム:日本ゼオン社製IR-2200
ミペロン:三井化学社製超高分子量ポリエチレンパウダーXM-220
ハイドロタルサイト:協和化学工業社製アルカマイザー1
酸化マグネシウム:協和化学工業社製キョウワマグ
酸化チタン:石原産業社製タイペークA100
シリカ:東ソー・シリカ社製ニップシルLP
タルク:イメリススペシャリティーズ社製ミストロンベーパー
ステアリン酸:日油社製NNA-180
PEG4000:日油社製ポリオキシエチレングリコール(平均分子量3100、凝固点55℃)
カーボンブラック:Cancarb社製サーマルMT
パーオキサイド系架橋剤:日油社製パーヘキサ25B-40
共架橋剤:トリメチロールプロパントリアクリレート:新中村化学工業社製TMPT
トリアジン誘導体:三協化成社製ジスネットDB
(1)ガス透過係数(cc・cm/cm2・sec・cmHg)
得られた医療用ゴム組成物から、ガス透過係数測定用の試験片を作製し、ガス透過係数を測定した。測定は、JIS-K6275-1に準じて、GTR社製GTR-30XASRを用いて、差圧法により行った。
試験ガス:N2
測定サンプル:ゴム組成物を180℃×6分間プレス成型して、厚みが0.5mm~1.0mmのスラブを作製した。
<相対評価>
ゴム組成物No.1を基準配合としそのN2透過係数を1として、N2透過係数を指数化した。
○:5以上
△:2以上、5未満
×:2未満
測定サンプル:前記のように配合したゴム組成物を180℃×6分間プレス成型して2mmのスラブを作製した。それをφ17mmのポンチで打ち抜いて試験サンプルとした。
製造したサンプルについて、第17改正日本薬局法「7.03輸液用ゴム栓試験法」所載の「溶出物試験」を実施した。適合条件は、以下の通りとした。
試験液の性状:無色澄明
UV透過率:層長10mmで、波長430nmおよび波長650nmの透過率が99.0%以上
紫外吸収スペクトル:波長220nm~350nmにおける吸光度が0.20以下
pH:試験液および空試験液の差が1.0以下
亜鉛:試料溶液の吸光度が、標準溶液の吸光度以下
過マンガン酸カリウム還元物質:2.0mL/100mL以下(薬局方の規格)
蒸発残留物:2.0mg以下
<相対評価>
表中、過マンガン酸カリウム還元物質濃度が、1.0mL/100mL未満の場合には、「○」を、過マンガン酸カリウム還元物質濃度が、1.0mL/100mL以上、1.4mL/100mL以下の場合には、「△」を、過マンガン酸カリウム還元物質濃度が、1.4mL/100mL超の場合には、「×」を記載している。
図3の試験用シリンジを作製した。シリンジ本体(バレル)15の材料としては、大成化成工業社製のシクロオレフィンポリマー(COP)樹脂を使用し、シリンジストッパー17は、ブチルゴムを使用した一般の医療用ゴム組成物から作製した。ノズルキャップ19は、表1の医療用ゴム組成物から成形した。菌として、BI(Bacillus atrophaeus ATCC cell 9372)21を用い、図3に示すようにセットし、ノズルキャップ19を絞めて、EOG滅菌試験用シリンジサンプルを作製した。測定装置としては、CROSSTEX社製STN-062を用い、試験用シリンジサンプルを、50℃、EOG雰囲気下で所定の時間滅菌した後、BI菌数の測定を行った。
<相対評価>
各医療用ゴム組成物について、10検体を用いて滅菌試験を行い、10検体すべてについて、滅菌処理により菌が死滅するのに必要な時間で評価した。表中、滅菌時間が6時間以内の場合には、「〇」を、滅菌時間が6時間超、10時間以内の場合には、「△」を記載している。10時間超の場合には、「×」を示した。
Claims (10)
- (a)ブチルゴムと、
(b)ポリブタジエンを含有するジエン系ゴムと、
(c)パーオキサイド系架橋剤と、
(d)共架橋剤とを含有し、
(b)前記ジエン系ゴムの含有量は、(a)ブチルゴムと(b)ジエン系ゴムからなるゴム成分100質量部中、15質量部以上、90質量部以下であり、
(c)前記パーオキサイド系架橋剤と(d)前記共架橋剤との配合量の質量比率((d)/(c))が、1.2以上、25以下であり、
(d)前記共架橋剤は、トリメチロールプロパントリアクリレートおよび/またはトリメチロールプロパントリメタクリレートであることを特徴とする医療用ゴム組成物。 - (a)前記ブチルゴムは、ハロゲン化ブチルゴムである請求項1に記載の医療用ゴム組成物。
- 前記ハロゲン化ブチルゴムは、塩素化ブチルゴムである請求項2に記載の医療用ゴム組成物。
- (b)前記ジエン系ゴムの含有量は、(a)ブチルゴムと(b)ジエン系ゴムからなるゴム成分100質量部中、20質量部以上、90質量部以下である請求項1~3のいずれか一項に記載の医療用ゴム組成物。
- (c)前記パーオキサイド系架橋剤の含有量は、(a)ブチルゴムと(b)ジエン系ゴムからなるゴム成分100質量部に対して、0.05質量部以上、7質量部以下である請求項1~4のいずれか一項に記載の医療用ゴム組成物。
- (d)前記共架橋剤の含有量は、(a)ブチルゴムと(b)ジエン系ゴムからなるゴム成分100質量部に対して、0.1質量部以上、10質量部以下である請求項1~5のいずれか一項に記載の医療用ゴム組成物。
- 請求項1~6のいずれか一項に記載の医療用ゴム組成物を成形してなる医療用ゴム部品。
- 請求項1~6のいずれか一項に記載の医療用ゴム組成物を成形してなるプレフィルドシリンジ用のノズルキャップ。
- 請求項8に記載のノズルキャップを有することを特徴とするプレフィルドシリンジ。
- 前記ノズルキヤップが、シリンジに取り付けられた状態でガス滅菌されるものである請求項9に記載のプレフィルドシリンジ。
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EP21162083.6A EP3888718B1 (en) | 2020-03-31 | 2021-03-11 | Medical rubber composition, medical rubber component, and prefilled syringe |
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