JP2017507126A - 強度の増加された経口投与型医薬用吸着剤 - Google Patents
強度の増加された経口投与型医薬用吸着剤 Download PDFInfo
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Abstract
Description
レーザ回折式粒度分布粒度測定装置(シンパテック社製、HELOS Particle Size Analysis)を用いて体積を基準とする粒度累積線図を作成し、体積平均径(Volume Mean Diameter;VMD)に相当する粒子径を平均粒子径とした。
ガス吸着法による比表面積測定器(マイクロメリティクス社製、ASAP 2420)を用いて球状活性炭のガス吸着量を測定し、BET式を用いて比表面積を計算した。
vm=1/{v×(1−x)}
を用いて、液体窒素温度における窒素吸着による1点法(相対圧力x=0.3)により、vm(m2/g)を求め、
下記式
比表面積=4.35×vm
を用いて、球状活性炭の比表面積を計算した。前記各計算式において、vは実際に測定されるガス吸着量(m2/g)であり、xは相対圧力である。
水銀気孔測定器(マイクロメリティックス社製、AUTOPORE IV 9500)を用いて気孔容積を測定した。球状活性炭を試料容器に入れ、30分間脱気した。水銀を試料容器内に取り込み、徐々に加圧して水銀を球状活性炭の気孔に押し込んだ。このときの圧力と水銀の圧入量との関係から、以下の各計算式を用いて球状活性炭試料の気孔容積分布を測定した。
球状活性炭1.0gを100mLのフラスコに取った後、酸消費量用の塩酸試液50mLを入れて、37±1℃において24時間かけて震とう器を用いて震とうさせた。室温において、フラスコの中身をろ過した後、前記溶液20mLを取って検液とし、0.1mol/Lの水酸化カリウム溶液に滴定した(指示薬:ブロモフェノールブルー試液2滴)。上記と同様の方法で空試験を行い補正した。下記式を用いて酸消費量を計算した。
球状活性炭1.0gを100mLのフラスコに取った後、塩基消費量用の塩酸試液50mLを入れて、37±1℃において24時間かけて震とう器を用いて震とうさせた。室温においてフラスコの中身をろ過した後、前記溶液20mLを取って検液とし、0.1mol/Lの塩酸を用いて滴定した(指示薬:フェノールフタレイン試液2滴)。 上記と同様の方法で空試験を行い補正した。下記式を用いて塩基消費量を計算した。
選択吸着率は、下記の通り計算する。
測定しようとする球状活性炭試料1錠を圧縮強度器チップの中間にくるように置いた後、圧縮強度器を20mm/分の速度で下降させ、最初の球状活性炭が破壊される強度を圧縮強度値とした。上記と同様の方法で球状活性炭試料22錠をそれぞれ測定した後、最大値及び最小値を除く20錠の値を平均として圧縮強度値を求めた。
以下に実施例を挙げて本発明をより具体的に説明するが、本発明は実施例に限定されるものではない。
球状フラン樹脂(株式会社ピュアスフィア社製)100gを金属製試料容器(内容量:1.5L)に収容した後、電気炉を用いて窒素ガス下で500℃の温度において1時間加熱して炭化させた。球状フラン樹脂炭化物をロータリー式外熱炉を用いて、水蒸気下で900℃の温度において140分加熱して活性化させることにより、球状活性炭を製造した。球状活性炭をロータリー式外熱炉を用いて酸素濃度を3vol%に調整した酸素−窒素混合ガス下で470℃の温度において5時間かけて酸化処理した後、窒素ガス下で900℃の温度において15分間還元処理を行って、多孔性球状活性炭を得た。
実施例1における水蒸気活性化時間を160分とし、それ以外は実施例1と同様にして多孔性球状活性炭を製造した。
実施例1における水蒸気活性化時間を180分とし、それ以外は実施例1と同様にして多孔性球状活性炭を製造した。
実施例1における水蒸気活性化時間を180分とし、且つ、炭化温度を450℃において1時間かけて行った以外は、実施例1と同様にして多孔性球状活性炭を製造した。
球状フラン樹脂100gを金属製試料容器(内容量1.5L)に収容した後、電気炉を用いて窒素ガス下で400℃の温度において1時間加熱して炭化させた。球状フラン樹脂炭化物をロータリー式外熱炉を用いて、水蒸気下で900℃の温度において180分加熱して活性化させることにより、球状活性炭を製造した。球状活性炭をロータリー式外熱炉を用いて酸素濃度を3vol%に調整した酸素−窒素の混合ガス下で470℃の温度において5時間かけて酸化処理した後、窒素ガス下で900℃の温度において15分間還元処理を行って、多孔性球状活性炭を得た。
球状フェノール樹脂100gを金属製試料容器(内容量1.5L)に収容した後、電気炉を用いて窒素ガス下で450℃の温度において1時間加熱して炭化させた。球状フェノール樹脂炭化物をロータリー式外熱炉を用いて、水蒸気下で900℃の温度において180分間加熱して活性化させることにより、球状活性炭を製造した。球状活性炭をロータリー式外熱炉を用いて酸素濃度を3vol%に調整した酸素−窒素の混合ガス下で470℃の温度において5時間かけて酸化処理した後、窒素ガス下で900℃の温度において15分間還元処理を行って、多孔性球状活性炭を得た。
実施例及び比較例のインドール吸着力を評価するために、インドールが1.0mg/mLの濃度で含有されているpH7.4のリン酸塩緩衝液900mLに多孔性球状活性炭300mgを投入し、回転数100rpmで3時間かけて溶出試験(溶出器:アジレント社製、708−DS)を行った。なお、選択吸着率は、DL−β−アミノイソ酪酸の除去及びα−アミラーゼの除去能に対する比較を用いて計算した。インドールの吸着速度は、下記のようにして求めるインドールの初期吸着率(%)で示す。
Claims (6)
- 強度の増加された多孔性活性炭からなる経口投与型医薬用吸着剤。
- 前記強度の増加された多孔性活性炭の気孔直径7.5〜15000nmの気孔容積が0.01mL/g以上0.10mL/g未満であり、
気孔直径20〜15000nmの気孔容積が0.005mL/g以上0.04mL/g未満であることを特徴とする請求項1に記載の経口投与型医薬用吸着剤。 - 前記強度の増加された多孔性活性炭の気孔直径7.5〜15000nmの気孔容積が0.03mL/g以上0.08mL/g未満であり、
気孔直径20〜15000nmの気孔容積が0.01mL/g以上0.03mL/g未満であることを特徴とする請求項1に記載の経口投与型医薬用吸着剤。 - 前記強度の増加された多孔性活性炭の選択吸着率が3.0以上であることを特徴とする請求項1乃至請求項3のうちのいずれか一項に記載の経口投与型医薬用吸着剤。
- 前記強度の増加された多孔性活性炭のインドールの初期吸着率が80%以上であることを特徴とする請求項1乃至請求項3のうちのいずれか一項に記載の経口投与型医薬用吸着剤。
- 前記強度の増加された多孔性活性炭は、10N/sphere以上であることを特徴とする請求項1乃至請求項3のうちのいずれか一項に記載の経口投与型医薬用吸着剤。
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