JP5439366B2 - 偏析防止効果に優れるセルロース粉末及びその組成物 - Google Patents
偏析防止効果に優れるセルロース粉末及びその組成物 Download PDFInfo
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- JP5439366B2 JP5439366B2 JP2010513050A JP2010513050A JP5439366B2 JP 5439366 B2 JP5439366 B2 JP 5439366B2 JP 2010513050 A JP2010513050 A JP 2010513050A JP 2010513050 A JP2010513050 A JP 2010513050A JP 5439366 B2 JP5439366 B2 JP 5439366B2
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- Prior art keywords
- cellulose
- powder
- active ingredient
- cellulose powder
- acid
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- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2301/00—Characterised by the use of cellulose, modified cellulose or cellulose derivatives
- C08J2301/02—Cellulose; Modified cellulose
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
Description
(1) セルロースI型結晶を含有し、平均粒子径が30μm未満、嵩密度が0.1〜0.45g/cm3、タッピング密度が0.1〜0.5g/cm3、安息角が35〜50°、比表面積が0.1以上20m2/g未満、内部摩擦角が36〜42°であることを特徴とするセルロース粉末。
(2) 一次粒子が凝集した二次凝集構造の粒子を含むことを特徴とする(1)に記載のセルロース粉末。
(3) 一次粒子が凝集した二次凝集構造の粒子が10〜100重量%であることを特徴とする(2)に記載のセルロース粉末。
(4) 1種以上の活性成分と、(1)〜(3)のいずれか一項に記載のセルロース粉末とを含むことを特徴とする組成物。
(5) 前記活性成分が、医薬用活性成分であることを特徴とする(4)に記載の組成物。
(6) 前記活性成分が、健康食品用活性成分であることを特徴とする(4)に記載の組成物。
(7) 前記医薬用活性成分又は前記健康食品用活性成分が、金属塩と化学反応する成分であることを特徴とする(5)又は(6)に記載の組成物。
(8) (4)〜(7)のいずれか一項に記載の組成物を直接打錠することを特徴とする成型体の製造方法。
(9) 天然セルロース質物質の平均粒子径が1〜20μm、固形分濃度が20重量%以下の水分散液を得る工程、該分散液を回転盤速度40〜200m/secで噴霧乾燥する工程を含むことを特徴とする、(1)〜(3)に記載のセルロース粉末の製造方法。
(10) 天然セルロース質物質が平均厚み0.5〜5μmのパルプ繊維を加水分解したものであることを特徴とする(9)に記載のセルロース粉末の製造方法。
CV(%)=活性成分の含有量の標準偏差/活性成分の含有量の平均値×100
天然セルロース質物質からなるセルロース一次粒子を、必要に応じて乾燥し、カーボンテープを貼った試料台に載せ、白金パラジウムを真空蒸着(この際の蒸着膜の膜厚は20nm以下)し、日本分光(株)製JSM−5510LV(商品名)を使用し、加速電圧6kV、倍率250、倍で観察し、代表的なセルロース一次粒子3個の平均値とした。
天然セルロース質物質からなるセルロース一次粒子を、必要に応じて乾燥し、カーボンテープを貼った試料台に載せ、金を真空蒸着した後、集束イオンビーム加工装置(日立製作所(株)製、FB−2100(商品名))を使用し、Gaイオンビームにより、セルロース一次粒子の断面を切り出した後、加速電圧6kV、倍率、1500倍で観察し、代表的なセルロース一次粒子3個の平均値とした。
水で分散したセルロース分散液を、レーザー回折式粒度分布計(堀場製作所製、LA−910(商品名))を使用し、超音波処理1分、屈折率1.20で測定した累積体積50%粒子として表した。ただし、この測定値は、以下のロータップ式で得られる乾燥粒子の粒度分布と測定原理が全く異なるため、必ずしも相関するものではない。レーザー回折により測定される平均粒子径は、繊維状粒子の長径に依存する体積頻度から測定されるものであるのに対し、ロータップ式で得られる平均粒子径は、得られた粉末を篩上で振とうさせて分画するため、繊維状粒子の短径に依存するものである。従って、繊維状粒子の長径に依存するレーザー回折式の方が、繊維状粒子の短径に依存するロータップ式に対し、大きい値となる場合がある。
X線ディフラクトメーターによりX線回折を行い、そのX線パターンにより判定した。
セルロース粉末の平均粒子径はロータップ式篩振盪機(平工作所製、シーブシェーカーA型(商品名))、JIS標準篩(Z8801−1987)を用いて、試料10gを10分間篩分することにより粒度分布を測定したときの累積重量50%粒径として表した。
容積25cm3の金属容器に、粉体試料を定量フィーダーなどを用いて2〜3分かけて粗充填し、粉体層上面をへらのような硬い板で水平にすり切った後、容器に投入された粉体重量を測定し、これを容積で割ることにより算出した。
市販粉体物性測定器(ホソカワミクロン製、パウダーテスターT−R型(商品名))を用い、100cm3カップに粉体を充填し、180回タッピングした後、カップの体積をカップに充填されて残る粉体層の重量で除して求めた。タッピング中に、粉体層がカップの体積よりも少なくなるので、測定中はカップに補助塔を付けて十分な粉体を入れておく。
杉原式安息角測定器(スリットサイズ奥行10×幅50×高さ140mm、幅50mmの位置に分度器を設置)を使用し、定量フィーダーを使用し、セルロース粉末を3g/分でスリットに投下した際の動的自流動性を測定した。装置底部とセルロース粉末の形成層との角度が安息角である。
マイクロメリティクス(株)製、商品名、TriSTARを用い、吸着ガスとして窒素を使用しBET法により測定した。各試料粉体を約1gずつセルに仕込み測定した。測定に用いた各試料粉体は、110℃で3時間減圧乾燥したものを使用した。
市販内部摩擦角測定器(日本ルフト株式会社製、ShearScan TS12((商品名))にて測定した。本装置において、垂直応力(σ)として3kPaかけた状態で剪断応力τを測定した時の内部摩擦角を使用した。本装置では、図1の破壊崩落線及び下記の(1)式から定常剪断値を結んだ直線CSLを求め、直線CSLの角度θを内部摩擦角としている。
(τ/c)n=1+(σ/σγ) ……(1)
ここで、τ;剪断応力 σ;垂直応力 σγ;引張応力 c;粘着強度 n;剪断指数
各セルロース試料を、カーボンテープを貼った試料台に載せ、白金パラジウムを真空蒸着(この際の蒸着膜の膜厚は20nm以下)し、日本分光(株)製、JSM−5510LV(商品名)を使用し、加速電圧6kV、倍率200〜1000倍で観察した場合に、一次粒子が連続して凝集し、一次粒子の境界が明確であり、確認できる細孔の中央細孔径が0.1μm以上である一次粒子が凝集した二次凝集粒子構造を有するものを有とし、それ以外の構造を取るものを無とした。
アスピリン(局方結晶アスピリンを小型粉砕機φ0.5mm、1パス処理)と、各セルロースサンプルを乾式で、1:1(全量0.5g)で粉体混合したものを、ガラス製サンプル瓶中で混合し、オーブン(タバイエスペック製、パーフェクトオーブン(商品名))に、密栓(60℃)で2週間保存した後、分解率を測定する。硫酸第二鉄(III)ナトリウム・12水和物8gを100mLのメスフラスコに導入し、純水を加え100mLとし、呈色試験液とする。保存後のアスピリン0.25g(粉体ブレンド品は全量で0.5g)を、50mLのメスフラスコに導入し、エタノールを加えて50mLとし、5分間振とうする。得られたエタノール溶液をろ過し、ろ液100mLのメスフラスコに移し、エタノールを加えて100mLとする。このエタノール溶液1mLと、上記呈色試験液1mLを50mLのメスフラスコに導入し、純水を加えて50mLとしたものを、紫外吸光度測定器(日本分光(株)製)を用いて、波長532nmの吸光度を測定する。分解率は、 分解率=(1−(保存後の吸光度/保存前の吸光度))×100(%)
として計算する。アスピリン単独の分解率である15%を超える分解率を示すものを反応性ありと判定した。
アセトアミノフェンとタルク、或はセルロース粉末と必要に応じてその他の添加剤を混合する工程において、粉体試料採取器(筒井理化学(株)製、サンプル容量0.8cm3)を使用し、混合5分後、15分後、30分後に混合機を停止し、各時点で上層、中層、下層より各3点ずつ、合計9点サンプリングを行った。サンプリングした粉体から2000mgを精秤し、100mlメスフラスコに入れ純水で100mlにメスアップし、樹脂フィルターにより水溶液中の不溶分をろ過した後、ろ液中の薬物のサンプリングした粉体重量に対する含有量を吸光度法(波長244nm)により定量した。錠剤の場合は錠剤1個約180mgを精秤した後、同様に操作して定量し、錠剤1個中に含まれる薬物含有量を算出した。混合粉体の場合は合計9点、錠剤の場合は合計10個について、薬物含量の平均値及び標準偏差を算出し、下式により、均一性の尺度である変動係数(CVとも言う)を求めた。変動係数は低いほど含量均一性が良好である。
変動係数(CV)(%)=(標準偏差/平均値)×100
装置(図2)は、幅105cm、高さ73cm、奥行き17.6cmのアクリル製枠内がホッパー状になっている(上下の枠は鉄製)。ホッパー状の上部幅は80.5cm、排出口は1cm、ホッパー角が60°である。この分離偏析測定装置に組成物を導入し、中心から0、7、10、17、25、27°の部分の粉体をサンプリングした。その後、サンプリングした各粉体中の活性成分の含有量を(11)と同様に操作して定量し、(11)と同様に変動係数を算出した。
溶解パルプ(広葉樹、幅19μm、厚み3μm)を細断したものを2kgと10%塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器(商品名))に入れ攪拌しながら、105℃、30分間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、純水で十分に洗浄した後、ろ過し、湿フロック(この酸不溶解性残渣のセルロース分散粒子の平均粒子径は9.0μmであった)を得た。90Lポリバケツに導入し、全固形分濃度が6重量%になるように純水を加え、3−1モーターで攪拌しながら、アンモニア水で中和(中和後のpHは7.5〜8.0)し、得られたセルロース分散液を噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃、回転盤直径8cm、回転数36000rpm)して、セルロース粉末Aを得た。セルロース粉末Aの諸物性を表1に示す。
溶解パルプ(広葉樹、幅19μm、厚み3μm)を細断したものを2kgと、4Nの塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器(商品名))に入れ攪拌しながら、40℃、48時間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、純水で十分に洗浄した後、ろ過し、湿フロックを得た。90Lポリバケツに導入し、全固形分濃度が4重量%になるように純水を加え、3−1モーターで攪拌しながら、アンモニア水で中和(中和後のpHは7.5〜8.0)し、高圧ホモジナイザー(APV製 RANNIE5−10.38(商品名))で70MPaで4回処理した。(この酸不溶解性残渣のセルロース分散粒子の平均粒子径は8.1μm)これを噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃、回転盤直径8cm、回転数30000rpm)して、セルロース粉末Bを得た。セルロース粉末Bの諸物性を表1に示す。
溶解パルプ(広葉樹、幅19μm、厚み3μm)を細断したものを2kgと、4Nの塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器(商品名))に入れ攪拌しながら、40℃、48時間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、純水で十分に洗浄した後、ろ過し、湿フロックを得た。90Lポリバケツに導入し、全固形分濃度が2重量%になるように純水を加え、3−1モーターで攪拌しながら、アンモニア水で中和(中和後のpHは7.5〜8.0)し、高圧ホモジナイザー(APV製 RANNIE5−10.38(商品名))で70MPaで8回処理した。(この酸不溶解性残渣のセルロース分散粒子の平均粒子径は6.9μm)これを噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃、回転盤直径8cm、回転数30000rpm)して、セルロース粉末Cを得た。セルロース粉末Cの諸物性を表1に示す。
溶解パルプ(広葉樹、幅19μm、厚み3μm)を細断したものを2kgと、10%塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器(商品名))に入れ攪拌しながら、105℃、30分間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、純水で十分に洗浄した後、ろ過し、湿フロック(この酸不溶解性残渣のセルロース分散粒子の平均粒子径は9μmであった)を得た。90Lポリバケツに導入し、全固形分濃度が8重量%になるように純水を加え、3−1モーターで攪拌しながら、アンモニア水で中和(中和後のpHは7.5〜8.0)し、得られたセルロース分散液を噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃、回転盤直径8cm、回転数36000rpm)して、セルロース粉末Dを得た。セルロース粉末Dの諸物性を表1に示す。
溶解パルプ(広葉樹、幅19μm、厚み3μm)を細断したものを2kgと、0.8%塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器(商品名))に入れ攪拌しながら、130℃、50分間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、純水で十分に洗浄した後、ろ過し、湿フロック(この酸不溶解性残渣のセルロース分散粒子の平均粒子径は6μmであった)を得た。90Lポリバケツに導入し、全固形分濃度が4重量%になるように純水を加え、3−1モーターで攪拌しながら、アンモニア水で中和(中和後のpHは7.5〜8.0)し、得られたセルロース分散液を噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃、回転盤直径8cm、回転数36000rpm)して、セルロース粉末Eを得た。セルロース粉末Eの諸物性を表1に示す。
溶解パルプ(広葉樹、幅19μm、厚み3μm)を細断したものを2kgと、1.5%塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器(商品名))に入れ攪拌しながら、135℃、90分間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、純水で十分に洗浄した後、ろ過し、湿フロック(この酸不溶解性残渣のセルロース分散粒子の平均粒子径は5μmであった)を得た。90Lポリバケツに導入し、全固形分濃度が4重量%になるように純水を加え、3−1モーターで攪拌しながら、アンモニア水で中和(中和後のpHは7.5〜8.0)し、得られたセルロース分散液を噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃、回転盤直径8cm、回転数36000rpm)して、セルロース粉末Fを得た。セルロース粉末Fの諸物性を表1に示す。
アセトアミノフェン((株)エーピーアイ製、粉末タイプを小型粉砕機で粉砕して使用。平均粒子径16μm)20g、セルロース粉末A400g、結晶セルロース「セオラス」PH−101(旭化成ケミカルズ製)400g、100メッシュ乳糖1180gを、容積5LのV型混合機(ダルトン社製)に投入し、30分間混合した(混合比率:アセトアミノフェン/セルロース粉末A/乳糖/結晶セルロース=1/20/59/20、充填率約65%)。これは、特許文献1の比較例1で用いられているタルク2gをセルロース粉末A400gに置き換えたものに相当し、混合比率が100%になるように乳糖で調整した。薬物濃度の変動係数を表2に示す。特許文献1の比較例1ではタルクを前混合していないため、混合15分の時点でも薬物濃度の変動係数が11.1%と高く、混合速度が遅い。一方、本願のセルロース粉末は分散性が良く、また飛散性が小さいため20重量%配合することが可能であることから、混合速度を速くすることが可能である。続いて得られた全薬物混合粉体を、ロータリー打錠機(菊水製作所製、LIBRA−II(商品名)、12本杵、回転盤径φ410mm)を使用し、直径8mm、12Rの杵を用いてターンテーブル回転数50rpmで重量約180mgの錠剤に成形した。打錠開始から10分後、30分後、60分後の錠剤中の薬物濃度の変動係数を表2に示す。変動係数の最大値と最小値の差は0.2と打錠中はほとんど偏析がなく良好であった。
セルロース粉末Aをセルロース粉末B〜Fとする以外は、実施例7と同様に操作した。結果を表2に示す。混合時の薬物濃度の変動係数及び、打錠開始から10分後、30分後、60分後の錠剤中の薬物濃度の変動係数を表2に示す。変動係数の最大値と最小値の差はいずれのセルロース粉末を用いた試料においても0〜0.2と打錠中はほとんど偏析がなく良好であった。
アセトアミノフェン((株)エーピーアイ製、粉末タイプを小型粉砕機で粉砕して使用。平均粒子径16μm)240g、セルロース粉末B200g、結晶セルロース「セオラス」KG−802(旭化成ケミカルズ製、文献7の実施例2相当)200g、噴霧乾燥乳糖(スーパータブ(商品名)、旭化成ケミカルズ販売)1360gを、容積5LのV型混合機(ダルトン社製)に投入し、30分間混合した(混合比率:アセトアミノフェン/セルロース粉末B/乳糖/結晶セルロース=12/10/68/10、充填率約65%)。薬物濃度の変動係数を表3に示す。続いて得られた混合粉体を、ロータリー打錠機(菊水製作所製、LIBRA−II(商品名)、12本杵、回転盤径φ410mm)を使用し、直径8mm、12Rの杵を用いてターンテーブル回転数50rpmで重量約180mgの錠剤に成形した。打錠開始から10分後、30分後、60分後の錠剤中の薬物濃度の変動係数を表3に示す。変動係数の最大値と最小値の差は0.1と打錠中はほとんど偏析がなく良好であった。
アセトアミノフェン((株)エーピーアイ製、粉末タイプを小型粉砕機で粉砕して使用。平均粒子径16μm)400g、セルロース粉末B200g、結晶セルロース「セオラス」KG−802(旭化成ケミカルズ製)200g、噴霧乾燥乳糖(スーパータブ(商品名)、旭化成ケミカルズ販売)1200gを、容積5LのV型混合機(ダルトン社製)に投入し、30分間混合した(混合比率:アセトアミノフェン/セルロース粉末B/乳糖/結晶セルロース=20/10/60/10、充填率約65%)。薬物濃度の変動係数を表4に示す。続いて得られた混合粉体を、ロータリー打錠機(菊水製作所製、LIBRA−II(商品名)、12本杵、回転盤径φ410mm)を使用し、直径8mm、12Rの杵を用いてターンテーブル回転数50rpmで重量約180mgの錠剤に成形した。打錠開始から10分後、30分後、60分後の錠剤中の薬物濃度の変動係数を表4に示す。変動係数の最大値と最小値の差は0.2と打錠中はほとんど偏析がなく良好であった。
アセトアミノフェン((株)エーピーアイ製、粉末タイプを小型粉砕機で粉砕して使用。平均粒子径16μm)20g、タルク(和光純薬(株))10g、結晶セルロース「セオラス」PH−101(旭化成ケミカルズ製)400g、100メッシュ乳糖1570gを、容積5LのV型混合機(ダルトン社製)に投入し、30分間混合した(特許文献1、比較例1に相当。混合比率:アセトアミノフェン/タルク/乳糖/結晶セルロース=1/0.5/78.5/20、充填率約65%)。薬物濃度の変動係数を表2に示す。本願のセルロース粉末より混合5分、15分の時点の変動係数が高く、混合速度の点で劣った。続いて得られた混合粉体を、ロータリー打錠機(菊水製作所製、LIBRA−II(商品名)、12本杵、回転盤径φ410mm)を使用し、直径8mm、12Rの杵を用いてターンテーブル回転数50rpmで重量約180mgの錠剤に成形した。打錠開始から10分後、30分後、60分後の錠剤中の薬物濃度の変動係数を表2に示す。変動係数の最大値と最小値の差は1.1と本願のセルロース粉末より大きく、偏析抑制効果は劣った。
市販のパルプ(木材由来の天然セルロース溶解パルプ、平均重合度1030、セルロース一次粒子の繊維平均幅は約39μm、平均厚みは約8μm)を細断したものを2kgを水に浸漬し、約70%の水分を含む状態で、カッターミル(URSCHEL LABORATORIES,INC.製、「コミトロール」(商品名)、モデル1700、マイクロカットヘッド/ブレード間隙:2.029mm、インペラー回転数9000rpm)を通した後、純水を加えて約2%濃度のセルロース分散液に調製し、高圧ホモジナイザー(MFIC Corp.製、商品名「マイクロフルイダイザー」M−140K型、処理圧力200MPa)で2回処理したものを、遠心力19600m/s2で遠心分離し、上澄みを捨て、沈降物を得た。沈降物を40℃で16時間乾燥したもの約2kgと、4N塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、50LGL反応器(商品名))に入れ攪拌しながら、40℃、48時間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、洗浄、ろ過、中和し、固形分濃度20重量%のセルロース分散液とし、これを噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃)し、特許文献2の実施例1相当のセルロース粉末を得、さらにミクロンセパレータで75μm以上の粗大粒子を除きセルロース粉末Gを得た。セルロース粉末Gの諸物性を表1に示す。
市販のパルプ(木材由来の天然セルロース溶解パルプ、平均重合度1030、セルロース一次粒子の繊維平均幅は約39μm、及び平均厚みは約8μm)を細断したものを2kgを水に浸漬し約70%の水分を含む状態で、カッターミル(URSCHEL LABORATORIES,INC.製、「コミトロール」(商品名)、モデル1700、マイクロカットヘッド/ブレード間隙:2.029mm、インペラー回転数9000rpm)を通した後、純水を加えて約2%濃度のセルロース分散液に調製し、高圧ホモジナイザー(MFIC Corp.製、「マイクロフルイダイザー」M−140K型(商品名)、処理圧力200MPa)で4回処理したものを、遠心力19600m/s2で遠心分離し、上澄みを捨て、沈降物を得た。沈降物を40℃で16時間乾燥したもの約2kgと、5N塩酸水溶液30Lを、低速型攪拌機(池袋琺瑯工業(株)製、50LGL反応器(商品名))に入れ攪拌しながら、40℃、20時間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、洗浄、ろ過、中和し、固形分濃度20重量%のセルロース分散液とし、これを噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃)し、特許文献2の実施例4相当のセルロース粉末Hを得た。セルロース粉末Hの諸物性を表1に示す。
広葉樹を公知のパルプ化処理、漂白処理を施すことにより、セルロース一次粒子の繊維平均幅は約19μm、平均厚みは約3μm、レベルオフ重合度140〜220、水分5〜10%、白色度92〜97%、粘度5〜40cps、S105〜15%、S181〜8%、銅価0.5〜1.5、及びジクロロメタン抽出物0.03ppm以下のパルプを得た。該パルプ2kgと5N塩酸水溶液30Lを、低速型攪拌機(池袋琺瑯工業(株)製、商品名、50LGL反応器)に入れ攪拌しながら、40℃、20時間加水分解し、酸不溶解性残渣を得た。得られた酸不溶解性残渣は、洗浄、ろ過、中和し、固形分濃度15重量%のセルロース分散液とし、これを噴霧乾燥(分散液供給速度6kg/hr、入口温度180〜220℃、出口温度50〜70℃)し、特許文献2の実施例4相当のセルロース粉末Iを得た。セルロース粉末Iの諸物性を表1に示す。
市販DPパルプを細断し、10%塩酸中で105℃、20分間加水分解して得られた酸不溶解残渣をろ過、洗浄、乾燥後、気流式粉砕機(セイシン企業(株)製、シングルトラックジェットミルSTJ−200型(商品名))で粉砕し、特許文献3の実施例、試料(C)相当のセルロース粉末Jを得た。得られたセルロース粉末Jの諸物性値を表1に示す。
市販DPパルプを細断し、10%塩酸中で105℃、20分間加水分解して得られた酸不溶解残渣をろ過、洗浄、乾燥後、気流式粉砕機(セイシン企業(株)製、シングルトラックジェットミルSTJ−200型(商品名))で粉砕し、特許文献3の実施例、試料(B)相当のセルロース粉末Kを得た。得られたセルロース粉末Kの諸物性値を表1に示す。
レーヨン糸くず1kgを細断し、1.5%塩酸溶液中で130℃、50分間加水分解して得られた酸不溶解残渣をろ過洗浄し、噴霧乾燥した後、ACMパルペライザーで解砕後、ミクロンセパレーターで30μm以上の粗大粒子を除き、特許文献4の実施例1試料(D)相当のセルロース粉末Lを得た。得られたセルロース粉末Lの諸物性値を表1に示す。
レーヨン糸くず1kgを細断し、1.5%塩酸溶液中で135℃、90分間加水分解して得られた酸不溶残渣をろ過洗浄し、噴霧乾燥した後、ACMパルペライザーで解砕後、ミクロンセパレーターで30ミクロン以上の粗大粒子を除き、特許文献4の実施例1試料(E)相当のセルロース粉末Mを得た。得られたセルロース粉末Mの諸物性値を表1に示す。
市販KPパルプ1kgを細断し、10%塩酸溶液中で、105℃、20分間加水分解して得られた酸不溶解残渣をろ過洗浄し、風乾後、通常のハンマーミルで解砕し、50メッシュの篩で粗大分を除き、特許文献5実施例3相当のセルロース粉末Nを得た。得られたセルロース粉末Nの諸物性値を表1に示す。
レーヨン糸くず1kgを細断し、1%硫酸溶液中で105℃、120分間加水分解して得られた酸不溶残渣をろ過洗浄し、風乾後、通常のハンマーミルで解砕し、50メッシュの篩で粗大分を除き、特許文献5実施例4相当のセルロース粉末Oを得た。得られたセルロース粉末Oの諸物性値を表1に示す。
結晶セルロース(平均重合度250)1.5kgを高速攪拌造粒機((株)パウレック製、VG−01)に仕込み、蒸留水900gを加え、30分間練合した。この湿顆粒2.4kgを転動流動型コーティング装置に仕込み、蒸留水を7.8g/minの速度で340g供給しながら給気温度25℃で45分転動させ、その後さらに30分転動させた。その後給気温度を100℃に上げて乾燥させ、乾燥後、目開き75μm篩と45μmの篩でふるい、特許文献6の実施例3(本願に最も平均粒子径が近いもの)相当のセルロース粉末Pを得た。得られたセルロース粉末Pの諸物性値を表1に示す。
市販SPパルプ(重合度790、レベルオフ重合度220)2kgを細断し、4N塩酸水溶液30L中に入れ、低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器、翼径30cm)で攪拌しながら、40℃、48時間加水分解した。得られた酸不溶解残渣はろ過、洗浄、固形分濃度8%のセルロース分散液とし、これを噴霧乾燥(液供給速度6L/hr、入口温度180〜220℃、出口温度50〜70℃)して、特許文献7の実施例2相当のセルロース粉末Qを得た。得られたセルロース粉末Qの諸物性値を表1に示す。
パルプを市販SPパルプ(重合度870、レベルオフ重合度は220)、加水分解条件を3N塩酸水溶液、40℃、24時間とする以外は比較例12と同様に操作し、特許文献7の実施例6相当のセルロース粉末Rを得た。得られたセルロース粉末Rの諸物性値を表1に示す。
市販SPパルプ2kgを細断し、0.5%塩酸水溶液30L中に入れ、低速型攪拌機(池袋琺瑯工業(株)製)で攪拌しながら、121℃、1時間加水分解した。得られた酸不溶解残渣を70℃で真空乾燥後、325メッシュの篩で粗大分を除き、特公昭40−26274実施例1相当のセルロース粉末Sを得た。得られたセルロース粉末Sの諸物性値を表1に示す。
セルロース粉末Sを38μm篩で分級し、セルロース粉末Tを得た。得られたセルロース粉末Sの諸物性値を表1に示す。
セルロース粉末Aをセルロース粉末G〜Tのいずれかとする以外は、実施例7と同様に操作した。結果を表2に示す。混合時の薬物濃度の変動係数及び、打錠開始から10分後、30分後、60分後の錠剤中の薬物濃度の変動係数を表2に示す。いずれのセルロース粉末も混合30分後で薬物濃度の変動係数が2%以下となることはなく、本願のセルロース粉末に劣った。また、セルロース粉末K、L、M、Oのいずれかを用いて30分間混合した混合粉体を分離偏析測定装置(図2参照、幅105cm、高さ73cm、奥行き17.6cmのアクリル製のホッパー状の円錐容器で、粉体投入部の幅は80.5cm、排出口は1cm、円錐の角度は60°)に投入し、装置の中心から、0°、7°、10°、17°、25°、27°の6箇所より混合粉体をサンプリングした。薬物濃度の変動係数を表5に示す。いずれも円錐容器内での薬物濃度の変動係数が高く、本願のセルロース粉末を使用した実施例7より劣った。
セルロース粉末Bをタルク又はセルロース粉末G、J、M、N、P、Q、Sのいずれかとする以外は、実施例13と同様に操作した。結果を表3に示す。いずれのセルロース粉末も混合30分後で薬物濃度の変動係数が2%以下となることはなく、本願のセルロース粉末に劣った。
セルロース粉末Bをタルク又はセルロース粉末G、J、M、N、P、Q、Sのいずれかとする以外は、実施例14と同様に操作した。結果を表3に示す。いずれのセルロース粉末も混合30分後に薬物濃度の変動係数が2%以下となることはなく、本願のセルロース粉末に劣った。
Claims (10)
- セルロースI型結晶を含有し、平均粒子径が30μm未満、嵩密度が0.1〜0.45g/cm3、タッピング密度が0.1〜0.5g/cm3、安息角が35〜50°、比表面積が0.1以上20m2/g未満、内部摩擦角が35〜42°であることを特徴とするセルロース粉末。
- 一次粒子が凝集した二次凝集構造の粒子を含むことを特徴とする請求項1に記載のセルロース粉末。
- 一次粒子が凝集した二次凝集構造の粒子が10〜100重量%であることを特徴とする請求項2に記載のセルロース粉末。
- 1種以上の活性成分と、請求項1〜3のいずれか一項に記載のセルロース粉末とを含むことを特徴とする組成物。
- 前記活性成分が、医薬用活性成分であることを特徴とする請求項4に記載の組成物。
- 前記活性成分が、健康食品用活性成分であることを特徴とする請求項4に記載の組成物。
- 前記医薬用活性成分又は前記健康食品用活性成分が、金属塩と化学反応する成分であることを特徴とする請求項5又は6に記載の組成物。
- 請求項4〜7のいずれか一項に記載の組成物を直接打錠することを特徴とする成型体の製造方法。
- 天然セルロース質物質の平均粒子径が1〜20μm、固形分濃度が20重量%以下の水分散液を得る工程、該分散液を回転盤速度40〜200m/secで噴霧乾燥する工程を含むことを特徴とする、請求項1から3のいずれか一項に記載のセルロース粉末の製造方法。
- 天然セルロース質物質が平均厚み0.5〜5μmのパルプ繊維を加水分解したものであることを特徴とする請求項9に記載のセルロース粉末の製造方法。
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