JPWO2009123102A1 - 崩壊性に優れる加工澱粉粉末及びその製法 - Google Patents
崩壊性に優れる加工澱粉粉末及びその製法 Download PDFInfo
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- JPWO2009123102A1 JPWO2009123102A1 JP2010505896A JP2010505896A JPWO2009123102A1 JP WO2009123102 A1 JPWO2009123102 A1 JP WO2009123102A1 JP 2010505896 A JP2010505896 A JP 2010505896A JP 2010505896 A JP2010505896 A JP 2010505896A JP WO2009123102 A1 JPWO2009123102 A1 JP WO2009123102A1
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- starch
- water
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- processed
- processed starch
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Abstract
Description
(1) 水溶性成分量が2重量%より大きく10重量%未満、及び保水量が600%よりも大きく1500%以下であって、かつ非複屈折性粒子であることを特徴とする加工澱粉粉末。
(2) 乾燥状態の一次粒子の平均粒子径が25〜80μm、水中での膨潤状態の一次粒子の平均粒子径が45〜160μmである、(1)に記載の加工澱粉粉末。
(3) 生澱粉粒由来の外殻構造を有している、(1)又は(2)に記載の加工澱粉粉末。
(4) アミロース含量が20重量%以上30重量%未満の天然澱粉質原料を化学的処理することなく得られる、(1)〜(3)いずれか一項に記載の加工澱粉粉末。
(5) 乾燥粒子の一次粒子の平均粒子径が天然澱粉質原料よりも大きい、(1)〜(4)いずれか一項に記載の加工澱粉粉末。
(6) 天然澱粉質原料がバレイショ澱粉である、(1)〜(5)いずれか一項に記載の加工澱粉粉末。
(7) (i)天然澱粉質原料を減圧条件下100〜130℃の蒸気による加熱処理をする工程、(ii)該加熱処理された澱粉質原料を固形分濃度1〜20重量%の澱粉乳液に調製する工程、(iii)該澱粉乳液を澱粉固有の糊化開始温度を10℃上回る温度を超え、90℃未満の温度範囲で加熱処理する工程、(iv)次いで、該加熱処理された澱粉乳液を乾燥する工程を含む方法により得られる、(1)〜(6)いずれか一項に記載の加工澱粉粉末。
(8) 沈降体積が7cm3/g以上20cm3/g以下である、(1)〜(7)のいずれか一項に記載の加工澱粉粉末。
(9) 乾燥状態と水中での膨潤状態の一次粒子の膨潤比が1.5〜5.0である、(1)〜(8)のいずれか一項に記載の加工澱粉粉末。
(10) 前記加工澱粉粉末が崩壊剤である、(1)〜(9)いずれか一項に記載の加工澱粉粉末。
(11) (1)〜(10)のいずれか一項に記載の加工澱粉粉末及び1種以上の活性成分を含む組成物。
(12) 直接打錠で得られる、硬度が100±10N、崩壊時間が70秒以下である(11)に記載の組成物。
(13) 攪拌造粒後、打錠して得られる、硬度が100±10N、崩壊時間が60秒以下である(11)に記載の組成物。
(14) 流動層造粒後、打錠して得られる、硬度が100±10N、崩壊時間が130秒以下である(11)に記載の組成物。
(15) 前記加工澱粉粉末を前記組成物中に0.2〜5重量%配合する、(11)〜(14)いずれか一項に記載の組成物。
(16) 1種以上の活性成分が、医薬品薬効成分、食品成分から選択されたものである、(11)〜(15)いずれか一項に記載の組成物。
(17) (i)天然澱粉質原料を減圧条件下100〜130℃の蒸気による加熱処理をする工程、(ii)該加熱処理された澱粉質原料を固形分濃度1〜20重量%の澱粉乳液に調製する工程、(iii)該澱粉乳液を澱粉固有の糊化開始温度を10℃上回る温度を超え、90℃未満の温度範囲で加熱処理する工程、(iv)次いで、該加熱処理された澱粉乳液を乾燥する工程を含む、(1)又は(7)に記載の加工澱粉粉末の製造方法。
÷加工澱粉1gの絶乾重量(g)×100・・・(1)
上記で計算した値は、マグネチックスターラーでの攪拌時間を10分、遠心力を2000Gとしても大きくは変化しなかった。
保水量が600%未満だと、澱粉粒子が十分に水を取り込むことができず、大きく膨潤することができないため、十分な崩壊性が得らず好ましくない。保水量が1500%を超えると、澱粉粒子が大きく膨潤しすぎてしまい、膨潤した澱粉粒子同士が会合する等して粘性の高いゲルを形成しやすくなり、固形製剤内部への吸水が阻害されてしまう等、十分な崩壊性が得られにくくなるため好ましくない。
W2(μm)/W1(μm)・・・(3)
乾燥状態と水中での膨潤状態の一次粒子の膨潤比が1.5倍以上で、澱粉粉末が吸水した際に大きな膨潤力が得られ、固形製剤を破壊してその内容物を放出するために十分な崩壊力を提供することができる。乾燥状態と水中での膨潤状態の一次粒子の膨潤比は大きいほど澱粉粉末が吸水した際の膨潤力が大きくなり、固形製剤を破壊する崩壊力が大きくなるので好ましい。しかし、膨潤比が大きすぎると膨潤した澱粉粒子同士が会合して粘性の高いゲルを形成してしまい、固形製剤内部への吸水が阻害されて崩壊時間が長くなってしまうので好ましくない。膨潤比が5.0以下では良好な崩壊性を確保できるので好ましい。
加工澱粉の沈降体積が7cm3/g未満だと、澱粉粒子が吸水した際の膨潤力が不十分なため、固形製剤に付与できる崩壊性が不十分となり好ましくない。一方、加工澱粉の沈降体積が20cm3/gより大きいと、膨潤した澱粉粒子同士が会合して粘性の高いゲルを形成してしまい、固形製剤内部への吸水が阻害されて崩壊時間が長くなってしまうので好ましくない。加工澱粉の沈降体積が7cm3/g以上20cm3/g以下の範囲であれば、固形製剤の崩壊を促進できるので好ましい。
加工澱粉粉末の光学顕微鏡像を画像解析処理し((株)インタークエスト製、装置:Hyper700,ソフトウエア:Imagehyper)、粒子に外接する長方形のうち面積が最小となる長方形の長辺を粒子の一次粒子径とした。乾燥状態の一次粒子の平均粒子径W1(μm)は少なくとも粒子400個の平均値とした。光学顕微鏡像は、個々の粒子ができるだけ重ならないように少量ずつを試料台上にばらまくようにして撮影し、画像解析時には、重なりがあり明確に一次粒子と判断できないものは除外して計測した。次に、20℃±5℃の純水200gを容器に入れ、マグネチックスターラー500rpmで攪拌しながら、加工澱粉1.0gを2分間かけて投入し、投入後から3分間分散させた。得られた分散液を超音波(シャープ株式会社、SILENTSONIC(商品名)、UC−6200、高周波出力600W、40kHz)で5分間処理し、分散液の一部を光学顕微鏡で観察した。視野内に粒子が20個以上入る倍率で観察し、判別可能な全ての一次粒子の最大径を計測した。最大径の計測を5回繰り返し、5回測定分の全粒子の最大径の平均値を求め、膨潤状態の一次粒子の平均粒子径W2(μm)とした。ここで、一次粒子の最大径とは、一次粒子の端と端を結ぶ直線が最大になる長さを指す。また、一次粒子とは、生の澱粉粒と同じ構成単位の粒子のことをいうが、重なりや凝集などで一次粒子と明確に識別できないものは除外して計測した。
(2)水溶性成分量(重量%)
加工澱粉3gに20℃±5℃の純水97gを加えてマグネチックスターラーで2時間攪拌して分散させ、得られた分散液の40cm3を50cm3の遠沈管に移し、5000Gで15分間遠心分離した。この上澄液30cm3を秤量瓶に入れ、110℃で一定重量になるまで乾燥して水溶性成分の乾燥重量(g)を求めた。また、加工澱粉1gを110℃で一定重量になるまで乾燥して加工澱粉の絶乾重量(g)を求めた。これらの値と下式(2)により求めた値で水溶性成分量(重量%)を定義する。
÷加工澱粉1gの絶乾重量(g)×100・・・(2)
(3)保水量(%)
加工澱粉W0(g)(約1g)を、約15cm3の20℃±5℃の純水が入った50cm3遠沈管へ少しずつ入れ、スパチュラで2分程度かき混ぜながら透明〜半透明になるまで純水に分散させた。50cm3沈降管の7割程度になるよう20℃±5℃の純水を追加して遠心分離(2000G、10分)した。遠心分離終了後1分以内に分離した上層を切り捨てた後、下層に残る重量W(g)(澱粉+澱粉が保持する純水量)から下式(3)により保水量(%)を求めた。
(4)沈降体積(cm3/g)
20±5℃の純水70gを容器に入れ、マグネチックスターラー500rpmで攪拌しながら、加工澱粉1.0gを約2分間かけて投入し、投入後から3分間分散させた。分散液は100cm3の沈降管に移し、容器に付着した分散液を純水で洗浄しながら、全量を100cm3とし、16時間放置した。その後、上下に分かれた下層の容積V(cm3)と加工澱粉1.0gの絶乾重量(g)とを測定し、下式(4)より沈降体積(cm3/g)を算出した(ここでの絶乾重量は水溶性成分量の計算の場合と同様に求めた)。
(5)水中での膨潤状態の一次粒子の平均粒子径
(1)で計測したW2(μm)の値を使用した。
(6)乾燥状態の一次粒子の平均粒子径
(1)で計測したW1(μm)の値を使用した。
20℃±5℃の純水200gを容器に入れ、マグネチックスターラー500rpmで攪拌しながら、加工澱粉1.0gを2分間かけて投入し、投入後から3分間分散させた。得られた分散液を超音波で5分間処理し、分散液の一部を光学顕微鏡で観察した。本発明の加工澱粉粉末は、澱粉質原料が本来有する外殻構造を有していた。外殻構造を有しているとは、光学顕微鏡で20個以上の粒子が視野内に観察される倍率で観察する時、澱粉質原料が本来有する外殻構造を示す粒子が、全粒子の個数に対して90%以上であることをいう。複数の一次粒子が凝集あるいは重なりにより、1個の一次粒子であることが不明瞭な状況にある粒子は除外して計測した。
(8)非複屈折性粒子
20℃±5℃の純水200gを容器に入れ、マグネチックスターラー500rpmで攪拌しながら、加工澱粉1.0gを2分間かけて投入し、投入後から3分間分散した。得られた分散液を超音波で5分間処理し、分散液の一部を偏光顕微鏡で観察した。複屈折性粒子は、粒子の4隅に輝きのあるいわゆる偏光十字模様を示すが、本発明では粒子の4隅のうち、2つ以上に明確な輝きがある粒子を複屈折性粒子と定義する。1つの輝きは明瞭だが、もう1つが不明瞭な粒子は除外した。一次粒子の全個数と本発明でいう複屈折性粒子の個数とから、非複屈折性粒子数(=全粒子−本発明でいう複屈折粒子の個数)を求め、全粒子数で除することにより非複屈折粒子の割合(百分率)を求めた。本発明の加工澱粉粒子は、非複屈折性粒子の割合が、識別された一次粒子の全個数に対して90%以上存在する。ここで、非複屈折性粒子であるとは、非複屈折性粒子の割合が識別された一次粒子の全個数に対して90%以上存在することをいう。識別された一次粒子とは、複数の一次粒子が凝集あるいは重なりにより、1個の一次粒子であることが不明瞭な状況にある粒子は含まず、明確に1個の一次粒子と確認できる一次粒子をいう。不明瞭な状況にある粒子が多い場合は、上記の超音波処理時間を延ばすか、純水で薄めるなどして適宜調整する。
崩壊時間(秒)は、処方粉末0.5gを静圧プレス(MODEL−1321DW CREEP/アイコーエンジニアリング株式会社製)を用いて130MPaの圧縮力で成形して得られる直径1.13cmの円柱状成形体の試験液中での崩壊時間で定義される。試験液は第14改正日本薬局方に記載の第2液(pH6.8)であり、崩壊試験は第15改正日本薬局方の崩壊試験法に準じ、補助盤を使用しない条件で行った。
シュロインゲル硬度計(8D型、フロイント産業(株)輸入販売)を用いて測定した。
第15改正日本薬局方に記載の方法に準拠し、崩壊試験機(NT−40 HS、富山産業製)を用い、純水37℃、ディスク無しの条件にて測定した。
バレイショ澱粉をステンレスバット(50cm×25cm)中に層厚5cmで充填して耐圧容器内で5分間減圧(600mmHg)にした後、加圧蒸気(120℃)にて20分間湿熱処理した。該湿熱処理したバレイショ澱粉を純水中に分散し、固形分濃度10重量%の澱粉乳液を調製した。該澱粉乳液を20L/hrでジェットクッカーで加熱・糊化(出口温度72℃)し、次いで噴霧乾燥し、加工澱粉Aを得た。得られた加工澱粉Aの基礎物性を表1に、水中での膨潤状態の粒子形態の光学顕微鏡写真を図5(a)、(b)に示した((b)は偏光写真)。水中での膨潤状態の粒子形態は、マイクロスコープ(デジタルマイクロスコープKH−1300(商品名)、HIROX社製)を用い、倍率350、透過光の条件で観察した。また、偏光下での粒子形態は、偏光を示さない粒子が観察されず、且つ、偏光を示す部位のみ光が透過し観察されるよう、光量及び偏光の程度を調節して観察した。
加工澱粉Aとエテンザミド(エーピーアイコーポレーション製)と結晶セルロース(「セオラス」(登録商標)KG−802、旭化成ケミカルズ株式会社製)と造粒乳糖(スーパータブ(商品名)、旭化成ケミカルズ株式会社製)と軽質無水ケイ酸(アエロジル200(商品名)、日本アエロジル)とを3/30/10/57/1の重量比になるように均一に混合した。次いで該混合粉体とステアリン酸マグネシウム(植物性ステアリン酸マグネシウム、太平化学産業)の重量比が100/0.5となるようにステアリン酸マグネシウムを加えて緩やかに混合し、ロータリー打錠機(クリーンプレスコレクト12HUK(商品名)/株式会社菊水製作所製)を用いて8、10、12MPaの圧力で圧縮し、直径8.0mm、重量0.18gの錠剤を得た。
加工澱粉Aとエテンザミド(エーピーアイコーポレーション製)と結晶セルロース(「セオラス」(登録商標)PH−101、旭化成ケミカルズ株式会社製)と結晶乳糖(200メッシュ乳糖、DMV製)とを3/30/10/57の重量比になるように均一に混合し、攪拌造粒機(VG−10、パウレック株式会社製)にて、ブレード回転数210rpm、クロスチョッパー回転数2000rpmの条件で、8%HPC−L(日本曹達製)を結合剤に用いて湿式造粒した。得られた顆粒を60℃で16時間乾燥し、次いで目開き1400μmの篩にて粗大粒子を除去して打錠用顆粒を得た。得られた造粒用顆粒とステアリン酸マグネシウム(植物性ステアリン酸マグネシウム、太平化学製)とを100/0.5の重量比になるよう緩やかに混合し、ロータリー打錠機(クリーンプレスコレクト12HUK(商品名)/株式会社菊水製作所製)を用いて8、10、12MPaの圧力で圧縮し、直径8.0mm、重量0.18gの錠剤を得た。
加工澱粉Aとエテンザミド(エーピーアイコーポレーション製)と結晶セルロース(「セオラス」(登録商標)PH−101、旭化成ケミカルズ株式会社製)と結晶乳糖(200メッシュ乳糖、DMV製)とを1/30/10/59の重量比になるように均一に混合し、流動層造粒機(MP−01、パウレック株式会社製)にて、流動層トップスプレー、スプレー位置下、スプレー条件0.1MPa、30L/min、風量20−40m3/hr、給気温度75℃、排気温度成り行き(28−33℃)、スプレー液速:約7g/min、排気温度が40℃になるまで乾燥する条件で、6%HPC−L(日本曹達製)を結合剤として用い湿式造粒した。得られた顆粒を目開き700μmの篩にて粗大粒子を除去して打錠用顆粒を得た。得られた造粒用顆粒とステアリン酸マグネシウム(植物性ステアリン酸マグネシウム、太平化学製)とを100/0.5の重量比になるよう緩やかに混合し、ロータリー打錠機(クリーンプレスコレクト12HUK(商品名)/株式会社菊水製作所製)を用いて8、10、12MPaの圧力で圧縮し、直径8.0mm、重量0.18gの錠剤を得た。
加熱・糊化の出口温度を76℃とする以外は実施例1と同様にして加工澱粉Bを製造した。加工澱粉Bの基礎物性を表1に示した。次いで、加工澱粉Aの代わりに該加工澱粉Bを用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法の3つの方法で錠剤を作製し、崩壊試験を行った結果を表2に示した。乾燥状態と水中での膨潤状態の一次粒子の膨潤比、水溶性成分量、保水量、沈降体積が本発明の範囲内にある加工澱粉Bを崩壊剤に用いた錠剤は、何れの製錠方法のものも崩壊時間が速く、クロスカルメロースナトリウム、クロスポビドンと同等であった。
加熱・糊化の出口温度を80℃とする以外は実施例1と同様にして加工澱粉Cを製造した。加工澱粉Cの基礎物性を表1に示した。次いで、加工澱粉Aの代わりに該加工澱粉Cを用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法の3つの方法で錠剤を作製し、崩壊試験を行った結果を表2に示した。乾燥状態と水中での膨潤状態の一次粒子の膨潤比、水溶性成分量、保水量、沈降体積が本発明の範囲内にある加工澱粉Cを崩壊剤に用いた錠剤は、何れの製錠方法のものも崩壊時間が速く、クロスカルメロースナトリウム、クロスポビドンと同等であった。
加熱・糊化の出口温度を84℃とする以外は実施例1と同様にして加工澱粉Dを製造した。加工澱粉Dの基礎物性を表1に示した。次いで、加工澱粉Aの代わりに該加工澱粉Dを用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法の3つの方法で錠剤を作製し、崩壊試験を行った結果を表2に示した。乾燥状態と水中での膨潤状態の一次粒子の膨潤比、水溶性成分量、保水量、沈降体積が本発明の範囲内にある加工澱粉Dを崩壊剤に用いた錠剤は、何れの製錠方法のものも崩壊時間が速く、クロスカルメロースナトリウム、クロスポビドンと同等であった。
加熱・糊化の出口温度を88℃とする以外は実施例1と同様にして加工澱粉Eを製造した。加工澱粉Eの基礎物性を表1に示した。次いで、加工澱粉Aの代わりに該加工澱粉Eを用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法の3つの方法で錠剤を作製し、崩壊試験を行った結果を表2に示した。乾燥状態と水中での膨潤状態の一次粒子の膨潤比、水溶性成分量、保水量、沈降体積が本発明の範囲内にある加工澱粉Eを崩壊剤に用いた錠剤は、何れの製錠方法のものも崩壊時間が速く、クロスカルメロースナトリウム、クロスポビドンと同等であった。
バレイショ澱粉1kgを60℃の温水7kgに分散させ、このスラリーを攪拌しながら、1℃/minの速度で昇温し、62℃になるまで加熱した後、約20℃の水2kgを加え、熱処理を止めた。次いで噴霧乾燥し、加工澱粉Fを得た(特許文献7の実施例15に相当)。加工澱粉Fの基礎物性を表1に示した。次いで、加工澱粉Aの代わりに該加工澱粉Fを用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法の3つの方法で錠剤を作製し、崩壊試験を行った結果を表2に示した。
加熱・糊化の出口温度を68℃とする以外は実施例1と同様にして加工澱粉Gを製造した。加工澱粉Gの基礎物性を表1に、水中での膨潤状態の粒子形態の光学顕微鏡写真を図6(a)、(b)に示した((b)は偏光写真)。
加熱・糊化の出口温度を92℃とする以外は実施例1と同様にして加工澱粉Hを製造した。加工澱粉Hの基礎物性を表1に、水中での膨潤状態の粒子形態の光学顕微鏡写真を図7(a)、(b)に示した((b)は偏光写真)。
加熱・糊化の出口温度を90℃とする以外は実施例1と同様にして加工澱粉Kを製造し、基礎物性を表1に示した。次いで、加工澱粉Aの代わりに該加工澱粉Kを用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法の3つの方法で錠剤を作製し、崩壊試験を行った結果を表2に示した。
バレイショ澱粉をステンレスバット(50cm×25cm)中に層厚5cmで充填して耐圧容器内で5分減圧(600mmHg)後、加圧蒸気(120℃)にて20分処理したものを原料とし、固形分濃度7.5重量%の澱粉乳液を調製した。この澱粉乳液を20L/hrでジェットクッカーで加熱、糊化(出口温度100℃)させ、3L容器の滞留管(100℃)を連続的に通過した後噴霧乾燥して加工澱粉Iを得た。加工澱粉Iの基礎物性を実表1に、水中での膨潤状態の粒子形態の光学顕微鏡写真を図8(a)、(b)に示した((b)は偏光写真)。この加工澱粉は、特許文献16の実施例6、特許文献18,19の実施例1に相当する。
コーンスターチをステンレスバット(50cm×25cm)中に層厚5cmで充填して耐圧容器内で5分間減圧(600mmHg)にした後、加圧蒸気(115℃)にて20分間湿熱処理した。該湿熱処理したコーンスターチを純水中に分散し、固形分濃度10重量%の澱粉乳液を調製した。該澱粉乳液を20L/hrでジェットクッカーで加熱・糊化(出口温度80℃)し、次いで噴霧乾燥し、加工澱粉Lを得た。得られた加工澱粉Lの基礎物性を表1に示した。
バレイショ澱粉1kgを60℃の温水7kgに分散させ、このスラリーを攪拌しながら、1℃/minの速度で昇温し、68℃になるまで加熱した後、約20℃の水2kgを加え、熱処理を止めた。次いで噴霧乾燥し、加工澱粉Jを得た(特許文献6の実施例17、サンプル7よりも低い加熱温度に相当)。加工澱粉Jの基礎物性を表1に、水中での膨潤状態の粒子形態の光学顕微鏡写真を図9(a)、(b)に示した((b)は偏光写真)。
市販部分アルファー化澱粉(PCS、三和澱粉工業株式会社製)を用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法で錠剤を作製し、崩壊試験を行った。該部分アルファー化澱粉の基礎物性を表1に、水中での膨潤状態の粒子形態の光学顕微鏡写真を図10(a)、(b)に示した((b)は偏光写真)。また、崩壊試験の結果を表2に示した。
加工澱粉Aの変わりに市販部分アルファー化澱粉(Starch1500)を用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法で錠剤を作製し、崩壊試験を行った。部分アルファー化澱粉の基礎物性を表1に、水中での膨潤状態の粒子形態の光学顕微鏡写真を図11(a)、(b)に示した((b)は偏光写真)。また、崩壊試験の結果を表2に示した。
市販スーパー崩壊剤であるクロスカルメロースナトリウム(キッコレートND−2HS、旭化成ケミカルズ株式会社製)を用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法で錠剤を作製し、崩壊試験を行った結果を表2に示した。クロスカルメロースナトリウムを崩壊剤に用いた錠剤の崩壊時間は速く、加工澱粉A〜Eと同等であった。
市販崩壊剤であるクロスポビドン(ポリプラスドンXL−10、ISP製)を用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法で錠剤を作製し、崩壊試験を行った結果を表2に示した。クロスポビドンを崩壊剤に用いた錠剤の崩壊時間は速く、加工澱粉A〜Eと同等であった。
市販スーパー崩壊剤である澱粉グリコール酸ナトリウム(Primojel、DMV製、エーテル化澱粉に相当)を用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法で錠剤を作製し、崩壊試験を行った結果を表2に示した。澱粉グリコール酸ナトリウムを崩壊剤に用いた錠剤の崩壊時間は比較的速いものであったが、クロスカルメロースナトリウム、クロスポビドン、加工澱粉A〜Eの崩壊時間よりは遅いものとなった。
市販崩壊剤である低置換度ヒドロキシプロピルセルロース(L−HPC、信越化学工業製)を用いる以外は実施例1と同様にして、直接打錠法、攪拌造粒/打錠法、流動層造粒/打錠法で錠剤を作製し、崩壊試験を行った結果を表2に示した。低置換度ヒドロキシプロピルセルロースを崩壊剤に用いた錠剤の崩壊時間は、クロスカルメロースナトリウム、クロスポビドン、加工澱粉A〜Eと比べて崩壊時間の遅いものしか得られなかった。
加工澱粉Aとアミノフィリン(和光純薬)とを50/50の重量比になるように均一に混合し、該混合粉末をスチール製の蓋の付いたガラス容器に入れ、温度40℃の雰囲気下に18週間保存した。2、8及び18週間経過後の混合粉体の色の変化を色示計(SE200、日本分光株式会社製)を用いて測定し、その結果を後述の比較例14〜17について行った同様の測定の結果と併せて図1に示した。
市販スーパー崩壊剤であるクロスカルメロースナトリウム(キッコレートND−2HS、旭化成ケミカルズ株式会社製)を用いる以外は実施例6と同様にし、混合粉体の保存試験を行い、結果を図1に示した。
市販スーパー崩壊剤であるクロスポビドン(ポリプラスドンXL−10、ISP製)を用いる以外は実施例6と同様にし、混合粉体の保存試験を行い、結果を図1に示した。
市販スーパー崩壊剤である澱粉グリコール酸ナトリウム(Primojel、DMV製)を用いる以外は実施例6と同様にし、混合粉体の保存試験を行い、結果を図1に示した。
市販崩壊剤である低置換度ヒドロキシプロピルセルロース(L−HPC、信越化学工業製)を用いる以外は実施例6と同様にし、混合粉体の保存試験を行い、結果を図1に示した。
加工澱粉Aとアスコルビン酸(BASFジャパン製)とを50/50の重量比になるように均一に混合し、該混合粉末をスチール製の蓋の付いたガラス容器に入れ、温度40℃の雰囲気下に18週間保存した。2、8及び18週間経過後の混合粉体の色の変化を色示計(SE200、日本分光株式会社製)を用いて測定し、その結果を後述の比較例18〜21について行った同様の測定の結果と併せて図2に示した。
市販スーパー崩壊剤であるクロスカルメロースナトリウム(キッコレートND−2HS、旭化成ケミカルズ株式会社製)を用いる以外は実施例7と同様にし、混合粉体の保存試験を行い、結果を図2に示した。
市販スーパー崩壊剤であるクロスポビドン(ポリプラスドンXL−10、ISP製)を用いる以外は実施例7と同様にし、混合粉体の保存試験を行い、結果を図2に示した。
市販スーパー崩壊剤である澱粉グリコール酸ナトリウム(Primojel、DMV製)を用いる以外は実施例7と同様にし、混合粉体の保存試験を行い、結果を図2に示した。
市販崩壊剤である低置換度ヒドロキシプロピルセルロース(L−HPC、信越化学工業製)を用いる以外は実施例7と同様にし、混合粉体の保存試験を行い、結果を図2に示した。
加工澱粉Aとアスピリン(和光純薬製)とを80/20の重量比になるように均一に混合し、静圧プレス(MODEL−1321DW CREEP(商品名)/アイコーエンジニアリング株式会社製)を用いて50MPaの圧力で圧縮し、直径0.8cm、重量0.225gの錠剤を得た。得られた錠剤3つを100ml試験管に入れ、蓋をせず、温度40℃相対湿度70%の雰囲気下に2週間保存した。1週間、及び2週間経過後の錠剤厚み、及び錠剤硬度を測定し、その結果を後述の比較例22〜23について行った同様の測定の結果と併せて図3、4に示した。
市販スーパー崩壊剤であるクロスカルメロースナトリウム(キッコレートND−2HS(商品名)、旭化成ケミカルズ株式会社製)を用いる以外は実施例8と同様にして錠剤を作製し、錠剤の保存試験を行い、結果を図3、4に示した。
市販スーパー崩壊剤であるクロスポビドン(XL−10、ISP製)を用いる以外は実施例8と同様にして錠剤を作製し、錠剤の保存試験を行い、結果を図3、4に示した。
加工澱粉Aとマンニトール(マンニット、東和化成製)と結晶セルロース(「セオラス」(登録商標)KG−802)とを5/85/10の重量比になるように均一に混合し、流動層造粒機(MP−01、パウレック株式会社製)にて、流動層トップスプレー、スプレー位置下、スプレー条件0.1MPa、30L/min、風量20−40m3/hr、給気温度75℃、排気温度成り行き(28−33℃)、スプレー液速約12.5g/min、排気温度が40℃になるまで乾燥する条件で、純水を結合剤として用い湿式造粒した。得られた顆粒を目開き700μmの篩にて粗大粒子を除去し、打錠用顆粒とした。次いで、該打錠用顆粒とステアリン酸マグネシウム(太平化学製)とを100/0.5の重量比になるよう緩やかに混合し、ロータリー打錠機(クリーンプレスコレクト12HUK(商品名)/株式会社菊水製作所製)を用いて50、80、100、120MPaの圧力で圧縮し、直径8.0cm、重量0.18gの口腔内崩壊錠を得た。得られた錠剤のうち硬度50N近くの錠剤を用いて10人による官能評価を行い、口腔内での崩壊時間、口当たり及び飲みやすさを調べ、結果を後述の比較例24〜25について行った同様の調査の結果と併せて表3に示した。
市販スーパー崩壊剤であるクロスカルメロースナトリウム(キッコレートND−2HS、旭化成ケミカルズ株式会社製)を用いる以外は実施例9と同様にして口腔内崩壊錠を作製、評価を行い、結果を表3に示した。
市販スーパー崩壊剤であるクロスポビドン(XL−10、ISP製)を用いる以外は実施例9と同様にして口腔内崩壊錠を作製、評価を行い、結果を表3に示した。口当たりは良好だが、モサつき、ネチャつきがやや感じられた。崩壊時間は加工澱粉A、クロスカルメロースナトリウムに較べ最も速くなったが、飲みやすさでは加工澱粉Aより劣った。
Claims (17)
- 水溶性成分量が2重量%より大きく10重量%未満、及び保水量が600%よりも大きく1500%以下であって、かつ非複屈折性粒子であることを特徴とする加工澱粉粉末。
- 乾燥状態の一次粒子の平均粒子径が25〜80μm、水中での膨潤状態の一次粒子の平均粒子径が45〜160μmである、請求項1に記載の加工澱粉粉末。
- 生澱粉粒由来の外殻構造を有している、請求項1又は2に記載の加工澱粉粉末。
- アミロース含量が20重量%以上30重量%未満の天然澱粉質原料を化学的処理することなく得られる、請求項1〜3いずれか一項に記載の加工澱粉粉末。
- 乾燥粒子の一次粒子の平均粒子径が天然澱粉質原料よりも大きい、請求項1〜4いずれか一項に記載の加工澱粉粉末。
- 天然澱粉質原料がバレイショ澱粉である、請求項1〜5いずれか一項に記載の加工澱粉粉末。
- (i)天然澱粉質原料を減圧条件下100〜130℃の蒸気による加熱処理をする工程、(ii)該加熱処理された澱粉質原料を固形分濃度1〜20重量%の澱粉乳液に調製する工程、(iii)該澱粉乳液を澱粉固有の糊化開始温度を10℃上回る温度を超え、90℃未満の温度範囲で加熱処理する工程、(iv)次いで、該加熱処理された澱粉乳液を乾燥する工程を含む方法により得られる、請求項1〜6いずれか一項に記載の加工澱粉粉末。
- 沈降体積が7cm3/g以上20cm3/g以下である、請求項1〜7のいずれか一項に記載の加工澱粉粉末。
- 乾燥状態と水中での膨潤状態の一次粒子の膨潤比が1.5〜5.0である、請求項1〜8のいずれか一項に記載の加工澱粉粉末。
- 前記加工澱粉粉末が崩壊剤である、請求項1〜9いずれか一項に記載の加工澱粉粉末。
- 請求項1〜10のいずれか一項に記載の加工澱粉粉末及び1種以上の活性成分を含む組成物。
- 直接打錠で得られる、硬度が100±10N、崩壊時間が70秒以下である請求項11に記載の組成物。
- 攪拌造粒後、打錠して得られる、硬度が100±10N、崩壊時間が60秒以下である請求項11に記載の組成物。
- 流動層造粒後、打錠して得られる、硬度が100±10N、崩壊時間が130秒以下である請求項11に記載の組成物。
- 前記加工澱粉粉末を前記組成物中に0.2〜5重量%配合する、請求項11〜14いずれか一項に記載の組成物。
- 1種以上の活性成分が、医薬品薬効成分、食品成分から選択されたものである、請求項11〜15いずれか一項に記載の組成物。
- (i)天然澱粉質原料を減圧条件下100〜130℃の蒸気による加熱処理をする工程、(ii)該加熱処理された澱粉質原料を固形分濃度1〜20重量%の澱粉乳液に調製する工程、(iii)該澱粉乳液を澱粉固有の糊化開始温度を10℃上回る温度を超え、90℃未満の温度範囲で加熱処理する工程、(iv)次いで、該加熱処理された澱粉乳液を乾燥する工程を含む、請求項1又は7に記載の加工澱粉粉末の製造方法。
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JP2015218322A (ja) * | 2014-05-21 | 2015-12-07 | 旭化成ケミカルズ株式会社 | 微小澱粉粒子及びその製造方法 |
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US8431618B2 (en) | 2013-04-30 |
CN101981059A (zh) | 2011-02-23 |
EP2261263A1 (en) | 2010-12-15 |
EP2261263A4 (en) | 2013-07-17 |
CN101981059B (zh) | 2014-08-20 |
WO2009123102A1 (ja) | 2009-10-08 |
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