JP5879668B2 - 澱粉顆粒の製造方法および口腔内崩壊錠 - Google Patents
澱粉顆粒の製造方法および口腔内崩壊錠 Download PDFInfo
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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Description
錠剤を服用するために水を摂取することなく、口腔内で実質的に唾液のみにより40s以内、好ましくは30s以内に崩壊する錠剤を意味する。口腔内崩壊性は、前記口腔内崩壊時間で判定する。そして、口腔内崩壊時間は、錠剤を口腔内に含んだ際に、舌等の動きを自然にした場合の値である。例えば、健康な成人男子の口腔内に、水分を口に含まず測定用錠剤を含ませ、前記錠剤が唾液のみで完全に崩壊するまでの時間を測定することにより、口腔内崩壊時間を決定することができる。この際、自然な舌の動き等までは抑制する必要はない。(特許文献1段落0012から引用)。
α化度(糊化度)の測定方法は、常法であるグルコアミラーゼ法(二國二郎編、「澱粉科学ハンドブック」、朝倉書店、1977年、p.242)を採用した。具体的には、下記の方法に従って測定したものである。
[式中、Aaは、被検液の吸光度であり、Abは、完全α化検液の吸光度であり、Aoは、ブランクの吸光度である](特許文献1段落0013から引用)。
篩いで分級した範囲。即ち、目開きの異なる篩い複数段を大きな篩が上段側に来るように重ね、最上段の篩いに測定する粉末を投入し、手動又は機械によって振動を与えて分級し、篩い上の目開きを下限値、篩下の目開きを上限値とする。
糊液作製に使用するβ澱粉質量(水分12.5%として)の水の質量に対する%濃度(wt%)である。
打錠等により成型した錠剤の硬度を意味する。錠剤の硬度は、錠剤を砕くに要する力(単位:N)で表され、数値が大きいほど錠剤の破壊強度が大きい。本発明においては、「ポータブルチェッカーPC−30」(岡田精工株式会社製ロードセル式錠剤硬度計)を用いて硬度を測定した。
なお、嵩密度は、「パウダーテスターPTX」(ホソカワミクロン社)で測定した。
流動層造粒乾燥装置は、前述の図2に示す構成において、投入容量:12L、流動分散板径d:230mm、ノズル高さh:600mmの仕様のエア式流動層の造粒装置を用いた。
実施例1において、旋回式の流動層造粒乾燥器に代えて前記「WSG−30」(容量:100L)を使用して、処理量をスケールアップ(5倍)とした。
実施例1において、図3に示す攪拌式造粒装置を用いて、表1に示す条件で3%の糊様澱粉分散液を表示の投入速度となるように滴下して攪拌造粒を行なった。該造粒物を、振動流動乾燥機(「VUA−20」中央化工機株式会社製)を用いて、90℃×30minの条件で振動流動層乾燥を行なって、比較例1の顆粒澱粉を得た。
13・・・流動層容器
14・・・糊液配管
15・・・噴霧ノズル
17・・・バッグフィルタ
19・・・切替弁
21・・・回収タンク
Claims (8)
- エア式流動層を用いて、β澱粉(原料澱粉)を流動化させながら、糊液を噴霧することにより、前記β澱粉の各粒子を前記糊液と接触させて流動層造粒後、さらに、前記β澱粉の糊化温度以上で流動層乾燥させる澱粉顆粒の製造方法であって、
前記糊液の濃度を1〜6%とするとともに、β澱粉100質量部に対する分散澱粉供給速度0.2〜5質量部/分として、糊液合計量が前記β澱粉100質量部に対して30〜70質量部となるまで噴霧することにより、
無数のβ澱粉の粒子相互が、各粒子形態を保持した状態で、α澱粉を結合剤として部分的に結合された粒子結合体であり、α化度が1〜15%であり、かつ圧縮度が20〜30%である澱粉顆粒であって、前記澱粉顆粒の200mgを圧縮成型(ここで、圧縮成型の条件は、圧縮速度が10mm/minであり、圧縮力が1000kgfである)により錠剤化を行ない、直径8mm×厚み3mmの錠剤としたときの硬度が、55N以上であり、かつ口腔内崩壊時間が40s以内である澱粉顆粒を製造することを特徴とする前記澱粉顆粒の製造方法。
- 前記糊液の噴霧を、前記エア式流動層のエア温度を60〜90℃の範囲に設定してβ澱粉の粒子を流動層造粒後、続いて、流動化を継続して、エア温度を80〜110℃(但し、前記流動層造粒における流動層エア温度より10〜20℃高い。)の範囲に設定して流動層乾燥させることを特徴とする請求項1記載の澱粉顆粒の製造方法。
- 前記澱粉顆粒中のα化度が、3〜12%であることを特徴とする請求項1記載の澱粉顆粒の製造方法。
- 無数のβ澱粉の粒子相互が、各粒子形態を保持した状態で、α澱粉を結合剤として部分的に結合された粒子結合体であり、α化度が1〜15%であり、かつ圧縮度が20〜30%である澱粉顆粒であって、前記澱粉顆粒の200mgを圧縮成型(ここで、圧縮成型の条件は、圧縮速度が10mm/minであり、圧縮力が1000kgfである)により錠剤化を行ない、直径8mm×厚み3mmの錠剤としたときの硬度が、55N以上であり、かつ口腔内崩壊時間が40s以内であることを特徴とする前記澱粉顆粒。
- 流動性が安息角(注入法)30〜40°を示すものであることを特徴とする請求項4記載の澱粉顆粒。
- 請求項4又は5に記載の澱粉顆粒で、実質的に他の口腔内崩壊性付与剤および硬度付与剤の一方又は双方を含有させずに錠剤化されてなることを特徴とする口腔内崩壊錠。
- 口腔内崩壊時間:40s以内で、かつ、硬度:55N以上を示すものであることを特徴とする請求項6記載の口腔内崩壊錠。
- 口腔内崩壊時間:30s以内で、かつ、硬度:70N以上を示すものであることを特徴とする請求項6記載の口腔内崩壊錠。
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US (1) | US9642807B2 (ja) |
EP (1) | EP2842986B1 (ja) |
JP (1) | JP5879668B2 (ja) |
KR (1) | KR101879197B1 (ja) |
IL (1) | IL235293A (ja) |
IN (1) | IN2014DN09313A (ja) |
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JP6632960B2 (ja) * | 2016-12-07 | 2020-01-22 | オルガノフードテック株式会社 | 澱粉の製造方法 |
CN115819806A (zh) * | 2022-12-27 | 2023-03-21 | 湖北三江丰源实业有限公司 | 一种阳离子淀粉颗粒的制备方法 |
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JPS5399340A (en) | 1977-02-08 | 1978-08-30 | Nisshin Flour Milling Co | Production of starch granules |
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JP2008032767A (ja) | 2006-07-26 | 2008-02-14 | Matsushita Electric Ind Co Ltd | 能動騒音低減システム |
KR101435229B1 (ko) * | 2006-09-14 | 2014-08-28 | 아스테라스 세이야쿠 가부시키가이샤 | 구강내 붕괴정 및 그 제조법 |
CN101802017B (zh) | 2007-07-26 | 2013-02-06 | 卡吉尔公司 | 改性淀粉的方法 |
CN101945895B (zh) | 2008-02-22 | 2012-12-05 | 卡吉尔公司 | 作为用于液体组分的载体材料的预凝胶化淀粉 |
EP2261263B1 (en) | 2008-03-31 | 2022-03-23 | Asahi Kasei Kabushiki Kaisha | Processed starch powder with excellent disintegration properties and manufacturing method thereof |
US20110288146A1 (en) * | 2008-11-19 | 2011-11-24 | Nandu Deorkar | Directly compressible granular microcrystalline cellulose based, excipient, manufacturing process and use thereof |
US20130029026A1 (en) | 2010-04-07 | 2013-01-31 | Cargill, Incorporated | Process for modifying starches |
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US11133732B2 (en) * | 2018-04-27 | 2021-09-28 | Exedy Corporation | Rotational electric machine |
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IL235293A (en) | 2017-02-28 |
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US20150141525A1 (en) | 2015-05-21 |
IN2014DN09313A (ja) | 2015-07-10 |
EP2842986A1 (en) | 2015-03-04 |
KR20150013562A (ko) | 2015-02-05 |
EP2842986B1 (en) | 2018-12-26 |
WO2013161805A1 (ja) | 2013-10-31 |
MY169160A (en) | 2019-02-19 |
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