JP5917078B2 - 固形状組成物 - Google Patents
固形状組成物 Download PDFInfo
- Publication number
- JP5917078B2 JP5917078B2 JP2011226404A JP2011226404A JP5917078B2 JP 5917078 B2 JP5917078 B2 JP 5917078B2 JP 2011226404 A JP2011226404 A JP 2011226404A JP 2011226404 A JP2011226404 A JP 2011226404A JP 5917078 B2 JP5917078 B2 JP 5917078B2
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- solid composition
- wheat albumin
- acid
- wheat
- carbonate
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Landscapes
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
通常、食後、特に糖質を含む食事を摂取した後は、血糖値が上昇することにより膵臓のβ細胞からインスリンが分泌される。インスリンは筋肉、肝臓、脂肪組織等に作用し、細胞内への糖の取り込みを促進することで、食後の急激な血糖値上昇を抑制する。しかし、インスリン感受性の低下(インスリン抵抗性)により、食後の高血糖状態が続くと、膵臓はインスリンを多量に分泌して血糖の上昇を抑えようとする。そして、このような状態が長く続くと膵臓が疲弊し、膵β細胞からのインスリンの分泌が低下し、最終的にインスリン作用機構が正常に機能しなくなると、II型糖尿病等になることが知られている。
そこで近年、食後の急激な血糖上昇やインスリンの分泌を抑制できる物質の開発が多く行なわれている。その一つとして、アミラーゼ阻害物質があり、小麦由来のアミラーゼ阻害物質が糖尿病や肥満等の予防、治療に用いられている(非特許文献1)。
しかしながら、本発明者らが検討したところ、一度少量摂取するだけで有効量を満たせるほどに高い濃度で小麦アルブミンを固形状組成物中に配合することは困難であることが判明した。すなわち、小麦アルブミンを高濃度化すると、摂食中にねとつきが生じ、口内に付着し易く、また、小麦アルブミンに由来する異味が感じられて摂食が困難であることが判明した。
(A)小麦アルブミン、
(B)炭酸塩、
(C)有機酸、
を含有し、成分(A)と成分(B)の含有質量比[(A)/(B)]が1.5〜16.5であり、且つ成分(C)と成分(B)の当量比が0.7〜1.9である固形状組成物を提供するものである。
本発明の固形状組成物は、一度少量摂取するだけで、小麦アルブミンの生理効果発現に必要な量を摂取できるので、該小麦アルブミンによる効果を長期に亘って十分に期待できる。
また、小麦アルブミンNA−1(日清ファルマ株式会社)等の市販品を用いてもよい。
(A)小麦アルブミン中の(a)0.19小麦アルブミンの含有量は、10〜60%、更に15〜40%、更に20〜35%、更に25〜31%であるのが、生理効果を有効に発現する摂取量の点から好ましい。
本発明の固形状組成物中の0.19小麦アルブミン含有量は、HPLCにより測定することがきる。例えば、特開平9−172999号公報に記載の0.19アミラーゼ阻害物質の含量の測定方法を用いることができる。
(a)0.19小麦アルブミンと(B)炭酸塩の含有質量比[(a)/(B)]は、摂食時の口中のねとつき・付着性を抑制でき、また、小麦アルブミン特有の異味を低減できる点から、0.2〜4.1、更に0.3〜3.8、更に0.35〜3が好ましい。
尚、本発明において、前記「当量比」とは、固形状組成物に含まれる(C)有機酸の当量を(B)炭酸塩の当量で除した値である。
このような剤型の組成物を調製するには、必要に応じて、乳糖、デンプン類、結晶セルロース、蔗糖、マンニトール、軽質無水ケイ酸、リン酸水素カルシウム等の賦形剤、ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロース、ゼラチン、アルファー化デンプン、ポリビニルピロリドン、ポリビニルアルコール、プルランメチルセルロース、硬化油等の結合剤、カルメロース、カルメロースカルシウム、クロスカルメロースナトリウム、クロスポピドン、トウモロコシデンプン、低置換度ヒドロキシプロピルセルロース等の崩壊剤、ステアリン酸カルシウム、ステアリン酸マグネシウム、ショ糖脂肪酸エステル、フマル酸ステアリルナトリウム、タルク、二酸化ケイ素等の滑沢剤、ステビア、アスパルテーム等の嬌味剤、香料、増量剤、界面活性剤、分散剤、緩衝剤、保存剤、被膜剤、希釈剤等を適宜組み合わせて用いることができる。
例えば、錠剤を製造する場合、原料粉末を直接圧縮して成形(直接粉末圧縮法)しても、乾式造粒法、湿式造粒法等を用いて造粒してから圧縮して成形(顆粒圧縮法)しても良い。なかでも、工程の簡便性の点から、直接粉末圧縮法を用いて錠剤とするのが好ましい。
直接圧縮して成形して錠剤を製造する場合、打錠成形機としてはロータリー式打錠機や単発式打錠機等通常使用されるものを用いることができる。
また、造粒法より造粒してから錠剤とする場合、円筒造粒機、球形整粒機、ペレッター等を使用する押し出し造粒法;スピードミル、パワーミル等を使用する破砕造粒法;転動造粒法、攪拌造粒法、流動層造粒法等により造粒物を製造し、乾燥・整粒した後、得られた造粒物を前記打錠成形機で圧縮して錠剤を形成できる。造粒物の粒子径は、45μm〜850μmとするのが好ましく、100μm〜500μmとするのが更に好ましい。
錠剤の形状としては、円形錠もしくは楕円形、長円形、四角形等の面形を有する各種異形錠であってもよい。
また、打錠時の圧縮成型圧は、成形物の硬度維持、崩壊性等の点から、100〜3000kg/cm2である。
固形状組成物中の有機酸の含有量の分析方法は以下の通りである。
固形状組成物を1g採取し5%過塩素酸20mLを加え、10分間振とうすることで抽出する。これを水で200mLに定容し10分間超音波処理を行なう。ろ過後高速液体クロマトグラフに供する。
<高速液体クロマトグラフ操作条件>
機種:LC−20AD[株式会社島津製作所]
検出器:紫外可視吸光光度計SPD−20AV[島津製作所]
カラム温度:40℃
移動相:3mmоl/L過塩素酸
反応液:0.2mmоl/Lブロムチモールブルー含有
15mmоl/Lりん酸水素二ナトリウム溶液
流量:移動相1.0mL/min、反応液1.4mL/min
測定波長:445nm
固形状組成物中の炭酸塩の含有量の分析方法は以下の通りである。
固形状組成物を0.1〜0.2g採取し、水10mLと50%りん酸2mLを加え密栓する。10分間超音波処理を行った後、1時間放置しヘッドスペースガスをガスクロマトグラフに供してCO2量を求め、発生したCO2量から算出する。
<ガスクロマトグラフ操作条件>
機種:GC−14B[島津製作所]
検出器:TCD
カラム:Chromosorb101,80〜100mesh
ガラス管,φ3.2mm×2m
温度:カラム50℃,注入口及び検出器100℃
セル電流75mA
ガス圧力:ヘリウム(キャリヤーガス)100kPa
注入量:ヘッドスペースガス0.2mL
小麦アルブミン:小麦アルブミンNA−1、日清ファルマ株式会社製 (0.19小麦アルブミン含有量25%)
クエン酸:無水クエン酸 80MP、扶桑化学工業株式会社
リンゴ酸:DL-リンゴ酸、扶桑化学工業株式会社
酒石酸:L−酒石酸、扶桑化学工業株式会社
アジピン酸:アジピン酸、和光純薬株式会社
炭酸水素ナトリウム:炭酸水素ナトリウム、和光純薬株式会社
粉糖:M−SPD、昭和産業株式会社
マルチトール:粉末マルチトールG3、三菱商事フードテック株式会社
ステアリン酸カルシウム:オーラブライトCA-65、日油株式会社
実施例1〜実施例15及び比較例1〜比較例9
粒径の大きい原料は粉砕し、50メッシュに通したのち、表1に記載の配合組成で各原料成分を混合した。次に単発式打錠機(RIKEN製)を用いて、穴径13mmのリング状杵で、錠剤重量1000mgで打錠し、チュアブル錠を得た。チュアブル錠中の(a)0.19小麦アルブミン含有量は表1のとおりであった。
尚、実施例3,4,6,7,11,14及び15は参考例である。
〔口内付着性〕
5:歯や舌への付着性が非常に弱い
4:歯や舌への付着性が弱い
3:歯や舌への付着性がわずかに強い
2:歯や舌への付着性が強い
1:歯や舌への付着性が非常に強い
〔小麦アルブミン特有の異味〕
5:異味を感じない
4:異味を殆ど感じない
3:異味を僅かに感じる
2:異味を強く感じる
1:異味を非常に強く感じる
〔泡の食感〕
5:口中での泡切れが非常に良い
4:口中での泡切れが良い
3:口中での泡切れがやや良い
2:口中での泡切れが悪い
1:口中での泡切れが非常に悪い
〔風味のバランス〕
5:有機酸や炭酸塩の風味が突出せずにバランスが非常に良い
4:有機酸や炭酸塩の風味が突出せずにバランスが良い
3:有機酸や炭酸塩の風味が突出せずにバランスがやや良い
2:有機酸や炭酸塩の風味が突出せずにバランスが悪い
1:有機酸や炭酸塩の風味が突出せずにバランスが非常に悪い
Claims (5)
- 次の成分(A)〜(C):
(A)小麦アルブミン 20〜70質量%、
(B)炭酸塩 13〜20質量%、
(C)クエン酸及びリンゴ酸から選ばれる有機酸
を含有し、成分(A)と成分(B)の含有質量比[(A)/(B)]が1.5〜5であり、且つ成分(C)と成分(B)の当量比が0.7〜1.9である固形状組成物。 - (A)小麦アルブミンが、(a)0.19小麦アルブミンを10〜60質量%含有するものである請求項1記載の固形状組成物。
- 次の成分(a)〜(C):
(a)0.19小麦アルブミン 2〜20質量%、
(B)炭酸塩 13〜20質量%、
(C)クエン酸及びリンゴ酸から選ばれる有機酸
を含有し、成分(a)と成分(B)の含有質量比[(a)/(B)]が0.2〜3であり、且つ成分(C)と成分(B)の当量比が0.7〜1.9である固形状組成物。 - (C)有機酸の含有量が8〜18質量%である請求項1〜3のいずれか1項記載の固形状組成物。
- 発泡錠である請求項1〜4のいずれか1項記載の固形状組成物。
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