JP2018138584A - 腸の前処理のための方法及びキット - Google Patents
腸の前処理のための方法及びキット Download PDFInfo
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- JP2018138584A JP2018138584A JP2018083189A JP2018083189A JP2018138584A JP 2018138584 A JP2018138584 A JP 2018138584A JP 2018083189 A JP2018083189 A JP 2018083189A JP 2018083189 A JP2018083189 A JP 2018083189A JP 2018138584 A JP2018138584 A JP 2018138584A
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- Prior art keywords
- acid
- kit
- gastrointestinal tract
- taste
- miraculin
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Abstract
Description
本出願は、米国仮出願第61/679,183号(2012年8月3日出願)、及び米国通常出願第13/708,430(2012年12月7日出願)に対する優先権を主張し、それら出願全体が本参照により本出願に組み込まれるものである。
本発明は、胃腸管洗浄を容易にする味修正キット、及び、診断の、外科的な、または治療の処置の前に患者の胃腸管を洗浄するための方法に関する。特に、本発明は、胃腸管前処理組成物を快い味にする。
(T1−T2)/T1*100%
(a)タンパク質:ソーマチン、モネリン、マビンリン、ブラゼイン、ペンタジン、クルクリン、ネオクリン、ミラクリン、及び、卵白リゾチーム;
(b)ジヒドロカルコン類、ステビア、ステビオシド類、レバウジオシドA、並びに、ダルコシド及び/またはルブソシドなどの更なるステビオール配糖体、グリチルリチン、ジヒドロフラベノールなどの水溶性甘味剤。糖アルコール(または、ソルビトール、マンニトール、マルチトール、キシリトール、グリセロール、エリスリトール、ガラクチトール、水素化イソマルツロース、ラクチトール、水素化デンプン加水分解物、L−アミノジカルボン酸アミノアルケン酸エステルアミド、及びそれらの混合物などの多価アルコール類)。グルコース、ガラクトース、及びフルクトースなどの、トリオースで始まるアルドース及びケトースを含むがこれに限定されない単糖類。スクロース、マルトース、ラクトースなどの、単糖類、二糖類、及びオリゴ糖類を含むがこれに限定されない、一般に砂糖として知られる化合物。ポリデキストロース及びマルトデキストリンを含むがこれに限定されない、炭水化物及び多糖類;
(c)可溶性サッカリン塩、つまりサッカリンのナトリウムまたはカルシウム塩、シクラミン酸塩、3,4−ジヒドロ−6−メチル−1,2,3−オキサチアジン−4−オン−2,2−ジオキシドのナトリウム、アンモニウム、またはカルシウム塩、3,4−ジヒドロ−6−メチル−1,2,3−オキサチアジン−4−オン−2,2−ジオキシド(アセスルファム−K)のカリウム塩、並びに、サッカリン、1,6−ジクロロ−1,6−ジデオキシ−ベータ−D−フルクトフラノシル−4−クロロ−4−デオキシ−アルファ−D−ガラクトピラノシド(スクラロース)、6−メチル−1,2,3−オキサチアジン−4(3H)オン2,2−ジオキシド(アセスルファム)、シクロヘキシルスルファミン酸(シクラミン酸)、N−(L−アスパルチル)−N‘(2,2,5,5,テトラメチルシクロペンタノイル)1,1−ジアミノエタン及びその関連化合物の遊離酸の形、グラニジニウム部類の甘味料、ジヒドロカルコン部類の甘味料、ステビオシド、及びこれらの生理的に許容可能な塩、並びにこれらの混合物などの水溶性の人工甘味料;
(d)L−アスパルチル−L−フェニルアラニンメチルエステル(アスパルテーム)、L−アルファアスパルチル−N−(2,2,4,4−テトラメチル−3−チエタニル)−D−アラニンアミド水和物(アリテーム)、N−−[N−(3,3ージメチルブチル)−L−アスパルチル]−L−フェニルアラニン1−メチルエステル(ネオテーム)、L−アスパルチル−L−フェニルグリセリン及びL−アスパルチル−L−2,5ージヒドロフェニル−グリセリンのメチルエステル、L−アスパルチル−2,5ージヒドロ−L−フェニルアラニン、L−アスパルチル−L−(1−シクロヘキセン)−アラニン、及びこれらの混合物などの、L−アスパラギン酸から誘導される甘味料などのジペプチドを基礎とした甘味料;
(e)通常の砂糖(スクロース)の塩素化誘導体などの、天然起源の水溶性甘味料から誘導される水溶性甘味料。例えば、クロロデオキシスクロースまたは例えば製品名称スクラロースで知られるクロロデオキシガラクトスクロースの誘導体などの、クロロデオキシ糖の誘導体。クロロデオキシスクロース及びクロロデオキシガラクトスクロースの誘導体の例は、1−クロロ−1‘−デオキシスクロース、4−クロロ−4−デオキシ−アルファ−D−ガラクトピラノシル−アルファ−D−フルクトフラノシド、または4−クロロ−4−デオキシガラクトスクロース、4−クロロ−4−デオキシ−アルファ−D−ガラクトピラノシル−1−クロロ−1−デオキシ−ベータ−D−フルクト−−フラノシド、または4,1’−ジクロロ−4,1’−ジデオキシガラクトスクロース、1’,6’−ジクロロ−1’,6’−ジデオキシスクロース、4−クロロ−4−デオキシ−アルファ−D−ガラクトピラノシル−1,6−ジクロロ−1,6−ジデオキシ−ベータ−D−−フルクトフラノシド、または4,1’,6’−トリクロロ−4,1’,6’−トリデオキシガラクトスクロース。4,6−ジクロロ−4,6−ジデオキシ−アルファ−D−ガラクトピラノシル−6−クロロ−6−デオキシ−ベータ−D−−フルクトフラノシド、または4,6,6’−トリクロロ−4,6,6’−トリデオキシガラクトスクロース、6,1’,6’−トリクロロ−6,1’,6’−トリデオキシスクロース、4,6−ジクロロ−4,6−ジデオキシ−アルファ−D−ガラクト−ピラノシル−1,6−ジクロロ−1,6−ジデオキシ−ベータ−D−フルクトフラノシド、または4,6,1’,6’−テトラクロロ−4,6,1’,6’−テトラデオキシガラクト−スクロース、及び4,6,1’,6’−テトラデオキシ−スクロース、並びにこれらの混合物を含むがこれに限られない。
No.2: Nulytely製剤で、風味パック添加あり pH8.0
No.3: Nulytely製剤で、レモネード粉末及びレモン抽出物添加あり pH4.8
11人の被験者それぞれが試料2オンスを受け取り、それを試飲した。試料No.1から開始し、次いで残りの試料No.2から3と続けた。
データシートは11人の被験者全員から回収された。塩味に対する平均評価が計算された。表2及び図1を参照。
前処理溶液の塩味は、ミラクルベリーの使用後、著しく減少した。
スクリーニング大腸内視鏡検査を受ける予定の患者が、本研究の対象として考慮される。患者は、以前に大腸内視鏡検査を受けたことがあっても良く、またはなくても良い。味覚にいかなる異常または機能不全がある患者は、本研究からは除外される。同様に、結腸、小腸または胃の手術を受けたことのある患者もまた、患者が本製剤に耐える能力を変更しうるため、除外基準に含まれる。口渇症、口内乾燥症などと診断されている患者は、本研究から除外される。大腸内視鏡検査を実施するための指示は、特定の診断上の病訴に対して出されているべきではなく、むしろスクリーニングまたは監視の目的のために出されているべきである。特定の胃腸に関する病訴を有する患者は、本研究からは除外される。
例えばCoumadin Plavixなどの血液希釈剤を服用している患者は、大腸内視鏡検査の少なくとも1週間前に、指示を出している医療提供者(例えば、医師)に投薬を中止することの認可を得るために連絡を取らなければいけない。
処置の直後に、結腸粘膜の可視化の質を評価するように設計された調査票を、外来患者用内視鏡検査ユニットの担当の消化器科医に完成させるようお願いすることにより、結腸洗浄の質が評価される。内視鏡での可視性は、結腸内の気泡量、及び結腸前処理の適切性が評価される。内視鏡医は、患者に腸前処理の詳細について質問しないよう指示される。
本研究の結果は、ミラクルベリー錠剤を含む味修正キットとともに胃腸管製剤を服用した患者は、製剤を単独で服用した患者に比べて、腸前処理の要件をより良く満たしたことを示すだろう。これらの結果は、ミラクルベリー錠剤とともに胃腸管製剤溶液を服用した患者は、製剤を単独で服用した患者に比べて、大腸内視鏡検査がより上手く行ったことも示すだろう。
胃腸管前処理溶液をミラクルベリー錠剤とともに服用した患者は、胃腸管前処理溶液を単独で服用した患者に比べて、前処理期間中に著しく大きい容積の流動体(例えば、前者が平均3.9から4リットル、後者は平均3リットル)を摂取したと報告するだろう。この2つの前処理方法の総合的な許容度もまた、異なるだろう。
内視鏡検査を実施した内視鏡医は、胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者と製剤を単独で服用した患者との間には、結腸粘膜の可視化の質に違いがあると報告するだろう。結腸粘膜の質は、胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者群の方が、製剤を単独で服用した患者群よりも著しく高くなるだろう。内視鏡医は、胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者の方が、製剤を単独で服用した患者と比べて、結腸粘膜の可視化がより明瞭だったと報告するだろう。彼らはまた、後者の群よりも前者の群からの患者の方が、患者の結腸領域に管腔内の気泡が少なく、また結腸から流動体及び糞便を吸引し粘膜を掃除するために結腸を洗うのに費やした時間が短かったとも報告するだろう。胃腸管製剤溶液をミラクルベリー錠剤とともに服用した患者では、製剤を単独で服用した者よりも、完了した大腸内視鏡検査の成功率が高く、また大腸内視鏡検査を完了するのに要する時間も短いだろう。
・ pH範囲: 0−14
・ 温度範囲: 0−80℃、32−176°F
・ 分解能: 0.01 pH、温度分解能は0.1℃/F
・ 精度: +/− 0.02 pH、温度精度は+/− 2%
・ 較正: デジタル式微調整機能付きデジタル式自動較正(1点)
・ 電極: 交換式ガラス製センサー及び対照チューブ電極
・ 外被: IP−67防水性(浸水可、水に浮く)
・ 電源: 1.5Vボタン型電池x3
・ 寸法: 18.5x3.4x3.4cm
・ 重量: 96.4g (3.4oz)
試飲実験当日、各試料のpHが実験開始の5分前に再び測定された。一晩前の試料調整時からpHに変化はなかった。溶液は一晩の保管後、沈殿物を含有していなかった。
No.1 本来の製剤で、Kool−Aid粉末を添加していないもの pH 8.0
No.2 試飲試料 pH 7.0
No.3 試飲試料 pH 6.0
No.4 試飲試料 pH 5.0
No.5 試飲試料 pH 4.0
No.6 試飲試料 pH 3.0
ミラクルベリーなし
4人の被験者それぞれが試料2オンスを受け取り、それを試飲した。上記の最も塩基性の溶液(試料No.1、pH8)から開始し、次いで残りの溶液No.2から6と続けた。試料は、甘味、塩味、及び総合的な嗜好性に関して被験者によって評価された。各被験者が自身の対照標準として機能した。
4人の被験者は次いで、The Great Green Miracle Fruit Farm Ltd.により生産されたMiracle Frooties錠剤(1回分あたり600mg)を1つ与えられた。Miracle Frooties錠剤は以下のものを含有した。乾燥ミラクルフルーツ果肉、ジャガイモデンプン、微結晶セルロース、二塩基性リン酸カルシウム、及びステアリン酸マグネシウム。
製剤溶液の総合的な嗜好性は、酸性環境下でのミラクルベリー錠剤の使用後、大いに向上した。ミラクルベリーありの場合、pH5の溶液が最も快い味がする製剤溶液と認められた。
No.2: Nulytely製剤で、風味パック添加あり pH8.0
No.3: Nulytely製剤で、レモネード粉末及びレモン抽出物添加あり pH4.8
No.4: Nulytely製剤で、レモネード粉末、並びにレモン及びオレンジ抽出物添加あり pH4.8
11人の被験者それぞれが試料2オンスを受け取り、それを試飲した。試料No.1から開始し、次いで残りの溶液No.2から4と続けた。
データシートは11人の被験者全員から回収された。各試飲試料に対する2つのカテゴリー(甘味、及び総合的な嗜好性)各々における、11人の被験者からの平均評価が計算された。表5及び図7を参照。
製剤溶液の総合的な嗜好性及び甘味は、酸性環境下(例えば、本実験ではpH4.8)でのミラクルベリー錠剤の使用後、大いに向上した。
Claims (30)
- 味修正キットであって、予め測定された量の少なくとも1つの無機酸または有機酸と、ミラクリンとを有し、前記キットは、対象者に投与される胃腸管前処理組成物の塩味を軽減することによって当該対象者の胃腸管の洗浄を容易にし、前記予め測定された量の少なくとも1つの無機酸または有機酸は、前記胃腸管前処理組成物のpHを約1〜約6.9の範囲にわたるpHへと調節するのに十分である、キット。
- 請求項1記載のキットにおいて、前記無機酸または有機酸が、クエン酸、酢酸及びアスコルビン酸、リン酸、リンゴ酸、コハク酸、ギ酸、フマル酸、マレイン酸、アジピン酸、酪酸、グリコン酸、乳酸、シュウ酸、酒石酸、及びこれらの混合物から成る群から選択される、キット。
- 請求項1記載のキットにおいて、ミラクリンが、ミラクルフルーツ、ミラクルフルーツの果肉、ミラクルフルーツ粒剤、ミラクルベリー、ミラクルベリーエキス剤、ミラクルフルーツ錠剤、ミラクルベリー錠剤、または遺伝子改変生物により産生されるミラクリンを有する、キット。
- 請求項1記載のキットにおいて、前記pHが約2〜約5.5の範囲にわたる、キット。
- 請求項1記載のキットにおいて、前記pHが約3〜約5の範囲にわたる、キット。
- 請求項1記載のキットにおいて、前記pHが約4.8である、キット。
- 請求項1記載のキットにおいて、ミラクリンが、胃腸管前処理組成物が投与される約1分〜約1時間前に前記対象者に提供される、キット。
- 請求項7記載のキットにおいて、ミラクリンが、前記胃腸管前処理組成物が投与される約5分〜約30分前に提供される、キット。
- 請求項8記載のキットにおいて、ミラクリンが、前記胃腸管前処理組成物が投与される約10分〜約15分前に提供される、キット。
- 請求項1記載のキットにおいて、前記胃腸管前処理組成物の塩味が、ミラクリンが提供されなかった場合の胃腸管前処理組成物の塩味と比較して、少なくとも約20%軽減される、キット。
- 請求項1記載のキットにおいて、前記胃腸管前処理組成物の塩味が、少なくとも50%軽減される、キット。
- 請求項1記載のキットにおいて、前記胃腸管が腸であり、かつ前記胃腸管前処理組成物が腸前処理溶液である、キット。
- 請求項12記載のキットにおいて、前記腸が結腸である、キット。
- 請求項1記載のキットにおいて、前記患者に対する診察の、治療の、及び/または外科的な処置を実施する前に前記胃腸管が洗浄される、キット。
- 請求項1記載のキットにおいて、前記胃腸管が内視鏡検査の前に洗浄される、キット。
- 請求項15記載のキットにおいて、前記内視鏡検査が、大腸内視鏡検査またはS状結腸鏡検査である、キット。
- 請求項1記載のキットにおいて、バリウム注腸検査、カプセル内視鏡検査、結腸手術、
または胃腸管手術の前に、前記胃腸管が洗浄される、キット。 - 請求項1記載のキットにおいて、ミラクリンが、カプセル剤、錠剤、丸薬、粒剤、散剤、小丸剤、固体混合物、溶液、分散体、乳剤、ペースト剤、エキス剤、または天然源からの単離物の形態で提供される、キット。
- 請求項1記載のキットにおいて、前記胃腸管前処理組成物が、カリウム塩、ナトリウム塩、カルシウム塩、アンモニウム塩、またはそれらの混合物を有する、キット。
- 請求項1記載のキットにおいて、前記胃腸管前処理組成物が溶液であり、かつ前記胃腸管前処理組成物の容積が約1リットル〜約4リットルの範囲にわたる、キット。
- 請求項1記載のキットにおいて、前記胃腸管前処理組成物がポリエチレングリコール(PEG)を有する、キット。
- 味修正キットであって、少なくとも1つのpH修正剤と、少なくとも1つの味修正物質とを有し、前記キットは、対象者に投与される胃腸管前処理組成物の塩味を軽減することによって当該対象者の胃腸管の洗浄を容易にし、前記少なくとも1つのpH修正剤は、前記胃腸管前処理組成物のpHを約1〜約6.9の範囲にわたるpHへと調節するのに十分であり、前記味修正物質は、ミラクリン、ソーマチン、モネリン、マビンリン、ブラゼイン、ペンタジン、クルクリン、ネオクリン、またはそれらの混合物である、キット。
- 請求項22記載のキットにおいて、前記味修正物質がミラクリンである、キット。
- 請求項22記載のキットにおいて、前記pH修正剤が、クエン酸、酢酸及びアスコルビン酸、リン酸、リンゴ酸、コハク酸、ギ酸、フマル酸、マレイン酸、アジピン酸、酪酸、グリコン酸、乳酸、シュウ酸、酒石酸、及びこれらの混合物から成る群から選択される酸である、キット。
- 請求項22記載のキットにおいて、前記pH修正剤が、水酸化アンモニウム、炭酸ナトリウム、炭酸カリウム、重炭酸ナトリウム、二酸化炭素、及びそれらの混合物の群から選択される、キット。
- 患者の胃腸管の洗浄を容易にするための請求項1記載のキットを製造するためのミラクリンの使用であって、
前記キットは、予め測定された量の少なくとも1つの無機酸または有機酸とミラクリンとを有し、
前記予め測定された量の少なくとも1つの無機酸または有機酸は、塩味を有する胃腸管前処理組成物のpHを約1〜約6.9に調節するためのものであり、
前記ミラクリンは前記患者に提供されるためのものであり、
前記胃腸管前処理組成物は前記患者に経口投与される、使用。 - 請求項26記載の使用において、前記胃腸管が腸であり、かつ前記胃腸管前処理組成物が腸前処理溶液である、使用。
- 請求項26記載の使用において、前記胃腸管が内視鏡検査の前に洗浄される、使用。
- 請求項26記載の使用において、前記ミラクリンが、前記胃腸管前処理組成物が投与される約5分〜約30分前に提供されるためのものである、使用。
- 請求項26記載の使用において、前記ミラクリンは、前記胃腸管前処理組成物の塩味を、ミラクリンが提供されなかった場合の胃腸管前処理組成物の塩味と比較して、少なくとも約20%軽減する、使用。
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CA2919487A1 (en) | 2014-02-06 |
US20170119846A1 (en) | 2017-05-04 |
DK2879715T3 (da) | 2023-04-24 |
EP2879715B1 (en) | 2023-03-29 |
US20140037775A1 (en) | 2014-02-06 |
US9433660B2 (en) | 2016-09-06 |
EP4215213A1 (en) | 2023-07-26 |
EP2879715A1 (en) | 2015-06-10 |
PT2879715T (pt) | 2023-04-26 |
JP2015528819A (ja) | 2015-10-01 |
US9585937B2 (en) | 2017-03-07 |
JP6676097B2 (ja) | 2020-04-08 |
CN109260455A (zh) | 2019-01-25 |
CN104736177A (zh) | 2015-06-24 |
US20160089331A1 (en) | 2016-03-31 |
WO2014022760A1 (en) | 2014-02-06 |
EP2879715A4 (en) | 2016-03-23 |
ES2942682T3 (es) | 2023-06-05 |
JP6338064B2 (ja) | 2018-06-06 |
US20180110827A1 (en) | 2018-04-26 |
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