JP6822734B2 - 経口補水組成物とその方法 - Google Patents
経口補水組成物とその方法 Download PDFInfo
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- JP6822734B2 JP6822734B2 JP2017546059A JP2017546059A JP6822734B2 JP 6822734 B2 JP6822734 B2 JP 6822734B2 JP 2017546059 A JP2017546059 A JP 2017546059A JP 2017546059 A JP2017546059 A JP 2017546059A JP 6822734 B2 JP6822734 B2 JP 6822734B2
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- oral rehydration
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- Coloring Foods And Improving Nutritive Qualities (AREA)
Description
消化の機能的な目標は、腸によって体内へ吸収され得る小さな構成成分(栄養素)へ複雑な食品を分解することであり、ここで前記栄養素は、正常な身体代謝の遂行に必要である複雑な分子へ再構成され得る。食品の3つの主要群は、タンパク質、炭水化物、及び脂肪であって、これらは、アミノ酸、糖類、及び脂質へそれぞれ分解される。正常な身体代謝の維持には、水と電解質(ナトリウム、カリウム、塩化物、及びマグネシウムのような無機質である)も必要とされる。食物を消化する胃腸(GI)管の能力は、消化酵素の分泌を引き起こして腸器官の運動性を制御する、神経内分泌応答の複雑な相互作用に依存する。
GI管は、多くの病原体による感染にさらされており、これらは、病気、機能低下(suboptimal performance)、及び死亡による経済損失の主因となる。参照として本明細書に組み込まれる、メルク獣医学マニュアル(Merck Veterinary Manual)(http://www.merckmanuals.com/vet/digestive_system/digestive_system_introduction/overview_of_digestive_system.html)において説明されているように、胃腸炎は、多くの異なる種類の細菌、ウイルス、及び寄生虫によって引き起こされ得る。
サルモネラ症、腸性毒血症、及び大腸菌症は、GI管の細菌性疾患の例である。細菌性病原体の多くは、正常な腸内細菌叢の一部であって、疾患が発現するのは、ストレス過多の事象の後だけである(例えば、ウマのサルモネラ症は、運搬の後に、またヒトのクロストリジウム・デフィシル(Clostridium difficile)下痢症は、術後に発現する)。
GI管の疾患を引き起こすウイルス病原体は、きわめて接触伝染性である。獣医学における重要な胃腸系ウイルスには、ロタウイルス、コロナウイルス、イヌパルボウイルス、ネコ汎白血球減少症ウイルス、ウシウイルス性下痢(BVD)ウイルス、ブタ伝染性胃腸炎(TGE)ウイルス、及びブタ流行性下痢ウイルス(PEDv)が含まれる。ヒトにおける重要なウイルス病原体には、ノロウイルスとロタウイルスが含まれる。
原生動物は、腸細胞に感染する単細胞性の寄生生物である。少数の原生動物の感染はよくあることで、疾患の証拠のない患者・患畜の顕微鏡による糞便検査の間によく見られる。寄生虫に感染された患者・患畜は、保因者であって、他の感染しやすい動物又はヒトへの可能な感染源とみなされる。この疾患は、それまでに曝露されたことがない幼若動物における曝露及び感染によって引き起こされる。獣医学において、一般的な腸の原生動物の疾患には、幼若の反芻動物、イヌ、ネコ、及びトリにおけるコクシジウム症;イヌのトリコモナス症及びジアルジア症;並びにトリのヘキサミタ症が含まれる。これらの疾患は、腸炎又は大腸炎を引き起こして、血液や粘液を伴うか又は伴わない下痢を特徴とする。ヒトでは、ジアルジア属種(Giardia spp)が最も一般的な原生動物である。原生動物の感染による死亡は、脱水と貧血に関連する。診断は、患者・患畜における臨床症状の存在と糞便中の原生動物の嚢子又は運動期の原生動物の検出に基づく。
蠕虫(ワーム)寄生虫によって引き起こされるGI疾患は、必ずしも臨床的に明らかでないが、臨床的疾患と準臨床的疾患のいずれもが患者・患畜の健康に影響を及ぼす。動物のGI管によく感染する蠕虫は、線虫(回虫)である。一般的な種には、反芻動物の胃と腸に感染する毛様線虫;ウマの大腸に感染する円虫;イヌ及びネコの小腸に感染する鉤虫;ブタ、イヌ、ネコ、ウマ、及びトリの小腸に感染する蛔虫;並びに、イヌ及びブタの大腸に感染する鞭虫が含まれる。幼虫期の寄生性ウマバエ(Gasterophilus intestinalis)は、ウマの胃に感染して、発育する。数が増えると、ウマバエ幼虫(bots)は、ウマにおいて胃痛と疝痛の症状を引き起こす場合がある。臨床的に罹患したウマは、貧血、下痢、及び痩せ衰えのような明確な疾患症状を示す。
プリオンは、古典的には、神経学的疾患、即ちヒツジ、ウシ、及びヒトにおける伝染性海綿状脳症に関連付けられてきた。しかしながら、プリオンは、最近、自律神経系異常や末梢神経障害だけでなく、慢性の下痢を引き起こすことが報告された(参照として本明細書に組み込まれる、Mead S, et al. A novel prion disease associated with diarrhea and autonomic neuropathy「下痢と自律神経障害に関連する新規プリオン疾患」, N Engl J Med 2013; 369: 1904-1914)。
すべての生物種におけるGI管の非感染性疾患の主因には、食餌の過剰負荷又は不消化の摂食物、化学的又は物理的な作因、異物の摂取によるか又は身体的変位(physical displacement)又は摂取物の流れを妨げるGI管への損傷によって引き起こされる胃及び腸の妨害、酵素欠乏症、正常機能を妨げる粘膜の異常(例、胃潰瘍、炎症性腸疾患、絨毛萎縮、新生物)、並びに先天性欠損が含まれる。尿毒症、肝疾患、及び副腎皮質機能低下症のような全身性又は代謝性疾患に続発して、嘔吐や下痢のようなGI徴候が発現する場合もある。
ブタ:下痢は、参照として本明細書に組み込まれる「The Pig Site」(http://www.thepigsite.com/pighealth/article/276/diarrhoea-or-scour)に述べられているように、ブタ、特に若い仔豚の最も一般的でおそらくは最も重要な胃腸疾患である。ある突発発生では、下痢が高い罹病率及び死亡率の原因となる。十分に管理された群では、どの時点でも治療を必要とする仔豚が3%未満であって、下痢による仔豚死亡率が0.5%未満であるべきとされている。重大な突発発生では、死亡率のレベルが7%以上へ上昇する可能性があって、個々の未治療の仔豚では100%まで上昇する可能性がある(TGEでは、全体で100%に達する場合がある)。仔豚の下痢の一般的な原因を下記の表に示す:
胃腸炎の感染性の原因と非感染性の原因は、いずれも、運動性、腸の膨張、嘔吐、下痢、体液喪失、分泌過多、及び吸収不良において一連の障害をもたらす。
腸の運動性は、交感神経系及び副交感神経系を介した刺激に(そして従って、これら神経系の中枢部分及び末梢部分の活性に)、そしてGI筋肉組織とその内在性神経叢に依存する。異常な運動機能は、通常、運動性の減少として顕現される。通常は、分節抵抗が低下して、通過速度が増加する。正常以下の運動性の主たる結果の1つが体液及びガスでの膨張である。蓄積した体液の多くが正常な消化の間に分泌される、唾液と胃液及び腸液である。膨張は、疼痛と、隣接する腸分節の反射痙攣を引き起こす。それはまた、腸内腔への体液のさらなる分泌を刺激して、その症状を増悪させる。膨張が臨界点を超えると、腸壁の筋組織の応答能力が減衰し、初期の疼痛は消えて、すべてのGI筋緊張が失われた麻痺性腸閉塞が発現する。GI膨張の主たる結果は、脱水、酸・塩基及び電解質の不均衡、及び循環不全である。
GI疾患の徴候には、過度の唾液分泌、下痢、便秘又は少量の糞便、嘔吐、吐き戻し、GI管出血、腹部の疼痛及び膨張、しぶり腹(tenesmus)、ショックと脱水、体重減少、及び機能低下が含まれる。嘔吐は、単胃の動物及びヒトにおいてごく一般的である。ウマ、ウサギ、及び反芻動物は、嘔吐しない。多量の体液性の下痢には、通常、分泌過多(例、新生の仔牛における腸管毒素原性大腸菌症)又は吸収不良(浸透圧)の影響が関連している。糞便中の血液とフィブリン円柱は、小腸又は大腸の出血性、線維素壊死性腸炎を示唆する(例、ウシウイルス下痢、コクシジウム症、サルモネラ症、又はブタ赤痢)。腹部膨張は、ガス、体液、又は摂取物の蓄積から生じ得る。嘔吐又は下痢により大量の体液が失われる場合、多様な度合いの脱水と酸・塩基及び電解質不均衡が見られ、これはショックや死亡につながる場合がある。
可能な場合はいつでも、疾患の原因又は感染の源の除去が主要目的である。主要原因の除去には、抗菌剤、抗コクシジウム剤、抗真菌剤、駆虫剤、毒物の解毒剤、又は変位の外科的矯正を必要とする場合がある。ブタの赤痢やヒトのコレラのような流行病の状況では、大規模な消毒や清浄な水源の開発が求められる場合がある。
経口補水療法の原理は、腸細胞として知られる、小腸の内層にある細胞によって直接吸収され得る単純栄養素を供給することに基づく。腸細胞は、胃と、膵臓及び小腸より放出される酵素によって達成された消化の最終産物を吸収することを担当する。消化によって、栄養素の3種の主要カテゴリー(炭水化物、タンパク質、及び脂肪)は、その構成分子、即ち、糖類、アミノ酸、及び脂質へ分解される。
[1]約0.01%〜約0.40%(w/w)の範囲のl-グルタミン酸と約0.05%〜約0.80%(w/w)の範囲のグルタミン酸一ナトリウムを含む、経口補水組成物。
[2]約1.50%(w/w)のグルコース一水和物を含む、[1]の経口補水組成物。
[3]約0.20%(w/w)の塩化ナトリウムを含む、[1]の経口補水組成物。
[4]約0.15%(w/w)の塩化カリウムを含む、[1]の経口補水組成物。
[5]約0.15%(w/w)のリン酸二水素ナトリウムを含む、[1]の経口補水組成物。
[6]約0.10%(w/w)のキサンタンガムを含む、[1]の経口補水組成物。
[7]約0.35%(w/w)のグリシンを含む、[1]の経口補水組成物。
[8]約0.30%(w/w)のクエン酸三ナトリウムを含む、[1]の経口補水組成物。
[9]約0.20%(w/w)のクエン酸一水和物を含む、[1]の経口補水組成物。
[10]約0.01%〜約0.03%(w/w)の範囲の85%ステビオールグリコシド(Steviol Glycoside)抽出物を含む、[1]の経口補水組成物。
[11]約0.15%〜約1.00%(w/w)の範囲の加水分解ホエイを含む、[1]の経口補水組成物。
[12]約1.00%(w/w)の加水分解コムギを含む、[1]の経口補水組成物。
[13]シリアル類をタンパク源として含む、[1]の経口補水組成物。
[14]異なる種又は個体の調味選好性に適するように設計される、[1]の経口補水組成物。
[15]すぐに使える組成物である、[1]の経口補水組成物。
[16]粉末濃縮物である、[1]の経口補水組成物。
[17]前記濃縮物を水に希釈する、[16]の経口補水組成物。
[18]前記濃縮物が酵素補因子を含む、[1]の経口補水組成物。
[19]前記濃縮物が単糖を含む、[1]の経口補水組成物。
[20]実施例1〜実施例5のいずれかの経口補水組成物。
[21]等張溶液剤である、[1]の経口補水組成物。
[22]前記等張溶液剤が塩化ナトリウムの0.9%溶液の等張性に相当する、[21]の経口補水組成物。
[23]低張溶液剤である、[1]の経口補水組成物。
[24]高張溶液剤である、[1]の経口補水組成物。
[25]ゲル剤、スプレー剤、又は速溶性錠剤であり得る、[1]の経口補水組成物。
[26]脱水を予防する方法であって:
a.経口補水溶液剤を調製する工程
b.前記経口補水溶液剤を個体へ投与する工程を含んでなり、
ここで前記組成物は、約0.01%〜約0.40%(w/w)の範囲のl-グルタミン酸と約0.05%〜約0.80%(w/w)の範囲のグルタミン酸一ナトリウムを含む、前記方法。
[27]前記個体がヒトである、[26]の方法。
[28]前記個体が動物である、[26]の方法。
[29]前記被験者が下痢に罹患している、[26]の方法。
以下:約0.01%〜約0.40%(w/w)の範囲のl-グルタミン酸と約0.05%〜約0.80%(w/w)の範囲のグルタミン酸一ナトリウム;約1.50%(w/w)のグルコース一水和物;約0.20%(w/w)の塩化ナトリウム;約0.15%(w/w)の塩化カリウム;約0.35%(w/w)のグリシン;約0.30%(w/w)のクエン酸三ナトリウム;約0.15%(w/w)のリン酸二水素ナトリウム;約0.10%(w/w)のキサンタンガム;約0.01%〜約0.03%(w/w)の範囲の85%ステビオールグリコシド(Steviol Glycoside)抽出物;約0.20%(w/w)のクエン酸一水和物;約0.15%〜約1.00%(w/w)の範囲の加水分解ホエイ;約1.00%(w/w)の加水分解コムギを含んでなる経口補水組成物は、タンパク源としてシリアル類を含み;酵素補因子を含み;単糖を含む。
1.嘔吐と下痢の期間の間、小腸の内層にある腸細胞に栄養分を与えること。これらの細胞は、腸の防護壁を提供する粘膜を創出する(悪玉菌が血流に侵入して他の身体部分に悪影響を及ぼすことを防ぐ)とともに、腸細胞はまた、身体が必要とする栄養分を引き込む吸収細胞でもある。直接的な栄養補給が無いと(このことは、動物が食べていない場合、嘔吐/下痢の間にしばしば生じる)、これらの細胞はすぐに死滅/萎縮する。利用可能な他の処方は、脱水に対処するのに電解質置換しか提供しない傾向があるか、又はアミノ酸を送達する完全な食餌/ミルク代用品ではあるものの、脂肪とタンパク質の含量が高すぎて、消化管は、胃腸炎の期間の間、これを忍容し得ない。
Pig Site(参照として本明細書に組み込まれる、http://www.thepigsite.com/pighealth/article/103/rehydration-by-mouth)は、以下の処方を提供する:
胃腸炎を有する患者・患畜に対して経腸投与品を投与することは直感に反するように思われるかもしれないが、これは、奏功することがヒト医学において確かに証明されたことなのである。家畜の胃腸炎には、多くの原因がある。ほとんどがウイルス性であるが、未知の理由で胃腸炎を発現する患畜もいる。無分別な摂食も、かなり一般的である。パルボウイルスは、イヌにおいて特に重篤な形態の胃腸炎となる。腸管の内層にある細胞がパルボウイルスによって直接攻撃され、炎症、栄養素の吸収不良、及び出血を引き起こす。パルボウイルスはまた、特に重篤な吐気と分泌性下痢を引き起こす。多くの獣医スタッフは、嘔吐している患畜、特にパルボウイルスを有する患畜に給餌することを嫌がるものである。しかしながら、24週齢未満のパルボウイルス感染した30匹の仔犬での十分に設計された試験において、Mohr らは、低脂肪の缶詰食品を給餌された仔犬と比較して、経鼻食道チューブにより早期の経腸栄養を受けた仔犬における、より迅速な食欲の回復、より迅速な体重増加、そしてより良好な腸壁の完全性を示した(参照として本明細書に組み込まれる、Mohr et al., Effect of early enteral nutrition on intestinal permeability, intestinal protein loss, and outcome in dogs with severe parvoviral enteritis「重篤なパルボウイルス腸炎のあるイヌにおいて、早期の経腸栄養が腸管透過性、腸タンパク質喪失、及び転帰に及ぼす効果」, J Vet Intern Med. 2003 Nov-Dec; 17(6): 791-8)。
経口補水療法剤を投与すること
本発明の経口補水療法補液は、必要ならばシリンジを使用して、初めは2時間ごとに約0.5ml/kgの速度で、経口で投与し得る。これは、ごく少量であって、ほとんど嘔吐を引き起こさない。嘔吐が起こらなければ、この容量を8〜12時間ごとに50%だけ増加させてよい。ネコと小型犬では、製氷皿を使用して、この経口液体補水製剤の小塊を凍らせてから、必要に応じて調合することができる。患畜がこの補液を舐め始めたならば、容量を速やかに増やして、よりカロリー豊富な食物を導入することができる。
本発明による、加水分解コムギタンパク源の経口補水製剤の例は、以下の通りである:
濃縮物を以下のように調製し得る:
ブタ、仔牛、及び仔羊用の経口液体補水製剤
本発明による、加水分解コムギタンパク源の経口補水製剤の例は、以下の通りである:
濃縮物を以下のように調製し得る:
ブタ、仔牛、及び仔羊用の経口液体補水製剤
本発明による、加水分解コムギタンパク源の経口補水製剤の例は、以下の通りである:
粉末を以下のように調製し得る:
ブタ、仔牛、及び仔羊用の経口液体補水製剤
本発明による、加水分解ホエイタンパク源の経口補水製剤の別の例は、以下の通りである:
粉末を以下のように調製し得る:
Claims (27)
- 水、グルコース一水和物、塩化ナトリウム、塩化カリウム、グリシン、キサンタンガム、l−グルタミン酸、及びグルタミン酸一ナトリウム、並びに加水分解ホエイタンパク質又は加水分解コムギタンパク質からなる成分を含む、等張性経口補水組成物。
- 水、グルコース一水和物、塩化ナトリウム、塩化カリウム、グリシン、リン酸二水素ナトリウム、キサンタンガム、クエン酸一水和物、加水分解ホエイタンパク質、ステビオールグリコシド(Steviol Glycoside)抽出物、l−グルタミン酸、及びグルタミン酸一ナトリウムからなる成分を含む、請求項1に記載の等張性経口補水組成物。
- 約0.01%〜約0.40%(w/w)の範囲のl−グルタミン酸と約0.05%〜約0.80%(w/w)の範囲のグルタミン酸一ナトリウムを含む、請求項1又は2の等張性経口補水組成物。
- 約1.50%(w/w)のグルコース一水和物を含む、請求項1〜3のいずれか一項の等張性経口補水組成物。
- 約0.20%(w/w)の塩化ナトリウムを含む、請求項1〜4のいずれか一項の等張性経口補水組成物。
- 約0.15%(w/w)の塩化カリウムを含む、請求項1〜5のいずれか一項の等張性経口補水組成物。
- 約0.15%(w/w)のリン酸二水素ナトリウムを含む、請求項2〜6のいずれか一項の等張性経口補水組成物。
- 約0.10%(w/w)のキサンタンガムを含む、請求項1〜7のいずれか一項の等張性経口補水組成物。
- 約0.35%(w/w)のグリシンを含む、請求項1〜8のいずれか一項の等張性経口補水組成物。
- 約0.30%(w/w)のクエン酸三ナトリウムを含む、請求項1〜9のいずれか一項の等張性経口補水組成物。
- 約0.20%(w/w)のクエン酸一水和物を含む、請求項2〜10のいずれか一項の等張性経口補水組成物。
- 約0.01%〜約0.03%(w/w)の範囲の85%ステビオールグリコシド抽出物を含む、請求項2〜11のいずれか一項の等張性経口補水組成物。
- 約0.15%〜約1.00%(w/w)の範囲の加水分解ホエイを含む、請求項1〜12のいずれか一項の等張性経口補水組成物。
- 約1.00%(w/w)の加水分解コムギを含む、請求項1〜13のいずれか一項の等張性経口補水組成物。
- シリアル類をタンパク源として含む、請求項2〜14のいずれか一項の等張性経口補水組成物。
- 異なる種又は個体の調味選好性に適するように設計される、請求項2〜15のいずれか
一項の等張性経口補水組成物。 - すぐに使える組成物である、請求項2〜16のいずれか一項の等張性経口補水組成物。
- 請求項2〜17のいずれか一項の等張性経口補水組成物の調製のために用いられる粉末濃縮物であって、グルコース一水和物、塩化ナトリウム、塩化カリウム、グリシン、リン酸二水素ナトリウム、キサンタンガム、クエン酸一水和物、加水分解ホエイタンパク質、ステビオールグリコシド(Steviol Glycoside)抽出物、l−グルタミン酸、及びグルタミン酸一ナトリウムからなる成分を含む、粉末濃縮物。
- 前記濃縮物が水に希釈される構成を有する、請求項18の粉末濃縮物。
- 前記濃縮物が酵素補因子を含む、請求項18又は19の粉末濃縮物。
- 前記濃縮物が単糖を含む、請求項18〜20のいずれか一項の粉末濃縮物。
- 以下のいずれかから選択される等張性経口補水組成物:
a.水96.27%、グルコース一水和物1.50%、塩化ナトリウム0.26%、塩化カリウム0.15%、グリシン0.40%、クエン酸三ナトリウム0.29%、キサンタンガム0.05%、加水分解コムギタンパク質1.00%、l−グルタミン酸0.04%、及びグルタミン酸一ナトリウム0.04%;
b.水62.70%、グルコース一水和物15.00%、塩化ナトリウム2.60%、塩化カリウム1.50%、グリシン4.00%、クエン酸三ナトリウム2.90%、キサンタンガム0.50%、加水分解コムギタンパク質10.00%、l−グルタミン酸0.40%、及びグルタミン酸一ナトリウム0.40%;
c.水96.26%、グルコース一水和物1.50%、塩化ナトリウム0.26%、塩化カリウム0.15%、グリシン0.40%、リン酸二水素ナトリウム0.10%、キサンタンガム0.05%、加水分解コムギタンパク質1.00%、l−グルタミン酸0.04%、及びグルタミン酸一ナトリウム0.04%;
d.水62.60%、グルコース一水和物15.00%、塩化ナトリウム2.60%、塩化カリウム1.50%、グリシン4.00%、リン酸二水素ナトリウム1.00%、キサンタンガム0.50%、加水分解コムギタンパク質10.00%、l−グルタミン酸0.40%、及びグルタミン酸一ナトリウム0.40%;
e.水97.00%、グルコース一水和物1.45%、塩化ナトリウム0.26%、塩化カリウム0.15%、グリシン0.30%、リン酸二水素ナトリウム0.10%、キサンタンガム0.10%、クエン酸一水和物0.20%、加水分解ホエイタンパク質0.15%、l−グルタミン酸0.04%、グルタミン酸一ナトリウム0.25%、及び85%ステビオールグリコシド(Steviol Glycoside)抽出物0.001%;
f.水97.00%、グルコース一水和物1.44%、塩化ナトリウム0.26%、塩化カリウム0.15%、グリシン0.30%、リン酸二水素ナトリウム0.10%、キサンタンガム0.10%、クエン酸一水和物0.20%、加水分解ホエイタンパク質0.15%、l−グルタミン酸0.04%、グルタミン酸一ナトリウム0.25%、及び85%ステビオールグリコシド(Steviol Glycoside)抽出物0.01%。 - 塩化ナトリウムの0.9%溶液の等張性に相当する、請求項1〜17および22の等張性経口補水組成物。
- 脱水を予防するための、請求項1〜17及び22〜23のいずれか一項の等張性経口補水組成物。
- ヒト用である、請求項24の等張性経口補水組成物。
- 動物用である、請求項24の等張性経口補水組成物。
- 下痢に罹患している対象用である、請求項24の等張性経口補水組成物。
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