JPWO2006033349A1 - 総合経腸栄養組成物 - Google Patents
総合経腸栄養組成物 Download PDFInfo
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Abstract
Description
(1)組成物100kcalあたり、銅含量を0.15mg以下とし、亜鉛と銅の質量比を10〜25、好ましくは13〜20、特に好ましくは15〜18とすることである。この場合亜鉛含量を1.5mg以上とし、銅含量を0.075〜0.15mgとすることが好ましい。これは、銅の含有量が高いと亜鉛の吸収が阻害されるという知見に基づいて導かれる特徴点である。
総合経腸栄養組成物の調製(組成物1)
低栄養状態に対する最適栄養効果を熟考し、栄養素組成〔表1〕を組み立てた。これを具現化するための液状物の原料配合表を〔表2〕に示す。乳化安定性に優れ、たんぱく質等の沈殿を起こさない組成物とするため、ナトリウム原材料とたんぱく質原材料および乳化剤を原料配合表に従い配合し、高圧乳化機の圧力を500〜1,000kg/cm2として複数回乳化工程を実施することによって、液状総合経腸栄養組成物を調製した。すなわち、原材料と水とを高圧乳化機を用いて高圧乳化を繰り返し良好な1kcal/mlの濃度の乳化液を調製した。動物性たんぱく質と植物性たんぱく質の比率は1:1.5とした。また、グルタミンペプチドと、大豆たんぱく質あるいはこの加水分解物の比率は1:1.4であり、さらに脂肪酸組成においてω−3系脂肪酸:ω−6系脂肪酸の比率は1:3となるよう配合した。これを通常の充填機を用いてアルミ製袋に充填し、レトルト殺菌機に入れ、通常の条件で滅菌を実施した。この液は1年後においても全成分は安定であり、粘度は9mPa・s(25℃)であった。
総合経腸栄養組成物の調製 (組成物2)
実施例1と同様に〔表3〕に示される栄養素組成を組み立てた。これを具現化するための液状物の原料配合表を〔表4〕に示す。実施例1と同様に、ナトリウム原材料とたんぱく質原材料および乳化剤の配合量を組み合わせ、さらに高圧乳化機の圧力を500〜1,000kg/cm2として複数回乳化工程を実施し、液状総合経腸栄養組成物を調製した。すなわち、原材料と水とを高圧乳化機を用いて高圧乳化を繰り返し良好な1kcal/mlの濃度の乳化液を調製した。動物性たんぱく質と植物性たんぱく質の比率は1:2とした。また、グルタミンペプチドと、大豆たんぱく質加水分解物の比率は3:1であり、さらに脂肪酸組成においてω−3系脂肪酸/ω−6系脂肪酸の比率は1:1とした。これを通常の充填機を用いてアルミ製袋に充填し、レトルト殺菌機に入れ、通常の条件で滅菌を実施した。この液は1年後においても全成分は安定であり、粘度は16mPa・s(25℃)であった。
実施例1と同様に〔表5〕に示される栄養素組成を組み立てた。これを具現化するための液状物の原料配合量を〔表6〕に示す。実施例1と同様に、ナトリウム原材料とたんぱく質原料および乳化剤を組み合わせ、さらに高圧乳化機の圧力を500〜1,000kg/cm2として複数回乳化工程を実施し、液状総合経腸栄養組成物を調製した。すなわち、原材料と水とを高圧乳化機を用いて高圧乳化を繰り返し良好な1kcal/mlの濃度の乳化液を調製した。これを通常の充填機を用いてアルミ製袋に充填し、レトルト殺菌機に入れ、通常の条件で滅菌を実施した。この液は1年後においても全成分は安定であり、粘度は10mPa・s(25℃)であった。
総合経腸栄養組成物の調製(組成物4)
実施例1と同様に〔表7〕に示される栄養組成を組み立てた。これを具現化するための液状物の原料配合量を〔表8〕に示す。実施例1と同様に、ナトリウム原材料とたんぱく質原料および乳化剤を組み合わせ、さらに高圧乳化機の圧力を500〜1,000kg/cm2として複数回乳化工程を実施し液状総合経腸栄養組成物を調製した。すなわち、原材料と水とを高圧乳化機を用いて高圧乳化を繰り返し良好な1kcal/mlの濃度の乳化液を調製した。これを通常の充填機を用いてアルミ製袋に充填し、レトルト殺菌機に入れ、通常の条件で滅菌を実施した。この液は1年後においても全成分は安定であり、粘度は8mPa・s(25℃)であった。
ヒトに対する試験
実施例1で調製した本発明の液状総合経腸栄養組成物(本発明品)を使用し、高齢PEM患者の栄養状態に対する改善効果の検証を行った。対象は病院に入院しており経管栄養で栄養管理をされている高齢患者でアルブミン値3.5g/dL以下のPEM患者9名で、平均年齢81.3±9.9歳であった。給与期間は8週間とした。本発明品の給与開始前には、市販栄養製品A、Bなど複数のものが給与されていた。市販栄養製品A、Bなどと本発明品の各栄養素の給与量と充足率を〔表9〕に示した。本発明品によって給与されるエネルギー(873±124kcal/日)は、それ以前に市販栄養製品A、Bなどによって給与されていた平均エネルギー(863±133kcal/日)と同等とした。市販栄養製品A、Bなどの給与時と本発明品の給与時における栄養状態を確認した。早朝採血にて開始前、4週間、8週間後に血液学的検査、血液生化学的検査の測定を行った。
実施例2、3および4で調製した栄養組成物2、3および4でも各指標で有効性が認められた。
ヒトの褥瘡に対する治療効果
実施例1で調製した本発明の液状総合経腸栄養組成物(本発明品)を使用し、難治療性の褥瘡を発症した高齢患者に対する褥瘡改善効果を検証した。患者は、病院に入院する95歳の超高齢であり、介助が必要な状態であった。栄養評価記録のある平成14年7月からアルブミン3.5mg/dL以下が2年以上つづく低栄養を呈していた。病歴は閉塞性動脈硬化症と診断され(両下肢特に右)、褥瘡が右第1趾根部に発症し、市販経腸栄養製品Aによる栄養補給が行われていた。院内カンファレンスによりこれ以上の処置による褥瘡回復は困難との結論が出た患者であった。この血行不良が基礎疾患としてあり、難治な高齢褥瘡患者に市販経腸栄養製品Aと同カロリーの本発明品を給与し褥瘡の回復を測定した。市販経腸栄養製品Aと本発明品の栄養素給与量は〔表10〕に示した。市販経腸栄養製品Aの給与時と本発明品の給与時におけるエネルギーは同じとした。
Claims (18)
- たんぱく質、糖質、脂肪、ミネラル、ビタミンを含有する総合経腸栄養組成物であって、該組成物100kcal当り、銅含量が0.15mg以下、亜鉛/銅の質量比が10/1〜25/1、ナトリウム含量が185mg以上、ビタミンB1含量が0.30mg以上、及びビタミンB2含量が0.25mg以上であることを特徴とする総合経腸栄養組成物。
- 該組成物100kcal当り、たんぱく質含量が4.0g以上である請求項1に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、たんぱく質含量が5.0g以上である請求項2に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、亜鉛含量が1.5mg以上、銅含量が0.075mg〜0.15mgである請求項1〜3のいずれか1項に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、亜鉛含量が1.5〜3.0mg、銅含量が0.075〜0.15mg、ナトリウム含量が185〜385mg、ビタミンB1含量が0.4〜2.0mg、ビタミンB2含量が0.25〜2.0mg、亜鉛/銅の質量比が10/1〜20/1である請求項1〜4のいずれか1項に記載の総合経腸栄養組成物。
- 亜鉛/銅の質量比が13/1から20/1である請求項1〜5のいずれか1項に記載の総合経腸栄養組成物。
- 亜鉛/銅の質量比が15/1から18/1である請求項1〜6のいずれか1項に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、亜鉛含量が1.8〜3.0mg、銅含量が0.09〜0.12mg、ナトリウム含量が200〜385mgである請求項1〜7のいずれか1項に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、ビタミンB6含量が0.3〜2.0mg、ビオチン含量が1.0〜10μgである請求項1〜8のいずれか1項に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、ビタミンB12含量が0.20〜0.70μg、葉酸含量が20〜80μg、β−カロチン含量が100〜450μg、ビタミンC含量が10〜70mgである請求項1〜9のいずれか1項に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、セレン含量が4.5〜18μgである請求項1〜10のいずれか1項に記載の総合経腸栄養組成物。
- 動物性たんぱく質と植物性たんぱく質の比率が4:1から1:4である請求項1〜11のいずれか1項に記載の総合経腸栄養組成物。
- たんぱく質としてグルタミンあるいはグルタミンペプチドと、大豆たんぱく質あるいはその加水分解物を含有する請求項1〜12のいずれか1項に記載の総合経腸栄養組成物。
- 該組成物100kcal当り、たんぱく質中の総グルタミンが少なくとも0.6gである請求項13に記載の総合経腸栄養組成物。
- グルタミンペプチドと、大豆たんぱく質あるいはこの加水分解物の比率が4:1から1:4である請求項13または14項に記載の総合経腸栄養組成物。
- 脂肪源として中鎖脂肪酸油を少なくとも脂肪中35重量%含有し、かつ脂肪中ω−3系脂肪酸:ω−6系脂肪酸が1:10から1:1である請求項1〜15のいずれか1項に記載の総合経腸栄養組成物。
- 中鎖脂肪酸トリグリセリドが脂肪中40〜65重量%でかつ脂肪中ω−3系脂肪酸:ω−6系脂肪酸が1:4から1:1である請求項16に記載の総合経腸栄養組成物。
- 該組成物の粘度が6〜18mPa・s(25℃)の範囲にある請求項1〜17のいずれか1項に記載の総合経腸栄養組成物。
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EP1797891A1 (en) | 2007-06-20 |
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