JP2012503615A - ヌクレオ塩基(nucleobase)と、真菌類、酵母、または細菌から得られる多糖と、を含む免疫刺激剤組成物 - Google Patents
ヌクレオ塩基(nucleobase)と、真菌類、酵母、または細菌から得られる多糖と、を含む免疫刺激剤組成物 Download PDFInfo
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Abstract
Description
式中、Rは、水素原子またはアセチル基で、その比は7:3である。
従来の方法で錠剤を調製する。
1錠当たりの活性成分の含量
Nucleoforce(登録商標)Dogs 450mg
AHCC(登録商標) 450mg
従来の方法で錠剤を調製する。
1錠当たりの活性成分の含量
Nucleoforce(登録商標) 1,000mg
AHCC(登録商標) 1,000mg
本実験の目的は、化学治療を受けるイヌの免疫機能に対する、Nucleoforce(登録商標)DogsとAHCC(登録商標)とを含む本発明の組成物の投与の効果を調べることであった。
臨床試験計画は無作為二重盲検法で行った。本プロトコルは、Murcia大のEthical Committee of Animal Researchで認証された。
対照群C:プラセボ製品(結晶性ミクロセルロース)
A群:Nucleoforce(登録商標)Dogs(60mg/kg体重)
B群:AHCC(登録商標)(60mg/kg体重)
(A+B)群:Nucleoforce(登録商標)Dogs(30mg/kg体重)とAHCC(登録商標)(30mg/kg体重)とを含む本発明の組成物
ロムスチン(70mg/m2体表面)を経口で1回投与、および
シクロホスファミド(180mg/m2体表面)を経口で1回投与
化学治療処置の1週間後、全てのイヌに、重度の白血球減少症(leucopoenia)が見られた。同日、対照群のイヌの50%(3/6)に、重度の抑鬱状態と下痢が記録された。影響のあった動物の割合は、Nucleoforce(登録商標)Dogsで処置した群(33%(2/6))と、AHCC(登録商標)で処置した群(33%(2/6))で僅かに低かったが、本発明の組成物(Nucleoforce(登録商標)DogsとAHCC(登録商標))で処置した群(0%(0/6))では、病気の臨床的症状を示した動物は無かった。
本実験の目的は、健康なイヌの免疫機能に対する、Nucleoforce(登録商標)DogsとAHCC(登録商標)とを含む本発明の組成物の投与の効果を調べることであった。
試験計画は無作為二重盲検法で行った。本プロトコルは、Murcia大のEthical Committee of Animal Researchで認証された。合計24匹の、平均体重15kgのビーグル成犬(1から2歳の、健康な雌雄)を無作為に4群(C、A、B、A+B)(n=6)に分け、以下のものを添加した標準的な市販飼料を30日間与えた。
対照群C:プラセボ製品(結晶性ミクロセルロース)
A群:Nucleoforce(登録商標)Dogs(60mg/kg体重)
B群:AHCC(登録商標)(60mg/kg体重)
(A+B)群:Nucleoforce(登録商標)Dogs(30mg/kg体重)とAHCC(登録商標)(30mg/kg体重)とを含む本発明の組成物
図5に示すように、供試製品を30日間与えた後において、本発明の組成物(Nucleoforce(登録商標)DogsとAHCC(登録商標)との組み合わせ)を与えた動物は、Nucleoforce(登録商標)Dogs(7.04±1.72 OD)、AHCC(登録商標)(7.18±1.79 OD)、またはプラセボ製品(8.01±1.81 OD)を与えた動物よりも、著しく高いリンパ球増殖指数(13.42±0.72 OD)(P<0.05)を示した。
本実験のねらいは、呼吸器疾患の発生率の高い営利農場の離乳子牛の、呼吸障害の発生率と免疫機能に対する、Nucleoforce(登録商標)とAHCC(登録商標)との組み合わせの効果を調べることであった。
78頭の交換用乳用子牛(dairy replacement calves)(開始時日齢18±6.3日、体重43±6.1kg)に、07時30分と16時30分の1日2回、瓶を用いて2リットルの代用乳(MR)を45日齢まで与えた後、更に1週間、1日量2リットルのMRを07時30分に与えた。37日齢から離乳時(52日齢)まで、半数の子牛に、1日量3gの、Nucleoforce(登録商標)(スペイン国、Bioiberica製)とAHCC((株)アミノアップ化学製)との組み合わせを、朝のMR給餌に添加して与えた。離乳後、子牛を個飼いの小屋から8頭飼いの囲いに移し、111±2.1日(試験終了時)まで置いた。52日齢から111日齢まで動物の行動を観察した。37日齢から111日齢まで毎日、呼吸器疾患を観察した。それぞれの処置群からランダムに選んだ半数の動物から、37日齢目と52日齢目に、頸静脈の静脈穿刺により血液サンプル採取した。混合効果ロジスティック回帰分析を用いて呼吸器疾患の発生率を、混合効果ポアソン回帰分析を用いて呼吸器の症例数を調べた。血液の測定値は、混合効果ANOVAを用いて解析した。
血小板(blood plateletcrit)は、添加したものの方が対照子牛よりも高かった(それぞれ、22.9%と21.5±0.45%)(P<0.05)。平均血小板体積も、添加したものは対照子牛よりも高かった(それぞれ、10.3fLと7.9±0.01fL)(P<0.05)。同様に、単球の割合も、添加したものが対照子牛より高かった(それぞれ、10.7%と9.1±0.10%)(P<0.05)。
Claims (33)
- ヌクレオ塩基および/またはヌクレオ塩基資源を含む成分a)と、
真菌類、酵母、または細菌の抽出物から得られる多糖を含む成分b)と、
を含むことを特徴とする組成物。 - 1単位用量中に、
15mgから3,000mgの、ヌクレオ塩基および/またはヌクレオ塩基資源を含む成分a)と、
15mgから3,000mgの、真菌類、酵母、または細菌の抽出物から得られる多糖を含む成分b)と、
を含むことを特徴とする、請求項1に記載の組成物。 - 1単位用量中に、
30mgから2,100mgの、ヌクレオ塩基および/またはヌクレオ塩基資源を含む成分a)と、
15mgから2,100mgの、真菌類、酵母、または細菌の抽出物から得られる多糖を含む成分b)と、
を含むことを特徴とする、請求項2に記載の組成物。 - 1単位用量中に、
150mgから750mgの、ヌクレオ塩基および/またはヌクレオ塩基資源を含む成分a)と、
150mgから750mgの、真菌類、酵母、または細菌の抽出物から得られる多糖を含む成分b)と、
を含むことを特徴とする、請求項3に記載の組成物。 - 1単位用量中に、
ヒトを含む哺乳動物の体重1kg当たり1mgから60mgの成分a)と、
ヒトを含む哺乳動物の体重1kg当たり1mgから60mgの成分b)と、
を含むことを特徴とする、請求項1に記載の組成物。 - 前記ヌクレオ塩基資源は、ヌクレオシド類、ヌクレオチド類、RNA、およびDNAから成る群より選ばれることを特徴とする、請求項1から請求項5のいずれか1項に記載の組成物。
- 前記多糖は、α−グルカンまたはβ−グルカンであることを特徴とする、請求項1から請求項6のいずれか1項に記載の組成物。
- 前記α−グルカン多糖は、α−1,4-グルカンまたはそのアセチル化誘導体であることを特徴とする、請求項7に記載の組成物。
- 前記成分a)と前記成分b)の重量比は、25:75から75:25であることを特徴とする、請求項1から請求項8のいずれか1項に記載の組成物。
- 前記成分a)と前記成分b)の重量比は、50:50であることを特徴とする、請求項1から請求項9のいずれか1項に記載の組成物。
- 前記成分a)は更にグルタミンを含むことを特徴とする、請求項1から請求項10のいずれか1項に記載の組成物。
- 前記成分a)は Nucleoforce(登録商標)であり、前記成分b)はAHCC(登録商標)であることを特徴とする、請求項1から請求項11のいずれか1項に記載の組成物。
- 前記成分a)はNucleoforce(登録商標)Dogsであり、前記成分b)はAHCC(登録商標)であることを特徴とする、請求項1から請求項11のいずれか1項に記載の組成物。
- 免疫刺激剤組成物であることを特徴とする、請求項1から請求項13のいずれか1項に記載の組成物。
- 医薬組成物であることを特徴とする、請求項1から請求項14のいずれか1項に記載の組成物。
- 食物組成物であることを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物。
- 前記成分a)と前記成分b)とを固体状態で混合する工程を含むことを特徴とする、請求項1から請求項16のいずれか1項に記載の組成物の調製法。
- 薬剤として使用することを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物。
- 免疫抑制、化学治療または放射線治療から生じる毒性、免疫系の疾患、癌、感染症の治療または予防、あるいは、ヒトを含む哺乳動物の免疫機能の刺激に使用することを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物。
- ヒトを含む哺乳動物の、免疫抑制を治療または予防する薬剤の調製であることを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物の使用法。
- 前記免疫抑制は、癌、外科手術、敗血症、外傷、やけど、免疫抑制剤治療、栄養不良、または感染症に伴うものであることを特徴とする、請求項20に記載の使用法。
- 前記免疫抑制は、化学治療または放射線治療に伴うものであることを特徴とする、請求項20に記載の使用法。
- ヒトを含む哺乳動物の、化学治療または放射線治療から生じる毒性を治療または予防する薬剤の調製における前記組成物の使用法であって、望ましくは、前記毒性は、血液、消化器、腎臓、泌尿器、心臓、呼吸器、神経、皮膚、および肝臓毒性から成る群より選ばれることを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物の使用法。
- ヒトを含む哺乳動物の、免疫機能を刺激する薬剤の調製であることを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物の使用法。
- ヒトを含む哺乳動物の、免疫系の疾患を治療または予防する薬剤の調製であることを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物の使用法。
- ヒトを含む哺乳動物の、癌を治療または予防する薬剤の調製であることを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物の使用法。
- ヒトを含む哺乳動物の、感染症を治療または予防する薬剤の調製であることを特徴とする、請求項1から請求項15のいずれか1項に記載の組成物の使用法。
- 前記感染症は、ウイルス、真菌、細菌、および/または寄生虫感染症であることを特徴とする、請求項27に記載の使用法。
- 前記感染症は、呼吸気道の、ウイルスおよび/または細菌感染症であることを特徴とする、請求項28に記載の使用法。
- 投与される前記薬剤は、請求項1から請求項15のいずれか1項に記載の組成物の、成分a)を、ヒトを含む哺乳動物の体重1kg当たり1mgから60mgと、成分b)を、ヒトを含む哺乳動物の体重1kg当たり1mgから60mgと、を含むことを特徴とする、請求項20から請求項29のいずれか1項に記載の使用法。
- 前記薬剤は、径腸経路または非経口経路で投与することを特徴とする、請求項20から請求項30のいずれか1項に記載の使用法。
- 人体または他の哺乳動物の体の免疫機能を刺激する食物組成物の調製工程中であることを特徴とする、請求項16に記載の組成物の使用法。
- 前記哺乳動物はイヌであることを特徴とする、請求項20から請求項32のいずれか1項に記載の使用法。
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ES200802731A ES2341163B1 (es) | 2008-09-26 | 2008-09-26 | Composiciones inmunoestimulantes. |
ESP200802731 | 2008-09-26 | ||
PCT/EP2009/061620 WO2010034615A1 (en) | 2008-09-26 | 2009-09-08 | Immunostimulant compositions comprising a nucleobase and a polysaccharide obtainable from fungi, yeast or bacteria |
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WO2007095313A2 (en) * | 2006-02-10 | 2007-08-23 | The Roan Group, Inc. | Microencapsulated nucleotide formulations for aquaculture and land animal feeds |
JP2007529220A (ja) * | 2004-03-17 | 2007-10-25 | フリーダム ヘルス,エルエルシー | 栄養補助食品及び消化器系関連障害の治療方法 |
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AU2001277737B2 (en) | 2001-02-08 | 2007-12-06 | Amino Up Co., Ltd. | Novel substance having physiological activity, process for producing the same, and use |
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WO2007095313A2 (en) * | 2006-02-10 | 2007-08-23 | The Roan Group, Inc. | Microencapsulated nucleotide formulations for aquaculture and land animal feeds |
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JPN5012000417; MARTINEZ-PUIG D: 'DIETARY NUCLEOTIDE SUPPLEMENTATION REDUCES OCCURRENCE OF DIARRHOEA IN EARLY WEANED PIGS' LIVESTOCK SCIENCE V108 N1-3, 200705, P276-279 * |
JPN5012000419; SPIERINGS EGILIUS L H: 'A PHASE I STUDY OF THE SAFETY OF THE NUTRITIONAL SUPPLEMENT, 以下備考' JOURNAL OF THE NUTRITIONAL SCIENCE AND VITAMINOLOGY V53 N6, 200712, P536-539 * |
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WO2010034615A1 (en) | 2010-04-01 |
ES2341163B1 (es) | 2011-05-11 |
CA2738599A1 (en) | 2010-04-01 |
ES2600281T3 (es) | 2017-02-08 |
ES2341163A1 (es) | 2010-06-15 |
US20110213020A1 (en) | 2011-09-01 |
EP2346530B1 (en) | 2016-07-27 |
EP2346530A1 (en) | 2011-07-27 |
US9161979B2 (en) | 2015-10-20 |
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