JP2015522631A - 癌関連の倦怠感の治療のための組成物 - Google Patents
癌関連の倦怠感の治療のための組成物 Download PDFInfo
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- JP2015522631A JP2015522631A JP2015523483A JP2015523483A JP2015522631A JP 2015522631 A JP2015522631 A JP 2015522631A JP 2015523483 A JP2015523483 A JP 2015523483A JP 2015523483 A JP2015523483 A JP 2015523483A JP 2015522631 A JP2015522631 A JP 2015522631A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
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- Natural Medicines & Medicinal Plants (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Abstract
Description
一例は、良く知られている抗疲労および活性化作用と共に免疫促進および抗癌特性を有するオタネニンジン抽出物である。一つの研究[Proc.Am.Soc.Clin.Oncol.2003 Abst.2947](非特許文献1)は、プラセボ群と比べて疲労が著しく改善された心強い結果を与えた。しかしながら、他の研究においては、おそらく製剤が標準化されていないことが原因で、結果は不安定または疑わしく、場合によっては好ましくない。
オタネニンジン抽出物:10〜500mg、好ましくは50〜250mg;
ショウガ抽出物:5〜100mg、好ましくは10〜50mg;
エキナセア抽出物:1〜50mg、好ましくは5〜20mg;
リン脂質とのシリビン複合体:10〜500mg、好ましくは50〜250mg
好ましくは、これらの投与量が1日1〜4回、好ましくは1日3回経口投与される。
単位組成(フィルム被覆錠剤)
オタネニンジン抽出物:100.0mg
リン脂質とのシリビン複合体:100.0mg
ショウガ抽出物:20.0mg
エキナセア抽出物:5.0mg
リン酸二カルシウム:115.0mg
微結晶セルロース:95.0mg
クロスカルメロースナトリウム13.5mg
二酸化珪素4.5mg
ステアリン酸マグネシウム2.0mg
ヒドロキシプロピルメチルセルロース10.0mg
タルク3.5mg
二酸化チタン1.5mg以上。
組み合わせの効能を調べるために、癌関連の倦怠感歴を有する成人患者を選択した。緩和ケアにおける症状の評価について認証されているツールであるESAS(Edmonton Symptoms Assessment Scale)を用いて、主要評価項目を評価した。ESASスケールは9種の異なる症状を評価し、0〜10のパラメーターを記録し、0は症状が存在しないことを表し、10はその最悪状態の症状を表している。用いられた9種の指標の平均スコアから誘導される10番目のパラメーター(生活の質)も加えた。
ジンゲロールおよびショウガオール含量が25%であるショウガ(ginger)の親油性抽出物20mg、
イソブチルアミド含量が25%であるエキナセア アンガスティフォリアの親油性抽出物5mg、および
1:2の比でのシリビンとリン脂質(ホスファチジルコリン30%)との複合体100mg
からなる組み合わせ物を、肺、前立腺、膵臓および結腸の原発腫瘍を有し、放射線および化学治療を事前に60日間受けた、男性患者に投与した。食事(朝食、昼食および夕食)の30分前に摂取する2つの錠剤を1日3回投与した。抽出物は、470mgの錠剤として調製した。
1群:プラセボ(実施例1に記載の組成の賦形剤)で治療;
2群:実施例1に記載の組成物で治療:
3群:ショウガ/エキナセア組成物で治療(実施例1の報告と同じ投与量);
4群:シリビンリン脂質複合体のみで治療(実施例1の報告と同じ投与量);
5群:オタネニンジン抽出物で治療(実施例1の報告と同じ投与量)
試験の結果を、以下の表に示す。
Claims (6)
- 活性成分としての
(a)オタネニンジン(Panax ginseng CA Mayer)抽出物、
(b)ショウガ(Zingiber officinale)抽出物、
(c)エキナセア アンガスティフォリア(Echinacea angustifolia)抽出物、および
(d)マリアアザミ(Silybum marianum)抽出物またはシリビンとリン脂質とのリン脂質複合体、
を適当な賦形剤と混合して含む組成物。 - 前記ショウガの抽出物および前記エキナセア アンガスティフォリアの抽出物が親油性抽出物である、請求項1に記載の組成物。
- 成分(d)がシリビンとリン脂質とのリン脂質複合体である、請求項1または2に記載の組成物。
- 前記オタネニンジン抽出物は、ジンセノサイド含量が8%であってジンセノサイドRg1/ジンセノサイドRb1比が0.5/1であり、前記ショウガ抽出物は、ジンゲロール含量が30%であり、前記エキナセア アンガスティフォリア抽出物は、イソブチルアミド含量が20重量%より大きい、請求項1〜3のいずれかに記載の組成物。
- 錠剤、糖衣錠、軟および硬ゼラチンカプセルおよびセルロースカプセルの剤形である、請求項1〜4のいずれかに記載の組成物。
- 癌関連の倦怠感の治療における使用のための請求項1〜5に記載の組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT001317A ITMI20121317A1 (it) | 2012-07-27 | 2012-07-27 | Composizioni per il trattamento della fatica oncologica |
ITMI2012A001317 | 2012-07-27 | ||
PCT/EP2013/064711 WO2014016137A1 (en) | 2012-07-27 | 2013-07-11 | Compositions for treatment of cancer-related fatigue |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2015522631A true JP2015522631A (ja) | 2015-08-06 |
JP6129314B2 JP6129314B2 (ja) | 2017-05-17 |
Family
ID=46939795
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015523483A Active JP6129314B2 (ja) | 2012-07-27 | 2013-07-11 | 癌関連の倦怠感の治療のための組成物 |
Country Status (22)
Country | Link |
---|---|
US (1) | US9566309B2 (ja) |
EP (1) | EP2877192B1 (ja) |
JP (1) | JP6129314B2 (ja) |
KR (1) | KR102091128B1 (ja) |
CN (1) | CN104540514B (ja) |
AU (1) | AU2013295227B2 (ja) |
BR (1) | BR112015001174B1 (ja) |
CA (1) | CA2879906A1 (ja) |
DK (1) | DK2877192T3 (ja) |
ES (1) | ES2590209T3 (ja) |
HK (1) | HK1209375A1 (ja) |
HR (1) | HRP20160774T1 (ja) |
HU (1) | HUE030002T2 (ja) |
IL (1) | IL236871B (ja) |
IN (1) | IN2015KN00222A (ja) |
IT (1) | ITMI20121317A1 (ja) |
PL (1) | PL2877192T3 (ja) |
PT (1) | PT2877192T (ja) |
RU (1) | RU2631612C2 (ja) |
SG (1) | SG11201500521XA (ja) |
SI (1) | SI2877192T1 (ja) |
WO (1) | WO2014016137A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2020502101A (ja) * | 2016-12-15 | 2020-01-23 | インデナ エッセ ピ ア | 粉末組成物の調製のための方法 |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10709749B2 (en) * | 2013-08-30 | 2020-07-14 | Green Cross Wellbeing Corporation | Composition for preventing and treating cancer-related fatigue, containing processed ginseng powder or processed ginseng extract having increased ginsenoside constituent |
CA3005700A1 (en) * | 2015-12-16 | 2017-06-22 | Vivek Anand PARACHUR | Tri-molecular complex of natural compounds |
CA3218320A1 (en) | 2021-05-18 | 2022-11-24 | Prostasis, Llc | Compositions comprising mixtures of compounds and uses thereof |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6222781A (ja) * | 1985-07-17 | 1987-01-30 | イ ディ ビ ホールディング ソシエタ ペル アチオニ | フラバノリグナンとリン脂質との錯体、その製造方法並びに肝臓病治療用薬学的組成物 |
WO2004093518A2 (en) * | 2003-04-16 | 2004-11-04 | The University Of Mississippi | Immunostimulatory agents in botanicals |
US20050031710A1 (en) * | 2003-08-08 | 2005-02-10 | D'adamo Peter James | Method of personal care and cosmetic product preparation and composition using human blood type |
WO2012013551A1 (en) * | 2010-07-26 | 2012-02-02 | Indena S.P.A. | Formulations containing extracts of echinacea angustifolia and zingiber officinale which are useful in reducing inflammation and peripheral pain |
JP2012515715A (ja) * | 2009-01-20 | 2012-07-12 | インデナ エッセ ピ ア | 胃−食道逆流および化学療法誘発嘔吐の予防および治療のための、ショウガおよびエキネシアの親油性抽出物を含む組成物 |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
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DK0464298T3 (da) | 1990-07-05 | 1995-11-13 | Indena Spa | Echinacea-ekstrakter, fremgangsmåde til fremstilling deraf og formuleringer, der indeholder dem |
CZ292832B6 (cs) * | 2001-08-30 | 2003-12-17 | Ivax Pharmaceuticals S.R.O. | Způsob přípravy silymarinu se zvýšenou rozpustností |
US20030206978A1 (en) * | 2001-11-29 | 2003-11-06 | Bob Sherwood | Agglomerated particles including an active agent coprocessed with silicified microcrystalline cellulose |
RU2277927C2 (ru) * | 2004-09-15 | 2006-06-20 | Наталья Ивановна Весельева | Лечебно-профилактический комплекс "бальзам долголетие" общеукрепляющего и тонизирующего действия (варианты) |
CN101502320B (zh) * | 2009-03-11 | 2012-09-05 | 王越 | 一种参姜红枣饮料冲剂的生产方法 |
-
2012
- 2012-07-27 IT IT001317A patent/ITMI20121317A1/it unknown
-
2013
- 2013-07-11 WO PCT/EP2013/064711 patent/WO2014016137A1/en active Application Filing
- 2013-07-11 US US14/416,346 patent/US9566309B2/en active Active
- 2013-07-11 CA CA2879906A patent/CA2879906A1/en not_active Abandoned
- 2013-07-11 HU HUE13744458A patent/HUE030002T2/en unknown
- 2013-07-11 EP EP13744458.4A patent/EP2877192B1/en active Active
- 2013-07-11 AU AU2013295227A patent/AU2013295227B2/en not_active Ceased
- 2013-07-11 PL PL13744458.4T patent/PL2877192T3/pl unknown
- 2013-07-11 ES ES13744458.4T patent/ES2590209T3/es active Active
- 2013-07-11 RU RU2015102002A patent/RU2631612C2/ru active
- 2013-07-11 KR KR1020157001976A patent/KR102091128B1/ko active IP Right Grant
- 2013-07-11 SG SG11201500521XA patent/SG11201500521XA/en unknown
- 2013-07-11 BR BR112015001174-8A patent/BR112015001174B1/pt not_active IP Right Cessation
- 2013-07-11 JP JP2015523483A patent/JP6129314B2/ja active Active
- 2013-07-11 SI SI201330255A patent/SI2877192T1/sl unknown
- 2013-07-11 IN IN222KON2015 patent/IN2015KN00222A/en unknown
- 2013-07-11 PT PT137444584T patent/PT2877192T/pt unknown
- 2013-07-11 CN CN201380039163.4A patent/CN104540514B/zh not_active Expired - Fee Related
- 2013-07-11 DK DK13744458.4T patent/DK2877192T3/en active
-
2015
- 2015-01-22 IL IL236871A patent/IL236871B/en active IP Right Grant
- 2015-10-20 HK HK15110306.1A patent/HK1209375A1/xx unknown
-
2016
- 2016-07-01 HR HRP20160774TT patent/HRP20160774T1/hr unknown
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6222781A (ja) * | 1985-07-17 | 1987-01-30 | イ ディ ビ ホールディング ソシエタ ペル アチオニ | フラバノリグナンとリン脂質との錯体、その製造方法並びに肝臓病治療用薬学的組成物 |
WO2004093518A2 (en) * | 2003-04-16 | 2004-11-04 | The University Of Mississippi | Immunostimulatory agents in botanicals |
US20050031710A1 (en) * | 2003-08-08 | 2005-02-10 | D'adamo Peter James | Method of personal care and cosmetic product preparation and composition using human blood type |
JP2012515715A (ja) * | 2009-01-20 | 2012-07-12 | インデナ エッセ ピ ア | 胃−食道逆流および化学療法誘発嘔吐の予防および治療のための、ショウガおよびエキネシアの親油性抽出物を含む組成物 |
WO2012013551A1 (en) * | 2010-07-26 | 2012-02-02 | Indena S.P.A. | Formulations containing extracts of echinacea angustifolia and zingiber officinale which are useful in reducing inflammation and peripheral pain |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2020502101A (ja) * | 2016-12-15 | 2020-01-23 | インデナ エッセ ピ ア | 粉末組成物の調製のための方法 |
Also Published As
Publication number | Publication date |
---|---|
KR102091128B1 (ko) | 2020-03-20 |
IN2015KN00222A (ja) | 2015-06-12 |
DK2877192T3 (en) | 2016-09-05 |
CN104540514B (zh) | 2020-03-27 |
EP2877192B1 (en) | 2016-06-08 |
WO2014016137A1 (en) | 2014-01-30 |
BR112015001174B1 (pt) | 2021-02-02 |
SI2877192T1 (sl) | 2016-09-30 |
CN104540514A (zh) | 2015-04-22 |
HRP20160774T1 (hr) | 2016-08-12 |
SG11201500521XA (en) | 2015-02-27 |
CA2879906A1 (en) | 2014-01-30 |
RU2631612C2 (ru) | 2017-09-25 |
ES2590209T3 (es) | 2016-11-18 |
HK1209375A1 (en) | 2016-04-01 |
US9566309B2 (en) | 2017-02-14 |
AU2013295227A1 (en) | 2015-02-19 |
US20150202246A1 (en) | 2015-07-23 |
EP2877192A1 (en) | 2015-06-03 |
RU2015102002A (ru) | 2016-09-20 |
ITMI20121317A1 (it) | 2014-01-28 |
HUE030002T2 (en) | 2017-04-28 |
AU2013295227B2 (en) | 2017-04-27 |
PL2877192T3 (pl) | 2016-12-30 |
IL236871B (en) | 2018-01-31 |
PT2877192T (pt) | 2016-09-13 |
KR20150037890A (ko) | 2015-04-08 |
BR112015001174A2 (pt) | 2017-06-27 |
JP6129314B2 (ja) | 2017-05-17 |
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