JP2023536053A - イトヒメハギの乾燥根の抽出物を含有する組成物 - Google Patents
イトヒメハギの乾燥根の抽出物を含有する組成物 Download PDFInfo
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- 239000000203 mixture Substances 0.000 title claims abstract description 24
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- 208000024714 major depressive disease Diseases 0.000 claims abstract description 27
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 6
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- YTFVRYKNXDADBI-UHFFFAOYSA-N 3,4,5-trimethoxycinnamic acid Chemical compound COC1=CC(C=CC(O)=O)=CC(OC)=C1OC YTFVRYKNXDADBI-UHFFFAOYSA-N 0.000 description 4
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- ZPEADZHVGOCGKH-YQTDNFGYSA-N Sibiricose A5 Chemical compound C1=C(O)C(OC)=CC(\C=C\C(=O)O[C@@H]2[C@](O[C@H](CO)[C@H]2O)(CO)O[C@@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)=C1 ZPEADZHVGOCGKH-YQTDNFGYSA-N 0.000 description 3
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- SFAJHJBOZNPSJH-UHFFFAOYSA-N polygalaxanthone III Natural products C1=C(O)C(OC)=CC(C(C2=C(O)C=C3O)=O)=C1OC2=C3C(C(C(O)C1O)O)OC1COC1OCC(O)(CO)C1O SFAJHJBOZNPSJH-UHFFFAOYSA-N 0.000 description 3
- ZPEADZHVGOCGKH-UHFFFAOYSA-N sibiricose A5 Natural products C1=C(O)C(OC)=CC(C=CC(=O)OC2C(OC(CO)C2O)(CO)OC2C(C(O)C(O)C(CO)O2)O)=C1 ZPEADZHVGOCGKH-UHFFFAOYSA-N 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000008215 water for injection Substances 0.000 description 3
- PBKBHCJPMCMBCZ-GDLYOHBGSA-N (2s,3s,4r,5r,6s)-2-[(3r,4r,5r,6s)-4,5-dihydroxy-6-(hydroxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)-4-phenylmethoxyoxane-3,5-diol Chemical compound O[C@@H]1[C@@H](O)[C@H](CO)OC[C@H]1O[C@H]1[C@@H](O)[C@H](OCC=2C=CC=CC=2)[C@H](O)[C@H](CO)O1 PBKBHCJPMCMBCZ-GDLYOHBGSA-N 0.000 description 2
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
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- 208000030852 Parasitic disease Diseases 0.000 description 2
- 241001080798 Polygala tenuifolia Species 0.000 description 2
- RXRSNDCGNOOFLH-VZNNHAMSSA-N Polygalatenoside A Polymers O[C@H]1[C@H](O)[C@@H](CO)OC[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](COC(=O)C=2C=CC=CC=2)O1 RXRSNDCGNOOFLH-VZNNHAMSSA-N 0.000 description 2
- LLMCZIBSELEBMK-UKHOTDCGSA-N Sibiricaxanthone B Chemical compound O([C@H]1[C@@H](O[C@@H]([C@H]([C@@H]1O)O)CO)C=1C(=C2C(=O)C3=CC(O)=CC=C3OC2=CC=1O)O)[C@@H]1OC[C@](O)(CO)[C@H]1O LLMCZIBSELEBMK-UKHOTDCGSA-N 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
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- 239000003792 electrolyte Substances 0.000 description 2
- 238000001704 evaporation Methods 0.000 description 2
- 230000008020 evaporation Effects 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 229960004801 imipramine Drugs 0.000 description 2
- BCGWQEUPMDMJNV-UHFFFAOYSA-N imipramine Chemical compound C1CC2=CC=CC=C2N(CCCN(C)C)C2=CC=CC=C21 BCGWQEUPMDMJNV-UHFFFAOYSA-N 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
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- 235000012054 meals Nutrition 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
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- 238000003305 oral gavage Methods 0.000 description 2
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- 238000009521 phase II clinical trial Methods 0.000 description 2
- 238000011548 physical evaluation Methods 0.000 description 2
- RXRSNDCGNOOFLH-UHFFFAOYSA-N polygalatenoside A Natural products OC1C(O)C(CO)OCC1OC1C(O)C(O)C(O)C(COC(=O)C=2C=CC=CC=2)O1 RXRSNDCGNOOFLH-UHFFFAOYSA-N 0.000 description 2
- UATGZWWXQGEIIT-UHFFFAOYSA-N polygalatenoside B Natural products OC1C(O)C(CO)OCC1OC1C(O)C(OC(=O)C=2C=CC=CC=2)C(O)C(CO)O1 UATGZWWXQGEIIT-UHFFFAOYSA-N 0.000 description 2
- 239000013641 positive control Substances 0.000 description 2
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- 239000012896 selective serotonin reuptake inhibitor Substances 0.000 description 2
- 229940124834 selective serotonin reuptake inhibitor Drugs 0.000 description 2
- LLMCZIBSELEBMK-UHFFFAOYSA-N sibiricoxanthone B Natural products OC1C(O)C(CO)OC(C=2C(=C3C(=O)C4=CC(O)=CC=C4OC3=CC=2O)O)C1OC1OCC(O)(CO)C1O LLMCZIBSELEBMK-UHFFFAOYSA-N 0.000 description 2
- 230000008685 targeting Effects 0.000 description 2
- 241000282472 Canis lupus familiaris Species 0.000 description 1
- 208000028017 Psychotic disease Diseases 0.000 description 1
- 241000700159 Rattus Species 0.000 description 1
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- 230000034994 death Effects 0.000 description 1
- 231100000517 death Toxicity 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
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- 239000007928 intraperitoneal injection Substances 0.000 description 1
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- 229930193144 polygalatenoside Natural products 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 238000011808 rodent model Methods 0.000 description 1
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- 231100000041 toxicology testing Toxicity 0.000 description 1
- 150000003626 triacylglycerols Chemical class 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 150000007964 xanthones Chemical class 0.000 description 1
Classifications
-
- 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)
- A61K36/69—Polygalaceae (Milkwort family)
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Psychiatry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
- Compounds Of Unknown Constitution (AREA)
Abstract
Description
植物抽出物は、
i)イトヒメハギの乾燥根の極性溶媒抽出物であり、極性溶媒は水または水とメタノールまたはエタノールとの混合物、
ii)極性溶媒抽出物を有機溶媒で抽出して得られる水性画分、
iii)極性溶媒抽出物または水性画分を逆相クロマトグラフィーカラムに導入し、水および有機溶媒でカラムを溶出することによる有機溶出剤、
iv)有機溶出剤中の分子量が30,000未満の濾液、
のうちの1つ、あるいは、その組合せである。
AE 有害事象
CGI 臨床全般印象尺度
C-SSRS コロンビア自殺重症度評価尺度
DSSS うつ病および身体症状評価尺度
HAM-D-17 ハミルトンうつ病評価尺度
HAM-A ハミルトン不安評価尺度
MADRS モンゴメリー-アスベルグうつ病評価尺度
NRI ノルエピネフリン再取り込み阻害剤
組成物は、1日用量380~3800mgの量の植物抽出物を含有する。
植物抽出物は、
i)イトヒメハギの乾燥根の極性溶媒抽出物であり、極性溶媒は水または水とメタノールまたはエタノールとの混合物、
ii)極性溶媒抽出物を有機溶媒で抽出して得られる水性画分、
iii)極性溶媒抽出物または水性画分を逆相クロマトグラフィーカラムに導入し、水および有機溶媒でカラムを溶出することによる有機溶出剤、
iv)有機溶出剤中の分子量が30,000未満の濾液、
のうちの1つ、あるいは、その組合せである。
Claims (11)
- 必要とする対象に、1日用量380~3800mgの量の植物抽出物を含有する組成物を経口投与することを含み、
前記植物抽出物は、
i)イトヒメハギの乾燥根からの極性溶媒抽出物で、極性溶媒は水または水とメタノールまたはエタノールの混合物、
ii)前記極性溶媒抽出物を有機溶媒で抽出して得られる水性画分、
iii)前記極性溶媒抽出物または前記水性画分を逆相クロマトグラフィーカラムに導入し、水および有機溶媒でカラムを溶出させることによる有機溶出剤、
iv)前記有機溶出剤中の分子量が30,000未満の濾液、
のうちの一つ、あるいは、これらの組み合わせである、大うつ病性障害を治療する方法。 - 前記組成物は、経口剤形で投与される、請求項1に記載の大うつ病性障害を治療する方法。
- 前記組成物は、二酸化ケイ素およびステアリン酸マグネシウムをさらに含有し、カプセルの形態である、請求項1に記載の大うつ病性障害を治療する方法。
- 前記組成物は、うつ病性障害の症状の発症時に投与される、請求項3に記載の大うつ病性障害を治療する方法。
- 前記組成物は、慢性的に投与される、請求項3に記載の大うつ病性障害を治療する方法。
- 前記組成物は、1日を通してスケジュールに従って投与される、請求項5に記載の大うつ病性障害を治療する方法。
- 前記1日用量は、1日1回、1日2回、または1日3回投与される、請求項6に記載の大うつ病性障害を治療する方法。
- 各用量は、前記植物抽出物380~760mgである、請求項7に記載の大うつ病性障害を治療する方法。
- 少なくとも25日間にわたって毎日投与する、請求項8に記載の大うつ病性障害を治療する方法。
- 前記対象は、投与終了時およびその後少なくとも1ヶ月後に評価を受ける、請求項5に記載の大うつ病性障害を治療する方法。
- 前記評価は、モンゴメリー-アスベルグうつ病評価尺度(MADRS)および/またはハミルトンうつ病評価尺度(HAM-D-17)および/またはハミルトン不安評価尺度(HAM-A)および/または臨床全般印象尺度(CGI)および/またはコロンビア自殺重症度評価尺度(C-SSRS)の結果を管理および評価することを含む、請求項10に記載の大うつ病性障害を治療する方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US16/936,032 | 2020-07-22 | ||
US16/936,032 US11554154B2 (en) | 2020-07-22 | 2020-07-22 | Polygala extract for the treatment of major depressive disorder |
PCT/US2021/026676 WO2022019967A1 (en) | 2020-07-22 | 2021-04-09 | Polygala extract for the treatment of major depressive disorder |
Publications (1)
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JP2023536053A true JP2023536053A (ja) | 2023-08-23 |
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JP2023502736A Pending JP2023536053A (ja) | 2020-07-22 | 2021-04-09 | イトヒメハギの乾燥根の抽出物を含有する組成物 |
Country Status (7)
Country | Link |
---|---|
US (1) | US11554154B2 (ja) |
EP (1) | EP4185132A4 (ja) |
JP (1) | JP2023536053A (ja) |
CN (1) | CN114502011A (ja) |
AU (1) | AU2021314052B2 (ja) |
TW (1) | TWI821593B (ja) |
WO (1) | WO2022019967A1 (ja) |
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---|---|---|---|---|
US5589182A (en) * | 1993-12-06 | 1996-12-31 | Tashiro; Renki | Compositions and method of treating cardio-, cerebro-vascular and alzheimer's diseases and depression |
TWI295576B (en) * | 2002-01-11 | 2008-04-11 | Medical & Pharm Ind Tech & Dev | Anti-depression pharmaceutical composition containing polygala extract |
US7507424B2 (en) * | 2004-04-26 | 2009-03-24 | Mmi Corporation | Natural immunostimulant compositions, methods for obtaining the same and pharmaceutical formulations thereof |
CN101590065A (zh) * | 2008-05-30 | 2009-12-02 | 中国人民解放军总医院 | 西伯利亚远志糖A1、西伯利亚远志糖A5和tenuifoliside A在制备治疗抑郁症产品中的应用 |
CN103877376B (zh) * | 2014-04-09 | 2016-09-14 | 山东大学齐鲁医院 | 一种治疗抑郁症的药物制剂 |
CN106266943A (zh) * | 2016-08-25 | 2017-01-04 | 黄连启 | 一种治疗抑郁症的中药组合物 |
-
2020
- 2020-07-22 US US16/936,032 patent/US11554154B2/en active Active
- 2020-09-03 TW TW109130285A patent/TWI821593B/zh active
-
2021
- 2021-04-09 CN CN202180001626.2A patent/CN114502011A/zh active Pending
- 2021-04-09 EP EP21846424.6A patent/EP4185132A4/en active Pending
- 2021-04-09 JP JP2023502736A patent/JP2023536053A/ja active Pending
- 2021-04-09 WO PCT/US2021/026676 patent/WO2022019967A1/en unknown
- 2021-04-09 AU AU2021314052A patent/AU2021314052B2/en active Active
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WO2022019967A1 (en) | 2022-01-27 |
EP4185132A1 (en) | 2023-05-31 |
EP4185132A4 (en) | 2024-08-28 |
CN114502011A (zh) | 2022-05-13 |
TW202203959A (zh) | 2022-02-01 |
US20220023373A1 (en) | 2022-01-27 |
AU2021314052A1 (en) | 2023-02-16 |
AU2021314052B2 (en) | 2024-01-11 |
TWI821593B (zh) | 2023-11-11 |
US11554154B2 (en) | 2023-01-17 |
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