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Plants of Genus Ampelopsis and Extracts Thereof For

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Plants of Genus Ampelopsis and Extracts Thereof For (19) & (11) EP 1 767 212 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 36/87 (2006.01) A23L 1/30 (2006.01) 20.07.2011 Bulletin 2011/29 (86) International application number: (21) Application number: 05752366.4 PCT/CN2005/000749 (22) Date of filing: 30.05.2005 (87) International publication number: WO 2005/117922 (15.12.2005 Gazette 2005/50) (54) PLANTS OF GENUS AMPELOPSIS AND EXTRACTS THEREOF FOR USE IN THE TREATMENT OF SLEEP DISORDERS PFLANZEN DER GATTUNG AMPELOPSIS UND DEREN EXTRAKTE ZUR BEHANDLUNG VON SCHLAFSTÖRUNGEN UNE PLANTE DU GENRE AMPELOPSIS ET D’EXTRAITS DE CETTE PLANTE POUR LE TRAITEMENT DE L’INSOMNIE (84) Designated Contracting States: • ZHOU T ET AL: "Isolation, structure AT BE BG CH CY CZ DE DK EE ES FI FR GB GR determination and pharmacological activity of HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR flavanonol from Ampelopsis grossedentata" ZHONGGUO YAOXUE ZAZHI - CHINESE (30) Priority: 04.06.2004 CN 200410048628 PHARMACEUTICAL JOURNAL, GAI KAN BIAN- WEI-HUI, BEIJING, CN, vol. 31, no. 8, 1 January (43) Date of publication of application: 1996 (1996-01-01), pages 458-461, XP009124783 28.03.2007 Bulletin 2007/13 ISSN: 1001-2494 • DU Q ET AL: "Purification of (+)-dihydromyricetin (73) Proprietor: Bright Future Pharmaceutical from leaves extract of Ampelopsis grossedentata Laboratories Limited usinghigh-speed countercurrent chromatograph Yuen Long Industrial Estate, with scale-up triple columns" JOURNAL OF Yuen Long (CN) CHROMATOGRAPHY, ELSEVIER SCIENCE PUBLISHERSB.V. AMSTERDAM, NL, vol. 973, no. (72) Inventors: 1-2, 11 October 2002 (2002-10-11), pages 217-220, • CHAN, Hsiaochang XP004382332 ISSN: 0021-9673 Hong Kong (CN) • "Amendment symposium in ZhengZhou" CELL • GOU, Yulin BIOLOGY INTERNATIONAL, ACADEMIC PRESS, Hong Kong (CN) GB, vol. 29, no. 10, 1 October 2005 (2005-10-01), • ROWLANDS, Dewi, Kenneth pages S1-S26, XP005086400 ISSN: 1065-6995 Taikoo Shing • DATABASE MEDLINE US NATIONAL LIBRARY Hong Kong (CN) OF MEDICINE (NLM), BETHESDA, MD, US; April • CHUNG, Yiu, Wa 2002(2002-04), WANG YAN; ZHOU LILING; LI RUI; Hong Kong (CN) WANG YING: "[Studies on the chemical constituents from Ampelopsis grossedentata]" (74) Representative: Kramer - Barske - Schmidtchen XP002552507 Database accession no. Landsberger Strasse 300 NLM12583176 80687 München (DE) • DATABASE MEDLINE US NATIONAL LIBRARY OF MEDICINE (NLM), BETHESDA, MD, US; (56) References cited: January 1997 (1997-01), CHEN Z; WANG M; CAI CN-A- 1 375 289 CN-A- 1 393 443 P; CHEN X: "[Determination of ampelopsin and CN-A- 1 442 136 CN-A- 1 457 646 myricetin in Ampelopsis cantoniensis]" CN-A- 1 457 774 CN-C- 1 130 198 XP002552508 Database accession no. CN-C- 1 142 155 NLM12572492 Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 767 212 B1 Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 1 767 212 B1 • DU Q ET AL: "Preparative separation of flavonoid glycosides in leaves extract of Ampelopsis grossedentata using high- speed counter-current chromatography" JOURNAL OF CHROMATOGRAPHY, ELSEVIER SCIENCE PUBLISHERS B.V. AMSTERDAM, NL, vol. 1040, no. 1, 18 June 2004 (2004-06-18), pages 147-149, XP004508928 ISSN: 0021-9673 2 EP 1 767 212 B1 Description [0001] Use of Ampelopsis plants and their extracts in the manufacture of a medicament for the treatment and prevention of sleep disorders. 5 Technical Field [0002] The present invention relates to the use of Ampelopsis plants and their extracts in the manufacture of a med- icament for the treatment and prevention of sleep disorders. 10 Background of the Invention [0003] Insomnia is a common sleep disorder that requires adequate attention and treatment. Each year, 35-49 % of the adults suffer from insomnia. Man’s sleep regulation center is located at the hypothalamus of the cerebral, where 15 there are many hypothalamic neurotransmitters regulating the sleeping-awakening cycle (see: Mignot, E., Taheri, S., and Nishino, S., Sleeping with the hypothalamus: emerging therapeutic targets for sleep disorders. Nat. Neurosci. 2002, 5 Suppl: 1071-1075). The mechanism or means that affects or regulates sleeping involves many neurotransmitter sys- tems, for instance, γ-aminobutyric acid, adenosine (purin), dopamine, hypocretins system (also known as orexins; phenyl dihydroquinazolin), monoaminergic system (for instance, 5-hydroxyptamine, noradrenalin and histamine). 20 [0004] Since drugs presently used for treating sleep disorders have different degrees of side effects, herbal medicines and other natural medicines that may help sleep are getting more and more attention. There are approximately 25 kinds of Ampelopsis plants around the world, including 17 in China, which are widely distributed in such provinces and auton- omous regions as Guangxi, Guangdong, Yun’nan, Guizhou, Hu’nan, Hubei, Jiangxi and Fujian, etc. Except common medicine [Ampelopsis japonica (Thunb.) Makino], the majority of Ampelopsis plants are folk Chinese herbal medicines, 25 most of which, Ampelopsis grossedentata (Hand- Mazz) W. T. Wang, [Ampelopsis cantoniensis (Hook.et Am.) Planch], Ampelopsis meliaefolia, Ampelopsis brevipedunculata (Uaxim.) Trautv, Ampelopsis megalophylla Diels et Gilg in par- ticular, have functions such as promoting blood circulation, dissipating blood stasis, clearing heat and removing toxic substances, etc; Ampelopsis plants can prevent and cure icteric hepatitis, cold, wind heat, pharyngeal swelling and pain, wind-damp pain, calenture, getting drunken, etc., and pharmacological experiments have shown that main components 30 of Ampelopsis plants have such functions as removing phlegm, reducing blood lipids, resisting inflammation, diuresis, and protecting the liver, etc. [0005] Zhou et al., Chinese Pharmaceutical Journal, vol. 31, no. 8, 458-461, disclose the isolation, structure determi- nation and pharmacological activity of flavanonol from Ampelopsis grossedentata. [0006] Du et al., Journal of Chromatography A, 973 (2002), 217-220, disclose the purification of (+)-dihydromyricetin 35 from leaves extract of Ampelopsis grossedentata using a high- speed countercurrent chromatograph with scale- up triple columns. [0007] "Amendment symposium in ZhengZhou", Cell Biology International, vol. 29, no. 10, page S16, discloses a study on the characterization of new sedative compounds from an Ampelopsis extract using functional and genomic approaches. 40 [0008] DATABASE MEDLINE US NATIONAL LIBRARY OF MEDICINE, BETHESDA, MD, US, April 2002, Wang et al., discloses studies on the chemical constituents from Ampelopsis grossedentata. [0009] DATABASE MEDLINE US NATIONAL LIBRARY OF MEDICINE, BETHESDA, MD, US, January 1997, Chen et al., discloses the determination of ampelopsin and myricetin in Ampelopsis cantoniensis. [0010] Du et al., Journal of Chromatography A, 1040 (2004), 147-149, disclose the preparative separation of flavonoid 45 glycosides in leaves extract of Ampelopsis grossedentata using high-speed counter-current chromatography. Summary of the Invention [0011] The technical problem that the invention will tackle is to screen and study plants that have the function of 50 treating sleep disorders and the parts of the plants that can treat sleep disorders. Since the mechanism or means that affects or regulates sleep involves many neurotransmitter systems, this invention screens and studies plant extracts that have synergetic effects on multiple mechanisms or means that affect or regulate sleep. [0012] In order to solve the above problem, the invention provides the following technical proposal: 55 The use of Ampelopsis plants in the manufacture of a medicament for the treatment and prevention of sleep disorders. The use of extracts of Ampelopsis plants in the manufacture of a medicament for the treatment and prevention of sleep disorders. 3 EP 1 767 212 B1 [0013] Said Ampelopsis plants include Ampelopsis grossedentata (Hand- Mazz) W. T. Wang, [Ampelopsis cantoniensis (Hook. et Am.) Planch], Ampelopsis meliaefolia, Ampelopsisbrevipedunculata (Uaxim.) Trautv, Ampelopsis megalophylla Diels et Gilg, Ampelopsis bodinieri (Levl. et Vant.) Rehd, Ampelopsis brevipedunculat (Maxim.) Maxim ex Trautv, Am- pelopsis brevipedunculat (Maxim.) Trautv. var. Hancei Rehd, Ampelopsis delavayana Planch, Ampelopsis japonica 5 (Thunb.) Makino, Ampelopsis aconitifolia Bmge, Ampelopsis aconitifolia Bge. var. glabra Diels et Grig, Ampelopsis brevipedunculata (Maxim.) Trautv. var. kulingensisRehd, Ampelopsis humulifolia Bge, Ampelopsis heterophylla (Thunb.) Sieb. & Zucc, Ampelopsis chaffanjoni (Levl. et Vant.) Rehd. [0014] According to said use, said Ampelopsis plants and/ or extracts of Ampelopsis plants can be mixed with drug carriers or food carriers. 10 [0015] Said extracts of Ampelopsis plants include extracts obtained through extraction of Ampelopsis plants with water, low alcohols, low ketone or acetic acid ethyl ester as solvents or random mixed solvents of these solvents; the low alcohols among the solvents used for extraction may be methanol, ethanol or n-butyl alcohol and the low ketones may be acetone; the extraction method may be self-immersion extraction, circumfluence extraction, ultrasonic extraction, circumfluence
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