PLANT EXTRACT COMPOSITIONS FOR AFFECTING SLEEP

• US 20100112107A1
• Filed: 11/03/2008
• Published: 05/06/2010
• Est. Priority Date: 11/03/2008
• Status: Active Grant

• Current Assignee: Viva Pharmaceutical Incorporated
• Original Assignee: Viva Pharmaceutical Incorporated
• Inventors: KO, Yu-Lung, KO, Jason Jiang-Chung, KO, Chien-Kuang, XIE, Xueji, Gafney, Richard William
• Granted Patent: US 7,968,128 B2
• Time in Patent Office: Days
• US Class Current: 424/769
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 36/14 Cupressaceae (Cypress family), e.g. juniper or cypress
• CPC Class Codes: A61K 36/69 Polygalaceae (Milkwort family)
• CPC Class Codes: A61K 36/725 Ziziphus, e.g. jujube
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives

Abstract

A composition for affecting physiological sleep disorders comprising a therapeutically effective amount of Baiziren extract or any of its derivatives, and a pharmaceutically acceptable carrier. The composition may additionally comprise a therapeutically effective amount of at least one of a Suanzaoren extract and a Yuanzhi extract, or mixtures thereof.

Claims

1. A composition for modulating physiological sleep disorders, said composition comprising a therapeutically effective amount of a Platycladus orientalis extract, and a pharmaceutically acceptable carrier.

2. A composition according to claim 1, further comprising a therapeutically effective amount of a Polygala spp. extract.

3. A composition according to claim 1, further comprising a therapeutically effective amount of a Zizyphus jujube extract.

4. A composition according to claim 1, further comprising a therapeutically effective amount of a Polygala spp. extract and a therapeutically effective amount of a Zizyphus jujube extract.

7. A composition according to claim 1, wherein the Platycladus orientalis extract is prepared from at least one of a fresh plant component selected from the group consisting of seeds, leaves, stems, roots, flowers and fruits, and combinations thereof, and a dried plant component selected from the group consisting of seeds, leaves, stems, roots, flowers and fruits, and combinations thereof.

8. A composition according to claim 2, wherein the Polygala spp. extract is prepared from at least one of a fresh plant component selected from the group consisting of seeds, leaves, stems, roots, flowers and fruits, and combinations thereof, and a dried plant component selected from the group consisting of seeds, leaves, stems, roots, flowers and fruits, and combinations thereof.

9. A composition according to claim 3, wherein the Zizyphus jujube extract is prepared from at least one of a fresh plant component selected from the group consisting of seeds, leaves, stems, roots, flowers and fruits, and combinations thereof, and a dried plant component selected from the group consisting of seeds, leaves, stems, roots, flowers and fruits, and combinations thereof.

10. A composition of claim 1, wherein the physiological sleep disorder is selected from the group consisting of insomnia, parasomnia, and combinations thereof.

25. A composition according to claim 1, wherein said composition is configured as one of a soft-gel capsule, a hard capsule, liquid, powder and a tablet.

27. A composition according to claim 3, wherein said Platycladus orientalis extract and said Zizyphus jujube extract are present in a ratio of about 1:

3.6.

5. (canceled)

6. (canceled)

11. A method for producing a Platycladus orientalis composition for modulating physiological sleep disorders, said method comprising the steps of:

soaking a Platycladus orientalis plant component in an aqueous solvent at a temperature selected from the range of about 20°

C. to about 110°

C., thereby producing a Platycladus orientalis extraction mixture.

separating a liquid fraction from the Platycladus orientalis extraction mixture, and filtering said liquid fraction to produce an aqueous Platycladus orientalis filtrate;

de-watering the aqueous Platycladus orientalis filtrate to at least a syrup-like consistency; and

configuring a composition comprising said de-watered Platycladus orientalis filtrate and an acceptable carrier or excipient therefor.

12. A method according to claim 11, additionally comprising steps for de-watering and processing the aqueous Platycladus orientalis filtrate to produce a dried powder.

13. A method according to claim 11, wherein the aqueous solvent comprises a mixture of water and at least one organic solvent selected from the group consisting of ethanol, methanol, isopropyl alcohol, ethyl acetate, hexane, ace tic acid, and mixtures thereof.

14. A method according to claim 11, wherein the aqueous solvent comprises a mixture of water and at least one of an inorganic acid and an inorganic base.

15. A method according to claim 11, wherein said composition is configured as one of a soft-gel capsule, a hard capsule, liquid, powder and a tablet.

16. A method according to claim 11, additionally comprising the steps of:

soaking a Polygala spp. plant component in an aqueous solvent at a temperature selected from the range of about 20°

C. to about 110°

C., thereby producing a Polygala spp. extraction mixture.

separating a liquid fraction from the Polygala spp. extraction mixture, and filtering said liquid fraction to produce an aqueous Polygala spp. filtrate;

de-watering the aqueous Polygala spp. filtrate to at least a syrup-like consistency; and

configuring a composition comprising said de-watered Platycladus orientalis filtrate, said de-watered Polygala spp. filtrate, and an acceptable carrier or excipient therefor.

17. A method according to claim 16, additionally comprising steps for de-watering and processing the aqueous Polygala spp. filtrate to produce a dried powder.

18. A method according to claim 16, wherein the aqueous solvent comprises a mixture of water and at least one organic solvent selected from the group consisting of ethanol, methanol, isopropyl alcohol, ethyl acetate, hexane, acetic acid, and mixtures thereof.

19. A method according to claim 16, wherein the aqueous solvent comprises a mixture of water and at least one of an inorganic acid and an inorganic base.

20. A method according to claim 16, wherein said composition is configured as one of a soft-gel capsule, a hard capsule and a tablet.

21. A method according to claim 11, additionally comprising the steps of:

soaking a Zizyphus jujube plant component in an aqueous solvent at a temperature selected from the range of about 20°

C. to about 110°

C., thereby producing a Zizyphus jujube extraction mixture.

separating a liquid fraction from the Zizyphus jujube extraction mixture, and filtering said liquid fraction to produce an aqueous Zizyphus jujube filtrate;

de-watering the aqueous Zizyphus jujube filtrate to at least a syrup-like consistency; and

configuring a composition comprising said de-watered Platycladus orientalis filtrate, said de-watered Zizyphus jujube filtrate, and an acceptable carrier or excipient therefor.

22. A method according to claim 11, additionally comprising steps for de-watering and processing the aqueous Zizyphus jujube filtrate to produce a dried powder.

23. A method according to claim 11, wherein the aqueous solvent comprises a mixture of water and at least one organic solvent selected from the group consisting of ethanol, methanol, isopropyl alcohol, ethyl acetate, hexane, acetic acid, and mixtures thereof.

24. A method according to claim 11, wherein the aqueous solvent comprises a mixture of water and at least one of an inorganic acid and an inorganic base.

26. A method according to claim 11, wherein the step for configuring the Platycladus orientalis composition additionally incorporates therein a Polygala spp. extract and a Zizyphus jujube extract.

28. A composition for modulating physiological sleep disorders, said composition comprising a therapeutically effective amount of a Zizyphus jujube extract, a therapeutically effective amount of a Polygala spp. extract, and a pharmaceutically acceptable carrier.

29. A composition of according to claim 28. wherein said Zizyphus jujube extract and said Polygala spp. extract are present in a ratio of about 2.4:

1.