COMPOSITION AND METHOD FOR TREATING OR PREVENTING GASTROINTESTINAL CANCER

• US 20080096854A1
• Filed: 12/06/2007
• Published: 04/24/2008
• Est. Priority Date: 06/28/2001
• Status: Active Grant

• Current Assignee: Rongxiang Xu
• Original Assignee: Rongxiang Xu
• Inventors: Xu, Rongxiang
• Granted Patent: US 7,919,123 B2
• Time in Patent Office: Days
• US Class Current: 514/182
• CPC Class Codes: A23L 33/11 Plant sterols or derivatives thereof, e.g. phytosterols
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/32 having an effect on the health of the digestive tract
• CPC Class Codes: A23V 2250/1872 Linoleic acid
• CPC Class Codes: A23V 2250/188 Oleic acid
• CPC Class Codes: A23V 2250/194 Triglycerides
• CPC Class Codes: A23V 2250/2116 Flavonoids, isoflavones
• CPC Class Codes: A23V 2250/21364 Campesterol
• CPC Class Codes: A23V 2250/21372 Sitosterol
• CPC Class Codes: A23V 2250/21376 Stigmasterol
• CPC Class Codes: A23V 2250/712 Vitamin E
• 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 31/20 having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
• CPC Class Codes: A61K 31/201 having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 36/31 Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
• CPC Class Codes: A61K 36/48 Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• CPC Class Codes: A61K 36/539 Scutellaria (skullcap)
• CPC Class Codes: A61K 36/66 : Papaveraceae (Poppy family), e.g. bloodroot
• CPC Class Codes: A61K 36/718 : Coptis (goldthread)
• CPC Class Codes: A61K 36/756 : Phellodendron, e.g. corktree
• CPC Class Codes: A61K 36/88 : Liliopsida (monocotyledons)
• CPC Class Codes: A61K 36/889 : Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
• CPC Class Codes: A61K 36/899 : Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/08 : Solutions composition of solutions A61K47/00
• CPC Class Codes: A61K 9/4858 : Organic compounds
• CPC Class Codes: A61K 9/4875 : Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/4858
• CPC Class Codes: A61P 1/04 : for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/14 : Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 35/00 : Antineoplastic agents

Abstract

The present invention provides novel compositions and methods for repair and regeneration of tissues or organs of the body, especially mucosa in the gastrointestinal tract. The composition can be used as a pharmaceutical or nutraceutical to treat or prevent gastrointestinal cancer such as colorectal carcinoma, stomach cancer and esophagus cancer. The composition is in an oral dosage form and comprises edible oil homogenized with a sterol compound at a concentration of at least 0.5% by weight and edible wax at a concentration ranging from 3% to 30% by weight.

Claims

1. A method for treating a patient having a gastrointestinal cancer, comprising:

orally administering to a patient having a gastrointestinal cancer a composition comprising an edible oil homogenized with an edible wax at a concentration ranging from 0.5% to 50% by weight and a sterol compound at a concentration of at least 0.1% by weight.

2. The method of claim 1, wherein the gastrointestinal cancer is an upper gastrointestinal cancer selected from the group consisting of esophagus cancer, stomach cancer, pancreas cancer, liver cancer, and cancer of bile ducts.

3. The method of claim 1, wherein the gastrointestinal cancer is a lower gastrointestinal cancer selected from the group consisting of colorectal carcinoma, primary lymphomas, melanoma, and sarcoma of the large bowel.

4. The method of claim 1, wherein the composition contains less than 1% of water by weight.

5. The method of claim 1, wherein the composition is orally administered in an amount of 0.5-15 g per day.

6. The method of claim 1, wherein the composition is orally administered in an amount of 2-8 g per day.

7. The method of claim 1, wherein the composition is formulated in 0.1-0.5 g soft gel capsules, 1-10 of which are orally administered to the host twice a day.

8. The method of claim 1, wherein the sterol compound is a combination of stigmasterol, β

-sitosterol, and campesterol.

9. The method of claim 1, wherein the sterol compound is β

-sitosterol.

10. The method of claim 1, wherein the edible wax is selected from the group consisting of beeswax, castorwax, glycowax, and carnaubawax.

11. The method of claim 1, wherein the edible oil is selected from the group consisting of corn oil, wheat germ oil, soy bean oil, rice bran oil, rapeseed oil, sesame oil, and fish oil.

12. The method of claim 1, wherein the edible oil is sesame oil.

13. The method of claim 1, wherein the concentration of the sterol compound is 0.5% to 20% by weight.

14. The method of claim 1, wherein the concentration of the sterol compound is 1% to 10% by weight.

15. The method of claim 1, wherein the concentration of the edible wax is 3% to 30% by weight.

16. The method of claim 1, wherein the composition is formulated in a soft or hard gel capsule.

17. The method of claim 1, wherein the composition further comprises baicalin.

18. The method of claim 1, wherein the composition further comprises an extract of huangqin.

19. The method of claim 1, wherein the composition further comprises an extract of a combination of huangqin, huangbai and huanglian.

20. The method of claim 1, wherein the sterol compound is selected from the group consisting of stigmasterol, campesterol, p-sitosterol, chalinosterol, clionasterol, brassicasterol, α

-spinasterol, daucosterol, desmosterol, and poriferasterol, at a concentration of at least 0.1% by weight based on the total weight of the composition.

21. The method of claim 1, wherein the edible oil, edible wax and sterol compound are homogenized to form colloid with the edible wax adopting a microcrystal form at ambient temperature.

22. The method of claim 21, wherein the microcrystal form of beeswax is 0.1-100 μ

m in length.

23. The method of claim 21, wherein the microcrystals of beeswax are dispersed substantially uniformly in the edible oil.

24. A method for preventing gastrointestinal cancer in a host comprising:

orally administering to the host a composition comprising an edible oil homogenized with an edible wax at a concentration ranging from 0.5% to 50% by weight and a sterol compound at a concentration of at least 0.1% by weight.

25. The method of claim 24, wherein the gastrointestinal cancer is an upper gastrointestinal cancer selected from the group consisting of esophagus cancer, stomach cancer, pancreas cancer, liver cancer, and cancer of bile ducts.

26. The method of claim 24, wherein the gastrointestinal cancer is a lower gastrointestinal cancer selected from the group consisting of colorectal carcinoma, primary lymphomas, melanoma, and sarcoma of the large bowel.

27. The method of claim 24, wherein the host is a human.

28. The method of claim 24, wherein the composition is orally administered in an amount of 0.5-15 g per day.

29. The method of claim 24, wherein the composition is orally administered in an amount of 2-8 g per day.

30. The method of claim 24, wherein the composition is formulated in 0.1-0.5 g soft gel capsules, 1-10 of which are orally administered to the host twice a day.

31. The method of claim 24, wherein the sterol compound is a combination of stigmasterol, P-sitosterol, and campesterol.

32. The method of claim 24, wherein the sterol compound is P-sitosterol.

33. The method of claim 24, wherein the edible wax is selected from the group consisting of beeswax, castorwax, glycowax, and carnaubawax.

34. The method of claim 24, wherein the edible oil is selected from the group consisting of corn oil, wheat germ oil, soy bean oil, rice bran oil, rapeseed oil, sesame oil, and fish oil.

35. The method of claim 24, wherein the edible oil is sesame oil.

36. The method of claim 24, wherein the concentration of the sterol compound is 0.5% to 20% by weight.

37. The method of claim 24, wherein the concentration of the sterol compound is 1% to 10% by weight.

38. The method of claim 24, wherein the concentration of the edible wax is 3% to 30% by weight.

39. The method of claim 24, wherein the composition is formulated in a soft or hard gel capsule.

40. The method of claim 24, wherein the composition further comprises baicalin.

41. The method of claim 24, wherein the composition further comprises an extract of huangqin.

42. The method of claim 24, wherein the composition further comprises an extract of a combination of huangqin, huangbai and huanglian.

43. The method of claim 24, wherein the sterol compound is selected from the group consisting of stigmasterol, campesterol, β

-sitosterol, chalinosterol, clionasterol, brassicasterol, α

-spinasterol, daucosterol, desmosterol, and poriferasterol, at a concentration of at least 0.1% by weight based on the total weight of the composition.

44. The method of claim 24, wherein the edible oil, edible wax and sterol compound are homogenized to form colloid with the edible wax adopting a microcrystal form at ambient temperature.

45. The method of claim 44, wherein the microcrystal form of beeswax is 0.1-100 μ

m in length.

46. The method of claim 44, wherein the microcrystals of beeswax are dispersed substantially uniformly in the edible oil.