Caralluma extract products and processes for making the same

• US 20040247702A1
• Filed: 05/04/2004
• Published: 12/09/2004
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Kamala Rajendran, Ramaswamy Rajendran
• Original Assignee: Kamala Rajendran, Ramaswamy Rajendran
• Inventors: Rajendran, Ramaswamy, Rajendran, Kamala
• Granted Patent: US 7,060,308 B2
• Time in Patent Office: Days
• US Class Current: 424/725
• 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 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 36/27 Asclepiadaceae (Milkweed family), e.g. hoya
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 33/10 Anthelmintics
• CPC Class Codes: A61P 39/06 Free radical scavengers or antioxidants
• CPC Class Codes: A61P 9/02 Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

A Caralluma extract and a method of making thereof which can be standardized and reproducible, and which prevents the glycosides from decomposition, which can reduce the undesirable non-glycoside components. In the first Caralluma extract, the resinous material does not exceed 0.5% by weight, and, in the second Caralluma extract, the resinous material does not exceed 1.0% by weight. The first extract is produced by optionally pretreatment of plant materials, optional crushing and/or grinding, extraction, and concentration. The filtration step and the resin removal step may be performed optionally. The second extract is produced by contacting the first Caralluma extract with excipients, drying, powdering, sifting and blending. The Caralluma extracts of the present invention can be used for medical purposes and as food additives.

Claims

1. A Caralluma extract, comprising:

pregnane glycoside; and

wherein said Caralluma extract contains resinous matter of equal to or less than about 0.5% w/w.

2. The Caralluma extract of claim 1, wherein said-Caralluma extract is liquid.

3. The Caralluma extract of claim 2, wherein said Caralluma extract comprises more than 15% w/w of said pregnane glycosides.

4. The Caralluma extract of claim 2, wherein an amount of said pregnane glycoside is in the range from 5% w/w to 15% w/w.

5. The Caralluma extract of claim 2, wherein said pregnane glycoside comprises caratuberside and bouceroside.

6. The Caralluma extract of claim 5, wherein a ratio of the content of said caratuberside to the content of said bouceroside is in the range from about 9:

1 to about 11;

1.

7. The Caralluma extract of claim 5, wherein a ratio of the content of said caratuberside to the content of said bouceroside is substantially equal to a ratio in one selected from the group consisting of the Caralluma species of fimbriata, attenuata, tuberculata, adscendens, and indica.

8. The Caralluma extract of claim 5, wherein the ratio of the content of said caratuberside to the content of said bouceroside is substantially equal to the ratio in one selected from the group consisting of the Caralluma species of stalagmifera, umbellata, lasiantha and edulis.

9. The Caralluma extract of claim 1, wherein said Caralluma extract is from Caralluma fimbriata.

10. The Caralluma extract of claim 1, wherein said Caralluma extract is from the group consisting of the Caralluma species of fimbriata, attenuata, tuberculata, indica, stalagmifera, umbellata, lasiantha and edulis.

11. A pharmaceutical composition comprising the Caralluma extract of claim 1.

12. A Caralluma extract, comprising:

pregnane glycoside, wherein resinous matter in said Caralluma extract does not exceed 1% w/w.

13. The Caralluma extract of claim 12, wherein said Caralluma extract is in a solid form.

14. The Caralluma extract of claim 13, wherein said Caralluma extract comprises more than 30% w/w of pregnane glycosides.

15. The Caralluma extract of claim 13, wherein an amount of said pregnane glycoside is in the range from 25% w/w to 30% w/w.

16. The Caralluma extract of claim 13, wherein said pregnane glycoside comprises caratuberside and bouceroside.

17. The Caralluma extract of claim 16, wherein the ratio of the content of said caratuberside to the content of said bouceroside is in the range from about 9:

1 to about 1;

1.

18. The Caralluma extract of claim 16, wherein the ratio of the content of said caratuberside to the content of said bouceroside is substantially equal to the ratio in one selected from the group consisting of the Caralluma species of fimbriata, attenuata, tuberculata, adscendens, and indica.

19. The Caralluma extract of claim 16, wherein the ratio of the content of said caratuberside to the content of said bouceroside is substantially equal to the ratio in one selected from the group consisting of the Caralluma species of stalagmifera, umbellata, lasiantha and edulis.

20. The Caralluma extract of claim 13, wherein said Caralluma extract is from Caralluma fimbriata.

21. The Caralluma extract of claim 13, wherein said Caralluma extract is from the group consisting of the Caralluma species of fimbriata, attenuata, tuberculata, indica, stalagmifera, umbellata, lasiantha and edulis.

22. A pharmaceutical composition comprising the Caralluma extract of claim 13.

23. A process for obtaining a Caralluma extract, comprising the steps of:

providing a Caralluma plant material;

extracting the Caralluma plant material by using a first solvent to obtain a solution in a condition minimizing an extraction of resinous material from said Caralluma plant material and a decomposition of glycosides; and

concentrating the solution to obtain the Caralluma extract.

24. The process of claim 23, wherein said Caralluma plant material is selected from the group consisting of the Caralluma species of fimbriata, attenuata, tuberculata, adscendens, and indica.

25. The process of claim 23, wherein said Caralluma plant material is selected from the group consisting of the Caralluma species of stalagmifera, umbellata, lasiantha and edulis.

26. The process of claim 23, further comprising the step of:

pretreating the Caralluma plant material by at least one operation selected from the group consisting of washing, cleaning, soaking, drying, cutting, chopping, blanching, crushing and grinding the Caralluma plant material.

27. The process of claim 26, further comprising the step of, between said pretreatment step and said extraction step, removing resinous material.

28. The process of claim 26, wherein said pretreatment step further comprises removing resinous material.

29. The process of claim 23, wherein said extraction step further comprises the step of extracting the Caralluma plant material by using said solution.

30. The process of claim 23, wherein said first solvent is selected from the group consisting of methanol, ethanol, aqueous methanol, aqueous ethanol, i-propyl alcohol, n-butanol, water, and ethylene dichloride.

31. The process of claim 23, wherein said first solvent is aqueous ethanol.

32. The process of claim 31, wherein said aqueous ethanol is about 10-80% v/v.

33. The process of claim 31, wherein said aqueous ethanol is about 20 to 40% v/v.

34. The process of claim 31, wherein said extraction step is carried out at temperature ranging from 70-80°

C.

35. The process of claim 31, wherein said concentration step is carried out at temperature ranging from 40-50°

C. under vacuum.

36. The process of claim 31, further comprising the step of removing resinous material.

37. The process of claim 36, wherein said removal step is carried out after said extraction step.

38. The process of claim 37, wherein said removal step further comprises using a second solvent selected from the group consisting of n-hexane, diethyl ether, ethylene dichloride, petroleum ether, benzene, toluene and methylene dichloride.

39. The process of claim 38, wherein said second solvent is n-hexane.

40. The process of claim 23, wherein said concentration step comprises concentrating the solution by evaporation.

41. The process of claim 40, further comprising recovering the first solvent evaporated by said evaporation.

42. The process of claim 23, wherein said concentration step comprises the steps of:

first concentrating the solution; and

second concentrating the first concentrated solution.

43. The process of claim 42, wherein, after the first concentrating step, a concentration of pregnane glycosides is about 3-8% w/w.

44. The process of claim 42, further comprising the step of, before said second concentration step, removing resinous material from the first concentrated solution.

45. The process of claim 44, further comprising the step of, between said removal step and second concentration step, filtrating the first concentrated solution to remove impurities.

46. The process of claim 45, wherein said removal step comprises the steps of:

washing the filtered first concentrate with a second solvent; and

separating the resinous material from the washed first concentrate.

47. The process of claim 42, further comprising the step of, before said second concentration step, filtrating the first concentrated solution to remove impurities.

48. The process of claim 47, further comprising, between said filtration step and the second concentration step, the step of removing resinous material from the concentrated solution.

49. The process of claim 23, further comprising the steps of:

adding excipient to absorb liquid from the concentrated Caralluma extract; and

after the adding step, drying the Caralluma extract to further remove liquid from the Caralluma extract.

50. The process of claim 49, wherein said excipient is selected from the group consisting of maltodextrin and magnesium carbonate.

51. The process of claim 49, further comprising the step of adding binding agents.

52. The process of claim 51, wherein said binding agents are selected from the group consisting of starch, gum acacia, guar gum and polyvinyl pyrolidone.

53. The process of claim 49, wherein said drying step is performed by using a dryer selected from the group consisting of a tray dryer, a fluid bed dryer, a spray dryer, and a vacuum dryer.

54. The process of claim 49, further comprising the step of powdering the dried Caralluma extract.

55. The process of claim 54, further comprising the step of sifting the powdered Caralluma extract and subsequently blending the sifted Caralluma extract.

56. The process of claim 55, wherein said powdering step is performed by using a multi-miller, a hammer mill or a pulverizer.

57. The Caralluma extract produced by the process of claim 56.

58. The Caralluma extract produced by the process of claim 49.

59. The Caralluma extract produced by the process of claim 23.

60. A process for obtaining a first Caralluma extract, comprising the steps of:

providing a Caralluma plant material;

optionally pretreating said Caralluma plant material;

optionally crushing or grinding of said Caralluma plant material;

extracting the Caralluma plant material by using a first solvent to obtain a solution;

optionally removing the resinous material after at least one of the providing step, the pretreating step, the crushing or grinding step, and the extracting step; and

concentrating the solution to obtain the first Caralluma extract.

61. A process for obtaining a second Caralluma extract, comprising the steps of:

providing a Caralluma plant material;

optionally pretreating said Caralluma plant material;

optionally crushing or grinding of said Caralluma plant material;

extracting the Caralluma plant material by using a first solvent to obtain a solution; and

concentrating the solution to obtain the first Caralluma extract;

optionally removing the resinous material after at least one of the providing step, the pretreating step, the crushing or grinding step, the extracting step, and the concentrating step;

adding excipient to absorb liquid from the first Caralluma extract;

drying the first Caralluma extract to obtain the second Caralluma extract;

optionally powdering the dried second Caralluma extract;

optionally sieving the powdered second Caralluma extract; and

optionally blending the second Caralluma extract.