Herbo-mineral formulation for prevention, treatment and management of diabetes and method of preparation thereof

• US 10,576,117 B2
• Filed: 12/26/2018
• Issued: 03/03/2020
• Est. Priority Date: 04/24/2017
• Status: Active Grant

• Current Assignee: Muniyal Ayurvedic Research Centre
• Original Assignee: Muniyal Ayurvedic Research Centre
• Inventors: Shetty, M Vijayabhanu
• Primary Examiner(s): Barker, Michael
• Assistant Examiner(s): Davis, Deborah A
• Application Number:
  US16/232,573
• Publication Number:
  US 20190125816A1
• Time in Patent Office: 433 Days
• Field of Search: 424756, 424779, 424773, 424748, 424777, 424728
• 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 33/30 Zinc; Compounds thereof
• CPC Class Codes: A61K 35/614 Cnidaria, e.g. sea anemones, corals, coral animals or jellyfish
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 36/24 Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
• CPC Class Codes: A61K 36/328 Commiphora, e.g. mecca myrrh or balm of Gilead
• CPC Class Codes: A61K 36/37 Celastraceae (Staff-tree or Bittersweet family), e.g. tripterygium or spindletree
• CPC Class Codes: A61K 36/59 Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
• CPC Class Codes: A61K 36/61 Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
• CPC Class Codes: A61K 36/67 Piperaceae (Pepper family), e.g. Jamaican pepper or kava
• CPC Class Codes: A61K 36/9066 Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
• CPC Class Codes: A61K 36/9068 Zingiber, e.g. garden ginger
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

Herbo-mineral formulation for prevention, treatment and management of Diabetes and method of preparing the same are disclosed herein. The disclosed herbo-mineral formulation includes herb and mineral elements which facilitate in treating Diabetes and Diabetes associated complications. Further the disclosed formulation has been observed to exhibit hypoglycemic, hypolipidemic, and pancreatic cell regenerative properties.

Claims

1. A formulation for treatment and management of Diabetes, comprising:

Salacia chinensis in an amount in the range of 4 to 8 wt %,

Gymnema sylvestre in an amount in the range of 4 to 8 wt %,

Emblica officinalis in an amount in the range of 2 to 6 wt %,

Eugenia jambolana in an amount in the range of 4 to 8 wt %,

Curcuma longa in an amount in the range of 3 to 7 wt %,

Commiphora mukul (Guggulu) in an amount in the range of 3 to 7 wt %,

Tinospora cordifolia in an amount in the range of 3 to 7 wt %,

Withania somnifera in an amount in the range of 1 to 4 wt %,

Terminalia chebula in an amount in the range of 1 to 4 wt %,

Terminalia bellerica in an amount in the range of 1 to 4 wt %,

Andrographis paniculata in an amount in the range of 1 to 4 wt %,

Boerhavia diffusa in an amount in the range of 1 to 4 wt %,

Azadirachta indica in an amount in the range of 1 to 4 wt %,

Aristolochia indica in an amount in the range of 1 to 4 wt %,

Aegle marmelos in an amount in the range of 1 to 4 wt %,

Cyperus rotundus in an amount in the range of 1 to 4 wt %,

Hemidesmus indicus in an amount in the range of 1 to 4 wt %,

Trichosanthes dioica in an amount in the range of 1 to 4 wt %,

Santalum alba in an amount in the range of 1 to 4 wt %,

Terminalia arjuna in an amount in the range of 1 to 4 wt %,

Woodfordia fruticosa in an amount in the range of 1 to 4 wt %,

Glycyrrhiza glabra in an amount in the range of 1 to 4 wt %,

Mucuna pruriens in an amount in the range of 1 to 4 wt %,

Myrica nagi in an amount in the range of 1 to 4 wt %,

Plumbago rosea in an amount in the range of 1 to 4 t %,

Inula racemosa in an amount in the range of 1 to 4 wt %,

Zingiber officinalis in an amount in the range of 1 to 4 wt %,

Piper longum in an amount in the range of 1 to 4 wt %,

Piper nigrum in an amount in the range of 1 to 4 wt %, or extracts thereof;

Shilajit in an amount in the range of 2 to 6 wt %;

Abhraka Bhasma in an amount of ≤

2 wt %;

Vanga Bhasma in an amount of ≤

1 wt %;

Yashada Bhasma in an amount of ≤

1 wt %;

Pravala Bhasma in an amount of ≤

2 wt %;

Loha Bhasma in an amount of ≤

2 wt %;

Swarna Makshika Bhasma in an amount of ≤

2 wt %; and

Gum acacia in an amount in the range of 8 to 10 wt %, of the total composition.

2. The formulation as claimed in claim 1, further comprising gum acacia.

3. The formulation as claimed in claim 1, further comprising at least one additive selected from the group consisting of a flavor, a colorant, a preservative, and a pH adjuster.

4. The formulation as claimed in claim 1, wherein said formulation is administered in a form selected from the group consisting of powder, emulsion, tablets, capsules, troches and pills.

5. The formulation as claimed in claim 1, wherein said formulation is in the form of a tablet.

6. The formulation as claimed in claim 5, wherein said tablet is in the form of 500 mg tablet.

7. A method for the treatment of a condition selected from a group consisting of diabetes, hyperglycemia, low glucose tolerance, hyperinsulinemia and related complications, comprising administering to a patient in need thereof an effective amount of the formulation as claimed in claim 1.

8. A process for the preparation of formulation as claimed in claim 1, comprising:

levigating bhasmas, Guggulu and shilajit;

adding finely powdered herbs; and

adding grinding decoction while continuing grinding to obtain a ground mass.

9. The process for the preparation of formulation as claimed in claim 8, wherein said bhasmas include Abhraka Bhasma, Vanga Bhasma, Yashada Bhasma, Pravala Bhasma, Loha Bhasma and Swarna Makshika Bhasma.

10. The process for the preparation of formulation as claimed in claim 8, wherein said finely powdered herbs comprises of finely powdered form of at least one herb selected from a group consisting of dried root of Salacia chinensis, dried root of Withania somnifera, dried root of Boerhavia diffusa, dried root of Aristolochia indica, dried root of Aegle marmelos, dried root of Cyperus rotundus, dried root of Hemidesmus indicus, dried root of Glycyrrhiza glabra, dried root of Inula racemosa, dried root of Plumbago rosea, dried fruits of Terminalia chebula, dried fruits of Terminalia bellerica, dried fruits of Emblica officinalis, dried fruits of Piper longum and dried fruits of Piper nigrum, dried bark of Azhadirachta indica, dried bark of Myrica nagi, dried bark of Terminalia arjuna, dried plant of Andrographis paniculata, dried plant of Trichosanthes dioica, dried leaves of Gymnema sylvestre, dried heartwood of Santalum alba, dried flowers of Woodfordia fruticosa, dried seeds of Mucuna pruriens, dried seeds of Eugenia jambolana, dried rhizome of Curcuma longa, dried rhizome of Zingiber officinalis and dried stem of Tinospora cordifolia.

11. The method of treating diabetes and associated complications as claimed in claim 7, wherein said therapeutically effective amount is 500 to 1000 mg administered one to three times a day.

12. The method as claimed in claim 7 wherein said formulation is administered along with administration of at least one other medication prescribed for treatment of Diabetes and associated complications.