Use of betel leaf extract to induce IFN-gamma production from human peripheral blood T cells and as a Th1 type immunomodulator

DETAILED DESCRIPTION OF THE INVENTION Accordingly, the invention relates to a method for inducing IFNγ from human peripheral blood mononuclear cells wherein the said method comprising preparing water extract of betel leaf; preparation of human peripheral blood mononuclear cells; incubation of hPBMC with betel leaf extract for a period of 18-48 hours; extraction of RNA for cytokine specific RT-PCR or for flow cytometry for the detection of intracellular cytokine protein.
; subjecting RNA for RT-PCR to obtain PCR products using IFNγ specific known primers and enhancement of IFNγ as reflected by IFNγ specific band.
Alternatively, one more method for inducing IFNγ produced from human peripheral blood mononuclear cells wherein the said process comprising subjecting incubated cells for intracellular staining for IFNγ; analysis of stained cells in flow cytometer; and enhancement of IFNγ positive cells to at least seven fold.
A method for using betel leaf extract as Th1 type immuno-modulator wherein the said method comprising: a) administering to a subject at least 5 to 10 mg/ml/kg body wt.
of betel leaf extract, and b) administering the extract through oral or intra-muscular route once in a day for a period of at least one month, In an embodiment of the present invention provides a pharmaceutical composition useful as Th1 type immunomodulator, said composition comprising an effective amount of betel leaf aqueous extract or lyophilized betel leaf extract together with or associated with an additive.
In still another embodiment of the invention, the additive is selected in such a manner that does not interfere with the activity of betel leaf extract.
Yet another embodiment of the invention, the additive is selected from nutrients such as proteins, carbohydrates, sugar, talc, magnesium stearate, cellulose, calcium carbonate, starch-gelatin paste and/or pharmaceutically acceptable carriers, excipient, diluent or solvent.
Yet another embodiment of the invention, the aqueous extract, lyophilized product or the composition is administered orally or intramuscularly