WO2020026104A1

WO2020026104A1 - Emblica officinalis extract standardized to diacyl glycerol of fatty acids

Info

Publication number: WO2020026104A1
Application number: PCT/IB2019/056425
Authority: WO
Inventors: Benny Antony
Original assignee: Benny Antony
Priority date: 2018-07-31
Filing date: 2019-07-27
Publication date: 2020-02-06

Abstract

The present invention discloses a Diacylglycerol (DAG) composition derived from the fruits of Emblica officinalis. DAG is a form of Alpha-linolenic acid (ALA) and, in the composition the DAG form of ALA and Triacylglycerol (TAG) form of ALA is in the range ratio of 4:1 to 15:1. The DAG has been enriched in the Emblica officinalis fruit extract to achieve such ratio. DAG derived from the fruit of Emblica officinalis has been identified to have medicinal property and is used to make medicinal composition that can be used for the treatment of dyslipidaemia, especially for the reduction of visceral fat and also modulating Thyroid Stimulating Hormones (TSH). The DAG form of ALA is combined with polyphenols, oil and other plant extracts to obtain the medicinal composition. The composition is also formed into different medicinal forms for oral administration purpose. The method of enriching DAG and preparation of a DAG composition is also disclosed.

Description

EMBLICA OFFICINALIS EXTRACT STANDARDIZED TO DIACYL GLYCEROL

OF FATTY ACIDS

FIELD OF INVENTION

[000l]Theinventionrelates to a medicinal composition derived from the fruit of Emblica officinalis. Said composition essentially comprises of Diacylglycerol (DAG) form of Alpha- linolenic acid (ALA)and Triacylglycerol (TAG) form of ALA.According to another embodiment under the invention, bioenhanced turmeric formulation can be added additionally to the Emblica officinalis composition. Similarly Emblica officinalis composition can be added with water dispersible bioavailable turmeric formulation instead of bioenhanced turmeric formulation.Disclosure also relatesto a method of preparation of ihcEmblica officinalis composition from the fruit of Emblica officinalis. The composition is effective even at lower dosage for the treatment of dyslipidaemia. The composition is used forreducing visceral fat, reducing total body fat, reducing body mass index and for reducing full body, hand, trunk and leg subcutaneous fat. The composition is also used for reducing atherogenic index of plasma, increasing Apo A-I levels, decreasing Apo B levels, decreasing Apo B to Apo A-I ratio, reducing the CRP level, reducing Homocysteine level, reduction in glycosylated Hb, modulating Thyroid stimulating Hormone (TSH) level, decrease in HMGCoA reductase activity, lowering total cholesterol without a change in CoQlO levels in mammals especially human beings.

BACKGROUND

[0002] Fatty acids are the basic building blocks of all lipids. They are generally constituted of a linear chain of 16 to 22 carbon atoms, with zero to six double bonds of cis or trans configuration. Omega-3 (also referred to as co-3 or n-3) and omega-6 (co-6) fatty acids are unsaturated "Essential Fatty Acids" (EFAs) that need to be included in the diet because the human metabolism cannot create them from other fatty acids. Omega-3 deficiency may contribute to the development of psychiatric disorders, increased inflammatory processes, poor foetal development, increased risk of cardiovascular disease, and increased risk of Alzheimer’s disease. The main n-3fatty acids in food sources are a-linolenic acid (ALA; l8:3n-3), docosahexaenoicacid (DHA; 22:6n-3), eicosapentaenoic acid (EPA; 20:5n-3) anddocosapentaenoic acid (DPA; 22:5n-3). [0003] Traditional sources of EPA and DHA have disappeared or are disappearing from our diet. An example is the disappearance of DHA-containing cattle brain, due to the threat of bovine spongiform encephalitis. Another is the reduction in the EPA and DHA content of farmed fish, due their replacement by other fatty acids in fish farming. Therefore, novel food sources of EPA and DHA need to be developed. One way is feeding EPA and DHA to animals to enrich their meat with both fatty acids; another is by feeding alpha-linolenic acid to animals capable of converting alpha-linolenic acid to EPA and DHA.

[0004] Alpha-linolenic acid (ALA) is a plant-derived polyunsaturated n-3 (omega-3) fatty acid that is considered an essential fatty acid because it cannot be produced in the human body. ALA, an essential fatty acid present as a relatively high proportion of the total fatty acids in some vegetable oils such as perilla (60-70%), flaxseed (55-60%), canola (-10%), soybean (-7%), and walnut (-13%) oils, is the precursorof C20 and C22 long-chain n-3 polyunsaturated fatty acids (PUFA).

[0005] Omega 3 fatty acids found in marine animals primary contain EPA and DHA form, whereas Omega 3 fatty acid found in vegetable source are Alpha-linolenic acid (ALA). ALA is a precursor to EPA and DHA, but the conversion is exceptionally slow. Vegetable source of omega 3 have ALA in diacylglycerol (DAG), Triacylglycerol (TAG) and Monoacylglycerol (MAG) form, largely in TAG form. TAG conversion to EPA and DHA is less than one percent, and because of such poor conversion rate plant source are not considered a source of EPA and DHA. The market has not yet produced a vegetable source of EPA and DHA.

[0006] WO2015/011724 describes an omega-3 fatty acid composition of enhanced bioavailability. Omega-3 fatty acid composition additionally contains one plant extract and one surfactant. Omega-3 source is fish oil rich in EPA and DHA. W02015/011724 does not disclose a vegetarian source for EPA and DHA. A plant based product as a dietary source of EPA and DHA is yet to be made. The present application discloses a new source of plant based omega-3 with better conversion of ALA to EPA and DHA.

[0007]An extract of Emblica Officinalisis made with standardised ALA which is in the form of DAG. The DAG form is purified and TAG form of ALA is removed from the extract. As an Omega-3 supplement the DAG form of ALA derived from Emblica OJJicinalisx s showing promising results compared to ALA found in other plant source. SUMMARY

[0008]An aspect of the invention is a medicinal composition derived from the fruit of Emblica officinalis comprises of Diacylglycerol form (DAG) of Alpha-linolenic acid (ALA) and Triacylglycerol (TAG) form of ALA in the range of ratio of 1:3 to 95:1. In a more preferred embodiment the DAG form of ALA and TAG form of ALA is in the range ratio of 4:1 to 15:1, more precisely in the ranges from 1% to 95%. Yet another embodiment Diacylglycerol form of Alpha-linolenic acid is at least 2% of the composition.

[0009]Another aspect of the invention is the inclusion of antioxidant in to the composition. The said antioxidant is selected from beta-carotene, lycopene, vitamin C, vitamin A, vitamin E, alpha lipoic acid, astaxanthin, bilberry, blueberries, Acai Berries, Co Q-10, curcumin, cysteine, ginkobiloba, glutathione, grape seed extract, green tea, turmeric, hydrogen peroxide, mangosteen, melatonin, oligomeric proanthocyanidins, olive leaf, polycosanol, pychnogenol, resveratrol, selenium, superoxide dismutase and combinations thereof.

[00l0]Another aspect of the invention is the inclusion of one or more plant oil with said composition so that range of ratio of composition to plant oil is maintained between 1:10 to 10:1. The plant oil is selected from turmeric oil, coconut oil, safflower oil, sun flower oil, soya oil, olive oil, ground nut oil, and sesame oil, flaxseed oil, peanut oil and combinations thereof.

[00l l]Another aspect of the invention is the inclusion of one or more Polyphenol with said composition so that range of ratio of composition to Polyphenol is maintained between 1:90 to 90:1, more preferable range of ratio of composition to polyphenol is 2:3 to 3:2. The Polyphenol blend is derived from Emblica ojficnalis, Green tea, Green coffee, Pomegranate, Grape seeds, Turmeric, and combinations thereof and said polyphenol blend is standardized to 1% to 99% of polyphenol.

[00l2]Another aspect of the invention is the inclusion of one or more bioactive components with said composition so that range of ratio of composition to bioactive component is maintained between 1:90 to 90:1. The bioactive components are bioavailable turmeric formulation, water dispersible bioavailable turmeric formulation, water dispersible curcumin formulation and combinations thereof.

[00l3]Another aspect of the invention is the inclusion of other ingredients selected from fillers, disintegrant, diluents, binders, a carrier, adsorbents, emulsifiers, lubricants, stabilizing agents, anti-adherents, glidants, antioxidants and mixtures thereof when it is made into dosage form for administering to mammals especially human beings.

[00l4]Another aspect of the invention is a dosage form for the composition, the dosage form can be a soft gelatin capsule, a hard gelatin capsule, a tablet, a granule, a sachet, a powder, a paste, an ointment, an infusion, an injection, an ampoule, a solution, a suspension, an emulsion, a pills, an oil, or a cream. The effective dosage form of the extract of Emblica Officinalis with 1% to 95% purity DAG form of ALA is 1 mg to 500 mg to a human subject.

[00l5]Yet another aspect of the invention is the use of the composition derived from the fruit of Emblica officinalis comprises of DAG form of ALA and TAG form of ALA for enhancing anti-hyperlipidemic activity in mammals, also for reducing visceral fat, for decreasing the total cholesterol level and triglyceride level, for decreasing total body fat and body mass index, for reducing full body, hand, trunk and leg subcutaneous fat, for decreasing atherogenic index of plasma, decreasing ratio of Apo B to Apo Al, for lowering homocysteine level, for lowering glycosylated hemoglobin level, for modulating TSH levels, for lowering HMGCoA reductase, and for lowering total cholesterol without altering CoQlO level in a mammal, especially in human.

[00l6]Yet another aspect of the invention is the method of preparation of medicinal composition derived from the fruit of Emblica officinalis. The method comprises the cleaning of fresh fruits of Emblica Officinalis followed by crushing, extracting the fresh fruits with 95% methanol to obtain a residue and a supernatant, and concentrating the resultant supernatant in to concentrated methanol extract. Later the concentrated methanol extract is dried to obtain a powder of methanol extract of Emblica Officinalis. Resultant powder of methanol extract of Emblica Officinalis is dispersed in water to obtain a dispersion, extracting said dispersion with hexane in a liquid-liquid extractor to obtain a hexane and a water phase and collecting both the phases separately and concentrating the hexane phase to strip out all the solvent and to obtain a liquid form of a concentrated hexane extract.

[00l7]Purifying the concentrated hexane extract by transferring the concentrated hexane extract in to the samplet of the cartridge in a flash chromatograph, eluting the loaded sample with chloroform in hexane followed by a gradient elution up to 50% chloroform, collecting the different fractions; and concentrating the column eluted with 20-30% chloroform in hexane to form purified Emblica Officinalis extract. [00l8]The resultant purified Emblica Officinalis extract can be further purified by column chromatography to get a purified composition of diacyl glycerol form of alpha linolenic acid derived from Emblica Officinalis. Diacylglycerol form of Alpha-linolenic of Emblica Officinalis is derived by extracting Emblica Officinalis plant parts by using solvents selected from methanol, ethanol, isopropanol, n-butanol, methyl acetate, ethyl acetate, propyl acetate, n-butyl acetate and combinations thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

[00l9]The above objectives and advantages of the disclosed teachings will become more apparent by describing in detail preferred embodiments thereof with reference to the attached drawings in which:

[0020]FIG.l provides method of preparation of purified diacyl glycerol form of ALA from Emblica officinalis.

DETAILED DESCRIPTION

[0021] An aspect of the invention is an extract of Emblica Officinalisc haracterised with 1% to 95% diacylglycerol (DAG) form of alpha lonolenic acid (ALA). Also said Emblica OJJicinaliscxlrdcl is devoid of any resin, water soluble part and fibre. The Emblica Officinaliscxlv&cl is water insoluble and is in a liquid form. The above said novel Emblica OJJicinaliscxlrdcl is referred to as“the extract” or“ Emblica Officinalise tract” throughout the specification unless defined otherwise.

[0022] The extract also contains triacylglycerol (TAG) form of ALA; compared to TAG form the quantity of DAG form is much higher in said extract. Further the ratio of DAG form of ALA to TAG form of ALA is about 1:3 to about 95:1. Disclosure also provides a composition where the DAG form of ALA extract is blended with polyphenols. The DAG form of ALA is blended with suitable excipient or a carrier for the purpose of oral administration.

[0023]In one embodiment ratio of DAG form of ALA to TAG form of ALA ranges from about 1:3 to about 95:1. In some embodiments ratio between DAG form of ALA to TAG form of ALA is about 1:3. In some embodiments ratio between DAG form of ALA to TAG form of ALA is about 10:3 or 3:1. In some embodiments ratio between DAG form of ALA to TAG form of ALA is about 4:1. In some embodiments ratio between DAG form of ALA to TAG form of ALA is about 5:1. In some embodiments ratio between DAG form of ALA to TAG form of ALA is about 15:1. In some embodiments ratio between DAG form of ALA to TAG form of ALA is about 95:1.

[0024]The Emblica Officinalis extract also contain ALA in free form. The ratio of DAG form of ALA to free ALA content in the extract of Emblica Officinalis ranges from about 1:3 to 10: 1.

[0025]The extract of Emblica Officinalis is used as a good source of long-chain polyunsaturated fatty acid n-3 (n-3 LCPUFAs) precursor. Within n-3 LCPUFAs, the most important for human health are eicosapentaenoic acid (C20:5, n-3, EPA) and docosahexaenoic acid (C22: 6 n-3, DHA). Both EPA and DHA are involved in multiple functions in the human body by playing a central role in the physiology and normal development of individuals from their early embrionary life to the elderly.

[0026]The said extract of Emblica Officinalis has about 1% to 95% DAG form of ALA. In some embodiment, the extract of Emblica Officinalis has at least 2% DAG form of ALA. In some embodiment, the extract of Emblica Officinalis has more than 15% DAG form of ALA. In some embodiment, the extract of Emblica Officinalis has more than 30% DAG form of ALA. In some embodiment, the extract of Emblica Officinalis has more than 60% DAG form of ALA. In some embodiment, the extract of Emblica Officinalis has more than 80% DAG form of ALA. In some embodiment, the extract of Emblica Officinalis has about 95% DAG form of ALA.

[0027]An aspect of the invention is a composition to be used as a supplement for DHA and EPA. The composition has extract of Emblica Officialise haracterised with 1% to 95% DAG form of ALA as its active constituent. Said composition would be referred to as “composition” or“ Emblica 6»/// ha//. s corn position” or“omega 3 composition” or“ Emblica officinalis formulation”throughout the specification if not described otherwise.

[0028]The composition is standardised for 1% to 80% of DAG form of ALA. In some embodiments, the composition has about 1% to 10% of DAG form of ALA, preferably 10%, more preferably 4%. In some embodiments, the composition has about 6% to 30% of DAG form of ALA, more preferably 30%. In some embodiments, the composition has about 31% to 50% of DAG form of ALA, more preferably 50%. In some embodiments, the composition has about 51% to 95% of DAG form of ALA more preferably 70%. In some embodiments, the composition has about 80% of DAG form of ALA. In some embodiments, the composition has about 95% of DAG form of ALA.

[0029]The composition includes one or more excipient selected from fillers, disintegrants, binder, lubricant, glidants, adsorbents, vegetable oils, emulsifier, antioxidants, polyphenol blend and combinations thereof.

[0030]Another aspect of the invention is the use of said composition of Emblica Officinalis characterised with DAG form of ALA in the treatment of dyslipidaemia in mammals especially human beings. The composition used for the treatment has Diacylglycerol (DAG) form of Alpha- linolenic acid (ALA) and Triacylglycerol (TAG) form of ALA in a ratio of 1:3 to 95:1. The composition enhances the bioavailability of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in blood/ tissue in mammals. The enhancement is significantly greater than other plant based Omega-3 source. The increase in bioavailability of EPA and DHA is observed because of extract of Emblica Officialise haracterised with 1% to 95% DAG form of ALA.

[003l]In some embodiment the composition used for the treatment of dyslipidaemia has DAG form of ALA to TAG form of ALA in a range ratio about 4:1 to 15:1. In some embodiment the composition use for the treatment of dyslipidaemia has DAG form of ALA to TAG form of ALA in a ratio about 4:1. In some embodiment the composition use for the treatment of dyslipidaemia has DAG form of ALA to TAG form of ALA in a ratio about 10:1. In some embodiment the composition use for the treatment of dyslipidaemia has DAG form of ALA to TAG form of ALA in a ratio about 15:1.

[0032]Another aspect of the invention is the use of the composition for reducing the visceral fat area (VLA) in mammals. Administering aneffective dose of the composition for a period of 30 to 90 days will lead to reduction in visceral fat in mammals, especially in humans. In anembodimentthe disclosed extract of Emblica Officinalis or the composition made from the extract is administered at an effective doseto decrease the total cholesterol level and triglyceride level in a mammal, especially human. In another embodiment, administering the disclosed extract of Emblica Officinalis or the composition made from the extract decreases the total body fat and decreases the body mass index (BMI)in mammals. In another embodiment, administering the disclosed extract of Emblica Officinalis or the composition made from the extract decreases body age, reducing full body, hand, trunk and leg subcutaneous fat. In another embodiment, administering the disclosed extract of Emblica Officinalis or the composition made from the extract reduces atherogenic index of plasma, increases Apo A-I levels, decreases Apo B levels, decreases Apo B to Apo A-I ratio, reduces the CRP level, reduces Homocysteine level, reduction in glycosylated Hb, modulating Thyroid stimulating Hormone (TSH) level, decrease in HMGCoA reductase activity, lowering total cholesterol without a change in CoQlO levels in mammals.

[0033] Yet another embodiment of the invention provides a method to reduce total cholesterol by administering an effective dose ofthe composition.Yet anotherembodiment provides a method to reduce triglyceride by administering an effective dose of the composition to a mammal, especially human. Another embodiment of the invention provides a method to reduce visceral fat, reduce total body fat and to reduce body mass indexby administering an extract of Emblica Officinalis characterised with 1% to 95% DAG form of ALA. In yet another embodiment, extract of Emblica Officinalis characterised with 1% to 95% DAG is used for reducing atherogenic index of plasma, increasing Apo A-I levels, decreasing Apo B levels, decreasing Apo B to Apo A-I ratio, reducing the CRP level, reducing Homocysteine level, reduction in glycosylated Hb, modulating Thyroid stimulating Hormone (TSH) level, decrease in HMGCoA reductase activity and lowering total cholesterol without a change in CoQlO levels.

[0034]The disclosure also provides anoral dosage form thecomposition. Dosage forms are selected from the group of a soft gelatin capsule, hard gelatin capsule, tablet, granule, sachet, powder, paste, ointment, infusion, injection, ampoule, solution, suspension, emulsion, pills, oil, or cream. Further an effective dosage form of an extract of Emblica Ojficinaliswit 1% to 95% purity DAG form of ALA is about 1 mg to about 500 mg to a human subject or O.Olmg to 10 mg/Kg body weight of a human.

[0035]In one embodiment the extract of Emblica Officinalis characterised with 1% to 95% DAG form of ALA is blended with one or more polyphenol, antioxidants vegetable oils, adsorbents, disintegrant, emulsifier, binder, lubricant, glidants and filler to form a composition.

[0036] In one embodiment, the extract of Emblica Ojficinalisc aracterised with 1% to 95% DAG form of ALA is blended with a polyphenol blend to obtain a composition. Polyphenol blend is derived from any one or combination of but not limited to Emblica ojficnalis, Green tea, Green coffee, Pomegranate, Grape seeds, Turmeric. The polyphenol blend is standardised to 1% to 99% of polyphenol. Emblica Officinalis polyphenol blend standardised to 1-99% polyphenol can be made from liquid juice of fruits of Emblica Officinalis, a powder of an alcoholic extract of fruits of Emblica Officinalis, a powder of a hydro alcoholic extract of fruits of Emblica Officinalis, a powder of a water extract of fruits of Emblica Officinalis, a powder of a juice of fruits of Emblica Officinalis, a powder of dried fruits of Emblica Officinalis, a powder of a water extract of dried fruits of Emblica Officinalis, and, a powder of a pectinase treated water extract of fruits of Emblica Officinalis, powder of hydroalcoholic extract of seed of Emblica Officinalis and any blend made by any combination thereof. The DAG form of ALA to polyphenol blend is blended in a proportion of 1:90 to 90:1, more preferably 2:3 to 3:2.

[0037]In one embodiment, the extract of Emblica Officinalis characterised with 1% to 95% DAG form of ALA is blended with bioactive component. Bioactive components are bioavailable turmeric formulation (Reference US7879373 and US 7736679), water dispersible bioavailable turmeric formulation, water dispersible curcumin etc. In one embodiment, the extract of Emblica Officinalis characterised with 1% to 95% DAG form of ALA is blended with bioavailable turmeric formulation to obtain a composition. In another embodiment, the extract of Emblica Officinalis characterised with 1% to 95% DAG form of ALA is blended with a water dispersible bioavailable turmeric formulation to obtain a composition. In another embodiment, the extract of Emblica Officinalis characterised with 1% to 95% DAG form of ALA is blended with curcumin to obtain a composition. In one embodiment, the extract of Emblica Officinalis characterised with 1% to 95% DAG form of ALA is blended with water dispersible curcumin to obtain a composition.

[0038]Some embodiments providean extract of Emblica Ojficinalisc haracterised with 1% to 95% DAG form of ALA blended withfiller to forma composition.The filler can have any one or more compounds selected from the group of lactose, spraydried lactose, starch, dibasic calcium phosphate, tribasic calcium phosphate, microcrystalline cellulose, hydroxypropyl methyl cellulose, calcium carbonate, or combinations thereof. The extract to filler is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[0039]Some embodiments provide extract of Emblica Ojficinalisc haracterised with 1% to 95% DAG form of ALAblended with a disintegrant to obtain a composition.The disintegrant can be any one or more compound selected from the group of starch, Polyvinyl-pyrrolidone, carboxymethyl cellulose, sodium starch glycolate or combinations thereof. The extract to disintegrant is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2. [0040]Some embodiments provide extract of Emblica Officinalisc aracicr cd with 1% to 95% DAG form of ALA blended with a binder to obtain a composition. The binders can be any one or more compound selected from the group of starch paste, gum acacia, cellulose derivative, polyvinylpyrrolidone or combinations thereof. The extract to binder is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[004l]Some embodiments provide extract of Emblica Officinalisc haracterised with 1% to 95% DAG form of ALA blended with a lubricant to obtain a composition. The lubricant can be any one or more compound selected from the group of magnesium sterate, calcium sterate, talc, liquid paraffin, propylene glycol, silica derivative or combinations thereof. The extractto lubricant is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[0042]Some embodiments provide extract of Emblica Officinalisdnaxacicxxscd with 1% to 95% DAG form of ALA blended with a glidants to obtain a composition. The glidants can be any one or more compound selected from the group of talc, colloidal silica, com starch or combinations thereof. The extract to glidants is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[0043]Some embodiments provide extract of Emblica Officinalisc haracterised with 1% to 95% DAG form of ALA blended with an adsorbents to obtain a composition. The adsorbents can be any one or more compound selected from the group of anhydrous calcium phosphate, starch, silica colloidalisanhydrica (Aerosil) or combinations thereof. The extract to adsorbents is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[0044]Some embodiments provide extract of Emblica Officinalisc haracterised with 1% to 95% DAG form of ALA blended with a vegetable oils/plant oil to obtain a composition. Vegetable oils can be any one or more compound selected from the group of coconut oil, flaxseed oil (linseed oil), turmeric oil, safflower oil, sunflower oil, soybean oil, olive oil, peanut oil, ground nut oil, sesame oil etc. The extract to vegetable oils is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[0045]Some embodiments provide extract of Emblica Officinalisc haracterised with 1% to 95% DAG form of ALA blended with an emulsifier/surfactant to obtain a composition. Emulsifying agents include any one or more compound selected from the group of Agar, Albumin, Alginates, Casein, CeatylAlcohol, Cholic acid, Desoxycholic acid, Diacetyl tartaric acid esters, Egg Yolk, Glycerol, Gums Irish Moss (carrageenan), Lecithin, Mono- and diglycerides, Monosodium phosphate, Monostearate, Ox bile extract, Propylene glycol, Soaps, Taurocholic acid (or its sodium salt), surfactant with a HLB less than 10 or a combination thereof. The extractto emulsifier is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[0046]Some embodiments provide extract of Emblica Officinalisc haracterised with 1% to 95% DAG form of ALA blended with an antioxidants to obtain a composition. Antioxidants are selected from a group consisting of Acai Berries, Beta Carotene, Blueberries, astaxanthin, bilberry, cysteine, ginkobiloba, Co Q-10, Curcumin, Glutathione, Grape seed extract, Green Tea extract, Polycosanol, Resveratrol, pychnogenol, Turmeric, hydrogen peroxide, mangosteen, melatonin, oligomeric proanthocyanidins, Olive leaf, Vitamin A, Vitamin C, Vitamin E, Zinc, selenium, superoxide dismutase, lipid solubleantioxidants and a combination thereof. The extractto antioxidants is blended in a proportion of 1:10 to 10:1, more preferably 2:3 to 3:2.

[0047]Some embodiments provide a dosage form for the delivery of the composition, suchdosage forms are selected from a groupof capsule, tablet, pills, granule, sachet, water soluble powder, lipid soluble powder, water dispersible powder and suspension. The dosage form may also contain fillers, disintegrant, diluents, binders, a carrier, adsorbents, emulsifiers, lubricants, stabilizing agents, antiadherents, glidants, antioxidants and mixtures thereof. The dosage mode can also be made in to a form of paste, ointment, infusion, injection, ampoule, solution, suspension, emulsion, oil, or, cream with use of suitable excipient. The dosage form of the Omega-3 composition is made into lOOmg to lOOOmg of deliverable forms.

[0048]Another aspect of the invention is a method of preparing an extract of Emblica Officinalis with 1% to 95% purity of DAG form of ALA. The extract of Emblica Officinalis can be prepared from fresh seeds, dried seeds, deseeded fruit, and whole fruit fresh or dried.

[0049]The disclosure also provides a method toenrich and standardize DAG form of ALAin Emblica Officinalis extract devoid of any resin, water soluble part and fibre. DAG form of ALA, which makes less than 0.1% by weight of the Emblica Officinalis fruit is enrichingup to 95% and not less than 1%. The 30% to 95% purified form is in liquid state.

[0050]In some embodiments the DAG form of ALA of Emblica Officinalis is derived from solvent extracts of Emblica Officinalis plant parts. Emblica Officinalisplants, parts can beextracted by using solvents include methanol, ethanol, isopropanol, n-butanol, methyl acetate, ethyl acetate, propyl acetate, n-butyl acetate and combinations thereof.

[005l]Low molecular weight alcohols that can be used in preparation of the extract include methanol, ethanol, isopropanol, n-butanol and combinations thereof. Esters that can be used for preparation of the extractinclude methyl acetate, ethyl acetate, propyl acetate, n-butyl acetate and combinations thereof. Alkanes that can be used for preparation of the extract include pentane, hexane, heptane, isooctane, chloroform and combinations thereof.

[0052]In an embodiment of the invention a method of preparing the extract of Emblica Officinalis enriched with diacyl glycerol form of ALA is disclosed. For the extraction process fresh fruits of Emblica Officinalisavc taken as raw material, are cleaned and crushed. The crushed fruits are extracted with 95% methanol to obtain a residue and a supernatant. The supernatant is taken forward and concentrated resulting in a concentrated methanol extract. The concentrated methanol extract is dried to obtain a powder of methanol extract of Emblica Officinalis (sample 1). The powder of methanol extract of Emblica Officinalis is dispersed in water to obtain a dispersion. The dispersion is extracted with hexane in a liquid- liquid extractor following which a hexane and a water phase areobtained; both the phases are collected separately. The hexane phase is concentrated to strip out all the solvent and to obtain a liquid form of a concentrated hexane extract (Sample 2). Concentrated hexane extract is further purified by flash chromatography. Concentrated hexane extract is transferred in to the samplet of the cartridge in a flash chromatograph. After sample loading, column is eluted with chloroform in hexane followed by a gradient elution up to 50% chloroform. Different fractions are collected. Column eluted with 20-30% chloroform in hexane is concentrated to form purified Emblica Officinalis extract (sample 3).

[0053] Purified Emblica Officinalis extract is further purified by column chromatography to get a purified composition of diacyl glyceride form of alpha linolenic acid derived from Emblica Officinalis (sample 4).

[0054]In some embodiments providea dosage form for the composition to be used as an omega-3 supplement to a human, the dosage of aboutlmg to about 1000 mg of the extract of Emblica Officinalis. The dosage form includes a dosage of an extract of Emblica Officinalis ranging from about 5 mg to about 100 mg. As anomega-3 supplement administer a dose of about 100 mg twice daily to a human. As an omega-3 supplement administer a dose of about 1 mg to about 500 mg per day to a human. As an omega-3 supplement administer a dose of about 1 mg to about 500 mg two or three times per day to a human. In some embodiments, the extract of Emblica Officinalis is administered in a dosage of 1 mg to 100 mg to humans. The dosage form is administered in single or multiple doses per day.

[0055]In studies conducted on animals, a simultaneous oral administration of the extract with DAG form of ALA with a purity of 30%at a dosage of 0.5mg/Kg in triton injected rats the cholesterol level is reduced to 176 mg/dlfrom 562 mg/dl, where 562 mg/dl is the average total cholesterol level of the untreated control group animals. That is, 79% inhibition in total cholesterol in the extract administering group compared to untreated control. Simultaneous oral administration of the extract in triton injected rats, triglyceride level is reduced to 226 mg/dl compared to untreated control group of triglyceride value 1120 mg/dl. That is, 84% inhibition in triglyceride level compared to untreated control.

[0056]Simultaneous oral administration of Emblica Officinalis fruit powder at a dosage of 0.5mg/Kg in triton injected rats, cholesterol level is 550 mg/dl. That is, only 2% inhibition in total cholesterol in Emblica Officinalis fruit powder administering group compared to untreated control. For the same group, triglyceride level is 1070 mg/dl which showed only 3% inhibition in triglyceride level compared to untreated control.

[0057] Simultaneous oral administration of commercial Emblica Officinalisoilat a dosage of 0.5mg/Kg in triton injected rats, the percentage inhibition of total cholesterol and triglyceride is only4% and 5% respectively compared to untreated control.

[0058] Oral administration of 95% ethanol extract concentrate of Emblica Officinalis^ DAG form of ALA is 1%) at a dosage of 0.5mg/Kg in triton injected rats, TC level is 490 mg/dl and TG level is 920 mg/dl. Percentage inhibition of total cholesterol and triglyceride is 15% and 19% respectively compared to untreated control.

[0059]After administration of sample 2 (DAG form of ALA is 10%) at a dosage of 0.5mg/Kg in triton injected rats, cholesterol level is 390 mg/dl and triglyceride level is 5l0mg/dl. This shows 35% inhibition in total cholesterol and 58% inhibition in triglyceride after administering sample 2 compared to untreated control.

[0060] Efficacy of Emblica officinalis extract with DAG (EODAG) in combination with bioavailable formulation and water dispersible bioavailable formulation is studied on animals. Simultaneous oral administration of the EODAG form of ALA with a purity of 10% in a dosage of 10 mg/Kg in triton injected rats the cholesterol level is reduced to 120 mg/dl from 156 mg/dl, average total cholesterol level of the untreated control group animals. That is, 38% inhibition in total cholesterol in the extract administering group compared to untreated control. Simultaneous oral administration of the extract in triton injected rats, triglyceride level is reduced to 215 mg/dl compared to untreated control group of triglyceride value 453 mg/dl. That is, 59% inhibition in triglyceride level compared to untreated control.

[0061] Simultaneous oral administration of Curcumin powder in a dosage of 22.5mg/Kg in triton injected rats, cholesterol level is 151 mg/dl and triglyceride level is 435 mg/dl. That is, only 5% inhibition in total cholesterol and 4% inhibition in triglyceride in curcumin administering group compared to untreated control.

[0062]0ral administration of combination of EODAG and curcumin in 1:2 ratioin triton injected rats, the percentage inhibition of total cholesterol and triglyceride is 48% and 68% respectively compared to untreated control

[0063]0ral administration of bioavailable formulation (curcuminoids and essential oil of turmeric with 45% Ar-turmerone) in triton injected rats, the percentage inhibition of total cholesterol and triglyceride is 11% and 7% respectively compared to untreated control.

[0064]Simultaneous oral administration of combination of EODAG and bioavailable formulation in 1:2 ratio in triton injected rats, the percentage inhibition in total cholesterol and triglyceride is 63% and 83% respectively compared to untreated control.

[0065]Simultaneous oral administration of water dispersible bioavailable formulation in triton injected rats, the percentage inhibition of total cholesterol and triglyceride is 17% and 11% respectively compared to untreated control.

[0066]Simultaneous oral administration of combination of EODAG and water dispersible bioavailable formulation in 1:2 ratio in triton injected rats, the percentage inhibition of total cholesterol and triglyceride is 77% and 92% respectively compared to untreated control.

[0067] Simultaneous oral administration of water dispersible curcumin in triton injected rats, the percentage inhibition of total cholesterol and triglyceride is 7% and 6% respectively compared to untreated control.

[0068] Simultaneous oral administration of combination of EODAG and water dispersible curcumin in 1:2 ratio in triton injected rats, the percentage inhibition of total cholesterol and triglyceride is 51% and 72% respectively compared to untreated control. [0069] Efficacy and safety of different doses of Emblica officinalis DAG formulation is studied in human subjects with dyslipidaemia. Efficacy of the study medication is assessed by measuring serum lipid parameters including triglycerides, total Cholesterol, HDL, LDL and VLDL. Other parameters measured are fasting plasma glucose, glycosylated haemoglobin, Apo lipoproteins Al, Apo lipoproteins B, homocysteine, Coenzyme Q10, high sensitivity C- reactive protein (hs-CRP), HMG CoA reductase inhibitory activity and TSH. Bioelectric Impedence Analaysis (Total Body fat percentage, visceral fat percentage, Resting metabolism, Body Age, Segmental Subcutaneous fat percentage (Fullbody, Trunk, Hands, Legs), Segmental Skeletal Muscle percentage (Fullbody, Trunk, Hands, Legs) using Omron Body Composition Monitor HBF-701) and Anthropometric measurements (BMI, Waist circumference, hip circumference, waist : hip ratio) are also measured.

[0070] 90 days treatment of patients with Emblica officinalis DAG formulation (EODAG formulation) 250mg capsule once daily decreased the total cholesterol 16% and triglyceride by 27% when compared with baseline value. Patients after treatment with 250 mg of EODAG formulation twice daily, total cholesterol reduction are 38% and triglyceride reduction is 50%. There is an increase of 19% in HDL level after administering EODAG formulation 250mg capsule once daily whereas HDL level is increased by 34% after administering EODAG formulation 250mg capsule twice daily . Decrease in LDL is very significant, and it is 23% in patients treated with EODAG formulation 250mg capsule once daily whereas patients treated with EODAG formulation 250mg capsule twice daily the decrease in LDL is 35%. VLDL is decreased about 50% in patients treated with EODAG formulation 250mg capsule twice daily and in patients treated with EODAG formulation 250mg capsule once daily, VLDL was decreased by 27%.

[0071] As a marker of plasma atherogenecity Atherogenic index of the plasma (AIP) is used, AIP is the logarithmically transformed ratio of molar concentrations of triglycerides (TGs) to HDL-cholesterol (log (TG/HDL [mmol]). AIP increases in people at higher risk for coronary heart disease and is inversely correlated with LDL particle size.

[0072] AIP values of -0.3 to 0.1 are associated with low, 0.1 to 0.24 with medium and above 0.24 with high cardiovascular risk. Study shows reduction in AIP from 0.44 to 0.014 mg/dL in patients treated with EODAG formulation 250mg capsule twice daily Patients treated with EODAG formulation 250mg capsule once daily, AIP is reduced from a baseline value of 0.42 to 0.21 mg/dL. That is after treatment with EODAG formulation in low and high dose, atherogenic index of plasma decreased by 50% and 96% respectively in 90 days treatment.

[0073]Apo A-l is a protein that has a specific role in the metabolism of lipids and is the main protein component in HDL, the "good cholesterol". Deficiencies in Apo A-l correlate with an increased risk of developing Cardio vascular disease (CVD). In the study, administering EODAG formulation 250mg capsule twice daily, the Apo A-l has been increased from 1.05 g/L to 1.59 g/L. That is an increase of 51% in Apo A-l after 90 days of treatment with EODAG formulation 250mg capsule twice daily. Apo Al increase is 37% after 90 days treatment with EODAG formulation 250mg capsule once daily.

[0074]Apolipoprotein B (Apo B) is an important component of many lipoproteins that are involved in atherosclerosis and cardiovascular disease. Usually, 85-90 percent of Apo B represents LDL particles. Apo B has been reduced from 1.62 g/L to 1.01 g/L (38% decreases) in patients administered with EODAG formulation 250mg capsule twice daily. Apo B decrease is from 1.6 g/L to 1.17 g/L (27% decreases) after 90 days treatment with EODAG formulation 250mg capsule once daily.

[0075]Ratio of the apoB/apoAl is more effective at predicting heart attack risk, than either the apo B or apoAl measure alone. Ratio of Apo B to Apo A-l has been decreased from 1.54 g/L to 0.63 g/L (59% decrease) in patients administered with EODAG formulation 250mg capsule twice daily. Subjects treatment with EODAG formulation 250mg capsule once daily shows 47% decrease in ratio of Apo B to Apo A-l.

[0076]Thereis a decrease of 56% hs-CRP value in patients administered with EODAG formulation 250mg capsule twice daily. There is a decrease in hs-CRP by 31% in subjects treated with EODAG formulation 250mg capsule once daily.

[0077]Homocysteine is an amino acid and breakdown product of protein metabolism that, when present in high concentrations, has been linked to an increased risk of heart attacks and strokes. Homocysteine level has been reduced from 27 to 13 pmol/L in group 2 subjects administered with EODAG formulation 250mg capsule twice daily. That is 90 days treatment with EODAG formulation (250mg twice daily) decreased the homocysteine level 52% when compared with baseline value. In group 1 subjects with daily intake of 250mg capsule of EODAG formulation for 90 days decreases the homocysteine level by 39%. This indicates the benefits of Emblica officinalis DAG formulation in managing cardiovascular health and preventing the risk of stroke, heart attack and other related risks.

[0078]HbAlc is a measure of the beta-N-l-deoxy fructosyl component of hemoglobin. Normal levels of glucose produce a normal amount of glycated hemoglobin. Excessive formation of early glycation products may adversely affect several functions of blood vessels, lipid metabolism and prone to develop diabetic complications. Level of HbAlc is reduced from 6.8% to 5.2% (24% reduction) in subjects administered with EODAG formulation 250mg capsule twice daily. In group 1 daily intake of 250mg capsule of EODAG formulation for 90 days decreases the glycosylated Hb by 18%. This indicates the benefits of Emblica officinalis DAG formulation in managing the blood sugar level and preventing diabetes.

[0079] Thyroid function regulates a wide array of metabolic parameters. Thyroid function significantly affects lipoprotein metabolism as well as some cardiovascular disease (CVD) risk factors, thus influencing overall CVD risk. In our study, EODAG formulation 250mg capsule twice daily administration increased the TSH level from 2.21 to 3.35(52% increase), thus increasing the lipoprotein lipase which reflects in decreasing the TGs. In group 1 daily intake of 250mg capsule of EODAG formulation for 90 days increases the TSH level by 43%.

[0080]Coenzyme Q10 is the coenzyme for mitochondrial enzyme complexes involved in oxidative phosphorylation in the production of ATP. A deficiency of CoQlO in the blood and the heart muscle has been documented in congestive heart failure. HMG-CoA reductase (3- hydroxy-3-methyl-glutaryl-coenzyme A reductase) is the rate-controlling enzyme of the mevalonate pathway, the metabolic pathway that produces cholesterol and other isoprenoids. Normally in mammalian cells this enzyme is suppressed by cholesterol derived from the internalization and degradation of low-density lipoprotein (LDL) via the LDL receptor as well as oxidized species of cholesterol.

[0081] Decrease in HMGCoA reductase activity is 22% in group 2 subjects administered with EODAG formulation 250mg capsule twice daily and at the same time there is no change in CoQlO level. Decrease in HMGCoA reductase activity is 11% in group 1 subjects with daily intake of 250mg capsule of Emblica officinalis DAG formulation and at the same time there is no change in CoQlO level. [0082]Fasting plasma glucose (FPG) is decreased by 10% after 90 days of treatment with EODAG formulation (250 mg capsule twice daily) compared to baseline value. In group 1 subjects with daily intake of 250mg capsule of EODAG formulation, Fasting plasma glucose (FPG) is decreased by 7%.

[0083]Depending on where fat is distributed in the body, it is classified as visceral fat or subcutaneous fat. Visceral fat =fat surrounding internal organs. The more visceral fat there is, the higher the risk of diseases caused by lifestyle. Too much visceral fat is thought to be closely linked to increased levels of fat in the bloodstream, which can lead to common diseases such as hyperlipidemia and diabetes, which impairs the ability of insulin to transfer energy from the bloodstream and using it in cells. In order to prevent or improve conditions of common diseases, it is important to try and reduce visceral fat levels to an acceptable level. People with high visceral fat levels tend to have large stomachs. However, this is not always the case and high visceral fat levels can lead to metabolically obese. Metabolically obese (visceral obesity with normal weight) represents fat levels that are higher than average, even if a person’s weight is at or below the standard for their height. Normal level of visceral fat is 0.5-9.5.90 days treatment with EODAG formulation (250 mg capsule twice daily) decreased the visceral fat 64% when compared with baseline value. 90 days treatment with EODAG formulation (250 mg capsule once daily) decreased the visceral fat by 33%. In case of total body fat, the reduction is 62% after treatment with EODAG formulation (250 mg capsule twice daily). Reduction in body fat is 35% after treatment with EODAG formulation (250 mg capsule twice daily).

[0084]BMI is an international standard to determine obesity. BMI can be obtained by means of very simple calculations. BMI=Weight (kg) / Height (m) / Height (m). Decrease in BMI is 38% after administering 250 mg capsule of EODAG formulation twice daily and a reduction of 17% in BMI is observed after administering 250 mg capsule of EODAG formulation once daily.

[0085]Reduction in body age and resting metabolism is observed after treatment with EODAG formulation. Subcutaneous fat not only accumulates around the stomach but also around the upper arms, hips and thighs, and can cause a distortion of the body’s proportions. Although not directly linked to increased risk of disease, it is thought to increase pressure on the heart and other complications. Subcutaneous fat is not displayed in this unit, but is included in the body fat percentage. Subcutaneous fat percentage (%) = (subcutaneous fat weight (kg)/body weight (kg)) xlOO. Reduction in full body subcutaneous fat, hand subcutaneous fat, trunk subcutaneous fat and leg subcutaneous fat is observed after treatment with EODAG formulation. 90 days treatment with EODAG formulation (250 mg capsule twice daily) decreased the full body subcutaneous fat by 60% when compared with baseline value and in EODAG formulation (250 mg capsule once daily), 42% reduction in full body subcutaneous fat is observed. 90 days treatment with EODAG formulation (250 mg capsule once daily) decreased the Hand subcutaneous fat by 35% whereas in group 2(EODAG formulation 250 mg capsule twice daily) Hand subcutaneous fat decreased by 51%. In case of trunk subcutaneous fat, the reduction is 54% in EODAG formulation (250 mg capsule twice daily) whereas in group 1, trunk subcutaneous fat decreased by 39%. Reduction in Leg subcutaneous fat is decreased by 38% in EODAG formulation (250 mg capsule once daily) and in group 2 (EODAG formulation 250 mg capsule twice daily) it is 54%. After treatment with EODAG formulation an increase in full body skeletal muscle, hand skeletal muscle, trunk skeletal muscle and leg skeletal muscle is observed.

[0086]It will be readily understood by thoseskilled in the art that numerous alterations may be made to the examples and instructions given herein. These and other objects and features of the invention will be made apparent from the following examples. The following examples as described are not intended to be construed as limiting the scope of the present invention.

EXAMPLE 1

EXTRACTION PROCESS

[0087] 500 Kg of fresh fruits of Emblica Officinalis were collected. Fresh fruits were washed and pulverized. 95% methanol in an amount 2 times the quantity of pulverized fruit was added to form a mixture for methanol extraction. The extraction was performed using an extractor with reflux condenser. The bottom of the extractor was fitted with a polypropylene (100 microns) filter cloth. The mixture was refluxed for one hour at 65°C to obtain a first residue and supernatant. The first residue and supernatant were separated by draining out the supernatant from the extractor bottom through the polypropylene filter cloth using a centrifugal pump. After the first extraction, the first residue was further extracted with two times the quantity of methanol at 65°C to get a second residue and supernatant. The second residue was further extracted with two times the quantity of methanol at 65°C to get a third residue and supernatant. All the supernatants were pooled and concentrated in an Agitated thin film evaporator (ATFE) at a temperature of 65°C to form a concentrated methanol extract. The concentrated methanol extract was dried under vacuum at above 500 mm of mercury to obtain 50 kg of powder of methanol extract of Emblica Officinalis. (Samplel). Sample 1 contains 1% DAG form of ALA, 3% TAG form of ALA and 2% MAG form of ALA.

[0088]Samplelwas dispersed in water and transferred into a liquid-liquid extractor and extracted with hexane. After extraction hexane phase and aqueous phase separated. Then the hexane phase was collected through side valve. Hexane phase was concentrated in an Agitated thin film evaporator to form 20Kg concentrated hexane extract (sample 2). Sample 2 contains 10% DAG form of ALA, 3% TAG form of ALA and 7% MAG form of ALA.

[0089]Sample 2 was further purified by flash chromatography. The silica gel particles of size about 40-63 pm are loaded in to a KP-SILl00g SNAP cartridge and the column was primed (wet) with 10% chloroform in hexane. Before loading to the column, sample 2 was impregnated with silica gel in 1:1 ratio. The impregnated fraction was transferred into the samplet of the cartridge in a flash chromatograph. After sample loading, column was initially eluted with 2 column volume of 10% chloroform in hexane followed by a gradient elution up to 50% chloroform. Each fraction was collected and concentrated. Column eluted with 20- 30% chloroform in hexane (5Kg) [sample 3] was subjected to further purification. Sample 3 contains 30% DAG form of ALA, 2% TAG form of ALA and 5% MAG form of ALA.

[0090]5Kg of sample 3 was further purified by column chromatography using silica gel (60- 120 mesh). Silica gel was loaded into the glass column. Before loading to the column, liquid product 2 was impregnated with silica gel in 1:1 ratio. After sample loading, column was eluted with petroleum ether: diethyl ether in 9:1 ratio. Petroleum ether: diethyl ether fraction was collected and concentratedto get 2Kg of purified extract of Emblica Officinalis [Sample 4]. Sample 4 contains diacyl glycerol form of alpha linolenic acid. Sample 4 contains 95% DAG form of ALA, 1% TAG form of ALA and 0.2% MAG form of ALA.

EXAMPLE 2

ANALYSIS OF DAG BY GC

[009l]Fatty acids were analysed by gas chromatography method. 250 mg of standard oil fatty acid methyl ester was weighed in 25 ml standard flask and made up to 25 ml with isooctane. 1 microlitre of the standard solution was injected in GC. Retention time of each component was found out. [0092]0.3 gm of the sample (extract) was weighed into a 100 ml RB flask and 1.5 ml of 0.5 N methanolicNaOH was added. Sample was kept in a boiling water bath with a water condenser and heated at l00°C for 5 minutes. Cooled and 2 ml of boron tri fluoride (BF3)-Methanol solution was added and heated at l00°C for 30minutes. Cooled to 30-40°C and 5ml isooctane was added and shook vigorously for 30 seconds.

[0093] 5 ml of saturated NaCl solution was added immediately and shook vigorously and cooled to room temperature. Iso-octane layer was separated, and aqueous layer was again extracted with iso-octane. Isooctane layers were mixed and dried. Then made up the residue to 25 ml with iso-octane and 2 micro litres was injected in GC. Retention time of each component was found out and compared with components of standard with the same retention time. By comparing the area of standard and sample, the percentage of fatty acids present in the sample was quantified. (European Pharmacopoeia, fifth edition, vol 1, ISBN: 92-871-5281-0, p-l lO).

EXAMPLE 3

SCREENING OF HYPOLIPIDEMIC ACTIVITY OF EMBLICA OFFICINALIS EXTRACT USING TRITON WR 1339 INDUCED D YS LIPIDEMIA MODEL.

[0094]Forty male Albino rats (Sprague Dawley strain) weighing approximate 250-300 gm were selected for the study. The animals were kept in the animal house maintained at temp 24±2°C, 65% relative humidity and 12 hr light/dark cycle. The rats were acclimatized for two weeks and during this period they had access to standard pellet diet and water ad libitum. After two weeks of acclimatization, all the rats were fasted overnight before injecting Triton WR 1339 (Tyloxapol) and administration of test extracts/standard. The animals were divided into ten groups. Following treatment was given to overnight fasted rats:

Group I: Normal control (vehicle only).

Group II: Triton WR 1339 (1000 mg/kg, intraperitoneal).

Group III: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by Emblica Officinalis fruit powder (0.5 mg/kg, per oral).

Group IV: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by commercial Emblica OfficinalisoiX (0.5 mg/kg, per oral). Group V: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by flaxseed oil(0.5 mg/kg, per oral).

Group VI: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by methanol -ethyl acetate extract of Amla seed (0.5 mg/kg, per oral).

Group VII: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by sample 1 of Emblica Officinalis prepared as per example 1(0.5 mg/kg, per oral).

Group VIII: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by sample 2 prepared as per example 1 (0.5 mg/kg, per oral).

Group IX: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by sample 3 prepared as per example 1 (0.5 mg/kg, per oral).

Group X: Triton WR 1339 (1000 mg/kg, intraperitoneal) followed by Atorvastatin (10 mg/kg, per oral)

[0095]The animals were deprived of food for next 24 hours but had free access to water ad libitum. After 24 hour of drug treatment 2 ml blood samples were collected from the retro orbital plexus. The blood was allowed to clot and then centrifuged at 3000 rpm for 10 min and the serum was carefully drawn and collected into separate tubes. The serum was analyzed for total cholesterol (TC) and triglycerides (TG) using auto-analyzer.

[0096] Table 1: Lipid profile (mg/dl) of rats treated with different Emblica Officinalis extract/powder.

[0097]Results indicated that Injecting Triton alone (Group II) significantly increased the total cholesterol level to 562 mg/dl. Whereas in Group III, simultaneous oral administration of Emblica Officinalis fruit powder in triton injected rats, cholesterol level was 550 mg/dl. That is, only 2% inhibition in total cholesterol in Emblica Officinalis fruit powder administering group compared to untreated control.

[0098]In group II triton injection increased the triglyceride level to 1120 mg/dl. Whereas in Group III, simultaneous oral administration of Emblica Officinalis fruit powder in triton injected rats, triglyceride level was 1090 mg/dl which showed only 3% inhibition in triglyceride level compared to untreated control.

[0099]In Group IV, simultaneous oral administration of commercial Emblica Officinalis oil in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 4% and 5% respectively compared to untreated control.

[0100] In Group V, simultaneous oral administration of flax seed oil in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 2% and 7% respectively compared to untreated control.

[0l0l]ln Group VI, simultaneous oral administration of methanol-ethyl acetate extract of Emblica Officinalis seed in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 41% and 45% respectively compared to untreated control.

[0l02]In group VII simultaneous oral administration of methanol extract of Emblica Officinalis fruit in triton injected rats, TC level was 490 mg/dl and TG level was 920 mg/dl. Percentage inhibition of total cholesterol and triglyceride was 15% and 19% respectively compared to untreated control. [0103]Ih Group VIII, simultaneous oral administration of sample 2 at a dosage of 0.5mg/Kg in triton injected rats, cholesterol level was 390 mg/dl and triglyceride level was 5l0mg/dl. That is, 35% inhibition in total cholesterol and 58% inhibition in triglyceride after administering sample 2 compared to untreated control.

[0l04]In Group IX, simultaneous oral administration of sample 3 at a dosage of 0.5mg/Kg in triton injected rats, cholesterol level was 176 mg/dl and triglyceride level was 226 mg/dl. That is, 79% inhibition in total cholesterol and 84% inhibition in triglyceride compared to untreated control.

[0l05]In Group X, simultaneous oral administration of Atorvastatin in triton injected rats, cholesterol level was 150 mg/dl and triglyceride level was 250 mg/dl. That is, 84% inhibition in total cholesterol and 82% inhibition in triglyceride compared to untreated control. The studies carried out indicate that the standard drug Atorvastatin was effective in lowering the cholesterol as well as triglyceride levels but less effective when compared with purified DAG form of ALA derived from Emblica Officinalis.

[0106] From the above results, purified DAG form of ALA derived from Emblicaojfcinalis at a dosage of 0.5mg/kg (sample 3)showed significant decreaseintotal cholesterol and triglyceride level whereasTAG form of ALA rich oilat the same dosage showed very less effect in cholesterol and triglyceride lowering. The other Emblica Officinalis extract with DAG form of ALA (sample 2) at 0.5 mg/kg were able to decrease the cholesterol and triglyceride level to a certain extent. These results clearly indicate the hypolipidemic activity of DAG form of ALA derived from Emblica Officinalis in triton induced hyperlipidemia in rats.

EXAMPLE 4

HYPOLIPIDEMIC ACTIVITY OF EMBLICA OFFICINALIS DAG EXTRACT IN COMBINATION WITH DIFFERENT BIO AVAILABLE FORMULATION USING TRITON WR 1339 INDUCED D YS LIPIDEMIA MODEL.

[0l07]Forty four male Albino rats (Sprague Dawley strain) weighing approximate 250-300 gm were selected for the study. The animals were kept in the animal house maintained at temp 24±2°C, 65% relative humidity and 12 hr light/dark cycle. The rats were acclimatized for two weeks and during this period they had access to standard pellet diet and water ad libitum. After two weeks of acclimatization, all the rats were fasted overnight before injecting Triton WR 1339 (Tyloxapol) and administration of test extracts/standard. The animals were divided intoeleven groups. Following treatment was given to overnight fasted rats:

Group I: Normal control (vehicle only).

Group II: Triton WR 1339 (300 mg/kg, intraperitoneal).

Group III: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by curcumin (22.5mg /Kg, per oral).

Group IV: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by bioavailable formulation (curcuminoids+ Essential oil of turmeric with 45% Ar- turmerone) (22.5 mg/kg, per oral).

Group V: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by water dispersible bioavailable formulation (22.5 mg/kg, per oral).

Group VI: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by Emblica officinalis DAG formulation (10 mg/kg, per oral).

Group VII: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by combination of Emblica officinalis DAG composition (EODAG) + curcumin in 1:2 ratio (32.5 mg/kg, per oral).

Group VIII: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by combination of Emblica officinalis DAG composition + bioavailable formulation in 1:2 ratio (32.5 mg/kg, per oral).

Group IX: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by combination of Emblica officinalis DAG composition + water dispersible bioavailable formulation in 1:2 ratio (32.5mg/Kg, per oral).

Group X: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by combination of Emblica officinalis DAG composition + water dispersible curcumin formulation in 1:2 ratio (32.5mg/Kg, per oral).

Group XI: Triton WR 1339 (300 mg/kg, intraperitoneal) followed by Atorvastatin (10 mg/kg, per oral) [0l08]The animals were deprived of food for next 24 hours but had free access to water ad libitum. After 24 hour of drug treatment 2 ml blood samples were collected from the retro orbital plexus. The blood was allowed to clot and then centrifuged at 3000 rpm for 10 min and the serum was carefully drawn and collected into separate tubes. The serum was analyzed for total cholesterol (TC) and triglycerides (TG) using auto-analyzer.

[0109] Table 1: Lipid profile (mg/dl) of rats

[0110] Injecting Triton alone (Group II) significantly increased the total cholesterol level to 156 mg/dl. Whereas in Group III, simultaneous oral administration of Curcumin powder in a dosage of 22.5mg/Kg in triton injected rats, cholesterol level was 151 mg/dl. That is, only 5% inhibition in total cholesterol in curcumin administering group compared to untreated control.

[0l l l]ln group II triton injection increased the triglyceride level to 453 mg/dl. Whereas in Group III, simultaneous oral administration of curcumin in triton injected rats, triglyceride level was 435 mg/dl which showed only 4% inhibition in triglyceride level compared to untreated control.

[0l l2]In Group VII, simultaneous oral administration of Emblica officinalis DAG extract in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 38% and 59% respectively compared to untreated control.

[0l l3]In Group VIII, simultaneous oral administration of combination of Emblica officinalis DAG extract and curcumin in 1:2 ratio in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 48% and 68% respectively compared to untreated control

[0l l4]In Group IV, simultaneous oral administration of bioavailable formulation in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 11% and 7% respectively compared to untreated control.

[0l l5]In Group IX, simultaneous oral administration of combination of Emblica officinalis DAG extract and bioavailable formulation in 1:2 ratio in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 63% and 83% respectively compared to untreated control.

[0l l6]In Group V, simultaneous oral administration of water dispersible bioavailable formulation in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 17% and 11% respectively compared to untreated control.

[0l l7]In Group X, simultaneous oral administration of combination of Emblica officinlais DAG extract and water dispersible bioavailable formulation in 1:2 ratio in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 77% and 92% respectively compared to untreated control. [0118]Ih Group VI, simultaneous oral administration of water dispersible curcumin in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 7% and 6% respectively compared to untreated control.

[0l l9]In group XI, simultaneous oral administration of combination of Emblica officinlais DAG extract and water dispersible curcumin in 1:2 ratio in triton injected rats, the percentage inhibition of total cholesterol and triglyceride was 51% and 72% respectively compared to untreated control.

[0l20]In Group XII, simultaneous oral administration of Atorvastatin in triton injected rats, cholesterol level was 105 mg/dl and triglyceride level was 95 mg/dl. That is, 54% inhibition in total cholesterol and 88% inhibition in triglyceride compared to untreated control.

[0l2l]The studies carried out indicate that the Emblica officinalis DAG formulation was effective in lowering the cholesterol as well as triglyceride levels. Combination Emblica officinalis DAG formulation with bioavailable turmeric formulation was more effective when compared with Emblica Officinalis DAG formulation. Combination of Emblica officinalis DAG formulation and water dispersible turmeric formulation was very effective in lowering the cholesterol as well as triglyceride levels compared to other combinations studied.

EXAMPLE 5

TO EVALUATE THE EFFICACY AND SAFETY OF DIFFERENT EMBLICA OFFICINALIS EXTRACTS IN SUBJECTS WITH D YS LIPID AEMIA

[0l22]A total of 45 subjects were divided into 3 groups of 15 subjects each. Both male and female patients having dyslipidaemia were selected for the study. Patients were not taking any medication (including herbal product) for management of dyslipidaemia. Subjects were divided as follows.

[0123] Efficacy of the study medication was assessed by measuring serum lipid parameters including triglycerides, total Cholesterol, LDL and VLDL. Other parameters measured were fasting plasma glucose, glycosylated haemoglobin, Apo lipoproteins Al, Apo lipoproteins B, homocysteine, Coenzyme Q10, high sensitivity C-reactive protein (hs-CRP), HMG CoA reductase inhibitory activity and TSH. Bioelectric Impedence Analaysis (Total Body fat percentage and visceral fat percentage, using Omron Body Composition Monitor HBF-701) and Anthropometric measurements (BMI) were also measured.

[0l24]Table 1: Lipid profile (mg/dl) of subjects treated with different doses of Emblica officinalis DAG formulation.

[0125]90 days treatment of group 1 patients with EODAG formulation 250mg capsule once daily decreased the total cholesterol 16% when compared with baseline value. In group 2 patients after treatment with 250 mg of EODAG formulation twice daily, total cholesterol reduction was 38%. In case of triglycerides the reduction was 27% in group 1 whereas in group 2, reduction in triglycerides was 50%. There was an increase of 19% in HDL level in group 1 whereas HDL level of group 2 was increased by 34%. Decrease in LDL was very significant and it was 23% in group 1 whereas in group 2 the decrease in LDL was 35%. VLDL was decreased about 50% in group 2 and in group 1 VLDL was decreased by 27%.

[0l26]As a marker of plasma atherogenecity Atherogenic index of the plasma (AIP) is used, AIP is the logarithmically transformed ratio of molar concentrations of triglycerides (TGs) to HDL-cholesterol (log (TG/HDL [mmol]). AIP increases in people at higher risk for coronary heart disease and is inversely correlated with LDL particle size.

[0127] AIP values of -0.3 to 0.1 are associated with low, 0.1 to 0.24 with medium and above 0.24 with high cardiovascular risk. In present study reduction in AIP was observed from 0.44 to 0.014 mg/dL in group 2 whereas in placebo group very minor increase in AIP was observed. In group 1, AIP was reduced from a baseline value of 0.42 to 0.21 mg/dL. That is after treatment with Emblica officinalis DAG formulation in low and high dose decreased the atherogenic index of plasma by 50% and 96% respectively in 90 days treatment.

[0l28]Table 2: Apo lipoprotein Al, Apo lipoprotein B, hs-CRP, Homocysteine, Glycosylated Haemoglobin, TSH, HMGCoA reductase inhibitory activity and CoQlO of subjects treated with different Amla extract and Placebo.

[0129]Aro A-l is a protein that has a specific role in the metabolism of lipids and is the main protein component in HDL, the "good cholesterol". Deficiencies in Apo A-l correlate with an increased risk of developing Cardio vascular disease (CVD).The reference range of Apo-Al varies by sex, as follows: Men: Greater than 120 mg/dL (1.2 g/L) and Women: Greater than 140 mg/dL (1.4 g/L). In this study, the Apo A-l has been increased from 1.05 g/L to 1.59 g/L in group 2 whereas in placebo group there was no change. That is an increase of 51% in Apo A-l after 90 days of treatment with EODAG formulation 250mg capsule twice daily. In group 1, Apo Al increase was 37% after 90 days treatment.

[0l30]Apolipoprotein B (Apo B) is an important component of many lipoproteins that are involved in atherosclerosis and cardiovascular disease. Usually, 85-90 percent of Apo B represents LDL particles. The reference range of Apo B levels in adults is less than 130 mg/dL (1.3 g/L). In this study, the Apo B has been reduced from 1.62 g/L to 1.01 g/L in group 2 whereas in placebo group there was no change. In group 1, Apo B decrease was from 1.6 g/L to 1.17 g/L after 90 days treatment. There was a decrease of 27% in Apo B level in group 1 whereas decrease in group 2 was about 38%.

[0l3l]Ratio of the apoB/apoAl is more effective at predicting heart attack risk, than either the apo B or apoAl measure alone. The normal values are 0.5 to 1.0. In this study, the ratio of Apo B to Apo A-l has been decreased from 1.54 g/L to 0.63 g/L in group 2 whereas in placebo group there was no change. That is ratio of Apo B to Apo A-l was decreased by 59% in group 2 whereas the decrease was only 2% in placebo group. In group 1, ratio of Apo B to Apo A-l was decreased by 47%.

[0l32]From the results it was observed that there was a decrease of 56% hs-CRP value of group 2 whereas in group 1, hs-CRP was decreased by 31%.

[Ol33]Homocysteine is an amino acid and breakdown product of protein metabolism that, when present in high concentrations, has been linked to an increased risk of heart attacks and strokes. Homocysteine levels are typically higher in men than women, and increase with age. Common levels are in range of 10-15 pmol/L in plasma. In our study, the homocysteine level has been reduced from 27 to 13 pmol/L in group 2 whereas in placebo group, there was no change as compared to baseline value. That is 90 days treatment with EODAG formulation (250mg twice daily) decreased the homocysteine level 52% when compared with baseline value whereas in placebo group the reduction was only about 2%. In group 1 daily intake of 250mg capsule of EODAG formulation for 90 days decreases the homocysteine level by 39%. This indicates the benefits of Emblica officinalis DAG formulation in managing cardiovascular health and preventing the risk of stroke, heart attack and other related risks.

[0l34]HbAlc is a measure of the beta-N-l-deoxy fructosyl component of hemoglobin. Normal levels of glucose produce a normal amount of glycated hemoglobin. Excessive formation of early glycation products may adversely affect several functions of blood vessels, lipid metabolism and prone to develop diabetic complications. HbAlc level below 5.7% is considered normal whereas between 5.7 and 6.4% signals pre-diabetes. In our study, the level of HbAlc was reduced from 6.8% to 5.2% in group 2 whereas in placebo group, there was no change in HbAlc level. In case of glycosylated Hb the reduction was 24% in group 2 whereas there was no change in placebo group when compared with the baseline value. In group 1 daily intake of 250mg capsule of EODAG formulation for 90 days decreases the glycosylated Hb by 18%. This indicates the benefits of Emblica officinalis DAG formulation in managing the blood sugar level and preventing diabetes.

[0l35]Thyroid function regulates a wide array of metabolic parameters. Thyroid function significantly affects lipoprotein metabolism as well as some cardiovascular disease (CVD) risk factors, thus influencing overall CVD risk. Thyroid hormones induce the 3-hydroxy-3- methylglutaryl-coenzyme A (HMG-CoA) reductase, which is the first step in cholesterol biosynthesis. Normal TSH level ranges from 0.4 to 4 pIU/ml. In our study, EODAG formulation administration increased the TSH level from 2.21 to 3.35, thus increasing the lipoprotein lipase which reflects in decreasing the TGs. In placebo group there was slight decrease in TSH level. Increase in the TSH level was 52% in group 2 whereas TSH level of placebo group was decreased by 4%. In group 1 daily intake of 250mg capsule of EODAG formulation for 90 days increases the TSH level by 43%.

[0l36]Coenzyme Q10 is the coenzyme for mitochondrial enzyme complexes involved in oxidative phosphorylation in the production of ATP. A deficiency of CoQlO in the blood and the heart muscle has been documented in congestive heart failure. Primary and secondary deficiencies of CoQlO result in a number of neurologic and myopathic syndromes. HMG- CoA reductase (3 -hydroxy-3 -methyl-glutaryl-coenzyme A reductase) is the rate-controlling enzyme of the mevalonate pathway, the metabolic pathway that produces cholesterol and other isoprenoids. Normally in mammalian cells this enzyme is suppressed by cholesterol derived from the internalization and degradation of low density lipoprotein (LDL) via the LDL receptor as well as oxidized species of cholesterol. In this study, highly significant reduction in HMGCoA reductase enzyme by group 2 explains its mechanism of decreasing blood cholesterol and management of cardio vascular health. At the same time, no change in CoQlO level puts an advantage of EODAG formulation over statin therapy and makes it better choice than statins for treatment of dyslipidaemia.

[0l37]Decrease in HMGCoA reductase activity was 22% in group 2 and at the same time there was no change in CoQlO level. There was no change in HMGCoA reductase activity and CoQlO level in placebo group after 90 days of treatment. Decrease in HMGCoA reductase activity was 11% in group 1 and at the same time there was no change in CoQlO level.

[0138] Table 3: Fasting Plasma Glucose (FPG) mg/dl of subjects treated with different doses of Emblica officinalis DAG formulation and Placebo.

[0l39]Fasting plasma glucose (FPG) was decreased by 10% after 90 days of treatment with EODAG formulation (250 mg capsule twice daily) whereas there was an increase of 10% in FPG of placebo group compared to baseline value. In group 1, Fasting plasma glucose (FPG) was decreased by 7%.

[0l40]Table 4: Visceral fat, BMI and total body fat of subjects treated with different doses of Emblica officinalis DAG formulation.

[0l4l]90 days treatment with group 2 decreased the visceral fat 64% when compared with baseline value whereas in placebo group the reduction was only 5%. 90 days treatment with group 1 decreased the visceral fat by 33%. In case of total body fat the reduction was 62% in group 2 whereas in placebo group, there was no change in total body fat. Reduction in body fat was 35% in group 1. Decrease in BMI was 38% in group 2 whereas in placebo the decrease in BMI was 3% only. Group 1 showed 17% decrease in BMI.This indicates the benefits of Emblica officinalis DAG formulation in reducing visceral fat, body fat and body mass index.

[0142] Table 5: Full body subcutaneous fat, hand subcutaneous fat, trunk subcutaneous fat and leg subcutaneous fat of subjects treated with different doses of Emblica officinalis DAG formulation.

[0143] 90 days treatment with group 2 decreased the full body subcutaneous fat by 60% when compared with baseline value and in group 1, 42% reduction in full body subcutaneous fat . 90 days treatment with group 1 decreased the Hand subcutaneous fat by 35% whereas in group 2 Hand subcutaneous fat decreased by 51%. In case of trunk subcutaneous fat, the reduction was 54% in group 2 whereas in group 1, trunk subcutaneous fat decreased by 39%. Reduction in Leg subcutaneous fat was decreased by 38% in group 1 and in group 2 it was 54%. This indicates the benefits of Emblica officinalis DAG formulation in reducing full body, hand, trunk and leg subcutaneous fat.

Claims

laim:

1. A medicinal composition derived from the fruit of Emblica officinalis comprises of Diacylglycerol form of Alpha-linolenic acid and Triacylglycerol form of ALA in the range of ratio of 1:3 to 95:1.

2. The medicinal composition as claimed in claim 1, wherein Diacylglycerol form of Alpha-linolenic acid and Triacylglycerol form of ALA in the range ratio of 4:1 to 15:1.

3. The medicinal composition as claimed in claim land 2, wherein Diacylglycerol form of Alpha-linolenic acid ranges from 1% to 95%.

4. The medicinal composition as claimed in claim 3, wherein Diacylglycerol form of Alpha-linolenic acid is at least 2%.

5. The medicinal composition as claimed in claim land 2, wherein antioxidant is added along with the composition.

6. The medicinal composition as claimed in claim 5, wherein said antioxidant is selected from beta-carotene, lycopene, vitamin C, vitamin A, vitamin E, alpha lipoic acid, astaxanthin, Acai Berries, bilberry, blueberries, Co Q-10, curcumin, cysteine, ginkobiloba, glutathione, grape seed extract, green tea extract, turmeric, hydrogen peroxide, mangosteen, melatonin, oligomeric proanthocyanidins, olive leaf, polycosanol, pychnogenol, resveritrol, selenium, superoxide dismutase and combinations thereof.

7. The medicinal composition as claimed in claim 1 to 6, wherein one or more plant oil with or without antioxidant is added along with said composition so that range of ratio of composition to plant oil is maintained between 1:10 to 10:1.

8. The medicinal composition as claimed in claim 7, wherein plant oil is selected from turmeric oil, coconut oil, safflower oil, sun flower oil, soya oil, olive oil, ground nut oil, and sesame oil, flaxseed oil, peanut oil and combinations thereof.

9. The medicinal composition as claimed in claim 1 to 8, wherein one or more Polyphenol is added along with said composition so that range of ratio of composition to Polyphenol is maintained between 1:90 to 90:1.

10. The medicinal composition as claimed in claim 9, wherein the more preferable range of ratio of composition to polyphenol is 2:3 to 3:2.

11. The medicinal composition as claimed in claim 9 wherein Polyphenol blend is derived from Emblica officnalis, Green tea, Green coffee, Pomegranate, Grape seeds, Turmeric and combinations thereof and said polyphenol blend is standardized to 1% to 99% of polyphenol.

12. The medicinal composition as claimed in claim 1 to 9, wherein one or more bioactive components are added along with said composition so that range of ratio of composition to bioactive component is maintained between 1:90 to 90:1.

13. The medicinal composition as claimed in claim 12 wherein bioactives are bioavailable turmeric formulation, water dispersible bioavailable turmeric formulation, waterdispersible curcumin formulationand combinations thereof.

14. The medicinal composition as claimed in claim 1 to 13, wherein said composition is blended with other ingredients selected from fillers, disintegrant, diluents, binders, a carrier, adsorbents, emulsifiers, lubricants, stabilizing agents, anti-adherents, glidants, antioxidants and mixtures thereof when it is made into dosage form for administering to mammals especially human beings.

15. The medicinal composition as claimed in claim 1 to 13, wherein it is made into dosage forms selected from soft gelatin capsule, hard gelatin capsule, tablet, granule, sachet, powder, paste, ointment, infusion, injection, ampoule, solution, suspension, emulsion, pills, oil, and cream.

16. The medicinal composition as claimed in claim 15, wherein the effective dosage form of the extract of Emblica Officinalis with 1% to 95% purity Diacylglycerol form of Alpha-linolenic acid is 1 mg to 500 mg to a human subject.

17. The medicinal composition as claimed in claim 16 to be used for: a) treatment of dyslipidaemia,

b) reducing visceral fat,

c) decreasing the total cholesterol level,

d) decreasing triglyceride level,

e) decreasing total body fat, f) decreasing body mass index

g) decreasing atherogenic index of plasma,

h) decreasing ratio of Apo B to Apo Al,

i) lowering homocysteine level,

j) lowering glycosylated haemoglobin level,

k) modulating Thyroid stimulating hormone levels,

l) lowering HMGCoA reductase,

m) lowering total cholesterol without altering CoQlO level, and

n) reducing full body, hand, trunk and leg subcutaneous fat in mammals in need thereof.

18. A method of preparation of medicinal composition derived from the fruit of Emblica officinalis comprising the steps of: a) cleaning the fresh fruits of Emblica Officinalis followed by pulverizing;

b) extracting with 95% methanol to obtain a residue and a supernatant;

c) concentrating the resultant supernatant in to concentrated methanol extract;

d) drying the concentrated methanol extract to obtain a powder of methanol extract of Emblica Officinalis,

e) dispersing the powder of methanol extract of Emblica Officinalis in water to obtain a dispersion;

f) extracting said dispersion with hexane in a liquid-liquid extractor to obtain a hexane and a water phase and collecting both the phases separately;

g) concentrating the hexane phase to strip out all the solvent and to obtain a liquid form of a concentrated hexane extract;

h) purifying the concentrated hexane extract by transferring the concentrated hexane extract in to the samplet of the cartridge in a flash chromatograph;

i) eluting the loaded sample with chloroform in hexane followed by a gradient elution up to 50% chloroform;

j) collecting the different fractions; and

k) concentrating the column eluted with 20-30% chloroform in hexane to form purified Emblica Officinalis extract.

19. The method of preparation of medicinal composition as claimed in claim 18, wherein resultant purified Emblica Officinalis extract is further purified by column chromatography to get a purified composition of diacyl glyceride form of alpha linolenic acid derived from Emblica Officinalis.

20. The method of preparation of medicinal composition as claimed in claim 18, wherein Diacylglycerol form of Alpha-linolenic of Emblica Officinalis is derived by extracting Emblica Officinalis plant parts by using solvents selected from methanol, ethanol, isopropanol, n-butanol, methyl acetate, ethyl acetate, propyl acetate, n-butyl acetate and combinations thereof.