FIELD OF INVENTION;
The present invention relates to the field of Withania Somnifera (Ashwagandha) extraction process. More specifically the present invention describes a simplified process and method for obtaining Withania somnifera extract with a defined composition comprising of withanolides and alkaloids as the primary constituents.
BACKGROUND AND PRIOR ART:
The plant Withania Somnifera Dunn. (Solanacaea), commonly known as Ashwagandha , has been used in herbal formulations of the Ayurvedic or Indian system of medicine to attenuate a cerebral function deficit in the geriatric population, and to augment the faculty of learning and memory to provide a nonspecific host defense. These beneficial effects help the organism to ward off stress and act as an adaptogen. Ashwagandha also shows significant protection against pentylene tetrazole induced seizures in experimental models of epilepsy, indicating its potential utility for treatment of petitmal epilepsy. Ashwagandha administration also produces a decrease in the core body temperature suggesting a reduced Body Metabolic Rate (BMR). enhanced body growth and increased longevity.
While Ashwagandha has been used for thousands of years in ayurvedic healing, until relatively recently western medical science was unsure how ashwagandha root achieved such success. Now. science has isolated several active constituents that are responsible for Withania somnifera's medicinal properties. So far, 12 alkaloids and 35 steroidal lactones have been isolated in the ashwagandha root.
Typically, commercially available extracts of Ashwagandha obtained from old roots stock are either completely devoid of sitoindosides, or contain only traces of sitoindosides admixed with large amounts of toxic metabolites of withanolide aglycones. and polysaccharides, and wherein the polyoxygenated withasteroids are degraded during conventional extract procedures.
US Patent No. 7318938 and US Patent No. 6.713.092 describes the composition of a high purity extract of the plant Withania Somnifera and an extraction process for obtaining such composition, as well as pharmaceutical, nutritional and
personal care use products thereof. The composition was obtained by extracting


the roots and leaves of a Withania Somnifera plant with an aqueous-alcoholic solvent in the presence of an exogenous saccharide, followed by concentrating the extract under vacuum, treating the residue with an apolar organic solvent to remove free withanolide A aglycones therefrom, vacuum drying the insoluble residue to provide a dry solid, and pulverizing the solid to a powder. The extract from the root and leaf stock of Withania Somnifera plant was obtained at about, 60.degree. C. with an aqueous-alcoholic solvent, such as water and methanol, ethanol or isopropyl alcohol, in a suitable ratio, e.g. 1:9, preferably with about 0.1-20% of an additive or exogenous saccharide such as dextrin, cane sugar, the plants oligosaccharide, .beta.-cyclodextrin. and the like, to convert the conjugation of free withananolides in the leaves into desirable bioactive withanolide glycoside: and to enhance the stability of the extract; (c) concentrating the extract under vacuum, (d) treating the residue with an aprotic organic solvent, e.g. chloroform, ethyl acetate, etc. to remove withanolide aglycones therefrom, (e) vacuum drying the insoluble residue below about 60.degree. C. or spray drying, to provide a dry solid, and (f) pulverizing the solid. under controlled temperature and humidity conditions. This method uses aprotic solvent which is not there in the present invention.
US Patent No. 6.866.872 relates to a composition comprising of Withania somnifera extract. The extract of Withania somnifera can be obtained by treating fragments of the root, leaf or whole plant of Withania somnifera with a suitable extractant. such as water (hot water) or an alcohol, and subjecting the extract to concentration, optionally to dryness. This extract is preferably one containing not less than 1.0 weight % of alkaloids and not less than 1.0 weight % of withanolides.
US Patent No. 6.153,198 provides a high purity Withania somnifera extract composition in the form of a high purity, stable, free-flowing, light yellow-to-brown herbaceous powder. The process for obtaining the extract comprises of extracting the root stock of Withania somnifera plant which is about 1-2 years old with an aqueous-alcoholic solvent, (c) concentrating the extract under vacuum, (d) treating the residue with an apolar organic solvent to remove free withanolide A aglycones therefrom, (e) vacuum drying the insoluble residue of such treatment below about 60.degree. ( . to provide a dry solid, and (0 pulverizing the solid

under controlled temperature and humidity conditions, to obtain the desired powder product.
Thus in view of the above prior art, this invention disclosure provides an improved process and method for obtaining Withania Somnifera extract. The method eliminates the use of hazardous aprotic solvent in the extraction process and reduces the time duration of the extraction process.
Table 1: Comparison between present invention and US Patent 7318938
(Table Removed)
OBJECTS OF THE INVENTION:
The principal object of the present" invention is to provide a simplified, economical method with reduced process time for obtaining Withania somnifera extract from the root stock of the plant.
Another object of the invention is to obtain a standardized extract of Withania somnifera.
Yet another object of the present invention is to eliminate the use of aprotic solvents in the extraction process.
Still another object of the invention is to obtain a Withania somnifera standardized extract with withanoioida and alkaloids as the defined constituents of the extract.
Another object of the present invention is to use the standardized extract of Withania somnifera for pharmaceutical applications.
SUMMARY:
Accordingly the present invention provides The present invention provides a process and a method for obtaining a standardized extract of Withania .somnifera (Ashwagandha). The extract is obtained from the root of the plant. The Withania somnifera extract comprises of withanoioida and alkaloids as the primary constituents. The extraction is by primary alcohol with water. The solvent mixture is filtered and concentrated to remove the solvent. The aqueous phase is concentrated under vacuum. Exogenous polysaccharide which may include maltodextrin is added to the concentrated aqueous phase. The mixture is then dried under vacuum to get the Withania somnifera extract in a powdered form. The standardized extracted from roots, is an as an adaptogenic. The extract is used in epilepsy and produces a decrease in the core body temperature suggesting a reduced Body Metabolic Rate (BMR), enhanced body growth and increased longevity.
In a preferred embodiment of the present invention, a process and a method is provided to obtain a standardized extract of Withania somnifera having not less

than 1.5% withanoloids and not less than 1.0% alkaloids, wherein the process comprises
a. drying the roots of Withania somnifera in dark;
b. extracting the dried roots of step a. with solvent, repeat the steps n times:
c. filtering the extract of step b. and distilling the solvent;
d. mixing of excipient after step c. to form a thick syrup;
e. heating of thick syrup of step d. to dry it;
f. grinding of dried form of step e. to obtain powder.
In another embodiment of the invention an extraction process wherein the
amount of solvent used for extraction is four times of the starting material and
further the said extraction is carried out not more than four times.
In yet another embodiment of the invention an extraction process wherein the
solvent used for extraction is a mixture of alcohol and water, the said alcohol
selected from the group comprising low molecular alcohol such as methanol,
ethanol, propanol.
In still another embodiment of the invention, an extraction process wherein
the temperature for the extraction step is ranging from 45 to 65 ° C.
In another embodiment of the present invention, an extraction process
wherein the temperature for the distillation of alcoholic extract is ranging from
40 to 55° C.
In yet another embodiment of the present invention, an extraction process
wherein the said exicipent added to the extract is selected from the group
comprising of maltodextrin. starch and further the mixture of exicipent and
extract is stirred, vacuum dried at a temperature ranging from 55 to 70°C
temperature for a duration of 6 to 9 hours.
In still another embodiment of the invention, the extract of Withania
somnifera is obtained from the root stock of the plant.
In another embodiment of the present invention, the use of aprotic solvent is
eliminated from the extraction process.
In yet another embodiment of the invention, the solvent mixture obtained
from the extraction of root stock of Withania somnifera is filtered and
concentrated under vacuum.
In still another embodiment of the invention, the standardized Withania
somnifera extract is obtained in a powder form.
In another embodiment of the invention, the standardized extract of Withania

somnifera is with a defined composition comprising total withanoloida not less
than 1.5% and alkaloids not less than 1.0%.
In yet another embodiment of the present invention, the standardized
Withania somnifera extract is used for pharmaceutical applications
In still another embodiment of the invention, the standardized Withania
somnifera extract is used as adaptogenic
In another embodiment of the invention, the standardized Withania somnifera
extract is used, in epilepsy.
In yet another embodiment of the invention, the standardized Withania
somnifera extract produces a decrease in the core body temperature causing
reduced Body Metabolic Rate (BMR), enhanced body growth and increased
longevity.
BRIEF DESCRIPTION OF TABLES:
It is to be noted, however, that the appended drawings and tables illustrate only
typical embodiments of this invention and are therefore not to be considered for
limiting of its scope, for the invention may admit to other equally effective
embodiments.
Table I showing comparison between present invention and US Patent 7318938
DETAILED DESCRIPTION OF THE INVENTION:
The present invention provides a process and a method for obtaining a standardized extract of Withania somnifera (Ashwagandha). The extract is obtained from the root of the plant. The Withania somnifera extract comprises of withanoloida and alkaloids as the primary constituents. The extraction is by primary alcohol with water. The solvent mixture is filtered and concentrated to remove the solvent. The aqueous phase is concentrated under vacuum. Exogenous polysaccharide which includes maltodextrin that is added to the concentrated aqueous phase. The mixture is then dried under vacuum to get the Withania somnifera extract in a powdered form. The standardized extracted from roots, is useful an as an adaptogenic. The extract is used in epilepsy and produces a decrease in the core body temperature suggesting a reduced Body Metabolic Rate (BMR). enhanced body growth and increased longevity.

The present invention discloses a method for the production of Withania somnifera (Ashwagandha) extract from Withania somnifera roots, having not less than 1.5% withanoloids and not less than 1.0% alkaloids. The purity was deciphered by gravimetric method.
The plant Withania Somnifera Dunn (Solanacaea), commonly known as Ashwagandha , has been used in herbal formulations of the Ayurvedic or Indian system of medicine to attenuate a cerebral function deficit in the geriatric population, and to augment the faculty of learning and memory to provide a non-specific host defense.
The plant was obtained for the present invention from the Amity herbal garden, Manesar. Haryana . India.
In the present invention method dry roots of the W. somnifera at room temperature to the exclusion of light, extracted with the a combination of water and low molecular weight primary alcohol at a temperature in the range of 45-65 0°C, with 4 times solvent (w/v) at each, at thrice. It was established that following aforesaid operating parameters after third extraction the herb completely exhaust for the desired ingredients.
Filter the extract and mix. Then distill the filtrate at a temperature in the range of 40-55° C under vacuum, till foaming appears. The aqueous syrup was mixed with, excipient like maltodextrin with stirring and vacuum dried at 55-70°C temperature for 6-9 hours, grounded the dry mass and sieve with 40 mesh, packed in nitrogen atmosphere. It has total withanoloida not less than 1.5% and alkaloids not less than 1.0% .
Method: Estimation of withanoloids; Accurately weighted amount was added in 30 times volume of methanol and refluxed for three hours, filter and repeat the process at twice again. Mixed all the filtrate, distill-out the methanol till syrup. The syrup was transferred into 4 times volume of diethyl ether, with stirring. Allow to cool at I0°C, decant the solvent, dry the ppt. at 65°C under vacuum for 4 hours. Weigh it and calculate the percentage purity of withanoloids in the extract. Estimation of Alkaloids; Accurately weighted amount was dissolved in lOtimes volumes of water and extracted with chloroform (half volume of total solution, at once), at thrice. Chloroform phase was passed through NaiSOa column, rinsed the column. Distill-out the chloroform and ppt. was vacuum

dried at 60°C for 4 hours. Calculate the percentage for total alkaloids, when analysed gravimetrically.
The invention is described in detail with reference to the example given below. The example is provided just to illustrate the invention and therefore, should not be construed to limit the scope of the invention. EXAMPLE!:
1 .Okg dried roots of W. somnifera was extracted with 4.0L solvent having 1.20L water with primary alcohol especially ethanol. at 45°Cfor three hours, with stirring. Filter the solvent and repeat the cycle at twice under similar conditions. Collect all the extract together and distill-out the solvent under vacuum at 50°C till the total volume is 300ml. Mix on it l00gm of maltodextrin and dry the thick syrup at 70°C for 8 hours. Grind it, sieve through40 mesh and pack under nitrogen atmosphere. Free flowing powder, 203 gm, on analysis have 1.79 % withanoloids and 1.25% alkaloids.
Estimation of withanoloids; 10.2314gm extract was added with 300ml methanol and refluxed for three hours, filter and repeat the process at twice again. Mixed all the filtrate, distill-out the methanol till volume 30ml. This syrup was transferred into 120ml of diethyl ether, with stirring. Allow to cool at I0°C. decant the solvent, dry the ppt. at 65°C under vacuum for 4 hours and calculate for total withanoloida.
Estimation of Alkaloids; 5.01651 gm extract was dissolved in 50ml of water and extracted with 25ml chloroform, at each, at thrice. Chloroform phase was passed through Na2SO4 column, rinsed the column. Distill-out the chloroform and ppt. was vacuum dried at 60°C for 4 hours. Calculate the percentage for total alkaloids. EXAMPLE 2:
1.0kg dried roots of W. somnifera was extracted with 4.0L solvent having 1.20L water with primary alcohol especially ethanol, at 55°Cfor three hours, with stirring. Filter the solvent and repeat the cycle at twice under similar conditions. Collect all the extract together and distill-out the solvent under vacuum at 65°C till the total volume is 300ml. Mix on it lOOgm of maltodextrin and dry the thick syrup at 70°C for 8 hours. Grind it. sieve through40 mesh and pack under nitrogen atmosphere. Free flowing powder. 203.6 gm. on analysis have 1.66 % withanoloids and 1.24% alkaloids.

Estimation of withanoloids: 10.0304gm extract was added with 300ml methanol and refluxed for three hours, filter and repeat the process at twice again. Mixed all the filtrate, distill-out the methanol till volume 30ml. This syrup was transferred into 120ml of diethyl ether, with stirring. Allow to cool at 10°C, decant the solvent, dry the ppt. at 65°C under vacuum for 4 hours and calculate for total withanoloida.
Estimation of Alkaloids; 5.003 lgm extract was dissolved in 50ml of water and extracted with 25ml chloroform, at each, at thrice. Chloroform phase was passed through Na2SO4 column, rinsed the column. Distill-out the chloroform and ppt, was vacuum dried at 60°C for 4 hours. Calculate the percentage for total alkaloids.
EXAMPLE 3:
2.0kg dried roots of W. sonmifera was extracted with 8..0L solvent having 2.40L water with primary alcohol especially ethanol, at 50°Cfor three hours, with stirring. Filter the solvent and repeat the cycle at twice under similar conditions. Collect all the extract together and distillrout the solvent under vacuum at 70°C till the total volume is 600ml. Mix on it 200gm of maltodextrin and dry the thick syrup at 70°C for 8 hours. Grind it. sieve through40 mesh and pack under nitrogen atmosphere. Free flowing powder, 405.14 gm, on analysis have 1.66 % withanoloids and 1.24% alkaloids.
Estimation of withanoloids; I0.0034gm extract was added with 300ml methanol and retluxed for three hours, filter and repeat the process at twice again. Mixed all the filtrate, distill-out the methanol till volume 30ml. This syrup was transferred into 120ml of diethyl ether, with stirring. Allow to cool at 10°C, decant the solvent, dry the ppt. at 65°C under vacuum for 4 hours and calculate for total withanoloida.
Estimation of Alkaloids; 5.090 lgm extract was dissolved in 50ml of water and extracted with 25ml chloroform, at each, at thrice. Chloroform phase was passed through Na2SO4 column, rinsed the column. Distill-out the chloroform and ppt. was yacuum dried at 60°C for 4 hours. Calculate the percentage for total alkaloids. EXAMPLE 4:
2.0kg dried roots of W somnifera was extracted with 8.0L solvent having 2.40L water with primary alcohol especially ethanol. at 60°Cfor three hours.

with stirring. Filter the solvent and repeat the cycle at twice under similar conditions. Collect all the extract together and distill-out the solvent under vacuum at 65°C till the total volume is 600ml. Mix on it 200gm of maltodextrin and dry the thick syrup at 70°C for 8 hours. Grind it, sieve through 40 mesh and pack under nitrogen atmosphere. Free flowing powder, 405.68 gm, on analysis have 1.63 % withanoloids and 1.21% alkaloids.
Estimation of withanoloids; 10.0800gm extract was added with 300ml methanol and refluxed for three hours, filter and repeat the process at twice again. Mixed all the filtrate, distill-out the methanol till volume 30ml. This syrup was transferred into 120ml of diethyl ether, with stirring. Allow to cool at I0°C. decant the solvent, dry the ppt. at 65°C under vacuum for 4 hours and calculate for total withanoloida.
Estimation of Alkaloids; 5.0101 gm extract was dissolved in 50ml of water and extracted with 25ml chloroform, at each, at thrice. Chloroform phase was passed through.Na2SO4 column, rinsed the column. Distill-out the chloroform and ppt. was vacuum dried at 60°C for 4 hours. Calculate the percentage for total alkaloids.
Numerous modifications and adaptations of the system of the present invention will be apparent to those skilled in the art, and thus it is intended by the appended claims to cover all such modifications and adaptations which fall within the true spirit and scope of this invention.

WE CLAIM:

1. A extraction process to obtain a standardized extract of Withania
somnifera having not less than 1.5% withanoloids and not less than 1.0%
alkaloids, wherein the process comprises
a. drying the roots of Withania somnifera in dark;
b. extracting the dried roots of step a. with solvent, repeat the steps n
times;
c. filtering the extract of step b. and distilling the solvent;
d. mixing of excipient after step c. to form a thick syrup;
e. heating of thick syrup of step d. to dry it;
f. grinding of dried form of step e. to obtain powder.
2. The extraction process as claimed in claim 1 wherein the amount of solvent used for extraction is four times of the starting material and further the said extraction is carried out not more than four times.
3. The extraction process as claimed in claim 1 wherein the solvent used for extraction is a mixture of alcohol and water, the said alcohol selected from the group comprising low molecular alcohol such as methanol, ethanol, propanol.
4. The extraction process as claimed in claim 1'wherein the temperature for the extraction step is ranging from 45 to 65 ° C.
5. The extraction process as claimed in claim 1 wherein the temperature for the distillation of alcoholic extract is ranging from 40 to 55° C.
6. The extraction process as claimed in claim I wherein the said exicipent added to the extract is selected from the group comprising of maltodextrin. starch and further the mixture of exicipent and extract is stirred, vacuum dried at a temperature ranging from 55 to 70°C temperature for a duration of 6 to 9 hours.
7. A extraction process to obtain a standardized extract of Withania somnifera having not less than 1.5% withanoloids and not less than 1.0% alkaloids substantially as herein described with reference to the figures, tables and examples accompanying this specification.