FIELD OF THE INVENTION
The present invention relates to a cosmetic or dermopharmaceutical comoosition, especially dermatological composition, comprising a hair growth promoting/ stimulating/ enhancing or preventing hair loss agent including an effective amount of selective extract of the plant Hedychium spicatum and a process for the preparation of the extract. Specifically, the invention is directed to the identification of the selective fraction of the extract to possess hair growth characteristics leading to the purification of the said selective fraction of the extract from plant species Hedychium spicatum. The purification of the extract was carried out physico-chemically and evaluated spectrometrically. More specifically, the compositions comprising the selective extract provides simple and cost effective hair care benefiting agents that can be used singly or in association with cosmetically/ dermopharmaceutically acceptable vehicle/ carriers containing additional skin benefiting agents.
BACKGROUND OF THE INVENTION
Human scalp hair has a great sociological importance and forms a vital part of human personality. Hair disorder, especially when severe, often profoundly affects the lives of those afflicted. Hair growth and better hair coverage on the scalp are long felt needs of every human being who suffer from hair fall/ loss problem. The other unmet needs are reduction in hair fall and thinning. Decreased hair growth in length is also another common problem seeking attention.
The hair fall or decrease in hair density could be due to several reasons. Aging, scalp infections, production of excessive sebum, post effect of certain diseases such as typhoid, jaundice, malaria, cardiovascular, smoking, hormonal imbalance, conversion of testosterone to 5-alpha dihydrotestosterone, reduction in anagen hair either due to anagen or telogen effluvium are known to contribute to hair fall/ loss problem. Poor nutrition and other general physiological reasons are also known to contribute to the hair fall/ loss problem. Autoimmune disorders do play a role as in the case of alopecia.
An important approach available for addressing the problem is hair transplantation through surgical method. The natural (autologus in the case of natural) or synthetic hair fibers are weaved into the scalp at equal distances. This treatment is not only

expensive but also requires continuous maintenance therapy. Further, this method does not offer any genuine hair growth or reduce hair fall.
Several attempts have been made to develop/ invent medicaments to address this problem. All the available preparations/ medicaments either increase anagen hair or augment neogenesis of hair follicle or reverse the effluvium status. Among the existing therapeutic agents for hair loss prevention, minoxidil for external application approved by the USA FDA was reported to have, in addition to vasodilation function as the characteristic potassium channel opener thereof, activities to induce the anagen phase from the telogen phase of the hair cycle and continuously maintain the induced anagen phase (British Journal of Dermatology, 2004; 150, 186-194). The hormone-based treatment is also known to have several side effects. Serious safety concern, poor efficacy, individual variability and continuous dependence to the therapy limit the available line of treatment for the above problem.
Also, an oral administration drug, called Finasteride, which inhibits the action of 5-alpha reductase to inhibit the production of dihydrotestosterone as potent male hormone, was approved by the USFDA and is being marketed as a hair growth stimulant. However, the use thereof has been limited, because it is expensive and has been reported to have side effects (Park, W. S. et al., WO 2007/04677 Al)
Some nitrogen containing molecules, like minoxidil and cantharidin are commonly used ingredients in formulations for promoting or stimulating hair growth (Bonte F. et. al., U. S. Patent, 5, 607, 693). Some of these molecules are now showing side effects.
Some hair growth promoters include an active ingredient extracted from plants. For example, extracts from the Orchidaceae species, Bletilla striata, and from plants of the Meliaceae and Lamiaceae families have been proposed to be used as hair growth promoters. (Japanese patent jp 1038012, Japanese patent JP 5155738; and Kobayashi, et al., Yakugaku Zasshi, 1993, 113, 718-724).
The acetone extract of Boehmeria nipononivea has shown both potent 5a-reductase inhibitory activity and hair re-growth promoting activity on mice. Bioactivity guided fractionation led to the isolation of six active fatty acid compounds, linoieic, linoienic, palmitic, elaidic, oleic and stearic acids and these acids showed the much desired 5a-

reductase inhibition where as linoieic, eiaidic and stearic acids exhibited hair re-growth activity (Shimizu. Et. a!., Biosci., Biotech., Biochem., 2000, 64, 875)
In one of the patents, it was disclosed that the essential oil from Alpinia galanga significantly stimulated hair growth of mice by reducing the telogen phase in their hair cycle (Koga, H; Niwano, Y and Kanai, K. JP 2000355525, 2000).
Nishizawa et al., JP 09-157136, is directed to obtain a hair restorer/ hair tonic having hair growth promoting effect comprising tocotrienol of vitamin E family (0.01-10 wt. %), forskolin or a derivative obtained from Coleus forskohlii root extract (0.00001-10 wt. %), and at least one component selected from among fatty acids, alcohols, and derivatives (0.01-20 wt. %) obtained therefrom. Hair from the dorsal side of C3H mouse was depilated and hair-growth was evaluated by applying the above said composition and the control.
Another patent by Nishizawa et al., JP 09-157138, 1997 discloses hair restorer/ hair tonic composition comprising; (a) atleast one kind of fatty acids, alcohols and derivatives therefrom, having odd-numbered carbon chains and (b) forskolin, its derivatives or an extract of a root of Coleus forskohlii.
Further, M. Nomura, US Patent 5,750,107 disclosed a useful composition for promoting hair growth when applied to an area of skin that is afflicted with alopecia. The composition comprises an extract of a plant having a pseudo bulb and is derived from the entire plant or bulb of the plant wherein the plant is of genera selected from Calanthe R. Br. and Phalus Lour.
Therefore, the above said existing state of the art clearly reveals that on one hand there is a need for newer, effective and safe hair growth promoters and on the other there is a need for processes to obtain a selective active extract.
Several prior arts on plant materials are available in alternative systems of medicine like Ayurveda and ethno medicine or folklore that recommend herbal remedies for hair growth / retardation of hair fail.
Recently Semaity et. al., in Indian Drugs, 2008, 45, 689-700, has reviewed the current status of herbal hair growth promoters. However, the claims have not been scientifically validated and even where claims were scientifically evaluated, the plant material / extract were not processed to offer reliable benefit to people.

Lack of selective herbal extracts Is the bane of the herbal personal or health care industry. Herbal extracts are generally mixtures of several compounds from the plant/s. Even when such extracts are obtained from single plant, there is no knowledge of the nature of the active ingredient(s) and of the amount required of the active ingredient in the extract for the product to be effective. Plant ingredients are known to vary depending on the strain of the plant used, the nature of the soil in which the plant grows, the age the plant, the time of the harvest and related factors. Therefore, it is imperative for herbal products to be made selective by some method that quantifies one or more of its ingredients to ensure quality control of the extracts from one plant to another. Such standardization enables one to treat regimens of disorders and deficiencies by prescribing such extracts from the plants based on the quantitative norms. Thus there is an urgent need for reliable herbal remedy for promotion of hair growth / reduction of hair fall through selective extracts from selected herbs.
During the course of our investigation on new hair growth promoters we observed hair growth promotion effect of a selective fraction of the extract from the plant Hedychium spicatum. Hedychlum spicatum (Zingiberaceae), also known as spiked Ginger Lily is employed in the preparation of Abir, a fragrant coloured powder used during the Holi festival. The rhizomes possess strong aromatic odour and bitter camphoraceous smell. The rhizomes of the plant have been used in the preparation of cosmetic powders used for promoting hair growth (The wealth of India, CSIR). However, no information was available on the preparation of an appropriate selective extract of the plant and its efficacy directed towards promoting hair growth or retarding hair fall. The prior arts related to Hedychium spicatum reveals that the cosmetic composition containing this plant extract regulates the firmness, tone or structure of skin, or regulate wrinkles (Martin K M. et. al., PCT Int. Appl. WO 02 56, 859, 2002). The compositions containing extract of Hedychium spicatum are useful for treating Tinea infections by topical applications (Chauhan V. S. et. al., PCT Int. Appl. WO20O6/082481 Al). The ethanolic extract of rhizomes of H. spicatum possessed anti-inflammatory and analgesic activity. The anti-inflammatory activity was found in the hexane fraction and the compound hedychienone was found responsible for such activity (Srimat, R. C. and Tandon, J. S, Indian J. Pharmacol, 1984, 16, 143-147). The cinnamic acid ester, obtained from the extracts of H. spicatum and Alpinia galanga has been patented for natural sunscreen property

(Mitra, S. K et. al., USP 2005 175, 557; 2005). The essential oil extracted from the rhizomes of H. spicatum was evaluated for in-vitro pediculicidal activity at 5, 25 and 1% level. At all the three concentrations, the essential oil showed more significant activity than 1% permethrin based product (Varsha J. et.al., Fitoterapia, 2007, 78, 470-473).
It is clearly apparent from the above existing state of the art and subsequent discussions that although several efficacious hair growth promoters are reported, there has been a continuing need in the art to provide for alternatives /superior hair care agent which would promote activation of the hair root, facilitate growth and strengthen hair and are safe to apply on the skin.
OBJECTS OF THE INVENTION:
It is thus the basic object of the present invention is to provide for a selective extract of a plant material for hair growth promotion or enhancement or stimulation or preventing hair loss that would be safe and compatible as a hair care active agent.
Yet another object of the present invention is directed to a hair growth promoting formulation including cosmetic or dermatological composition containing the said selective extract in an effective amount along with an acceptable vehicle with or without hair care benefiting agent that would promote hair growth thereby catering to the needs of various people.
Yet another object of the present invention is directed to a hair growth promoting agent comprising of the selective fraction of the extract and /or formulations thereof that can be sourced simply and cost-effectively for variety of hair care applications/ formulations and the like.
A further object of the present invention is directed to a method of purification or processing of the extract from a plant source having hair care benefiting action and to the processes of extraction of selective hair care actives from such plant sources especially directed to favour hair growth promoting / enhancing/ stimulating benefit or prevention of hair fall/ loss.

Another object of the present Invention is directed to a selective extraction process by using silica gel in the presence of a preferred solvent in order to improve upon the concentration of one of the ingredients present in the extract.
Yet a further object of the present invention is to provide for an Improved process to enhance the concentration of one of the Ingredients of the extract by treating the above extract with an absorption material such as silica gel wherein the absorption material may be present In the root powder during extraction or may be treated with before or after concentration of the extract, dry charging on the absorbent and elutlng the same with hexane to obtain an enriched extract with the desired ingredient.
A still further object of the present invention is directed to hair care formulations comprising hair growth compositions involving selective extracts/ actives from safe plant sources that would have good hair and/ or sikn compatibility.
SUMMARY OF THE INVENTION
Tfius according to the basic aspect of the invention there Is provided a hair growth promoting or enhancing or stimulating or preventing hair loss composition comprising a selective fraction of the herbal extract in an effective amount prepared from the plant, Hedychium spicatum.
In accordance with a preferred aspect of the invention there is provided hair growth promoting or enhancing or stimulating or preventing hair loss composition wherein the selective fraction of the extract comprise extracts Identified for purification showing a spot at Rf 0.84 In thin layer chromatography using pre-coated silica gel plates with hexane as the mobile phase that comprises of at least two ingredients; one of which has a mass spectrometric M+ value of m/z 212 mass units and is present to an extent of not less than 20 % of the two Identified peak areas of GC elutlng at Rt of 9.69 minutes and the other Ingredient which has a mass spectrometrjc M"^ value of m/z 206 mass units and is present to an extent of not more than 80% of the two Identified peak areas of the GC eluting at Rt of 23.46 minutes.
It is important to clarify herein that the selective finding of the present Invention is instilled in the identification of the above said selective fraction of the extract from

the plant Hedychium spicatum in a particular solvent media revealing hair growth promoting / enhancing / stimulating or preventing hair loss characteristics.
According to yet a preferred aspect of the invention there is provided a hair growth promoting or enhancing or stimulating or preventing hair loss composition wherein the said selective fraction of the extract comprise further purified or processed extract wherein the purity of one of its ingredients is increased beyond 80 % having mass spectrometric M* value of m/z 212 mass units and eluting in GC with Rt at 9.69 minutes.
Interestingly, the above said process of purification to improve upon the concentration of one of the ingredients of the extract was conducted in the presence of an adsorption material comprising silica gel In the root powder during extraction. The purification process may also be conducted by treating the extract with the said adsorption material prior to concentration or after the concentration, dry charging on the adsorbent and eluting the same with hexane to obtain the above said enriched extract.
According to a another aspect of the invention there is provided a hair growth promoting or enhancing or stimulating or preventing hair loss composition wherein the selective fraction of the herbal extract comprise purified or processed extract on the basis of its hair growth promoting activity as measured by the reduction of time required for hair growth by a value of not less than 10 % growth over a base value, and on the basis of its constituents.
According to a preferred aspect there is provided a hair growth promoting or enhancing or stimulating or preventing hair loss composition wherein the said selective fraction of the extract Is derived from appropriate plant Ex. Hedychium spicatum.
In accordance with yet another aspect of the invention there is provided a dermopharmaceutical / cosmetic composition for topical use comprising an effective amount of the purified selective fraction of the extract from appropriate plant Hedychium spicatum
and a cosmetically acceptable vehicle with or without other skin/ hair care benefiting agents.

In accordance with a further aspect of the invention there is provided a dermopharmaceuticai/ cosmetic composition for topical use comprising an effective amount of the purified selective fraction of the extract as hair growth promoting agent derived from appropriate plant including extract/ concentrate of rhizomes/ roots in preferably fow polar solvents and most preferably (ow boiling non-polar solvents such as hexane
and a cosmetically acceptable vehicle with or without other skin/ hair care benefiting agents.
According to a preferred aspect the dermopharmaceutical/ cosmetic composition for topical use comprises:
a) 0.0001 wt. % to 20 wt. %, preferably 0.001 wt. % to 10 wt. % and more
preferably 0.01 wt. % to 5 wt. % of the said hair growth promoting agent
and
b) a cosmetically acceptable vehicle with or without other skin/ hair care benefiting
agents.
According to yet a further aspect of the invention a dermopharmaceutical/ cosmetic composition is provided comprising a cosmetic composition for topical use in the form of products preferably creams, ointments, emulsions, gels, lotions, oils, sticks, sprays, packs, wraps, woven or non-woven wipes, films or patches as a vehicle of the said hair growth composition.
In accordance with yet another aspect of the invention there is provided a dermopharmaceutical/ cosmetic composition wherein the said hair growth promoting selective fraction comprises selectively any one or more of ingredients having mass spectrometric M* m/z value of 212 mass units and retention time (Rt) at 9.69 minutes in GC.
According to yet another aspect of the invention a dermopharmaceutical /cosmetic composition is provided wherein the said hair growth promoting agent comprises selectively any one or more of (a) selective fraction of the herbal extract/ concentrate in an effective amount in appropriate solvent; (b) a purified and

processed selective fraction extract/ concentrate in an effective amount in appropriate solvent; and (c) extract/ concentrate of the natural source materia) itself in an effective amount extracted by an appropriate solvent in the presence of an adsorption material such as silica gel.
The details of the invention, its objects and advantages are explained hereunder in greater detail in relation to non-iimiting exemplary illustrations as per the following exemplary illustrations:
DETAILED DESCRIPTION OF THE INVENTION
As discussed herein before, the present invention provides for a selective active fraction of the extract from the plant Hedychium spicatum acting as hair care agent and, in particular, hair growth promoting or enhancing or stimulating agent in a cosmetic and dermatological composition for topical use.
The invention is further directed to a process for producing the said selective combination of hair care/ growth promoting actives with or without other carriers/ hair care additives involving the selective fraction of the extract from rhizomes of Hedychium spicatum and to processes for producing and using the said compositions to achieve hair growth promoting or enhancing or stimulating effect.
Based on the above discussed facts, it is a selective finding of the present invention to provide for a selective fraction of the extract in a preferable solvent from Hedychium spicatum which can be further purified or processed to generate the selective active extract included in the cosmetic compositions of the invention. The process for purifying the said selective fraction of the extract from Hedychium spicatum of the invention comprises their extraction from rhizomes, in air-dried form, using appropriate solvents, foDowed by concentration and anaiyzing the extract mentioned in the invention according to procedures generally known to those skilled in the art.
The present invention is directed to the purification and processing of the extract from Hedychium spicatum by using an adsorption material I.e. sifica gel In the extraction process and using a preferable solvent to improve on the concentration of one of the ingredients in the extract.

The extracting solvents can be low polar solvents like: hexane, benzene, toluene etc., and chlorinated solvents like: dlchloromethane, chloroform, carbon tetrachloride etc, esters like, methyl acetate, ethyl acetate etc., ethers like: diethyl ether, methyl ethyl ether etc., ketones tike: acetone, ethyl methyl ketone etc., and or combinations thereof. The most preferable solvents are low boiling non-polar solvents such as hexane or petroleum ether (60-80 °C).
Preferably the hair growth promoting / stimulating / enhancing or preventing of hair loss activity of the composition of the Invention comprises of the said selective fraction of the extract / concentrate from Hedychium spicatum that is prepared by using preferably low polar solvents and most preferably with low boiling non-polar solvent such as hexane.
The cosmetic and/or dermatologlcal composition for topical use derived from the above said composition can be products wherein the delivery system comprises creams, ointments, emulsions, gels, lotions, oils, sticks, sprays, soaps, packs, wraps, woven or non-woven wipes and films as a vehicle for topical application of the said hair growth promoting composition.
The ingredients essentially employed In such a composition other than herbal extract/ ingredients are emulsifiers, emollients, silicones, antioxidants, sunscreen agents, perfumes, colors, antimicrobial agents.
Selective extraction from Hedychium spicatum:
The plant, Hedychium spicatum used in the invention Is native to Southeast Asia. It Is an erect perennial shrub, 4m high, with long, stout, woody rhizome stock found in the alpine Himalayas at an altitude of 3,000 to 5,000 m. Hedychium spicatum has an agreeable odour with a bitter aromatic taste and is used as a substitute for valerian rhizomes {Valeriana offlcfnafis Unn). It yields up to 1.9 % of a pale yellow essential oil with a pleasant odour, suggestive of patchouli and valerian (The Wealth of India).
General Extraction Procedure:
The extracts to be used according to the Invention are obtained from the rhizomes of the plant belonging to the family, specifically from Hedychium spicatum including its variants.

Extraction:
The extracts to be used according to the invention are prepared by customary methods of extraction of the roots/ rhizomes the plant. The suitable conventional extraction methods, such as maceration, agitation maceration, remaceratlon, fluidlzed-bed extraction, ultrasound extraction, countercurrent extraction, super critical fluid extraction, percolation, repercolation, evacolatlon, diacolatlon and solid-liquid extraction (Soxhlet extraction) each of which Is known to the person skilled in the art and any of which can be used in principle, reference may be made by way of example to Hagers Handbuch der Pharmazeutlschen Praxis (5 th Sup. edition. Vol. 2, pp. 1026 1030, Springer Verlag, Berlin-Heidelberg-New York 1991). Starting material which may be used are fresh or dried rhizomes the plants, which can be mechanically comminuted prior to extraction. In this connection, all comminution methods known to the person skilled in the art are suitable, mention being made by way of example to comminution using a device containing blades.
Solvents which can be used for carrying out the extractions are preferably organic solvents, in particular low molecular weight esters, ethers, hydrocarbons, ketones or halogen-containing hydrocarbons (distilled or un-distilled). The extraction usually takes place at a temperature range of 20 to 140°C, preferably at 60 to 120°C, in particular at the boiling temperature of the solvents or solvent mixtures. The preferred solvent is low boiling non-polar solvent such as hexane or petroleum ether (60-80°C). In one possible embodiment, the extraction is carried out under an inert gas atmosphere to avoid oxidation of the ingredients of the extract. The extraction times are adjusted by the person skilled In the art depending on the starting material, method of extraction, temperature and the ratio of solvent to raw material, etc. After the extraction, the resulting crude extract can optionally be subjected to further customary steps, such as, for example, concentration, fractionation by partitioning between solvents, followed by concentration and/or de-coloration. If desired, the extracts prepared in this way can, for example, be subjected to selective removal of individual undesired ingredients. The extraction can be carried out to any desired degree of extraction, but is usually carried out exhaustively.
In accordance with another aspect of the invention there Is provided a process to obtain a selective fraction of the extract and improve upon the concentration of one of the ingredients in the said selective fraction of the extract by passing the above fraction of the extract through an adsorption material such as silica gel. The

adsorption material may be present in the root powder during extraction or may be treated with before concentration of the extract or after the concentration, dry charging on the absorbent and eluting the same with hexane to get more enriched extract.
The present invention mainly encompasses the finding that the extraction conditions and also the yields of the end extracts can be selectively chosen depending on the desired field of use, through deployment of appropriate precise screening techniques, including hair growth promoting screens on animals.
An exemplary illustration of a selective fraction of the extract from plant Hedychium spicatum is discussed hereunder in the following Example.
Under this example a process for maicing the selective active extract showing hair growth promoting/ enhancing / stimulating or preventing hair loss activity from said rhizomes of H. spicatum was carried out as follows;
a) the air-dried rhizomes / roots of H. spicatum were coarsely powdered and subjected to extraction with an organic solvent, preferably hexane, to provide an extract;
b) concentrating the extract in vacuo to provide a residue;
c) subjecting the residue for different analyses
d) evaluating the extract on the basis of a selective fraction showing a spot at Rf 0.84 on thin layer chromatographic experiments performed using pre-coated silica gel plates with hexane as the mobile phase
e) analyzing the said selective fraction of the extract by GCy GCMS for the presence of two ingredients, one of which has a molecular weight of 212 constituting a minimum of 20 % of the composition by GC and which elutes with Rt of 9.69 minutes in GC and another one having a molecular weight of 206 constituting a maximum of 80% of the composition by GC and which elutes with Rt of 23.46 minutes in GC.
The above said selective fraction of the extract was tested for hair growth characteristics and it showed excellent hair growth promoting / enhancing /

stimulating or preventing hair loss activity indicating its role as a hair growth promoter / enhancer / stimulator or prevention of hair loss.
Additionally, the above said selective fraction of the root extract was further processed to enhance the purity of one of its ingredient. The concentrated extract was thus adsorbed on silica gel, packed in the glass column and eluted with hexane. The hexane eluent was further concentrated under vacuum to obtain another concentrate which was analysed by GC to reveal 84% of the major peak having a retention time (Rt) at 9.69 minutes.
Alternatively, the roots were extracted with hexane by incorporating silica gel in the extraction process to remove the impurities or to enhance the purity of the extract.
a) Taking the silica gel in the soxhiet apparatus,
b) loading the root/rhizome material on the top of silica gel
c) extracting the material with hexane, and concentrating the extract to get crude extract
d) submitting the crude extract to GC analysis.
According to another aspect of the present invention, the extract was prepared by packing silica gel in the thimble of the soxhiet apparatus followed by plant material which was extracted with hexane to obtain the selective extract concentrate.
Alternatively, in another aspect of the present invention, the extract was prepared by taking silica gel in RB flask of soxhiet apparatus and loading the plant material in the thimble of the soxhiet apparatus which was then extracted with hexane to get the selective extract concentrate.
The invention is thus based upon a selective and surprising finding that hair growth promotion / enhancement / stimulation or preventive hair loss activity could be realized by the above said selective fraction of the extract sourced from the plant Hedychium spicaWm.
It is thus possible by way of this invention to provide for a selective active fraction of the extract in effective amounts for hair growth promoting or stimulating or enhancing or preventing hair loss applications sourced from plant Hedychium

spicatum, which would also be safe and compatible as a hair care active agent. Importantly, the inventive composition is thus directed to meet the much required simple and cost-effective use in a variety of hair care applications/ formulations and the like which would also be safe for topical use.
Processing the Extract of Hedychium spicatum:
The hair growth promoting agent of the invention is a novel selective fraction of the herbal extract in effective amounts prepared from the plant Hedychium spicatum, which is selected on the basis of its hair growth promoting activity as measured by its potential to reduce the growth time by value of not less than 10% over a base value and on the basis of its constituents. The process for purification of the extract of the plant Hedychium spicatum comprises determining or analyzing the extract by the technique of Thin Layer Chromatography (TLC) and / or Gas Chromatography (GC) or Gas Chromatography - Mass Spectrometry (GCMS), and establishing a range within which the content of the said selective fraction of the extract lie. The said selective fraction of the extract shows a spot at Rf 0.84 on TLC using pre-coated silica gel plates on using hexane as the mobile phase. The abovesaid selective extract has at least two ingredients one of which has a mass spectrometric M+ value of m/z 212 mass units and is present to an extent of not less than 20% of the two identified peak areas of the GC and which eiutes with Rt of 9.69 minutes in GC and the other ingredient has a mass spectrometric M+ value of m/z 205 mass units and is present to an extent of not more than 80% of the two identified peak areas of the GC and which eiutes with Rt of 23.46 minutes in GC. No extract of Hedychium spicatum has been previously described which has been quantitatively purified in the manner as described herein. The invention was rendered possible because of thorough and indepth studies conducted in analyzing different extracts of Hedychium spicatum by following the techniques of liquid chromatography, looking into hair growth reduction time of the extracts, and identification of finger print pattern of hair growth active extracts through these.
GC Analysis of Hedychium spicatum Extract:
A number of extracts of H. spicatum of the invention was prepared and purified according to the process of the invention as mentioned below. All the samples were subjected to GC assay. The details of the said GC assay method as developed are described in the experimental section.

Hair Growth Promotion Activity of the purified selective fraction of the Extract;
The percentage of hair growth reduction time of the extract is measured by observing that less time is required to complete hair growth vs. control experiments without any treatment (Adhirajan et. al., Journai of Ethano Pharmacoiogy, 2003, 88, 235; Adhirajan et. al., Indian Drugs, 2001, 38, 559). All active extracts of the invention have a percentage reduction of hair growth time over a control.
The composition according to the invention can be used for the production of cosmetic and/or dermopharmaceutical preparations, such as, for example, lotions, creams, gels, sprays, alcoholic and aqueous/alcoholic solutions, emulsions, wax/fat compositions, stick preparations or ointments. These preparations can also comprise, as further auxiliaries and additives, surfactants, oily bodies, emulsifies, pearlescent waxes, bodying agents, thickeners, superfattfng agents, stabilizers, polymers, silicone compounds, fats, waxes, lecithins, phospholipids, biogenic active ingredients, deodorants, antiperspirants, film formers, swelling agents, hydrotropes, solubilizers, preservatives, perfume oils, dyes and the like.
The hair care composition of the invention can also incorporate conventional cosmetic and hair/ skin care ingredients such as discussed hereunder:
The various components usually used for cosmetic composition, i.e., an aqueous component, an oily component, a powder component, alcohols, ester, a surfactant, a moisturizer, a whitening agent, an antioxidant, an ultraviolet ray absorbent, a thickener, a coloring material, perfume, an anti-oxidant, pH regulator, a chelating agent, and antiseptics, can be blended with these cosmetics
The ingredients essentially employed in such a composition are surfactants, oil bodying agents, emulsifiers, fats and waxes, stabilizers, polymers, silicone compounds, deodorants and antimicrobial agents, film formers, swelling agents preservatives, thickeners /herbal extracts/concentrates/active ingredients, p" adjusting agents, perfume oils, and water to qs.
Surfactants
Surface-active substances which may be present are anionic, nonionic, cationic and/or amphoteric surfactants, the content of which in the compositions is usually

about 1 to 70% by weight, preferably 5 to 50% by weight and in particular 10 to 30% by weight.
Oily Bodies
Suitable oily bodies can also be incorporated which include for example, Guerbet aJcohols based on fatty aicotiois leaving 6 to 18, preferably 8 to 10, carbon atoms, esters of linear C^ - C22-fatty acids with linear or branched Ce - C22-fatty alcohols or esters of branched Ce - Ci3-carboxyllc acids with linear or branched Ce - C22-fatty alcohols. Such oily bodies can be used in amounts of 0.1 to 50.0% by wt.
Emulsifiers
Suitable emulsifiers are, for example, nonionic surfactants.
The addition products of ethylene oxide and/or of propylene oxide onto fatty alcohols, fatty acids, alkylphenols or onto castor oil are also known, commercially available products which can be included. Alkyl and/or aikenyl oligoglycosides, their preparation and their use are known from the prior art.
Furthermore, zwitterionic surfactants can be used as emulsifiers. The term "zwitterionrc surfactants" refers to those surface-active compounds which carry at least one quaternary ammonium group and at least one carboxylate and one sulfonate group in the molecule. Likewise suitable emulsifiers are ampholytic surfactants. The term "ampholytic surfactants" means those surface-active compounds which, apart from a C.sub.8/18- alkyl or -acyi group in the molecu\e, contain at least one free amino group and at least one —COOH or —SO3H group and are capable of forming internal salts- Finally, cationic surfactants are also suitable emulsifiers, those of the ester quat type, preferably methyl quaternized difatty acid triethanolamine ester salts, being particularly preferred.
Such emulsifiers can be used in amounts of 0.1 to 50.0 % by wt.
Fats and Waxes
Typical examples of fats are glycerides, i.e. solid or liquid vegetable or animal products whichconsist essentially of mixed glycerol esters of higher fatty acids, suitable waxes are inter alia natural waxes. In addition to the fats, suitable additives are also fat-like substances, such as lecithins and phospholipids. The term lecithins is understood by the person skilled in the art as meaning those glycerophospholipids

which form from fatty acids, glycerol, phosphoric acid and choline by esterification. Lecithins are thus frequently also known as phosphatidylcholines (PC). Examples of natural lecithins which may be mentioned are the cephalins, which are also referred to as phosphatidic acids and represent derivatives of l,2-diacyl-sn-glycerol-3-phosphoric acids. By contrast, phospholipids are usually understood as meaning mono- and, preferably, diesters of phosphoric acid with glycerol (glycerophosphates), which are generally considered to be fats. In addition, sphingosines and sphlngolipids are also suitable. Such fats and waxes can be used in amounts of 0.1 to 10% by wt.
(Moreover, known Pearlescent Waxes, Bodying Agents and Thickeners as well as superfatting agents can also be used.
Superfatting agents which can be used are substances such as, for example, lanolin and lecithin, and polyethoxylated or acylated lanolin and lecithin derivatives, polyol fatty acid esters, monoglycerldes and fatty acid alkanolamides, the latter also serving as foam stabilizers. Such super fatting agents can be used in amounts of 0.1 to 15% by wt.
Stabilizers
Stabilizers which can be used are metal salts of fatty acids, such as, for example, magnesium, aluminum and/or zinc stearate or ricinoleate. Such stabilizers can be used in amounts of O.lto 10% by wt.
Polymers
Suitable polymers include anionic, zwitterionic, amphoteric, nonionic and cationic polymers. Suitable polymers are, for example, suitable polymers and thickeners are listed in Cosm. Toil. 108, 95 (1993). Such polymers can be used in amounts of 0.001 to 5% by wt.
Silicone Compounds
Suitable silicone compounds which are volatile or non-volatile, for example, dimethylpolysiloxanes, methylphenylpolysiloxanes, linear and cyclic silicones, and amino-, fattyacid-, alcohol-, polyether-, epoxy-, fluorine-, glycoside- and/or alkyl-modified silicone compounds, which can either be liquid or in resin form at room temperature. Also suitable are simethicones, which are mixtures of dimethicones

lavIng an average chain length of from 200 to 300 dimethylsiloxane units and lydrogenated silicates. Such silicone compounds can be used in amounts of 0.1 to .0% by wt.
leneficlal Ingredients
Jiogenic active ingredients can also be included meaning those which do not arise rem the plant Trachyspermm ammi Linn, such as, for example, tocopherol acetate, ocopherol palmitate, ascorbic add, (deoxy)ribonucleic acid and fragmentation products thereof, retinol, bisabolol, allantoin, phytantriol, panthenol, menthol, AHA acids, amino acids, ceramides, pseudoceramides, essential oils, further plant extracts and additional vitamin complexes. Such biogenic active ingredients can be used in amounts of 0.001 to 5.0% by wt.
Deodorants and Antimicrobial Agents
Cosmetic deodorants are also possible ingredients which can be added to counteract, mask or remove body odors. Body odors arise as a result of the effect of skin bacteria on apocrine perspiration, with the formation of degradation products which have an unpleasant odor. Accordingly, deodorants comprise active ingredients which act as antimicrobial agents, enzyme inhibitors, odor absorbers or odor masking agents.
Antiperspirants can also be added in the cosmetic preparation to reduce the formation of perspiration by influencing the activity of the eccrine sweat glands, thus counteracting underarm wetness and body odor.
Suitable astringent antiperspirant active ingredients are primarily salts of aluminum, zirconium or of zinc.
Customary water-soiuble additives are, for example, preservatives, water-soluble fragrances, pH regulators, e.g. buffer mixtures, water-soluble thickeners, e.g. water-soluble natural or synthetic polymers, such as, for example, xanthane gum, hydroxyethylceliulose, polyvinylpyrrolidone or high molecular weight polyethylene oxides.
Such deodorant and antimicrobial agents can be used in amounts of 0.001 to 5.0% by wt.

Film Formers
Conventionally the film formers are selected from, for example, chitosan, microcrystalline chitosan, quaternized chitosan, polyvinylpyrrolidone, vinylpyrrolidone - vinyl acetate copolymers, polymers of the acrylic acid series, quaternary cellulose derivatives, collagen, hyaluronic acid and salts thereof, and similar compounds. Suitable film formers can be used in amounts of 0.001 to 5.0% by wt.
Thickeners
Thickeners/ rheology modifiers may also be utilized as part of the cosmetically acceptable carrier of compositions according to the present invention. Amounts of the thickener may range from 0.0001 to 10%, usually from 0.001 to 5%, by weight.
Swelling Agents
The swelling agents for aqueous phases may be montmorillonites, clay mineral substances, Pemulen, and aIkyl-modified Carbopol grades (Goodrich). Such additives can be incorporated in amounts of 0.001 to 2.0% by wt.
Hydrotropes
To improve the flow behavior, hydrotropes can be added, such as, for example, ethanot, isopropyl alcohol, or polyols, can also be used. Such additives can be incorporated in amounts of 0.1 to 15% by wt.
Preservatives
Suitable preservatives are, for example, phenoxyethanol, formaldehyde solution, parabenes, pentanediol or sorbic acid, and the other classes of substance listed in Annex 6, Part A and B of the Cosmetics Directive. Such preservatives can be incorporated in amounts of 0.001 to 5 % by wt.
Other adjunct minor components may also be incorporated into the cosmettc compositions. These ingredients may include coloring agents, opacifiers, and perfumes. Amounts of these other adjunct minor components may range anywhere from 0.001% up to 20% by weight of the composition.
The composition according to the invention involving the above hair growth agent Is intended primarily as a product for topical application to hair for the purpose of hair

growth. In use, a small quantity of the composition, for example about 0.1 to about 5 ml, can be applied to exposed areas of the skin, from a suitable container or applicator and, if necessary, it is then spread over and/or rubbed into the skin using the hand or fingers or a suitable device for desired hair growth benefit activity.
The details of the invention, its objects and advantages are explained hereunder in greater detail in relation to non-limiting exemplary Illustrations as per the following examples;
EXAMPLES:
Example 1 - TLC Analysis Conditions:
Pre-coated silica gel plates (Merck 1.05554.0001) were used for the identification of the spot. The isolated selective fraction provides a spot with an Rf value of 0.84 in hexane.
Example 2 - GC Instrumentation and Chromatography Conditions:
i) The Shimadzu GC-17A capillary GC unit consists of FID detector. The chromatographic system consists of capillary glass column of ZB-5 column (30 m length X 0.25 mm ID, 1µ film thickness) where nitrogen was used as the carrier gas. The total flow rate of nitrogen is 30 ml/ minute. The oven and Injection port temperatures are 200''C and 225°C and detector temperature is 250°c. The retention time of the two major peaks are 9.69 minutes and 23.46 minutes. The hexane concentrate was dissolved in heptane and directly injected for the GC analysis.
ii) The Shimadzu GC-17A capillary GC unit consists of FID detector. The chromatographic system consists of capillary glass column of DB-1 column (30 m length X 0.53 mm ID, 0.5n film thickness) where nitrogen was used as the carrier gas. The total flow rate of nitrogen is 21 ml/ minute. The oven and Injection port temperatures are 200°C and 225°C and detector temperature is 250''C. The retention time of the two major peaks are 8.36 minutes and 13.11 minutes. The hexane concentrate was dissolved In heptane and directly injected for the GC analysis.


The air-dried rhizomes/ roots of Hedychium spicatum (1.5 kg) were powdered, extracted with hexane through Soxhlet apparatus for about 8 hrs. The dilute extract was concentrated under reduced pressure to get 25 g of hexane concentrate. The extract was submitted to hair growth studies and GC analysis. It's gas chromatographic analysis (GC with capillary glass column of ZB-5 column) showed two major peaks with distinct retention times at 9.69 (not less than 20%) and 23.46 minutes (not more than 80%). The hair growth studies showed 33% reduction in hair growth completion time.

The air-dried rhizomes/ roots of Hedychium spicatum (250 g) were powdered, extracted with hexane through soxhiet apparatus for about 8 hrs. The dilute extract was concentrated under reduced pressure to get 4.5 g of hexane concentrate. The entire extract was loaded on the silica gel column (76 g, 100-200 mesh, Acme make) and eluted with hexane (500 ml). The eluent was concentrated under vacuum to get concentrate (0.76g). The concentrate was analyzed by GC with capillary glass column of ZB-5 column where it showed 84 % of major peak having a retention time (Rt) at 9.69 minutes.

The air-dried rhizomes/roots of Hedychium spicatum (200 g) were powdered and kept aside. 150 g of silica gel (100-200 mesh, Acme make) was packed in the thimble of the soxhiet apparatus, followed by powered plant material (200 g) and extracted with hexane for about 8 hrs. The dilute extract was concentrated under reduced pressure to get 1.65 g of hexane concentrate. The concentrate was analyzed by GC with capillary glass column of ZB-5 column where it showed 81% of major peak having retention time at 9.69 minutes.


The air-dried rhizomes/ roots of Hedychium spicatum (250 g) were powdered. 50 g of silica gel (100-200 mesh, Acme make) was taken the RB flask and the plant material (250 g) was packed in the thimble of the soxhiet apparatus and extracted with hexane for about 8 hrs. The dilute extract was concentrated under reduced pressure to get 1.12 g of hexane concentrate. The concentrate was analyzed by GC with capillary glass column of ZB-5 column to show 80% of major peak having retention time at 9.69 minutes.

This example demonstrates the method of hair growth property of the specially preferred concentrates / fractions/ compounds / formulations of the invention by estimation of time reduction of hair growth.
Female Wistar rats weighing 120-150 gm were used for the study. The animals were maintained in a clean cage and were provided with food and water ad libitum. The floor mat husk in each cage was removed and laid afresh on daily basts.
The hair on the dorsal portion of the body of each animal was depilated using a standard, commercially available depilatory cream. After removal of the hair, the skin was cleaned with distilled water and wiped with surgical spirit. Four centimeter square area in the depilated dorsal skin was marked with permanent ink marker. The animals which showed any skin irritant response to the depilatory were removed from the experiment and new animal was replaced.
The experimental animals were divided Into 3 groups of 6 animals each. Group 1 animals were served as negative control without any treatment. The negative control comprised of the vehicle for application (only) without any selective fraction of the extract. To the Group 2 animals, 50 micro liters of 2 % Minoxidil (commercially available) was applied in the pre defined area. To the Group 3 animals, the Test samples (extract/ fractions) prepared in liquid paraffin at 2 % was applied. The quantity of the extract used for the experiment was 50 micro liters per 4 cm sq. area per animal. The application of the Minoxidil and the test samples were continued for 30 days. The observations such as hair growth initiation time in days

and hair growth completion time in days were recorded for all the animals on daily basis. The hair growth initiation time was defined as the presence of new hair in the treated site of 4 cm sq area. The hair growth completion time was defined as completing filling of hair in the treated site of 4 cm sq area in each animal which become indistinguishable from the adjacent untreated portion of the body. The average of hair growth initiation time and hair growth completion time was calculated for each group along with control animals. The hair growth initiation time (HGIT) of the negative control Is 10 days whereas the hair growth completion time (HGCT) is 30 days. The percentage reduction in hair growth completion time (% Reduction in HGCT) for the treatment is calculated by the formula given below and is



It Is thus concluded from the above tables that the crude concentrate in solvent hexane is much more effective in promoting hair growth which reduces the hair growth completion time (HGCT). It Is also noteworthy that the purified selective fraction considered as the active extract when administered as a 2% solution in the hair depilated region of Female WIstar rats shows 30% reduction in HGCT as compared to 47% in the case of much popularly known and marketed Minoxidil, administered similarly as a 2% solution.
Thus the present invention provides for the desired hair growth promoting composition and a dermopharmaceutical / cosmetic composition for external application in promoting/ enhancing/ stimulating hair growth or preventing hair loss and methods for making the same. More specifically, the present invention is directed to serve the much desired need for hair care actives/ formulations which would serve as more efficacious, safe to apply and cheap hair growth promoting agent with better consumer acceptance. Importantly, the present invention thus favours In obtaining a hair care agent where the actives from Hedychium spicatum are spooled out In an appropriate solvent such as hexane In the presence of an adsorbing material such as silica gel that can be used either singly or In combination with a cosmetically/ dermopharmaceutlcally acceptable vehicle containing other skin benefiting agents.

We Claim:
1. A hair growth promoting or enhancing or stimulating or preventing hair loss composition comprising a selective fraction of the herbal extract in an effective amount prepared from the plant, Hedychium spicatum.
2. A hair growth promoting or enhancing or stimulating or preventing hair loss composition according to claim 1, wherein the selective fraction of the extract comprise extracts identified for purification showing a spot at Rf 0.84 In thin layer chromatography involving pre-coated silica gel plates with hexane as the mobile phase that comprises of at least two ingredients having Rt of 9.69 minutes and 23.46 minutes in GC; one of which has a mass spectrometric M* value of m/z 212 mass units and is present to an extent of not less than 20 % of the two identified peak areas of GC elutlng at Rt of 9.69 minutes and the other ingredient which has a mass spectrometric M* value of m/z 206 mass units and is present to an extent of not more than 80% of the two identified peak areas of the GC elutlng at Rt of 23.46 minutes.

3. A hair growth promoting or enhancing or stimulating or preventing hair loss composition according to claim 2, wherein the said selective fraction of the extract comprise further purified or processed extract wherein the purity of one of its ingredients is increased beyond 80 % having mass spectrometric M* value of m/z 212 mass units and elutlng in GC with Rt at 9.69 minutes.
4. A hair growth promoting or enhancing or stimulating or preventing hair loss composition according to claim 3 wherein the selective fraction of the herbal extract comprise purified or processed extract on the basis of its hair growth promoting activity as measured by the reduction of time required for hair growth by a value of not less than 10 % over a base value, and on the basis of Its constituents.
5. A hair growth promoting or enhancing or stimulating or preventing hair loss composition as claimed in any of the preceding claims wherein the said selective fraction of the extract Is derived from appropriate plant Ex. Hedychium spicatum.

6. A dermopharmaceutical / cosmetic composition for topical use comprising an
effective amount of the purified selective fraction of the extract from appropriate
plant Hedychium spicatum as claimed in anyone of the preceding claims
and
a cosmetically acceptable vehicle with or without other skin/ hair care benefiting agents.
7. A dermopharmaceutical/ cosmetic composition for topical use as claimed in claim
6 comprising an effective amount of the purified selective fraction of the extract as
hair growth promoting agent derived from appropriate plant including extract /
concentrate of rhizomes/ roots preferably in low polar solvents and most preferably
low boiling non-polar solvent such as hexane
and
a cosmetically acceptable vehicle with or without other skin/ hair care benefiting agents.
8. A dermopharmaceutical/ cosmetic composition for topical use as claimed in anyone of Claims 6 and 7 comprising
a) 0.0001 wt. % to 20 wt. %, preferably 0.001 wt. % to 10 wt. % and more preferably 0.01 wt. % to 5 wt. % of the said hair growth promoting selective fraction
and
b) a cosmetically acceptable vehicle with or without other skin/ hair care benefiting agents.
9. A dermopharmaceutical/ cosmetic composition as claimed in anyone of claims 6 to 8 comprising a cosmetic composition for topical use in the form of products preferably creams, ointments, emulsions, gels, lotions, oils, sticks, sprays, packs, wraps, woven or non-woven wipes, films or patches as a vehicle of the said hair growth composition.

10. A dermopharmaceutical/ cosmetic composition as claimed in anyone of claims 6
to 9 wherein the said hair growth promoting selective fraction comprises selectiveiy
any one or more of ingredients having mass spectrometric M* m/z value of 212 mass
units and retention time (Rt) at 9.69 minutes in GC.
11. A dermopharmaceutical /cosmetic composition as claimed in anyone of claims 6
to 10 wherein the said hair growth promoting agent comprises seiectively any one or
more of (a) selective fraction of the herbal extract/ concentrate in an effective
amount in appropriate solvent; (b) a purified and processed selective fraction
extract/ concentrate in an effective amount in appropriate solvent; and (c ) extract/
concentrate of the natural source material itself in an effective amount extracted by
an appropriate solvent In the presence of an adsorption material such as silica gel.
12. A hair growth promoting or enhancing or stimulating or preventing hair loss
composition comprising a purified selective fraction of the extract of rhizomes/ roots
of Hedychium spicatum as an active ingredient in effective amounts and a
dermopharmaceutical/ cosmetic composition obtained thereof substantially as herein
described and illustrated with reference to the accompanying examples.