Title of Invention	A PROCESS FOR PREPARATION OF A POLYHERBAL COMPOSITION AND THE PRODUCT THEREOF
Abstract	The present invention provides a poly herbal composition comprising the extracts of saraca indica and other herbs along with 'anupana’, a key component to improve the drug efficacy and a method for preparing the herbal composition. The herbal composition is effective in the treatment of irregular menstrual cycle and pre menstrual syndrome.

Full Text

FORM 2 THE PATENTS ACT 1970 (39 of 1970) & The Patents Rules, 2003 COMPLETE SPECIFICATION (See section 10 and rule 13) 1. TITLE OF THE INVENTION: "POLY HERBAL COMPOSITION AND PROCESS THEREOF" 2. APPLICANT(S): (a) NAME: CHARAK PHARMA PRIVATE LIMITED (b) NATIONALITY: Indian Company incorporated under the Indian Companies ACT, 1956 (c) ADDRESS: Evergreen Industrial Estate, Opp. Shakti Mills Lane, Dr. E. Moses Road, Mahalaxmi, Mumbai - 400 Oil, Maharashtra, India. 3. PREAMBLE TO THE DESCRIPTION The following specification particularly describes the invention and the manner in which it is to be performed. Technical field of Invention The present invention relates to a non-synthetic hormonal or natural NSAID poly herbal composition. The present invention particularly relates to a poly herbal synergistic composition of saraca indica and other herbs along with 'anupana' and process of preparation thereof. More particularly the present invention relates to a poly herbal composition wherein the herbal extracts are prepared by selective solvent extraction of the crude herbs. The poly herbal composition of the present invention is effective in the treatment of irregular menstrual cycle resulting from the synergy of the composition. Background and prior art Irregular menstrual cycle is a disorder that affects the female reproductive system due to various reasons like an alteration or an imbalance in hormonal levels of estrogen and progesterone during the menstrual cycle. Pre-menstrual syndrome is also due to a hormonal imbalance, caused by excessive levels of estrogen and inadequate progesterone levels which leads to fluid retention. Fluid retention affects the blood flow and reduces oxygen in the uterus and the brain. At present in modern medicine different treatment options are available, depending on the severity of the symptoms. Mild analgesics in mild cases and in severe cases, restriction of salt intake and the use of diuretic to control fluid retention may be indicated. In some cases hormonal replacement is also advised. Menstruation is considered normal, if it occurs regularly every month for a period of five days, this fluid is not having mucous, neither too much nor too less in quantity and accompanied without burning sensation and pain. Reference, Sushruth Samhita, Sutrasthan.chap-2 Common causes of irregular menstrual cycle are, the alteration in estrogen and progesterone during the menstrual cycle (hormonal imbalance); uterine lesions e.g. fibroids, polyps, cancer; damage caused from an intra-uterine contraceptive device (IUD); pelvic inflammatory disease like bacterial infection of the uterus, fallopian tubes and 1 other areas of pelvic; adenomiosis, the growth of the endometrium in to the underlining muscular layer of the uterus; ectopic pregnancy; hydatid mole, an abnormal mass in the uterus caused by poorly developed or degenerating fertilized egg; uterine leiomyoma, benign, fibrous tumor that occurs in 40% of women by age 40; endometriosis, inflammation of the endometrium caused by bacterial infection; trauma; sexual abuse; medications; foreign bodies viz. tampoons and condoms Ayurveda attributes the causes of irregular menstrual cycle as indulging excess of incompatible foods, over eating, alcoholic, beverages and uncooked foods, frequent abortions, excessive sexual intercourse, riding on animals, walking long distances, emaciation due to any cause, trauma, sleeping at day time and other causes afflicted with 'pradara' (excessive discharge of menstrual fluid) 'Pradara' is of four kinds, produced by kapha, pitta and vata separately and also by all of them together. General symptoms of this disease are aches all over the body and pain in abdomen during the menstrual period. If there is too much of menstrual discharge it produces debility, giddiness, fainting, toxic state, thirst, burning sensation, delerium, paler of the skin, stupor, and some of the diseases of vata origin. The menstrual discharge will be Ama (ill processed) if it smells, is heavy, mixed with mucous, yellowish white in color and resembles rice washed water. It is produced by pitta, if the discharge is yellow, blue, black and red in color, warm and comes out in gushes. It is produced by vata, if the discharge is viscid, crimson in color, froathy, scandy, resembling mutton washed water and accompanied with vataj type of pain. If the disease is caused by all the three dosas together the flow will be like a honey, ghee, orpiment or bone marrow in color and emitting cadaveric smell. Etiopathogenesis of Amenorrhea: According to Ayurveda, aggravated vata and pitta affect blood by drying-up menstrual blood (raja), which ceases the regular flow of menses (nashtartava or ksheenartava). General symptoms that are associated with this condition are emaciation and pallor. It suggests the deficiency of blood or a severely anaemic condition and weakness. 2 Conventional medicine indicates that amenorrhea is due to a wide range of causes that include anatomic or structural and physiological or functional defects. It can be congenital or develop at a certain age because of a particular change. There can be a defect from the ovarian or uterine level to hypothalamus and pituitary level. Structurally or anatomically there are four major congenital anomalies viz., absence of uterus or some part of the vagina, failure of the vagina to develop or underdeveloped vagina, imperforate hymen, or intrauterine synechiae. All these consequently result in primary amenorrhea. In Ayurveda several herbal ingredients have been reported for the treatment of irregular menstrual cycle, one of them is the popular so called women's drug Saraca indica. Saraca indica is locally known as 'Ashoka' and is found through out India. The whole herb is useful for the treatment of menorrhagia, dysmenorrhea, uterine fibroids, leucorrhoea and is considered as a uterine sedative and tonic. Oral administration of the whole plant in the form of powder significantly reduces signs and symptoms of irregular menstrual cycle and other dysfunctional uterine bleeding (DUB). Reference, BHMA .1983. British herbal pharmacopoeia, Bournemouth and Bradley PR, 1992. British herbal compodium. US Patent 6642212 describes a novel health supplement containing phytoestrogens, analogues or metabolites there of. This particular patent discloses a method for the management of premenstrual syndrome and/or postmenopausal symptoms. Another US Patent 6589569 describes method and composition for treatment of premenstrual syndrome in women. In this patent a medicinal composition consisting of Asparagus racemosus and other herbs useful in the treatment of PMS are disclosed. The active component of Asparagus racemosus is saponin glucoside (A 4). Currently antispasmodic, anti-inflammatory and other hormonal drugs are available in allopathic treatment but in long term antispasmodics, anti-inflammatory drugs have harmful side effects. 3 The present invention describes a novel poly herbal synergistic composition using the extract of Saraca indica and other herbs along with 'anupana' and process of preparation thereof. The poly herbal composition is effective for the treatment of irregular menstrual cycle. According to Ayurveda ‘anupana’ (catalyst) is one of the key components to improve the drug efficacy .e.g.: Honey, ghee, taila, jeera etc. Object of the invention The object of the present invention is to provide non-synthetic hormonal or natural NSAID poly herbal composition. Another object of the present invention is to provide novel poly herbal synergistic composition comprising the extracts of Saraca indica and other herbs along with ‘anupana’ Another object of the present invention is to provide novel process for preparation of the poly herbal composition. Another object of the present invention is to provide novel poly herbal composition effective for the treatment of irregular menstrual cycle, resulting from the synergy of the composition. Another object of the present invention is to provide novel poly herbal composition which is formulated as an orally administrable liquid, capsule, tablet or any other pharmaceutically acceptable dosage form using suitable pharmaceutically acceptable excipients. Yet another object of the present invention is to provide cost effective treatment for irregular menstrual cycle. 4 Summary of the invention The present invention relates to poly herbal synergistic composition for the treatment of irregular menstrual cycle and the process of preparation thereof. The herbal extracts are prepared by selective solvent extraction of the crude herbs. The present invention relates to poly herbal composition comprising of the extracts of Saraca indica and 13 other herbs along with 'anupana' Cuminum cyminum. The herbs comprising: Ashoka : Shatavari : Dashmool (Salaparni Prsniparni Brharti Kantakari Goksura Bilva Agnimantha Syonaka Kasmari (gambhari) Patala Lodhra Amalaki Bibhitaki Kamal pushpa Devadaru Nagakesar Jatamansi Shalmali Shunthi Haritaki Saraca indica Asperagus racemosus Desmodium gageticum Urariapicta Solanum indicum Solanum xanihocarpum Tribulus terristris Aegle marmelos Premna integrifolia Oroxylum indicum Gmelina arborea Stereospermum suaveolens) Symplocos racemosa Emblica officinalis Terminalia belerica Nelubium speciosum Cedrus deodara Mesuaferrea Nardostachys jatamansi Bombax malabaricum Zingiber officinale Terminalia chebula The process of preparing the poly herbal composition comprising the steps of: 5 (i) Extraction of the herbs viz, Saraca asoka, Asperagus racemosus, Dashmool, Symplocos racemosa, Emblica officinalis,Terminalia belerica, Nelubium speciosum, Cedrus deodar a, Mesuaferrea, Nardostachys jatamansi, Bombax malabaricum, Zingiber officinale, Terminalia chebula and Cuminum cyminum by selective solvent extraction method. (ii) Drying the said extracts under vacuum at temperature in the range of 15°C-60°C to obtain flowing powder. (iii) Blending of the extracts except Cuminum cyminum, well together in a mass mixture for 2-3 hours continuously with the addition of anupana i.e. jeeraka {Cuminum cyminum) during the mixing in the mass mixture. (iv) Formulating the composition mixture to a convenient orally administrable dosage form using suitable pharmaceutically acceptable excipients. The poly herbal composition is formulated as either liquid orals, capsules, tablets or any other pharmaceutically acceptable form. Detailed Description of the Invention The present invention relates to a non-synthetic hormonal or natural NSAID poly herbal composition. The present invention relates to poly herbal synergistic composition for the treatment of irregular menstrual cycle and the process of preparation thereof. The herbal extracts are prepared by selective solvent extraction of the crude herbs. To improve the efficacy of the extracts, the extraction is prepared by selective solvent extraction method, which enhances and enriches the extracts with reference to the herbal actives to make the formulation for the treatment of irregular menstrual cycle. The present invention relates to herbal composition comprising the extracts of Saraca indica, Asperagus racemosus, Dashmool, Symplocos racemosa, Emblica officinalis,Terminalia belerica, Nelubium speciosum, Cedrus deodara, Mesua ferrea, Nardostachys jatamansi, Bombax malabaricum, Zingiber officinale, Terminalia chebula, Cuminum cyminum {'anupana'). 6 The present invention describes a novel poly herbal composition using the extract of Saraca indica and other herbs mentioned above along with ‘anupana’ for the treatment of irregular menstrual cycle. 'Anupana' (catalyst) is one of the key components to improve the drug efficacy .e.g.: Honey, ghee, taila, jeeraka etc. In the present composition jeeraka is the anupana. Our scientists have conducted comparative clinical trials of composition comprising anupana and composition without anupana, with the view to establish the synergy. Clinical trials studies show composition comprising anupana is more effective than those without anupana and also the time for the treatment for irregular menstrual cycle is reduced to 20% when compared to the composition without anupana. The synergy in the composition has been proved as above. 7 The active principle of Saraca asoka i.e. Saracin, and other active principles of 13 herbs are mentioned as follows: Latin/English Name Active principles Extracts derived from: Ashoka Saraca indica Tannin,catechol,sterol and organic calcium compounds Shatavari Asperagus racemosus Steroidal saponins known as shatavarins I- IV Dashmool »» Lodhra Symplocos racemosa Three aIkaloids,viz. loturine,loturidine and colloturine Amalaki Emblica officinalis Vitamin C (Ascorbic acid)Phyllembin, Phyllemblic acid, Gallic acid, Ellagic acid, Tannins Bibhitaki Terminalia belerica Tannins,gallic acid,ellagic acid,ethyl gallate,galloyl glucose and chebulaginic acid Kamal pushpa Nelubium speciosum Nelumbine,isoliensinine, Nuciferine,pronuciferine, Anonaine,starch,raffinose, Protein,sitosterol Devadaru Cedrus deodara himachalol, sesquiterpenoids a - and himachalenes. Deodarone and deodardione are also isolated from the essential oil. Nagakesar Mesua ferrea Xanthones, a number of 4-phenylcoumarin derivatives, friedelin and triterpenes. Mesuferrone-A and B, mesuaferrol, mesuanic acid, a-and P-amyrin, and P sitosterol, Volatile oil. Jatamansi Nardostachys jatamansi Essential oil, Valeranone-(Jatamansone) a sesquiterpenoid.jatamanshic acid, virolin.umarin: jatamansinol , 8 jataminsin, valeranal Shalmali Bombax malabaricum n- hexacosanol , gallic acid, Tannic acid. Shunthi Zingiber officinale Zingiberene,zingiberol, Shogaol,volatile oil and resinous matter, starch and mucilage,monoterpenes, gingerol, sesquiterpenes gingreniols,methylgingediol, gingeryldiacetates and methyl gingediacetates. Haritaki Terminalia chebula Tannins- tannic acid (45%), gallic acid, chebulic acid, mucilage, sennoside. Chebulagic, chebulinic acid and corilagin Jeeraka Cuminum cyminum Cuminaldehyde,perilla aldehyde,cumin alcohol, a-andp-pinendipentene, pcymeneand|3phellandrene fatty oil, resin, mucilage, gum, proteins(17.7%), malates and an essential oil, a -phellandrene and an uninvestigated paraffin, Mosiene1 , pyrazines. The poly herbal composition of the present invention is formulated to convenient orally administrable dosage form. The dosage forms of the composition are either liquid orals, capsules, tablets or any other pharmaceutically acceptable form. In one embodiment of the present invention, a blend of enriched extracts in the form of an orally administrable liquid formulation which essentially comprises of the extracts of Saraca indica, and 13 other herbs along with anupana which gave desired results. 9 COMPOSITION Each 5 ml contains Name of ingredient Latin/English Name Extracts derived from: Ashoka Saraca indica 1800 mg Shatavari Asperagus racemosus 100 mg Dashmool 100 mg Lodhra Symplocos racemosa 50 mg Amalaki Emblica officinalis 50 mg Bibhitaki Terminalia belerica 50 mg Kamal pushpa Nelubium speciosum 50 mg Devadaru Cedrus deodara 50 mg Nagakesar Mesua ferrea 25 mg Jatamansi Nardostachys jatamansi 25 mg Shalmali Bombax malabaricum 25 mg Shunthi Zingiber officinale 25 mg Haritaki Terminalia chebula 25 mg Jeeraka Cuminum cyminum 25 mg (ANUPANA) Flavoured syrupy base q.s The process of preparation of the herbal composition comprising the steps of: (i) Each herb including jeeraka, is coarsely powdered separately in a suitable cutting mill. The separate coarse powder is extracted with polar solvents like water and suitable organic solvents such as alcohol, chloroform, acetone or hexane etc. with approximately 3-10 times, the quantity of coarse powder in a suitable closed vessel to minimize the loss of solvents. The decoction (extract) obtained thus is stored in a suitable vessel. (ii) The individual decoction (extract) is dried under vacuum at temperature in the range of 15°C-60°C to obtain free flowing powder of each herb separately. 10 (iii) The total composition of the individual extracts are combined and mixed well together in a mass mixture for at least 2-3 hours continuously During the mixing of the individual extracts, "anupana" ie. jeeraka is mixed in the mass mixture. (iv) The poly herbal composition is formulated to a convenient orally administrable dosage form using suitable pharmaceutically acceptable excipients. The dosage forms of the poly herbal composition are formulated as either liquid orals, capsules, tablets or any other pharmaceutically acceptable form. In a further embodiment the present invention can be formulated as a tablet or capsule, the tabletting of the composition mixture may be performed by the conventional method of tabletting well known in the art. The present invention is illustrated by the way of the following non-limiting examples. The examples are not limited to the particular embodiments illustrated herein but include the permutations, which are obvious set forth in the description. Example Each 5 ml contains Name of ingredient Latin/English Name Extracts derived from: Ashoka Saraca indica 1800 mg Shatavari Asperagus racemosus 100 mg Dashmool ~ 100 mg Lodhra Symplocos racemosa 50 mg Amalaki Emblica officinalis 50 mg Bibhitaki Terminalia belerica 50 mg Kamal pushpa Nelubium speciosum 50 mg Devadaru Cedrus deodara 50 mg 11 Nagakesar Mesuaferrea 25 mg Jatamansi Nardostachys jatamansi 25 mg Shalmali Bombax malabaricum 25 mg Shunthi Zingiber officinale 25 mg Haritaki Terminalia chebula 25 mg Jeeraka Cuminum cyminum 25 mg(ANUPANA) Flavoured syrupy base q.s The process of preparation of the herbal composition comprising the steps of: (i) Each powder is coarsely powdered separately in a suitable cutting mill. The separate coarse powder is extracted with water and alcohol in the ratio of 9:1 to 1:9, with approximately 3-10 times the quantity of coarse powder in a suitable closed vessel to minimize the loss of solvents. The decoction (extract) obtained thus is stored in a suitable vessel. (ii) The individual decoction (extract) is dried under vacuum at temperature in the range of 25°C to 60°C to obtain free flowing powder of each herb separately. (iii) The total composition of the individual extracts are combined and mixed well together in a mass mixture for at least 2-3 hours continuously. During the mixing of the individual extracts, "anupana" ie. jeeraka is mixed in the mass mixture. (iv) The poly herbal mixture is formulated to liquid syrup using flavoured syrupy base and other suitable well known pharmaceutically acceptable excipients. The clinical trials for the efficacy of the novel poly herbal formulation in the form of syrup of the actives has shown excellent efficacy of the formulation to control spasmodic pains and maintain regularity in menstrual cycles. 12 We claim, 1. A poly herbal synergistic composition used for the treatment of irregular menstrual cycle comprising extracts of Saraca indica in combination with Asperagus racemosus, Dashmool, Symplocos racemosa, Emblica officinalis, Terminalia belerica, Nelubium speciosum, Cedrus deodara, Mesua ferrea, Nardostachys jatamansi, Bombax malabaricum, Zingiber officinale, Terminalia chebula, alongwith a key component for improved drug efficacy termed as ’anupana’ prepared by a process which comprising: (i) coarsely powdering each herb separately in a suitable cutting mill, (ii) extracting the coarsely powdered herbs individually using polar organic solvents, preferably with 3-10 times, the quantity of coarse powder in a suitable closed vessel to minimize the loss of solvents, (iii) obtaining a free flowing powder by drying individual herb decoction under vacuum at temperature range 15°C-60°C, (iv) combining and mixing the said free flowing powders of individual herbs to form a composition and mixing them together for atleast 2-3 hrs continuously and (v) mixing ‘anupana’ in the above composition during the mixing process. 2. A poly herbal composition as in claim 1, wherein Dashmool is a mixture of Desmodium gageticum, Uraria picta, Solanum indicum, Solanum xanthocarpum, Tribulus terristris, Aegle marmelos, Premna integrifolia, Oroxylum indicum, Gmelina arbore and Stereospermum suaveolens. 3. A poly herbal composition as in claim 1, wherein 'anupana' is selected from a group consisting of honey, ghee, taila and jeeraka. 4. A poly herbal composition as in claims 1 and 2 wherein the preferred 'anupana' is jeeraka. 5. A poly herbal composition as in claim 1, wherein the extracts of individual herbs is obtained by using polar and organic solvents. 13 6 A poly herbal composition as in claim 1, wherein the preferred polar solvent is water. 7 A poly herbal composition as in claim 1, wherein the organic solvent is selected from a group consisting of alcohol, chloroform, acetone and hexane. 8 A poly herbal composition as in claim 1, wherein the preferred organic solvent is alcohol. 9 The poly herbal composition of claim 5-8, wherein the solvent used is a mixture of water and alcohol, in the ratio of 9:1 to 1:9. 10 The poly herbal composition of claim 1, wherein the composition is formulated to convenient orally administrable dosage form like liquid orals, capsules, tablets or any other pharmaceutically acceptable form. Dated this 1st Day of June 2006 Dr. Gopakumar G. Nair Agent for the applicant 14 Abstract The present invention provides a poly herbal composition comprising the extracts of saraca indica and other herbs along with 'anupana’, a key component to improve the drug efficacy and a method for preparing the herbal composition. The herbal composition is effective in the treatment of irregular menstrual cycle and pre menstrual syndrome.

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