FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION
"A SYNERGESTIC HERBO MINERAL FORMULATION WITH ENHANCED ANALGESIC PROPERTIES AND PROCESS OF PREPARATION FOR THE SAME"
2. APPLICANT
NAME : PITAMBARI PRODUCTS PVT.LTD
NATIONALITY : INDIAN
ADDRESS : HEMENDRA CO.HSG.SOC, 3RD FLOOR, GOKHALE
ROAD,
THANE -400602,MAHARASHTRA
The following specification particularly describes the invention and manner in which it is to be performed.

FIELD OF THE INVENTION
The present invention relates to a synergistic herbo mineral formulation with enhanced analgesic properties for the treatment of musculoskeletal disorder and process for the preparation of same.
BACKGROUND OF INVENTION
Pain is an unpleasant feeling often caused by intense or damaging stimuli. To get relieved from such pain various oral formulations are in use such as tablet, capsules, syrups, and for topical pain ointments, creams, balm & lotions are in wide use. Along with the same there are few more formulation in the medical fields of homeopathy and allopathic to treat the pain and pain related ailments. However when it comes to side effect of such preparation none of the preparations in these fields are devoid of side effects, and specifically when the medicine is prescribed on daily basis to get rid from pain, various factors cumulatively worsen its side effect.
Herbal and ayurvedic preparation uses naturally occurring minerals and herbs in to its formulation. Some patented formulations composed of herbs and minerals targeting musculoskeletal diseases are disclosed in IN244133 as synergistic herbal ointment to be applied topically for the treatment of analgesic, rheumatoid arthritis, backache, spondilitis, sprains, joint pains, headache, cold, inflammations and muscular pain. It discloses a formulation to be used topically.
U.S. 5,494,668 discloses a method of treating degenerative musculoskeletal diseases such as rheumatoid arthritis and osteoarthritis in an animal, typically a human, involving administering to the animal in a convenient dosage form, a therapeutically effective amount of the beneficiated extracts of the plants Ashwagandha, Sallai

Guggul, Turmeric, and Ginger, in a predetermined proportion relative to each other with or without other biologically active inorganic ingredients.
U.S 5,683,698 discloses an herbal formulation and its use for reducing/alleviating symptoms associated with rheumatoid arthritis, osteoarthritis, and reactive arthritis and for reducing the production of pro-inflammatory cytokines. The formulation contains an herbal extract from the roots, rhizomes and/or vegetation of six herbal plant varieties, specifically, the species of Alpinia, Smilax, Tinospora, Tribulus, Withania, and Zingiber, The patent further discloses foods, beverages and medicaments in the form of capsules, tablets, liquids, and the like, containing the herbal formulation..
U.S. 5,908,628 discloses compositions for treating osteoarhritis and rheumatoid arthritis, containing talc, silkworm excrement, and ingredients of plants of species of the genera stephania, oix, Pinellia, Prunus, Phellodendron, Sophora, Tetrapanax, Stemona, Glycerrhiza, tripterygium, Forsythia, andSiegesbeckia.
U.S.6,187,314 discloses different compositions extracted from Gingko biloba leaves. Said compositions comprise new active components. This invention also provides a method of preparation of the compositions and individual components of said compositions. Uses of the compositions for arthritis and various other conditions are provided.
U.S.6, 264,995 discloses an herbal composition capable of reducing inflammation in bones and joints. The invention further relates to methods of using such herbal composition to reduce inflammation. More, particularly, the herbal composition of the present invention contains therapeutically effective amounts of the supercritical

extracts of ginger, rosemary and oregano, and therapeutically effective amounts of extracts of holy basil, turmeric, green tea, huzhang, Chinese goldthread, barberry, rosemary and Scutellariae baicalensis.
U.S. 6,274,176 discloses an edible composition for use as anti-inflammatory agent for alleviation of arthritis and gout in mammals. The edible composition is a mixture of at least three, preferably at least seven, herbs collected from the group consisting of Tanacetum parthenium, Zingiber officinale, Curcuma longa, Coriandrum sativum, Centella asiatica, Oenothera biennis, Valeriana officinalis, Tabebuia impetiginosa, Thymus vulgaris and Sambucus nigra.
U.S.6,576,271 discloses a method for inhibiting cyclooxygenase enzymes and inflammation in a mammal using a cherry or cherry anthocyanins, bioflavonoids and phenolics. In particular a mixture including the anthocyanins, the bioflavonoids and the phenolics is described for this use. The method and compositions of the present invention are useful for the treatment of arthritis.
JP 11-071290 discloses a hyaluronidase inhibitor improved in inhibitory effects and high in safety, useful as a therapeutic agent for rheumatism and deformant arthriti's, containing an extract of Phyllanthus emblucus as an active ingredient.
US8420132 discloses dietary supplement compositions comprising enriched 3-0-acetyl-11-keto-β-boswellic acid, enriched demethylated curcuminoids that have a synergistic effect on specific inhibition of—COX-2 and 5-LOX activity and optionally containing glucosamine, resveratrol, garlic extract, chondroitin, methlysuiphonymethane, bromelain, serratiopeptidase, quercitine. gallic acid, caffeic

acid, green tea extract, aspirin and ibuprofen, herbal extract are used in combination with synthetic drugs.
US 7658957 discloses a novel herbal composition for treatment of arthritis and inflammation. The herbal composition comprises a therapeutically effective combination of extracts obtained from the plants Terminalia chebula, Pluchea lanceolata, Desmodium gangeticum, Vitex negunto and Zingiber officinale, optionally along with pharmaceutically acceptable additives. The invention further comprises methods of making the herbal composition and methods of use for the treatment of arthritis and inflammation.
US 20120021077 discloses a synergistic herbal composition useful for treatment of rheumatic and musculoskeletal disorders (RMSDs) comprising a base formulation (50-60%) and plant parts and/or extracts of the plant (40-50%) selected from the group consisting of Withania somnifera, Tribulus terrestris, Phyllanthus emblica and Boswellia serrata optionally along with pharmaceutically acceptable excipients. With the base of effective developed science there is a need to develop a formulation which could take care of pain but in turn will also take care of associated problems and symptoms, the existing formulation are either topical application which provide temporary relief, or else when oral formulations are considered they are combined with synthetic drugs or else are used as dietary or nutritional supplement. Hence there is a need to develop a formulation which can overcome the drawbacks of prior art.
As evident from the prior art, it becomes challenging to formulate a composition containing with herbal content with reduced side effect and improved efficacy . Thus, the present invention holds an advantage of formulating a composition that provides enhanced analgesic properties with minimal side effect.

The discussion of documents, acts, materials, devices, articles and the like is included in this specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.
OBJECTIVES OF THE INVENTION
A primary object of the present invention is to develop an oral synergistic Herbal-mineral formulation with enhanced analgesic properties.
Another object of the invention is to provide a formulation which can be used for chrome pain with minimal or negligible side effect.
Another object of the invention is to provide a simple and convenient dosage form.
Yet another object of the present invention is to provide a formulation which can be used for chronic pain with symptomatic relief.
SUMMARY OF THE INVENTION
The present invention provides an oral synergistic Herbal-mineral formulation with enhanced analgesic properties comprises a therapeutically effective combination of-Sameer pannag Rasa, Mahavatvidhwansa Rasa, Laxadi Guggul, Sunthi (Zinziber officinalies), Deodaru (Cedrus Deodaru), Sahachar (Barleria Prionitis), Gulvel

(Tinospora cordifolia) extract, Gokshur(Tribulus terrestris) optionally along with pharmaceutically acceptable additives. The invention further comprises methods of making the herbal composition.
DESCRIPTION OF THE INVENTION:
While the making and using of various embodiments of the present invention are
discussed in detail below, it should be appreciated that the present invention provides
many applicable inventive concepts that can be embodied in a wide variety of specific
contexts. The specific embodiments discussed herein are merely illustrative of
specific ways to make and use the invention and do not delimit the scope of the
invention.
To facilitate the understanding of this invention, a number of terms are defined below.
Terms defined herein have meanings as commonly understood by a person of
ordinary skill in the areas relevant to the present invention. Terms such as "a", "an"
and "the" are not intended to refer to only a singular entity, but include the general
class of which a specific example may be used for illustration. The terminology herein
is used to describe specific embodiments of the invention, but their usage does not
delimit the invention, except as outlined in the claims.
The present invention relates to a synergistic herbomineral formulation with enhanced
analgesic properties, further it also relates to the process for preparation of synergistic
herbo mineral formulation with enhanced analgesic properties for the treatment of all
musculoskeletal disorder.
For the puipose of this invention, the definitions by way of explanation of terms are as
follows:

Bhavna implies to the procedure where medicinal ingredients (most probably heavy metals and minerals but occasionally herbs and entire formulations) are pre-treated or processed with specific liquid preparation to purify/detoxify them or manipulate their potency
Sameer Pannag Ras is an Ayurvedic preparation prepared with a special kupipakwa technique consisting of Shuddha Parada (purified and processed mercury), Shuddha Gandhaka (purified and processes green vitriole), Malla (purified arsenic oxide), Shuddha Haratala (purified orpiment), Manashila (purified Realgar). It is used to treat chronic and complicated diseases, joint diseases with stiffness, fever, Asthma, Bronchitis, cold and cough.
Mahavat yidhwansan Ras is an Ayurvedic preparation used in the treatment of Vata disorders, abdominal pain, neuralgia, aches and pains, abdominal colic, bloating, epilepsy, paralysis, splenic disorders and hemorrhoids. It is prepared from Shuddha Parada (Herbal purified Mercury), Shuddha Gandhaka (Herbal purified Sulphur), Naga Bhasma ( Lead Calx), Vanga Bhasma( Tin Calx), Loha Bhasma (Bhasma prepared from Iron), Tamra Bhasma (Bhasma prepared from Copper), Abhraka Bhasma( Purified and processed Mica), Pippali (Long pepper fruit) (Piper longum), Tankana Bhasma( Borax), Maricha (Black pepper) (Piper nigrum), Shunti (Dry Ginger Rhizome) ( Zingiber officinalis), Shuddha Vatsanabha. (Purified Aconitum ferox), Juice extract / water decoction of each of following for levitation 3 times with each - Trikatu (Pepper, long pepper and ginger), Triphala kwath, Chitrakamoola, Bhringaraja (Eclipta alba), Kushta (Saussurea lappa), Nirgundi (Vitex negundo), Arkaksheera( Latex of Calotropis procera), Amalaki (Indian gooseberry fruit)

(Emblica officinalis Gaertn), Ardraka (Ginger Rhizome) (Zingiber officinalis), Nimbu Swarasa( Lemon fruit juice extract).
Lakshadi Guggul is Ayurvedic preparation which is used in treatment of bone related problems such as healing broken bones, fractures, Improper alignment of bone, Osteoarthritis, Ostealgia (Pain in bones), Sprains, stiffness, Low bone density. This medicine contains lakh which is secretion from insect Laccifer lacca, it also contain Coccus lacca (Laksha), Terminalia Arjuna (Arjun twak), Withania somnifera (Ashwagandha), Cissus, quadrangularis (Hadjor), Sida veronicaefolia (Nagbala), Purified Commiphora mukul (Shuddh Guggul).
Sunthi (Zingiber officinale): Ginger inhibits both COX-2 and 5-LOX and further functions as an antioxidant. [6]-gingerol is a potent inhibitor of NO synthesis and also an effective protector against peroxynitrite-mediated damage. In the present invention crude ginger powder is used.
Ginger contains 1-4% essential oil (oleoresin). This essential oil contains mixture of various terpenes as well as some other non-terpenoid compounds. Due to large number of compounds belonging to various chemical classes, it is likely that crude ginger powder intake brings about amelioration of symptoms by interfering with the production and release of products of lipid membranes (eicosanoids, reactive oxygen), peptides and proteins (lysosomal enzymes, growth factors, lymphokines, bradykinin), amino acids (histamin, serotonin) etc. Ginger gives relief from muscular discomfort and pain. In a multicentric, randomnized controlled trial, a highly purified and standardized ginger extract showed statistically significant effect on reducing symptoms of OA of the knee. It inhibits prostaglandin and leukotriene biosynthesis

and histamine release and thus acts as an anti-inflammatory agent. Ginger root has been used for thousands of years to treat inflammatory diseases, including osteoarthritis.
Ginger extract was compared to placebo and Ibuprofen in patients with osteoarthritis of the hip or knee in a controlled, double blind, double dummy, cross-over study with a wash-out period of one week followed by three treatment periods in a randomized sequence, each of three weeks duration. Acetaminophen was used as rescue medication throughout the study. A ranking of efficacy of the three treatment periods: Ibuprofen>ginger extract>placebo was found for visual analogue scale of pain (Friedman test: 24.65, P<0.00001) and the Lequesne-index (Friedman test: 20.76, PO.00005). In the cross-over study, no significant difference between placebo and ginger extract could be demonstrated (Siegel-Castellan test), while explorative tests of differences in the first treatment period showed a better effect of both Ibuprofen and ginger extract than placebo (Chi-square, P<0.05). There were no serious adverse events reported during the periods with active medications. (Blidda, H. et. al., Osteoarthritis Cartilage, 2000, 8(1):9-12). Effect of different concentrations (0-2,000 microg/mL) of ginger root extract (GRE) on the viability and the production of nitric oxide (NO) and prostaglandin E (2) (PGE (2)) by sow osteoarthrotic cartilage explants has been investigated. Increasing GRE concentration (1-100 microg/mL) reduced (P<0.05) NO and PGE (2) production suggesting an important role for GRE as an anti-arthritic agent in osteoarthritis in sow. (Shen, C. L. et. al., J Med Food, 2003, 6(4):323-8).
It is a dual-inhibitor of the lipoxygenase and cyclooxygenase system. (Srivastava, et. al, Medical Hypotheses, 1992, 39:342-48). Melatonin, a constituent of ginger, has

been found to exert potent anti-inflammatory effects via COX-2 inhibition. (Cuzzocrea, S. et. al, J. Pineal Res., 1999, 27(1):9-14; Hattori, A. et. al, Biochem. Mo) Biol Int, 1995, 35(3):627-34; Srivastava, K. C. et al, Biomed Biochim Acta, 1984, 43(8-9): S335-46; Katiyar, S. et. al. Cancer Res, 1996, 56(5): 1023-30). The ability of 20 pungent constituents of ginger and related substances to inhibit arachidonic acid (AA) induced platelet activation in human whole blood was studied. [8]-Gingerol, [8]-shogaol, [8]-paradoI and gingerol analogues (1 and 5) exhibited antiplatelet activities with 1C (50) values ranging from 3 to 7 microM, whilst under similar conditions the IC (50) value for aspirin was 20+/-11 microM. The findings show that gingerol compounds and their derivatives are more potent anti-platelet agents than aspirin under the conditions described in this study. [8]-Paradol, a natural constituent of ginger, was found to be the most potent COX-1 inhibitor and antiplatelet aggregation agent. The mechanism underlying AA-induced platelet aggregation inhibition may be related to attenuation of COX-l/Tx synthase enzymatic activity. (Nurtjahja-Tjendraputra, E. et. al, Thromb Res, 2003, 111(4-5): 259-65). Another constituent of ginger, eugenol has also been found to be a 5-lipoxygenase inhibitor and to possess potent anti-inflammatory and/or anti-rheumatic properties. (Sharma, J. N. et. al, Pharmacology, J994, 49(5):314-8). The effects of the crude hydralcoholic extract of ginger rhizomes have been investigated on the classical models of rat paw and skin edema. The carrageenan-, compound 48/80- or serotonin-induced rat paw edema was inhibited significantly by the intraperitoneal administration of alcoholic ginger extract. The antiedematogenic activity seems to be related, at least partially, to an antagonism of the serotonin receptor. (Penna, S. C. et. al, Phytomedicine, 2003, 10(5):381-5)

Recent reports suggest ginger might be a potent and novel therapeutic agent for scavenging of NO and the regulation of pathological conditions caused by excessive generation of NO and its oxidation product, peroxynitrite. (Baliga, M. S. et. al., Nahrung, 2003, 47 (4):261-4). Another study indicates that [6]-gingerol is a potent inhibitor of NO synthesis and also an effective protector against peroxynitrite-mediated damage. (Jppoushi, K. et. al., Life Sci, 2003, 73(26): 3427-37).
Used alone fresh ginger is required to be used in substantially high doses (50 gm daily), which is not only inconvenient but can act as an irritant to the gastric mucosa. In dry form for any significant results 7-10 gm of dry ginger powder has to be taken daily. These therapeutic doses of ginger are extremely inconvenient for the patient and affect compliance on a daily basis. (U.S.5,494,668).
Deodaru (Cedrus deodara) is also known as Himalayan cedar doors are gymnosperms, Pinaceae, cedar species, widely cultivated in our country. The pharmacological effect of deodaru include expelling blood, eyes and nerves, pain relief itching, can treat influenza, rheumatoid arthritis, hypertension diseases. Other studies show that with analgesic anti-inflammatory, antitussive and anti-asthmatic, adjusting blood fat, anti-aging, anti-oxidation, anti-tumor and antibacterial variety of pharmacological effects.
Sahachar is (Barleria Prionitis) is is spinescent bushy shrub native to India & Sri Lanka., Its leaves are known to contain 6-Hvdroxyflavone, one of the chemical compounds that is a noncompetitive inhibitor of the protein cytochrome P450 2C9. A wide range of phytochemical constituents including balarenone, pipataline prionisides, barlerinoside, verbascoside, shanzhiside methyl ester, barlerin, acetylbarlerin, lupulinoside, scutetlarein have been isolated from the different parts of this plant. Extracts and isolated phytochemicals from this plant have been found to

posses wide range of pharmacological include anti-inflammatory, anti-arthritic, antimicrobial, anthelmintic, antifertility, antioxidant, antidiabetic, cytoprotective, hepatoprotective, diuretic, antidiarrhoeal, enzyme inhibitory and antinociceptive activities without any toxic effects.
Guduchi (Tinospora cordifolia)! Gw/ve/:Guduchi, described as a rasayana plant in Ayurveda is used for its immunomodulatory, adaptogenic, antistress and antioxidant properties. It inhibits prostaglandin and leukotriene biosynthesis and histamine release. Thus it acts as an anti-inflammatory as well as an antacid agent.
Guduchi is widely used in Ayurvedic medicines. It is known for its immunomodulatory, antihepatotoxic, antistress and antioxidant properties. It has been used in combination with other plant products to prepare a number of Ayurvedic preparations. (Tasaduq, SA. et. al., Hum Exp Toxicol, 2003, 22(12): 639-45; Diwanay, S. et. al, J Ethnopharmacol, 2004, 90(1): 49-55; Goel, HC. et. al., Indian J Exp Biol, 2002, 40(3): 282-7.). Guduchi, a rasayana plant from Ayurveda has been shown to have adaptogenic potential (Rege, N. N. et. al., Phytother Res,. 1999, 13(4): 275-91). The immunomodulatory activity of tinospora cordifliahas been widely studied (Nair, P. K. et. al., Int Immunopharmacol, 2004, 4(13):1645-59; Jagetia, G. C. et. al., J Med Food, 2004, 7(3):343-8; Spellman, K., et. at, Altem Med Rev, 2006, 11(2):128-150).
The active principles of Guduchi were found to possess anticomplementary and immunomodulatory activities. Syringin (TC-4) and cordiol (TC-7) inhibited the in vitro immunohaemolysis of antibody-coated sheep erythrocytes by guinea pig serum.

The reduced immunohaemolysis was found to be due to inhibition of the C3-convertase of the classical complement pathway. However, higher concentrations showed constant inhibitory effects. The compounds also gave rise to significant increases in IgG antibodies in serum. Humoral and cell-mediated immunity were also dose-dependently enhanced. Macrophage activation was reported for cordioside (TC-2), cordiofolioside A (TC-5) and cordiol (TC-7) and this activation was more pronounced with increasing incubation times. (Kapil, A. et. al. J Ethnopharmacol, 1997, 58(2): 89-95). T. cordifolia has been found to be a potent immunostimulant, with effects comparable to lithium and glucan. (Thatte, U. M. et. al., Methods Find Exp Clin Pharmacol, 1988, 10(10):639-44). Immunomodulatory and anti-tumor actions of medicinal plant Tinospora cordifolia are mediated through activation of tumor-associated macrophages (Singh, N, et. al., Immunopharmacol Immunotoxicol, 2004, 26(1): 145-62).
Gokshur (Tribulus terrestris):Tribulus terrestris has potent anti-inflammatory activity through inhibition of COX-2.The inhibitors of prostaglandin biosynthesis and nitric oxide production have been considered as potential anti-inflammatory and cancer chemo preventive agents. Methanol extract of Tribulus terrestris has been tested' for the inhibition of prostaglandin E (2) production (for COX-2 inhibitors) and nitric oxide formation (for iNOS inhibitors) in lipopolysaccharide (LPS)-induced mouse macrophages RAW264.7 cells. Tribulus terrestris showed potent inhibition of COX-2 activity (>80% inhibition at the-test concentration of 10 micro gram/ml) (Hong, C. H. et. al., J Ethnopharmacol, 2002, 83(1-2):153-9)

Accordingly, the main embodiment of the present invention relates to a synergistic herbomineral composition useful for the treatment of musculoskeletal disorder, said composition comprising a therapeutically effective amount of Sameer Pannag Rasa, Mahavatvidhwansa Rasa, Laxadi Guggul and extracts obtained from the plants Sunthi (Zinziber officinalis), Deodaru (Cidrus Deodaru), Sahachar, Gulvel extract, Gokshur, Guduchi extract, optionally along with pharmaceutical^ acceptable additives.
In one embodiment the extracts are selected from plant parts of Sunthi (Zinziber officinalies), Deodaru (Cidrus Deodaru), Sahachar, Gulvel extract, Gokshur, Guduchi extract, the plant part for extraction are selected from not limiting to flower, leaves, seed, fruits, root, rhizome and aerial parts.
In another embodiment, the additives are selected from binders, diluents and lubricants and preservatives. In further embodiments, the binders used include starch, starch paste, gum acacia and carboxy methyl cellulose, the diluent used include lactose, and the lubricants used include starch and lactose.
In another preferred embodiment, the present invention provides a novel synergistic herbal-mineral composition comprising combination of therapeutically effective . amount of,
a) Sameer Pannag Rasa in an amount of about 2-12%;
b) Mahavatvidhwansa Rasa in an amount of about 10-24%;
c) Laxadi Guggul in an amount of about 10-95%;
d) Sunthi in an amount of about 10-95%;
e) Deodaru in an amount of about 10-95%;

f) Sahachar in an amount of about 10-95%;
g) Gulvel extract in an amount of about 02-48%;
h) Gokshur in an amount of about 10-95%; of the total composition along with pharmaceutically acceptable additives.
In another preferred embodiment, the present invention provides a novel synergistic herbal-mineral composition comprising combination of preferred therapeutically effective amount of.
a) Sameer Pannag Rasa in an amount of about 4.76 % wt;
b) Mahavatvidhwansa Rasa in an amount of about 9.52% wt;
c) Laxadi Guggul in an amount of about 47.61 % wt;
d) Sunthi in an amount of about 9.52% wt;.
e) Deodaru in an amount of about 9.52% wt;

f) Sahachar in an amount of about 9.52% wt;
g) Gulvel extract in an amount of about 9.52% wt;
h) Gokshur in an amount of about 9.52% wt of the total composition along with pharmaceutically acceptable additives.
In another embodiment, the present invention provides a novel synergistic herbomineral composition is suitable for oral, nasal, topical (including buccal and sublingual), vaginal or parenteral (including subcutanous, intramuscular, intravenous, intradermal, intrathecal, intraocular and epidural) and rectal administration and also in other pharmaceutically accepted drug delivery systems.
In another embodiment, the present invention provides a novel synergistic herbomineral composition suitable for oral administration may be presented as

discrete units such as capsules, cachets or tablets each containing a predetermined amount of active ingredient; as powder or granules; these granules or powder are subjected to oral formulation, either compressed to tablet, Sustained release tablets or filled into capsules or are dispensed as fast melt granules, or coated or masked granules. Also powder is subjected to smooth paste or suspension, or in other pharmaceutically accepted form
In another embodiment, the present invention provides a novel synergistic herbomineral composition particularly in the form of a tablet or capsule.
The herbomineral composition of the present invention is suitable for both humans as well as veterinary use, consists of a synergistic combination of aforesaid herb extracts together with one or more acceptable carriers and optionally ingredients. The carriers must be acceptable in the sense of being compatible with the other ingredients of the formulation and not deleterious to the recipient thereof.
Still another embodiment involves where the plant extracts comprise about 8-27% wt of the total composition. Bhawana (Trituration) is the process mentioned in Ayurveda used to amplify properties of formulations. In this process aqueous extracts or decoction of herbs of desired properties are added to formulation and triturate until it dries up. Same process can be repeated for three time to 'twenty one times as per efficacy required. While decoction derived from Gokshur, Sunthi, Deodaru Sahachar used for levitation for three times. Decoction is prepared by heating herbs/part of plants-in water (4 /8/16/times) till it reduces to desire volume (1/4 or 1/8). This is unique method of herbal extraction wherein maximum active Component gets extracted in water.

In another embodiment, a method is provided for preparing a herbo mineral composition wherein the said method comprises the steps of:
a) Mixing of fine powder of Sameer Pannag Rasa , Mahavatvidhwansa Rasa and Laxadi Guggul in Mass mixture for 1 hr.;
b) blending mixture of fine powder of Sunthi (Zinziber officinalies), Deodaru (Cidrus Deodaru), Sahachar, Gulvel extract in Mass mixture for 2 hrs.
c) Preparation decoction :-

1. Add water (8 times) to herbs; Gokshura, Sunthi (Zinziber officinalies), Deodaru (Cidrus Deodaru) and Sahachar.
2. Heat & reduced up to 1/8 to prepared decoction ( Kwatha)
3. Filter decoction though mesh sizeofl00#

d) Add decoction to powder blend in Edge runner mixer till it get absorbed completely.
e) Transfer wet mixture to tray dryer for drying at temperature 60-75 C for next 24 hrs.
f) Pass dried mixture though multi Mill to prepare Powder of mesh size 80#
g) Use above mixture with or without excipient for different pharmaceutical dosage form such as tablet, capsule etc.
In another embodiment, this novel formulation decoction of Deodaru, Sunthi, Gokshur, Sahachar are used for bhawana (three times each) to improve anti -inflammatory, analgesic properties of formulation. It reduces the pain by blocking neuromuscular junction so that central nervous system fails to percept p-substance

(pain substance). Through its anti- inflammatory it reduces underlying pathological changes which lead prolonged relief as compare to other available pain killer. The herbomineral compositions of the present invention show activity as potent mucoprotectants. In another embodiment, the herbomineral compositions of the present invention show efficacy in the protection of adjuvant induced chronic arthritis as well as in the treatment of chemical mediator-induced arthritis. In still another embodiment, the herbomineral compositions of the present invention show potent anti-inflammatory activity in acute and chronic inflammation. In still another embodiment the herbomineral compositions of the present invention show efficacy in the treatment of simple pain acting centrally and peripherally. This formulation can be used for the treatment of rheumatoid arthritis, backache, Cervical/lumbar Spondylitis, sprains, joint pains, general headache and headache due sinusitis etc, inflammations, Osteoarthritis, Muscular spasm, Frozen shoulder, Gout, Arthralgia and other muscular pain.
The safety and clinical efficacy of the composition is proved on humans with effective relief and treatment of musculoskeletal disorder like inflammation and pain related problems.
The present invention is further described with the help of the following examples, which are given by way of illustration all the parts, percent's and ratios are by weight unless otherwise indicated and therefore should not be construed to limit the scope of the invention in any manner.

EXAMPLES:
Ingredients of composition in weight percentage range or in other unit in following
conditions:
Example 1:
Preparation of Decoction:
Ingredient Qty
Gokshur 238 mg
Sunthi 119 mg
Sahachar 119mg
Deodaru 319 mg
Preparation decoction by adding 8 times water to herbs, Gokshura; Sunthi (Zinziber officinalies), Deodaru (Cidrus Deodaru) and Sahachar. Heat & reduced up to 1/8 to prepared decoction (Kwatha) and filter it.
Example 2: Preparation of Powder Blend
Ingredients Quantity for 250 mg dosage
Samir Pannag Rasa 1.1.9 mg
Mahavat Vidhvansa Rasa 23.8 mg
Laxadi Guggulu 119.02 mg
Sunthi 23.8 mg
Deodar 23.8 mg

Sahachar 23.8 mg
Gulvel extract 23.8 mg
Powder blend is prepared by mixing of fine powder of Sameer Pannag Rasa, Mahavatvidhwansa Rasa and Laxadi Guggul for 1 hr., To this blend mixture of fine powder of Sunthi (Zinziber officinalies), Deodaru (Cidrus Deodaru),Sahachar, Gulvel extract for 2 hrs.
Example 3: Preparation of Unit dosage form
Decoction from example 1 is added to powder blend of example 2 till it get absorbed completely. Wet mass is dried at temperature 60-75°C for next 24 hrs. Dried mixture is passed through multi mill to prepare powder was compressed as tablet also can be filled in capsule.
Example 4: Anti-inflammatory & analgesic activity
Anti-inflammatory & analgesic activity is tested in patient by using Visual analogue scale for assessment, 30 patients with severe symptoms of musculoskeletal disorder were treated,with synergistic herbal-mineral tablets, where on body weight the dosage was calculated with minimum dosage of 250mg divided and maximum of 1050 mg, for the same results are as below

Sr.no
Symptoms Before treatment After treatment Difference % of relief
1 Pain 2.13 0.71 1.42 66.40
2 Tenderness 1.76 0.53 1.23 68.86
3 Stiffness 0.56 0.16 0.40 70.50
4 Swelling 1.33 0.35 0.98 73.75
Table no. 1: Anti-inflammatory & analgesic activity

Parameter No.of Patient %
Cured 10 35
Remarkably improved 14 46.66
Improved 4 15
Unchanged 2 8.34
Table no. 2: Results of Anti-inflammatory & analgesic activity
The formulation shows significant improvement in peripheral analgesic activity, the efficacy of combination of active principle of ingredients used in combination are more than the additive efficacy of the active principles of individual ingredients. Thus, it is seen that the combination of Sameer Pannag Rasa, Mahavatvidhwansa Rasa, Laxadi Guggul, Sunthi (Zinziber officinalies), Deodaru (Cedrus Deodaru), Sahachar (Barleria Prionitis), Gulvel (Tinospora cordifolia) extract, Gokshur (Tribulus terrestris) extracts has better synergistic result in the treatment of muscoskeletal diseases and its related disorder.

Example 5: Toxicity studied
LD50 of QUINTACHE TABLETS was observed to be 3981.0 mg kg in rats and 5012.0 mg/kg in mice when administered orally.
it will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative example and that the present invention may be embodied in other specific forms without departing from the essential attributes thereof, and it is therefore desired that the present embodiments and examples be considered in all respects as illustrative and not restrictive, reference being made to the appended claims, rather than to the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

We claim,
1) An novel synergistic Herbal-mineral composition comprising combination of therapeutically effective amount of:
a) Sameer Pannag Rasa in an amount of about 2-12%;
b) Mahavatvidhwansa Rasa in an amount of about 10-24%;
c) Laxadi Guggul in an amount of about 10-95%;
d) Sunthi in an amount of about 10-95%;
e) Deodaru in an amount of about 10-95%;

f) Sahachar in an amount of about 10-95%;
g) Gulvel extract in an amount of about 02-48%; h) Gokshur in an amount of about 10-95%;
along with pharmaceutically acceptable additives, useful for the treatment of musculoskeletal disorder and related symptoms.
2. The novel synergistic Herbal-mineral composition as claimed in claim 1, wherein said plant extracts are obtained from leaf, rhizome or aerial plant parts.
3. The novel synergistic Herbal-mineral composition as claimed in claim 1, further comprising a pharmaceutically acceptable additive, wherein said additive is a binder, a diluent, disintegrant or a lubricant
4. The novel synergistic Herbal-mineral composition as claimed in claim 1, wherein said composition is formulated for oral delivery, and wherein said composition is in the form of a tablet, a capsule, a powder, paste, or a liquid.
5. Process for preparation of novel synergistic Herbal-mineral composition as claimed in claim 1 comprising steps :
i) Mixing of fine powder of Sameer Pannag Rasa , Mahavatvidhwansa Rasa and Laxadi Guggul in Mass mixture for 1 hr;

j) blending mixture of fine powder of Sunthi (Zinziber officinalies), Deodaru (Cidrus Deodaru), Sahachar, Gulvel extract in Mass mixture for 2hrs. k) Preparation decoction :-
i. Add water (8times) to herbs; Gokshura, Sunthi (Zinziber
officinalies), Deodaru (Cidrus Deodaru) and Sahachar. ii. Heat & reduced up to 1/8 to prepared decoction (Kwatha) iii. Filter decoction though mesh size of 100# 1) Add decoction to powder blend in Edge runner mixer till it get absorbed
completely. m) Transfer wet mixture to tray dryer for drying ay temperature 60-75°C for
next 24 hrs n) Pass dried mixture though multi Mill to prepare Powder of mesh size 80# o) Use above mixture with or without excipient for different pharmaceutical oral dosage.
6. The novel synergistic Herbal-mineral composition as claimed in claim 1, is useful in treating painful musculoskeletal conditions such as osteoarthritis, Rheumatoid arthritis, Muscular spasm, anklosing spodylitis, sprain , frozen Shoulder, Gout etc