The following specification particularly describes the invention and the manner in which it is to be performed: Technical Field
The present invention relates to an herbal health protective and promotive nutraceutical formulations. Background Art
It is increasingly being realized that a majority of the disease of today are due to the shift in the balance of the pro-oxidant and the antioxidant homeostatic phenomenon in the body. Pro-oxidant conditions dominate either due to the increased generation of the free radicals or due to the excessive oxidative stress of the current life or due to the poor scavenging/ quenching in the body due to the depletion of the dietary antioxidants. Thus antioxidants has become the most common prescription drug of today. Further work at the molecular level and clinical trials of the extracts and formulations will ensure that the formulation meets the needs of the society. The development of next generation antioxidants consisting traditional natural plants. Their ingredients have tremendous impact on the health care system and may provide medical health benefits including the prevention and or treatment of diseases. Antioxidants have potential to be used as supplyment along with preventive medicines. The major phytonutrients identified to have antioxidant properties include terpenes,
phytosterols. phenols, vitamins and theols. Carotenoids found in green leafy vegetables like amaranth. Chenopodium (goose foot),mustard,'Methi', spinach and cabbage etc are precursor of vitamin A. They have preventive action against many eye diseases, cancer and also acts as antioxidant. Limonoids also acts as antioxidants by protecting lung tissues from oxygen free radicals. Antioxidants have been associated with reduced risk of cardiovascular diseases and several types of cancer. They are known to act to defuse the volatile toxic molecules of free oxygen radicals, a by-product of cell metabolism.
These are also produced in the body on exposure to sunlight. X-rays, ozone, tobacco smoke, auto-exhaust and other environmental pollutants. Carotenoids. tocopherols, ascorbates andpolyphenols are strong natural antioxidants generally found in plants and foods.They enhance thebody's detoxification activity and protect against certain type of cancers by eliminating ill health causing chemical from the body to prevent degenerative diseases. Phytosterols competes with dietary cholesterol for uptake in intestine thereby blocking cholesterol absorption into the body and can also prevent the development of tumor in breast and prostate glands. Phenols a large group of phytonutrients, with sub classes in flavonoids, biflavonoids, anthocyanines and isoflavonoids have profound importance in preventive
medicine. Berries, grapes and eggplants are rich in phenolics and have protective action against oxidative damage of tissues and inflammation. It has been proved that phytochemicals can enhance the efficacy of vitamin C, can also act against allergies, ulcers, tumors, platelet aggregation, controlling hypertension and can reduce the risk of estrogen induced cancer.
The present invention provides a process for the preparation of synergestic herbal antioxidant formulation with specific combination herbs/medicinal plants with significant medicinal values to provide optimum balance of free radica in body and general health protective, preventive and promotive benefits. To the best of our knowledge any process for antioxidant preparation does not exist comprising a synergestic combination of four herbal drugs/medicinal plants used in the present investigation.
Prior art References Reference is made to Khanna, N.M., Current Set 76:! 351-1356, 1999; Ammon, H.P.T., Wahi M.A. Planta Med 57:1-7, 1991.showed that Curcuma longa is used as an antacid, carminative, stomachic, blood purifier, wound healing, anti-inflammatory, antibacterial, antiviral and antioxidant activities. Reference is made to book of Kirtikar K.R, Basu B.D. Indian Medicinal Plants 1975 which showed that Zingiber officinale is a valuable medicine because of its action as rubifacierit, antiasthmatic and stimulant to the gastrointestinal tract. Reference is made to Jose JK, Kuttan G, Kuttan R . .1 Ethnopharmacol 75:65-69 2001; Bhattacharya A, Chatterjee A, Ghosal S, Bhattacharya SK. Indian J Experimental Biol 37:676-680,1999 showed that Embtica officinalis have been reported to possess antioxidant and antitumor properties. Reference is made to Singh HK, Dhawan BN. Indian J Pharmacol 10:72, 1978; Tripathi YB, Chaurasia S, Tripathi E, Upadhyay A, Dubey GP. Indian J Experimental Biol 34:523-526, 1996 showed that Bacopa monneirci is reported to be useful in the treatment of epilepsy and as a memory enhancer and antioxidant activity. Reference is made to a Bhattacharya, A., Muruganandam, A.V., Kumar, V., Bhattacharya. S.K. Indian J Exp Biol 40(10), 1161-1163.2002 who studied the effect of poly herbal formulation, EuMil, on neurochemical perturbations induced by chronic stress. EuMil. a polyherbal formulation consisting of standardised extracts of Withania somnifera (L) Dunai. Ocimum sanctum L, Asparagus racemosus Wilid and Emblica officinalis Gaertn., is used as an anti-stress agent to attenuate the various aspects of stress related disorders. In the present study, the neurochemical mechanisms underlying the anti-stress activity of EuMil were evaluated by measuring the rat brain monoamine neurotransmitter levels and tribulin activity. The amelioration of chronic stress-induced neurochemical perturbations by EuMil explains
the neurocheinical mechanisms underlying the observed putative anti-stress activity of the product. Jena G.B., Nemmani, K.V., Kaul, C.L., Ramarao, P. Phytother Res 17(4), 306-310, 2003 evaluated the effects of a polyherbal formulation, lmmu-21. against cyclophosphamide (CP)-induced chromosomal aberrations (CA) and micronuclei (MN) in mice. CP alone (40 mg/kg, i.p.) produced classical as well as non-classical chromosomal aberrations in mice, and the incidence of CA was significantly more in the CP treated group when compared with that of the control group, [mmu-21, which contains extracts of'Ocimum sanctum. Withaniu \omnifera, Emblica officinalis and Tinospora cordifolia, was given at 100 mg/kg, daily, over 7 days, and 30 mg/kg daily over 14 days and inhibited both CP-induced classical and non-classical chromosomal aberrations (approximately 40%-60% of control). The present results indicate that chronic treatment with lmmu-21 prevented CP-induced genotoxicity in mice. Reference is made to patent (Patent no. United States Patent 20040009240) wherein a herbal formulation was prepared containig Withania somnifera, Chlorphyton borivilianum, Boerhavia diffusa, Elephantopus scaber. Moringa oleifera, Tecoma undulata, Bauhinia purpurea, Ficus racemosa, Cyperus rotundus, Sphaeranthus acmella and Tinospora cordifolia; or a mixture of the active ingredients that have been extracted from those herbs or chemically synthesised. The herbal formulation of the invention is effective for the treatment of cancer, in particular squamous cell carcinomas, tumours and other metastaiic states, including lung cancer.
A literature survey and internet screening revealed that antioxidant formulation comprising a proper combination of natural herbs and medicinal plants usedin this study, has not yet been prepared to provide adequate health protective benefits.
Objects of the invention The main object of the present invention relates to the custom made tailored herbal composition (s), in a proper combination of natural edible seeds, herbs/ medicinal plants to provide health protective, preventive and promotive benefits for general health care.
Another object of the present invention is to provide an herbal health protective nutraceutical formulation, which obviates the drawbacks as detailed above.
Another object of the present invention is to formulate a synergestic combination of herbs/medicinal plants with promising potential for the development of base' material to provide essential protective effect against oxidative stress.
Still another object of the present invention is to develop health protective and preventive antioxidant formulation as food supplements with specific functional attributes by fortifying nutritional base material with herbs/medicinal plants.
Yet another object of the present invention is to provide antioxidant formulation for optimum nutrition, general health promotive and well being of the human to ameliorate the general health.
Summary of the invention The present invention relates to the custom made tailored antioxidant functional composition (s), in a proper synergestic combination of natural herbs/medicinal plants to provide optimum health protective, preventive and promotive benefits for general health care of humans.
Detailed description Accordingly, the present invention provides a herbal health protective, promotive antioxidant formulation for human beings, said formulation comprising plant parts/products selected from the four plants and an extracts in synergestic combintion. Also, the present invention provides a composition used as a herbal health protective, promotive antioxidantl formulation for humans, said composition comprising the said formulation consisting of plants parts powder mixture herbs/medicinal plant extract, and the composition further comprising additives like lactose starch paste etc. The present invention also provide a process for the preparation of custom made herbal health protective, synergestie antioxidat formulations which may be used as antioxidants to ameliorate the general health of humans.
Process The process comprises the whole plant rhizome from selected plant Bacopa monnien, Curcuma longa, Emblica officinallis and Zingiber officinaie may be powdered separately to pass through a sieve ranging from 50 to 400-mesh, the herb powders may be mixed ranging from 0 to 75% to get the base products, in a mixer grinder ranging from 5 to 55 minutes and may be collected from different natural sources in India and may be cut into small pieces 1-10 cm, dried under shade ranging from 20 to 50 °C, crushed and powdered ranging from 10 to 20-mesh separately, the powdered roots, fruits, bark, whole plant of natural authentic herbs/medicinal plants may be mixed ranging from 0 to 50% and may be extracted with aqueous alcohol mixture ranging from 5 to 90% v/v thrice for a period ranging from 24 to 72 hours, the alcohol may be selected from a group of methanol. ethanol, propanol and butanol, at temperature ranging from 20 to 50°C, the solvent from combined extractives may be removed under reduced pressure ranging from 20 to 100 psi at a temperature ranging from 25 to 65 °C and the viscous residue thus obtained may be called as
the plants extract, the residue may be suspended in water/alcohol in the ratio ranging from 20 to 70% and mixed with mixer grinder for a period ranging from 10 to 50 minutes, the suspension of plants extract may be mixed with the mixture additives ranging in the ratio from 0.4 to 20% and mixed thoroughly for a period of ranging from 10 to 50 minutes, the plants extract mixture may be dried for a period ranging from 12 to 48 hours at a temperature ranging from 30 to 50°C, the dried plants extract mixture may be again mixed thoroughly in a mixer grinder for a period of ranging from 5 to 50 minutes, to get the final antioxidant products in the mixture of base product and plants extract, some additional ingredients to get the antioxidants. The end product may be used in the form of powder, granules, tablet or capsule etc. The combination of the present antioxidanr is not a mere admixture of the ingredients used resulting in aggregation of their properties but a mixture having synergistically enhanced properties useful as food supplement for health protective, preventive and promotive benefits of the humans.
Embodiments: In an embodiment of the provides a herbal health protective, promotive and antioxidant formulation for humans wherein the said formulation comprising herbs/their products selected from the group consisting of plant Bacopa monnieri, Curcuma longa. Emblica officinallis and Zingiber officinale.
Novelty The novelty of present invention is the specific combination of Bacopa monnieri. Curcuma longa, Emblica officinallis and Zingiber officinale herbs/medicinal plants and the process for the preparation of herbal antioxidant formulation. The antioxidants are with optimum nutrition, non toxic, natural herbal plant products, easy to digest, have protective, preventive and health promotive properties for the best health and vigour. The present invention provides value added products with synergistic health promotive, protective and preventive effects of natural herbs/medicinal plants to get specifically designed antioxidant for well balanced natural plants, to get optimum effect against free radicals for general health protective benefits.
The combination of the present antioxidant have synergistic health protective and promotive properties useful against free radical induced disease. A pharmaceutical or medicinal preparation wherein the amount of the herbs is as under: Bacopa monnieri: Curcuma longa, : Emblica officinale : Zingiber officinale 1:1:1:1 to 5:5:5:5.

Claim:
1. A herbal health protective, promotive and synergestic antioxidam formulation which
comprises a mixture of the following four herbs: Bacopa monnieri, Curcuma longa,
Emblica officinale and Zingiber officinal? (in the ratio 1:1:1:1 to 5:5:5:5) or a mixture
of the active ingredients that have been extracted from those herbs or their extracts.
2. A herbal formulation as claimed in claim 1 wherein, the said herbs/medicinal plant
parts used is selected from rhizome, fruits, and whole plants.
3. A composition as claimed in claim 1 wherein, the composition is suitable for use in
the form of powder, granules, tablets, syrups or capsules.
4. A process for the preparation of herbal health protective, promotive antioxidant
compositions useful as food supplements to ameliorate the general health.
5. A process as claimed in claim 1 wherein, the herbs/medicinal plant parts are cut into
small pieces ranging from 1 to 10 cm, dried under shade at a temperature ranging
from 20 to 50°C and crushed to coarse powder having size ranging from 10 to 20
mesh before extraction.
6. A process as claimed in claim 1 wherein, the powdered herbs/medicinal plants
mixture is extracted with aqueous alcohol in the range of 5 to 90% v/'v thrice or 24 to
72 hours, at a temperature ranging between 20 to 50 °C.
7. A process as claimed in claim 6 wherein, the alcohol used is selected from methanol,
ethanol, propanol and butanol.
8. A process as claimed in claim 6 wherein, the said solvent from the combined extracts
is removed under reduced pressure ranging from 20 to 100 PSI at a temperature
ranging from 30 to 65 °C to obtain viscous residue which is called as plants extract.
9. A process as claimed in claim 3 wherein, the dried plants extracts and additives are
again mixed thoroughly in a mixer grinder for a period ranging from 5 to 50 minutes
and obtaining the powder which is used to prepare final nutraceuticals.
10. A process as claimed in claim 3 wherein, the mixture is dried for a period ranging
from 24 to 72 hours at a temperature ranging between 30 to50 °C.