FIELD OF THE INVENTION
The present invention relates to a herbal preparation as composition for therapeutic and prophylactic management of neurological disorders. More specifically it relates to a herbal composition comprising processed parts of plants Ricinus communis, Wrightia arborea and Calendula officinalis, along with pharmaceutically acceptable adjuvants, excipients and necessary solvents for preventing and treating epilepsy and associated neurological conditions. The invention further relates to process (es) of preparing said herbal composition in form (s) of formulation.
BACKGROUND OF THE INVENTION
Epilepsy is characterized as a group of neurological diseases described by epileptic seizures. Epileptic seizures are episodes that can vary from brief and nearly undetectable to long periods of vigorous shaking. An epileptic seizure (colloquially a fit) is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure). Diseases of the brain characterized by an enduring predisposition to generate epileptic seizures are collectively called epilepsy.
The cause of most cases of epilepsy is unknown, although some people develop epilepsy as the result of brain injury, stroke, brain tumors, infections of the brain, and birth defects. Known genetic mutations are directly linked to a small proportion of cases. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the cortex of the brain.
The mainstay treatment of epilepsy is anticonvulsant medications, possibly for the person's entire life. The choice of anticonvulsant is based on seizure type, epilepsy syndrome, other medications used, other health problems, and the person's age and lifestyle. A single medication is recommended initially; if this is not effective, switching to a single other medication is recommended.
There are a number of medications available. Phenytoin, carbamazepine and valproate appear to be equally effective in both partial and generalized seizures but accompany side effects along. Adverse effects from medications are reported in 10 to 90% of people, depending on how and from whom the data is collected. Most adverse effects are dose-related and
2

mild. Some examples include mood changes, sleepiness, or un-steadiness in gait. Certain
medications have side effects that are not related to dose such as rashes, liver toxicity,
or suppression of the bone marrow. Up to a quarter of people stop treatment due to adverse
effects. Despite this, treatment is often continued once effective, because the risk of untreated
epilepsy is believed to be greater than the risk of the medications. Epilepsy surgery may be an
option for people with partial seizures that remain a problem, despite other treatments.
Alternative medications /therapies, including acupuncture, psychological
interventions, routine vitamins, and yoga, have no reliable evidence to support their use in epilepsy.
The physician who treats patients with epilepsy also encounters the task of selecting an appropriate drug or combination of drugs that may best control the conditions, seizures in a given patient at an acceptable level of adverse effects. Generally, complete control (90-100%) of seizures may be attained in as much as 50% of patients, and another 25% may evidence significant reductions in the incidence of seizures.
In view of this, there remains an unmet need to develop alternative yet effective treatment or prophylaxis to manage epilepsy and associated neurological complications, as being securely effective, natural, safe, and also cost effective.
Till date, treatments of neurological disorders have met with limited success due to side effects and toxicities associated with these therapies. Accordingly, a need exists for better approaches to neuro-protection and for improved therapies for epilepsy, and associated neurological disorders.
Thus, the present invention provides a herbal preparation for therapeutic management of epilepsy and associated neurological and neurodegenerative disorders naturally with no side effects.
OBJECTS OF THE INVENTION
In view of the foregoing disadvantages inherent in the prior arts, an object of the present invention is to provide an improved combination of convenience and utility, to include the advantages of the prior art, and to overcome the drawbacks inherent therein.
3

It is the main object of present invention to provide a herbal preparation effective for the therapeutic management of the neurological disorders with no side effects.
Another object of the present invention is to provide herbal composition effective for neurological disorders are selected from epilepsy and other seizure related complications.
Another object of the present invention is to provide herbal composition that can naturally reduce extension-to-flexion ration thereby, inducing significant reduction in seizure severity.
Further object of present invention is to provide a herbal pharmaceutical composition that acts as a cognition enhancer, thereby, reducing the effect of neurological seizure under the effect of epilepsy disease.
Still another object of present invention to provide process (es) of preparing said herbal composition for neurological disorder.
Another object of the present invention is to provide herbal composition that is safe and non-toxic.
SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.
Aspects of the present invention relates to a herbal preparation effective for the therapeutic management of the neurological disorders comprising processed whole or parts of plants Ricinus communis, Wrightia arborea and Calendula officinalis and at least one pharmaceutically acceptable carrier.
In an embodiment, the Ricinus communis, Wrightia arborea and Calendula officinalis comprises at least one part of the whole plant, parts of the plant, an extract of parts of plant,
4

and a combination thereof. Said parts of plant comprise at least one of a rhizome, a root, a bud, a tender shoot, a leaf, a stem, a fruit, a bark, a flower, a seed, and a combination thereof.
In an important embodiment, Ricinus communis is present in an amount ranging about 20% to 30%, Wrightia arborea is present in an amount ranging about 10% to 15% and Calendula officinalis is present in an amount ranging about 10% to 15% by weight of the herbal composition. Said at least one pharmaceutically acceptable carrier is selected from the group comprising of a preservative, a pH buffer, a chelating agent, a humectant, a thickener, a base, a colouring agent, a diluent, a fragrance, a solvent and a combination thereof.
In an aspect of the present invention is provided a process of preparing herbal composition for therapeutic management of neurological disorders, comprising the steps of:
i. collecting parts of Ricinus communis, Wrightia arborea and Calendula
officinalis;
ii. washing and drying the collected parts of Ricinus communis, Wrightia arborea
and Calendula officinalis at room temperature, until removal of moisture to
obtain dried plant; iii. grinding the dried plant and passing it through a sieve to obtain a herbal
powder of Ricinus communis, Wrightia arborea and Calendula officinalis
particle size about less than 200µm; iv. extracting the herbal powder with a solvent in an amount about 20% to 30%
w/v of Ricinus communis, 10% to 15% w/v of Wrightia arborea and 10% to
15% w/v of Calendula officinalis to obtain an extract;
v. filtering the extract and concentrating the filtered extract at temperature about
60°C to about 80°C for about 1 to 2 hours to obtain a concentrate; and vi. formulating the extract in a suitable dosage form to obtain final herbal
preparation.
In an embodiment, said parts of plants comprise at least one of a rhizome, a root, a bud, a tender shoot, a leaf, a stem, a fruit, a bark, a flower, a seed, and a combination thereof.
Other aspects, advantages, and salient features of the invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the exemplary embodiments of the invention.
5

DETAILED DESCRIPTION OF THE INVENTION
The following description is provided to assist in a comprehensive understanding of exemplary embodiments of the invention. It includes various specific details to assist in that understanding, but these are to be regarded as merely exemplary.
Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
The terms and words used in the following description and claims are not limited to the bibliographical meanings, but, are merely used by the inventor to enable a clear and consistent understanding of the invention.
Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention as defined by the appended claims and their equivalents.
It is to be understood that the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
Features that are described and/or illustrated with respect to one embodiment, aspects or implementations may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments, aspects or implementations.
It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
6

It is also understood that the terms “collecting”, "sieving", "washing", “grinding", "drying", "extracting", “concentrating”, used herein intend to cover all kinds of conventional methods used for the said purpose carried out at room temperature unless specified particularly herein. The term "herbal composition", as used herein, intends to cover herbal composition useful in managing neurological disorders.
As used herein, "treatment", “management” and "treating" and the like generally mean obtaining a desired pharmacological and physiological effect. The effect may be prophylactic in terms of preventing or partially preventing a disease, symptom or condition thereof and/or may be therapeutic in terms of a partial or complete cure of a disease, condition, symptom or adverse effect attributed to the disease. The term "treatment" as used herein covers any treatment of a disease in a mammal, particularly a human, an animal, and includes: (a) preventing the disease from occurring in a subject; (b) inhibiting the disease, i.e., arresting its development; or relieving the disease, i.e., causing regression of the disease and/or its symptoms or conditions.
The term "subject" as used herein refers to mammals. For examples, mammals contemplated by the present invention include humans, animals and the like.
Aspects of the present invention relates to a herbal composition for neurological disorders, comprising extracts or compounds of Ricinus communis, Wrightia arborea, Calendula officinalis and at least one pharmaceutically acceptable carrier.
In an embodiment, the Ricinus communis, Wrightia arborea and Calendula officinalis comprises at least one part of the whole plant, parts of the plant, an extract of parts of plant, and a combination thereof. Said parts of plant comprise at least one of a rhizome, a root, a bud, a tender shoot, a leaf, a stem, a fruit, a bark, a flower, a seed, and a combination thereof.
In an important embodiment, Ricinus communis, Wrightia is present in an amount ranging about 20% to 30%, Wrightia arborea is present in an amount ranging about 10% to 15% and Calendula officinalis is present in an amount ranging about 10% to 15% by weight of the herbal composition. Said at least one pharmaceutically acceptable carrier is selected from the group comprising of a preservative, a pH buffer, a chelating agent, a humectant, a thickener, a base, a colouring agent, a diluent, a fragrance, a solvent and a combination thereof.
7

Applicant of the present invention unexpectedly found that plants Ricinus communis, Wrightia arborea and Calendula officinalis useful in treating neurological disorder, particularly epilepsy.
Ricinus communis, commonly known as castor bean belong to the botanical family Euphorbiaceae. Castor is indigenous to the southeastern Mediterranean Basin, Eastern Africa, and India, but is widespread throughout tropical regions. It is a fast-growing, suckering shrub that can reach the size of a small tree, around 12 m (39 ft). The glossy leaves are 15–45 cm long, long-stalked, alternate and palmate with five to twelve deep lobes with coarsely toothed segments. The stems and the spherical, spiny seed capsules also vary in pigmentation. The flowers are borne in terminal panicle-like inflorescences of green or red, monoecious flowers without petals. The fruit is a spiny, greenish capsule containing large, oval, shiny, bean-like, highly poisonous seeds with variable brownish mottling. Castor seeds have a warty appendage called the caruncle, which is a type of elaiosome. An alcoholic extract of the leaf was shown, in lab rats, to protect the liver from damage from certain poisons. Methanolic extracts of the leaves of Ricinus communis were used in antimicrobial testing against eight pathogenic bacteria in rats and showed antimicrobial properties. The pericarp of Ricinus showed central nervous system effects in mice at low doses. At high doses mice quickly died. A water extract of the root bark showed analgesic activity in rats. Antihistamine and anti-inflammatory properties were found in ethanolic extract of Ricinus communis root bark.
Wrightia arborea belong to family Apocynaceae. A small deciduous tree reaching 7.5-9 m high, with yellow milky latex; branchlets and leaves softly tomentose. Leaves distichous, elliptic or obovate, 7-12 cm long, acuminate, entire or obscurely serrulate, velvety tomentose on both sides. Flowers about 2.5 cm across, greenish white, turning pale yellow to dull purple, in many-flowered terminal corymbose cymes. Fruit 20-30 cm long, 2 connate follicles. Leaves are used in toothache and fever. Roots are also used in fever. The latex of the plant is used to stop haemorrhage. Bark is antidysenteric; used in menstrual and renal complaints. An isoflavone, wrightiadione, has been isolated from this plant, which displays cytotoxic activity against leukaemia cells. It also contains the amoebicidal steroidal alkaloids, as those of Holarrhena antidysenterica, such as conessine, conessidine, kurchine, kurchicine,
8

conkurchine and holarrhine. Strophanthus acid (9-hydroxy-cis-12-octadecanoic acid) occurs as the major component of the seed fat.
Calendula officinalis belongs to family Asteraceae. Calendula is native to Mediterranean countries, but has been naturalized in North America and Asia and now blooms in gardens throughout the world. This plant thrives in almost any soil type, but prefers light to sandy and moderately rich, well-drained, soils. Plants grow 30-60cm high with a branching stem pattern. The lower leaves are paddle-shaped compared with the smaller pointed upper leaves. Calendula is normally resistant to pests and diseases. Calendula has been used for medicinal purposes since at least the 12th century, primarily as a topical application to boost the healing rate of wounds and prevent infection. Calendula contains high amounts of flavonoids, which are thought to increase the rate of neo-vascularization and deposit hyaluronan, the principal component of the extracellular matrix in cells. Hyaluronan contributes to cell proliferation and migration as well as the formation, alignment and migration of capillaries, which may explain why calendula speeds healing. The antifungal properties of calendula could make it useful as an herbal remedy for fungal infections like thrush, athlete’s foot, and ringworm.
For the purpose of this invention the herbs Ricinus communis, Wrightia arborea and Calendula officinalis and its parts are collected from Nawada district of Bihar state, India.
In an aspect of the present invention is provided a process of preparing herbal composition for therapeutic management of neurological disorders, comprising the steps of:
i. collecting parts of Ricinus communis, Wrightia arborea and Calendula
officinalis;
ii. washing and drying the collected parts of Ricinus communis, Wrightia arborea
and Calendula officinalis at room temperature, until removal of moisture to
obtain dried plant; iii. grinding the dried plant and passing it through a sieve to obtain a herbal
powder of Ricinus communis, Wrightia arborea and Calendula officinalis
particle size about less than 200µm; iv. extracting the herbal powder with a solvent in an amount about 20% to 30%
w/v of Ricinus communis, 10% to 15% w/v of Wrightia arborea and 10% to
15% w/v of Calendula officinalis to obtain an extract;
9

v. filtering the extract and concentrating the filtered extract at temperature about
60°C to about 80°C for about 1 to 2 hours to obtain a concentrate; and
vi. formulating the extract in a suitable dosage form to obtain final herbal preparation.
In an embodiment, where said process utilizes Ricinus communis, Wrightia arborea and Calendula officinalis comprises at least one part of the whole plant, parts of the plant, an extract of parts of plant, and a combination thereof. Said parts of plant comprise at least one of a rhizome, a root, a bud, a tender shoot, a leaf, a stem, a fruit, a bark, a flower, a seed, and a combination thereof.
In a preferred implementation, the composition comprises extracts of plant or plant parts of Ricinus communis, Wrightia arborea and Calendula officinalis in precise combination or its one or more compounds, or phyto-constituents.
In an implementation, the herbal extract is prepared in a solvent. The solvent is selected from polar, moderately polar or non-polar. More preferably, the extract is an aqueous extract.
In yet another implementation, the solvent may be selected from ethanol, methanol and water and a combination thereof.
In an implementation, the present composition is useful for managing neurological disorders, more particularly epilepsy.
In an implementation, the present herbal composition primarily be formulated in various pharmaceutical formulations with active ingredient of said plants, wherein said forms of formulation includes (but not limits to) nano-formulations, encapsulations, parenteral formulations, or any kind of enteral formulations.
In an implementation, the present invention of the herbal composition is administered in the form selected from the group of powders, tablets, capsules, syrups, liquids, solutions, suspensions, gels, and pastes.
10

In an implementation, the herbal composition may also comprise of chemical or functional equivalents or botanical equivalents of the parts of plants of Ricinus communis, Wrightia arborea and Calendula officinalis. In an implementation, additionally, one or more naturally occurring substances, medicinal herbs, or a blend thereof, may be added to enhance the effect of the herbal pharmaceutical composition. In another implementation, the herbal composition for neurological disorders may also optionally include any drug having anti-epileptic property or mixture thereof. In yet another implementation, the herbal composition may further comprise of medicaments including anti-epileptic agents, or like.
The embodiments of the present invention can be elaborated wherein the pharmaceutically acceptable excipients of said herbal composition may include but not limit to diluents, binders and adhesives, lubricants, disintegrants, preservatives, artificial sweeteners, coloring agents, bulking agents, flavoring agents, tonicity agents etc. according to the need and dosage formation of the herbal composition.
A diluent or solvent can be selected from a group comprising, (but not limited to) water, dimethylisosorbide, glycols, propylene glycol, ethyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl alcohol, diethylamine, glyceryl oleate, glycerine, myristyl alcohol, gelatin, simple syrup, cyclodextrin, polyvinyl pyrrolidone (Povidone), benzyl alcohol, glycerin, propylene glycol, ethanol, sorbitol, maltitol, xylitol, inositol, mannitol, invert sugars, sorbitol and the like or combination thereof.
According to an embodiment of the present invention, the herbal composition comprises pharmaceutically acceptable excipients which can be a buffer system. Buffer system can be selected from a group comprising sodium citrate, potassium citrate, sodium citrate di-hydrate, citric acid, citric acid monohydrate, sodium bicarbonate, potassium bicarbonate, sodium di-hydrogen phosphate and potassium di-hydrogen phosphate and combination thereof.
Said pharmaceutically acceptable carriers or additives can be preservatives also acting as flavoring agent, are the substances added to food to preserve flavor or enhance its taste and appearance. It preserves food by pickling or for example salting under the procedure of anaerobic fermentation. In a preferred embodiment, said food pharmaceutically acceptable carrier or additive in said herbal composition is of natural origin. Said pharmaceutically acceptable carrier or food additives as flavoring agents and preservatives can be selected
11

from a group comprising sugar, salt, jagerry, rosemary, spices, alcohol, glycerin, propylene glycol or a combination thereof.
Said pharmaceutically acceptable food carriers or additives can be divided into several groups as categories, although there is some overlap between them and pharmaceutically acceptable excipients disclosed earlier. Said categories includes acids as antioxidants, anticaking agents such as milk powders, antioxidants such as vitamin C, bulking agents such as starch, colouring agents, emulsifiers, flavouring agents, humectants, preservatives, stabilizers, sweeteners, thickeners etc.
In an aspect of the present invention, where the plant extract is utilized for preparation of herbal composition in processed forms of formulation, said extract of the plant Ricinus communis, Wrightia arborea and Calendula officinalis are obtained by standard solvent extraction procedures under controlled temperature. The choice of extraction solvent is typically dependent upon the chemical nature of the herbal plant component undergoing extraction, the toxicity characteristics of the solvent, boiling and freezing points of the solvent, and the like considerations. Alcohols, such as ethanol, etc., are quite suitable as extraction solvents, neat or dissolved in water, and acetone, diethyl ether and aqueous ammonia are useful solvents in select cases.
In one of the preferred embodiment water is used as solvent for extraction purposes. In an aspect the extraction procedure involves an Open Pan Boiling Technique. Accordingly, the coarsely ground powder of the plants or herbal material is subjected to a boiling pan along with required quantity of water. This mixture is then, heated/boiled and the filtrate is then collected discarding the marc. In case the extraction procedure involves a cold infusion technique, the coarse powder of the plants or herbal material is soaked in solvent for a fixed duration at room temperature and a filtrate is obtained.
The present invention is illustrated by the following best examples as preferred embodiments, so far, which is not intended to limit the effective scope of the invention.
Example 1
Plant parts of Ricinus communis, Wrightia arborea and Calendula officinalis were collected, washed and dried under shade. The dried plant parts were then grinded to obtain powder. 1.48
12

g powedered Ricinus communis was weighed and added 36 ml of water. 0.74 g powdered Wrightia arborea and 0.74 g powdered Calendula officinalis was weighed, mixed and then added 36 ml of water. Both preparations were mixed and filtered using muslin cloth. Final volume of extract after filtration was 60 ml. Taken 50 ml by adult once in a day for a month for therapeutic management of epilepsy and associated complications, naturally.
Example 2
Ricinus communis plant essentially including leaves, Wrightia arborea plant herb including bark and Calendula officinalis plant essentially including flowers were collected, washed and dried under shade until removal of moisture. The dried herbs were grinded to obtain a coarse powder. The powder was passed further through sieve to obtain powder with preferable particle size of≤2 00µm. The fine powder was then extracted in an amount about 20% - 30% w/v of Ricinus communis, 10% - 15% w/v of Wrightia arborea and 10% - 15% w/v of Calendula officinalis in a solvent, preferably water. The combined extract was then filtered and solvent was evaporated to dryness by vacuum drying at 35°C for 1 hour and a dried herbal preparation was obtained as composition and taken to effectively manage neurological disorders.
Example 3
Another process of preparing a herbal composition for therapeutic or prophylactic management of neurological disorders comprising whole or parts of plants Ricinus communis, Wrightia arborea and Calendula officinalis, said process comprises of steps: the mentioned plants were washed, wherein said plant parts preferably included leaves of Ricinus communis, bark of Wrightia arborea and flower Calendula officinalis; were shade dried in atmosphere until removal of moisture; Said dried plant parts are then pulverizing into powder form followed by passing through a mesh to obtain powder with a preferable particle size of ≤200µm. An extract was obtained by boiling said powder in a preferable amount of 100g in a suitable solvent, preferably water or alcohol or a combination thereof, at a temperature of 30 to 600C to obtain an extract with value ranging 20% - 30% w/v of Ricinus communis, 10% -15% w/v of Wrightia arborea and 10% - 15% w/v of Calendula officinalis. The extract thus obtained was filtered, through filter paper or muslin cloth and concentrated at 40 to 600C till it got considerably dried; the predefined amount of concentrated extract was reconstituted with one or more pharmaceutically acceptable excipients and suitable solvents QS to 100 ml to obtain the herbal composition in forms of formulation.
13

Example 4
Ricinus communis plant essentially including leaves, were collected, washed and dried under shade until removal of moisture. The dried plant parts were grinded to obtain a coarse powder. 20% to 30% of powdered herb was added to solvent, preferably water and kept for agitation for 1 hour and filtered through filter paper or muslin cloth. Wrightia arborea plant herb including bark and Calendula officinalis plant essentially including flowers was also collected and washed thoroughly and dried under shade until removal of moisture. The dried herb was grinded to obtain a coarse powder. 10% to 15 % of powdered herb of Wrightia arborea and 10% to 15 % of powdered herb of Calendula officinalis was added to solvent and boiled to extraction, the extract was then filtered and combined with previously obtained Ricinus communis extract. The combined extract was concentrated at 40 to 60ºC till it got considerably dried. The final dried extract was then reconstituted in a final composition: mixed with diluent with addition of at least one tableting carrier, preferably microcrystalline cellulose in an amount of 10 % to 15 % w/w, 0.5% of disintegrant, 0.05 % w/w of preservative, and 2 % w/w of sweetening agent was added followed by wet granulation. The granules obtained were then compressed to obtain the herbal composition in tablet form.
Example 5
Evaluation of anti-epileptic activity of herbal extracts using pentylenetetrazole (PTZ) – induced convulsion model
Study details:
Animal: Male Mice (Age: 7 to 9 weeks) and body weight (20-25gm)
Group-I : Vehicle control (10 ml/kg po)
Group-II : Standard control_Diazepam (10 ml/kg ip)
Group-III: Herbal extract_ (8.33 ml/kg po)
The animals were sensitized and epileptic seizure conditions were induced in the animals. Animals were injected with PTZ (80mg/kg, 10ml/kg in saline ip). Animals were observed for 1hr after injection of PTZ. Observation parameters were onset of seizure, seizure duration, number of jerks, and incidence of mortality, myoclonic jerks and incidence of generalized clonic seizure. The animals were treated with the herbal composition as mentioned.
14

Results:
Significant results were obtained in groups treated with herbal composition in duration of
seizures and incidence and number of jerks.
Thus, the studies indicate that said herbal composition has ability to therapeutically manage the neurological disorders of epilepsy and other associated complications and clinical conditions effectively with no side effects. Being herbal in nature have a comparable capacity to synthetic control drug to manage neurological disorders without any side effects and hence may prove effective in therapeutic and prophylactic management of neurological disorders associated complications. The efficacy of the disclosed herbal composition is demonstrated by above example.
It is to be understood that this invention is not limited to particular methodologies and materials described, as these may vary as per the person skilled in the art. Further, it is to be understood that the present invention is not limited to the methodologies and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described, as these may vary within the specification indicated. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only, and is not intended to limit the scope of the present invention.
One skilled in the art will realise the disclosure may be embodied in other specific forms without departing from the disclosure or essential characteristics thereof. Scope of the invention is thus indicated by the appended claims, rather than the foregoing description, and all changes that come within the meaning and range of equivalence of the claims are therefore intended to be embraced therein.
15

I claim:

1. A herbal composition for therapeutic and prophylactic management of neurological
disorders, said composition comprising:
extracts or compounds of Ricinus communis, Wrightia arborea,Calendula officinalis;
and
at least one pharmaceutically acceptable carrier.
2. The herbal composition as claimed in Claim 1, wherein Ricinus communis, Wrightia arborea and Calendula officinalis comprises at least one part of the whole plant, parts of the plant, an extract of parts of plant, and a combination thereof.
3. The herbal composition as claimed in Claim 2, wherein the parts of plant comprise at least one of a rhizome, a root, a bud, a tender shoot, a leaf, a stem, a fruit, a bark, a flower, a seed, and a combination thereof.
4. The herbal composition as claimed in Claim 2, wherein Ricinus communis is present
in an amount ranging about 20% to 30%, Wrightia arborea is present in an amount
ranging about 10% to 15% and Calendula officinalis is present in an amount ranging
about 10% to 15% by weight of the herbal composition.
5. The herbal composition as claimed in Claim 1, wherein said at least one pharmaceutically acceptable carrier is selected from the group comprising of a preservative, a pH buffer, a chelating agent, a humectant, a thickener, a base, a colouring agent, a diluent, a fragrance, a solvent and a combination thereof.
6. The herbal compositions as claimed in claim 1, wherein said forms of formulation is selected from decoction, liquids, solutions, suspensions, syrups, gels, tablets, capsules, bolus, granulations, pellets, blender form, powders, pastes, base mix, emulsifiable concentrates and parenteral injectable.
7. A process of preparing herbal composition for therapeutic management of neurological disorders, comprising the steps of:
16

i. collecting parts of Ricinus communis, Wrightia arborea and Calendula
officinalis;
ii. washing and drying the collected parts of Ricinus communis, Wrightia arborea
and Calendula officinalis at room temperature, until removal of moisture to
obtain dried plant; iii. grinding the dried plant and passing it through a sieve to obtain a herbal
powder of Ricinus communis, Wrightia arborea and Calendula officinalis
particle size about less than 200µm; iv. extracting the herbal powder with a solvent in an amount about 20% to 30%
w/v of Ricinus communis, 10% to 15% w/v of Wrightia arborea and 10% to
15% w/v of Calendula officinalis to obtain an extract;
v. filtering the extract and concentrating the filtered extract at temperature about
60°C to about 80°C for about 1 to 2 hours to obtain a concentrate; and vi. formulating the extract in a suitable dosage form to obtain final herbal
preparation.
8. A process of preparing herbal composition as claimed in Claim 7, the parts of Ricinus communis, Wrightia arborea and Calendula officinalis comprise at least one of a rhizome, a root, a bud, a tender shoot, a leaf, a stem, a fruit, a bark, a flower, a seed, and a combination thereof.
9. A process of preparing herbal composition as claimed in Claim 7, wherein the solvent is water, alcohol and a combination thereof.
10. A process of preparing herbal composition as claimed in Claim 7, wherein the pharmaceutical dosage selected from decoction, liquids, solutions, suspensions, syrups, gels, tablets, capsules, bolus, granulations, pellets, powder, blender form, pastes, base mix, emulsifiable concentrates and parenteral injectable.