DESC:HERBAL COMPOSITION FOR TREATMENT OF EPILEPSY AND PROCESS OF PREPARATION THEREOF

FIELD OF THE INVENTION
The invention relates to a field of herbal formulation for therapeutic management of asthma and associated respiratory disorders. More specifically, the invention relates to a herbal composition comprising solvent extracts of at least a part of Caesalpinia mimosoidesand Citrus limon and a process of preparation thereof.

BACKGROUND OF THE INVENTION
Asthma is a chronic disease involving troubles in respiratory tract, specifically affecting the bronchial tubes through which air enters and exits the lungs. The lungs usually get inflamed in asthmatic conditions and leads to swelling of tissues around the airways, tightening the airway and causing difficulty in breathing. This makes it difficult for air to move in and out of the lungs, causing symptoms such as coughing, wheezing, shortness of breath and/or chest tightness.

For many asthma patients, timing of these symptoms is closely related to physical activity. Some otherwise healthy people can also develop asthma symptoms only when exercising. This is called exercise-induced bronchoconstriction (EIB), or exercise- induced asthma (EIA). People with a family history of allergies or asthma are more prone to developing this condition. Many people with asthma also have allergies. This is called allergic asthma. Occupational asthma is caused by inhaling fumes, gases, dust or other potentially harmful substances while on the job. Childhood asthma impacts millions of children and their families and the majority of children who develop asthma do so before the age of five.

The most common symptom associated with asthma is wheezing, which is presented as a scratchy or whistling sound during breathing. Other symptoms include: shortness of breath, chest tightness or pain, chronic coughing, trouble sleeping due to coughing or wheezing. Asthma symptoms, also called asthma flare-ups or asthma attacks, are often caused by allergies and exposure to allergens such as dust mites, pollen or mold. Non-allergic triggers include smoke, pollution or cold air or changes in weather. Asthma symptoms may be worse during exercise, when an affected individual has cold or during times of high stress. Children with asthma may show the same symptoms as adults with asthma: coughing, wheezing and shortness of breath. In some children chronic cough may be the only symptom.

While there is no cure for asthma, the symptoms can be controlled with effective asthma treatment and management. Management of factors that trigger this disease has been beneficial to some extent while use of prescribed drugs can surely benefit the patient. Prescribed medications which are recommended for daily use include inhaled corticosteroids: fluticasone (Flovent Diskus, Flovent HFA), budesonide (Pulmicort Flexhaler), mometasone (Asmanex), ciclesonide (Alvesco), flunisolide (Aerobid), beclomethasone (Qvar) and others). Combination inhalers contain an inhaled corticosteroid plus a long-acting beta-agonist (LABA). LABAs are symptom-controllers that are helpful in opening the patient’s airways. However, in certain people these may carry some risks.

Medicinal herbs and their derivative phytocompounds are being increasingly recognized as useful complementary treatment option for many diseases. While a majority of the diseases have prescribed synthetic organo-chemical medications, the usage of traditional remedies have been found to be increasingly relied upon when conventional medicine is ineffective for the treatment of disease. Furthermore, traditional medicines are widely perceived as natural and safe, that is, not toxic.

US6413553B1 presents an herbal formulation for treatment of the respiratory tract disorders and is formulated out of extracts of Piper betel and Murrya koeniggi. This formulation is claimed for blocking lipoxygenase activities and does not cover cure for all respiratory disorders specially asthma.

US6630176B2 presents an herbal formulation for treatment of the respiratory allergies and is formulated out of extracts of Fructus Pruni Mume, Pericarpium Zanthoxyli Bungeanum, Herba cum Radice Asari, Rhizoma Coptidis, Corex Phellodendri, Rhizoma Zingiberis Officinalis, Radix Lateralis Aconiti Carmichaeli Praeparata, Ramulus Cinnamomi Cassiae, Radix Ginseng, and Radix Angelicae Sinensis. This formulation is claimed for reducing the duration of allergies related to respiration and does not cover cure for all respiratory disorders specially asthma.

US6413553B1 presents an herbal formulation for treatment of the bronchial asthma and is formulated out of extracts of Solanum xanthocarpum, Albizzia lebbeck, Tribulus terrestris, Glycyrrhiza glabra, Pistachia integerrima, Adathoda vasica and Woodfordia fruticosa. This formulation is claimed for bronchial asthma only and does not cover cure for all respiratory disorders specially asthma of all types.

There is a continuous need for developing new, effective, safer and cheaper herbal formulations for the management of the respiratory tract disorders including asthma and related conditions. Therefore, the innovator has formulated an herbal composition for effectively treating the respiratory tract problems including asthma and associated respiratory disorders in humans. Further, the formulation comprises of two herbal ingredients and therefore easy to prepare in comparison to formulations comprising of multiple herbal ingredients.

OBJECT OF THE INVENTION
The main object of the invention is to provide a herbal composition for management of asthma and associated respiratory disorders comprising therapeutically effective amounts of Caesalpinia mimosoides and Citrus limon.

Another object of the invention is to provide an herbal composition for management of asthma and associated respiratory disorders, which is safe, effective and doesn’t have any side effects on the human body and exhibits optimum anti-asthmatic activities.

A further objective of the invention is to provide a herbal composition which can reduce the damage of respiratory tissues caused by excessive neutrophil & leukocyte infiltration and excessive histamine release.

Another object of the invention is to provide a process of preparation of the herbal composition, comprising therapeutically effective amounts of Caesalpinia mimosoidesand Citrus limon, with advantages hereinbefore mentioned.

SUMMARY OF THE INVENTION
Thus according to the basic aspect of the present invention there is provided a herbal composition for management of asthma and associated respiratory disorders, comprising solvent extracts of Caesalpinia mimosoides and Citrus limon.

It is another aspect of the present invention wherein herbal composition comprises of about 80-90 active weight percent of Caesalpinia mimosoides.

It is another aspect of the present invention wherein herbal composition comprises of about 10-20 active weight percent of Citrus limon.

It is another aspect of the invention wherein parts of Caesalpinia mimosoides and Citrus limon preferably include roots of Caesalpinia mimosoides and fruit of Citrus limon.

One aspect of the present invention provides a process for preparing a herbal composition for therapeutic management of asthma and associated respiratory disorders.

The process of preparation of the herbal composition comprising the steps of:

(i) washing, drying and grinding of roots of Caesalpinia mimosoides to get powdered forms of herbs;
(ii) lyophilizing juice from fruits of Citrus limon to prepare powdered form;
(iii) mixing powdered forms of Caesalpinia mimosoides and Citrus limon from step (i) and (ii), in a ratio of 9:1 (w/w) to get an admixture;
(iv) adding admixture from step (iii) in a solvent in a ratio of 1:100 (w/v) to prepare a solution;
(v) extracting the solution from step (iv) at a temperature of about 25oC to about 40oC for about 6-8 hours;
(vi) filtering the extract from step (v) to obtain a herbal composition.

DETAILED DESCRIPTION
The present invention is thus directed to a herbal composition for therapeutic management of asthma and associated respiratory disorders, comprising therapeutically effective amounts of Caesalpinia mimosoides and Citrus limon.

The term “respiratory tract disorders” as used herein includes of all types of respiratory disorders viz., asthma, respiratory allergies, exercise-induced bronchoconstriction and inflammatory disorders of the respiratory tract.

The term “therapeutically effective amount” refers to the amount sufficient to provide a therapeutic benefit in the treatment or management of a disease or condition or to delay or minimize one or more symptoms associated with the disease or condition.

In an embodiment of the present invention, the herbal composition comprises of about 80-90 active weight percent of at least one part of Caesalpinia mimosoides.

In another embodiment of the present invention, the herbal composition comprises of about 10-20 active weight percent of at least one part of Citrus limon.

In a preferred embodiment the parts of Caesalpinia mimosoides and Citrus limon preferably include roots of Caesalpinia mimosoides and fruits of Citrus limon.

In regard to this invention, the parts of Caesalpinia mimosoides and Citrus limon were collected from Kasargod district of Kerala, India.

An important aspect of the present invention is that the formulation contains extracts of two herbs and therefore extracted in such a manner that it won’t create any harmful effect on usage and thus healthy and helpful for consumption.

In an embodiment of the present invention, said herbal composition comprising processed plant parts of Caesalpinia mimosoides and Citrus limon, as active ingredients may also contain a blend of extracts or processed parts of other medicinal herbs or aromatics to enhance the efficacy of said herbal composition in treatment of asthma and associated respiratory disorders.

In an embodiment the herbal composition shall include at least one pharmaceutically acceptable excipient suitable for therapeutic administration.

One skilled in art shall appreciate that the formulation is directly dependent on the form of consumption and all such necessary forms are covered by the present invention.

In an embodiment of the present invention, the herbal formulation for the treatment of asthma and associated respiratory disorders can be made in a delivery system of any form which will include but not limited to powders, tablets, capsules, syrups, liquids, solutions, suspensions, gels, and pastes.

The illustrated embodiments of the present invention can be elaborated wherein the pharmaceutically acceptable excipients of said herbal composition may include but not limits to diluents, binders/ adhesives, bulking agents, lubricants, dis-integrants, buffering agents, preservatives, artificial sweeteners, coloring agents, flavoring agents, tonicity agents etc. according to the need and dosage formation of the herbal composition.

A diluent 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.

A bulking agent can be selected from a group comprising fibers, including pectin, psyllium seed, and guar gum, that provide laxative properties and like.

A binder, can be selected from a group comprising natural binders like acacia, gelatin, alginic acid, cellulose or commonly used binders like starch 1500, methocel, walocel HM and like.

Disintegrant, can be selected from a group comprising pre-gelatinized starch, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, and like.

A suspending agent, can be selected from a group comprising alginates, methylcellulose, hydroxyethyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, and like.

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.

The preservative can be selected from a group comprising antioxidants, T-50 vitamin E oil, rosemary oil extract, anti-microbial and like.

In another embodiment of present invention, the herbal formulation manages and reduces damage of respiratory tissues caused by excessive neutrophil infiltration.

In another embodiment of present invention, the herbal formulation manages and control histamine release and reduce histamine mediated damage of respiratory tissues caused by excessive leukocyte infiltration.

In an important embodiment, the dosage of the claimed herbal composition for treatment of asthma and other associated respiratory disorders is 150 ml twice a day. Total human dose is 300 ml per day.

An exemplary process of preparation of the herbal composition of the present invention is described below.

A process of preparation of herbal composition for therapeutic management of asthma and associated respiratory disorders, comprising the steps of:
(i) washing, drying and grinding of roots of Caesalpinia mimosoides to get powdered forms of herbs;
(ii) lyophilizing juice from fruits of Citrus limon to prepare powdered form;

(iii) mixing powdered forms of Caesalpinia mimosoidesand Citrus limon from step (i) and (ii), in a ratio of 9:1 (w/w) to get an admixture;
(iv) adding admixture from step (iii) in a solvent in a ratio of 1:100 (w/v) to prepare a solution;
(v) extracting the solution from step (iv) at a temperature of about 25oC to about 40oC for about 6-8 hours;
(vi) filtering the extract from step (v) to obtain a herbal composition.

In an aspect of the present invention, 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.

EXAMPLES
The present disclosure is further explained in the form of following examples. However, it is to be understood that the foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

Example 1
A process of preparation of the herbal composition for management of asthma and associated respiratory disorders, comprising the steps of:
(i) washing, drying and grinding of roots of Caesalpinia mimosoidesto get powdered forms of herbs;
(ii) lyophilizing juice from fruits of Citrus limon to prepare powdered form;

(iii) mixing powdered forms of Caesalpinia mimosoidesand Citrus limon from step (i) and (ii), in a ratio of 9:1 (w/w) to get an admixture;
(iv) adding admixture from step (iii) in a solvent in a ratio of 1:100 (w/v) to prepare a solution;
(v) extracting the solution from step (iv) at a temperature of about 25oC to about 40oC for about 6-8 hours;
(vi) filtering the extract from step (v) to obtain a herbal composition.

Example 2
A simple process of preparation of the herbal composition for therapeutic management of respiratory tract disorders including asthma and associated respiratory disorders, is given and comprised of washing, drying and powdering of roots of Caesalpinia mimosoides, adding 8 g of powdered Caesalpinia mimosoides to 700 ml of water. To this solution, about 2-3 ml of juice from fruits of Citrus limon was added. The solution was mixed thoroughly. Intake of 150 ml of filtered solution twice a day to the patient suffering from asthma resulted in significant relief.

Example 3
Anti- asthmatic efficacy of herbal composition was checked in experimental ovalbumin (IgE)- sensitized animal model of asthma.

The study revealed potent anti-asthmatic activity of herbal composition comprising Caesalpinia mimosoides and Citrus limon

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. 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. While this detailed description has disclosed specific details about the present invention but for those skilled in art shall appreciate the fact the current explanation is mere illustration of the art and do not lead to the limitation of the innovation that is it is mere illustrative and hence not fully covers the spirit and scope as defined.
,CLAIMS:I CLAIM:
1. An anti-asthmatic herbal composition comprising solvent extracts of Caesalpinia mimosoides and Citrus limon, wherein solvent extract of Caesalpinia mimosoides comprises of about 80% -90% w/w of actives; and solvent extract of Citrus limon comprises of about 10%- 20% w/w of actives.

2. The herbal composition as claimed in claim 1, wherein the solvent can be selected from water, alcohol and a combination thereof.

3. The herbal composition as claimed in claim 1, wherein the solvent is an alcohol selected from the group consisting of methanol, ethanol, is-propanol, and butanol.

4. A process of preparation of the herbal composition for management of asthma and associated respiratory disorders, comprising the steps of:
(i) washing, drying and grinding of roots of Caesalpinia mimosoides to get powdered forms of herbs;
(ii) lyophilizing juice from fruits of Citrus limon to prepare powdered form;
(iii) mixing powdered forms of Caesalpinia mimosoides and Citrus limon from step (i) and (ii), in a ratio of 9:1 (w/w) to get an admixture;
(iv) adding admixture from step (iii) in a solvent in a ratio of 1:100 (w/v) to prepare a solution;
(v) extracting the solution from step (iv) at a temperature of about 25oC to about 40oC for about 6-8 hours;
(vi) filtering the extract from step (v) to obtain a herbal composition.

5. The process of preparation of herbal composition as claimed in claim 4, wherein the solvent is selected from water, alcohol and a combination thereof.
6. The process of preparation of herbal extract as claimed in claim 4, wherein the solvent is an alcohol selected from the group consisting of methanol, ethanol, iso- propanol, and butanol.