INFLAMMATORY DISEASES

BACKGROUND:

Inflammation is a complex reaction of the body responding to damage of its cells and vascularised tissues. The damaged sites are susceptible to infiltration by a multitude of pathogens including viruses, bacteria, fungi, and protozoan and metazoan parasites, as well as cancerous cells and other harmful agents and so the animal defends itself by initiating an inflammatory reaction at the damaged site.

There is a vast array of diseases exhibiting an inflammatory component. Among these diseases is Mastitis, in which there is inflation of the mammary gland, and is mainly caused by bacteria. It is commonly observed in dairy cattle such as cows and goats.

The usual mode of treatment for chronic inflammatory conditions is by administration of non-steroidal anti-inflammatory drugs (NSAIDs) such as Diclofenac, Ibuprofen, Aspirin, Phenylbutazone, Indomethacin, Naproxen and Piroxicam. Although NSAIDs and other the synthetic medicines and associated treatment methods pose the threat of side effects and chemical toxicity which can adversely affect a subject's overall health, and mostly involve high cost and effort in manufacturing.

Considering the significance of treatment or prevention of inflammatory diseases such as mastitis, there is a continuous requirement for medicines or compositions for their treatment or prevention, which would be economical, easily available and may have lower side effects and lower toxicities affecting a subject's body, which can be addressed by herbal compositions of the present invention.

OBJECT OF THE INVENTION:

The object of the invention is to provide novel herbal compositions which may be cost effective and easily available for treatment or prevention of inflammatory diseases such as mastitis, and which have less or no side effects to the health of a subject.

SUMMARY OF THE INVENTION: The present invention in a preferred embodiment provides herbal compositions for treatment or prevention of inflammatory diseases such as mastitis, comprising of at least a part of Coccinia indica, to which parts of one or more additional complimentary herb may be optionally added, wherein the additional complimentary herb is also a herb for treatment or prevention of inflammatory diseases such as mastitis, and is selected from but not limited to Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia, or any combination thereof. The invention also provides for methods of preparation of the herbal compositions.

DETAIL DESCRITION OF THE INVENTION:

The present invention in a preferred embodiment provides herbal compositions for treatment or prevention of inflammatory diseases such as mastitis, comprising of at least a part of Coccinia indica, to which parts of one or more additional complimentary herb may be optionally added, wherein the additional complimentary herb is also a herb for treatment or prevention of inflammatory diseases such as mastitis, and is selected from but not limited to Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia, or any combination thereof.

Parts of Coccinia indica for the purpose of this invention includes the whole Coccinia indica, extract of Coccinia indica, pulverized form of Coccinia indica, crushed form of Coccinia indica, pieces cut or severed from Coccinia indica, chemical constituents of Coccinia indica along with their derivatives, or any combination thereof.

In an embodiment of the invention, parts of Coccinia indica are severed by different methods such as but not limited to cutting, slicing, pounding, grinding, mashing or mincing.

The term 'herbal composition' for the purpose of this invention means a substance or mixture comprising of at least one natural component having medicinal property, wherein the natural component shall include a component extracted or derived from a natural source such as a herb or a plant or a tree or parts thereof.

The term subject for the purpose of the invention means one or more of a human or any other animal which has acquired or may acquire a disease or irregularity of health. The herbs used for the compositions in accordance with the present invention, shall include other herbs of their respective species or family or genus which display similar medicinal properties.

In an embodiment of the invention a solvent may be used for preparing the herbal compositions of the present invention, and the solvent used may be any suitable solvent such as but not limited to one or more of methanol, ethanol, n-propanol, isopropanol, hexane, heptane, petroleum ether, cyclohexane, diethyl ether, dusopropyl ether, ethyl acetate, methyl acetate, ethyl formate, methyl formate, isobutyl acetate, n-butyl acetate, methylene chloride, ethylene chloride, chloroform, carbon tetrachloride, acetone, ethyl methyl ketone, diisobutyl ketone, methyl isobutyl ketone, 1,4- dioxane, toluene, ammonia solution, glacial acetic acid, ammonium hydroxide, sodium hydroxide, calcium hydroxide, calcium carbonate, potassium hydroxide, potassium carbonate, water and other solvents known by those of skilled in the art.

In an embodiment of the invention, a suitable excipient is added to the herbal compositions of the present invention to prepare a consumable formulation for effective therapeutic delivery.

In an embodiment of the invention, the herbal compositions of the present invention may be formulated for oral administration by compounding the active ingredients with the usual nontoxic pharmaceutically acceptable excipients for tablets, pellets, granules, capsules, solutions, emulsions, suspensions, and any other form suitable for use. Formulations in accordance with the present invention may include one or more of talc, water, glucose, lactose, gum acacia, gelatin, mannitol, starch paste, magnesium trisilicate, corn starch, keratin, colloidal silica, potato starch, urea, and other excipients suitable for use in manufacturing preparations, in solid, semisolid or liquid form, or any combination thereof. Additionally, auxiliary, stabilizing, thickening, flavoring, fragrance and coloring agents may be used.

In an embodiment of the invention, the herbal compositions can be administered in a solid form such as but not limited to tablets, capsules, pills, pellets, granules, boluses or powder. For preparing the solid form, the herbal compositions may be mixed with a pharmaceutical excipient such as but not limited to corn starch, lactose, sucrose, sorbitol, talc, stearic acid, magnesium stearate, dicalcium phosphate or gums, along with other pharmaceutical diluents. The solid compositions may be further subdivided into unit dosage forms containing an effective amount of compositions of the present invention.

In an embodiment of the invention, the herbal compositions can be administered in a liquid form such as but not limited to aqueous solution, suitably flavored syrups, aqueous suspensions, oil suspensions, tinctures, tisanes, macerates and flavored emulsions with edible oils as well as elixirs or similar pharmaceutical carriers. The liquid form may include suitable dispersing or suspending agents for aqueous suspensions such as but not limited to tragacanth, acacia, alginate, dextran, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone or gelatin. Liquid preparations for oral administration may take the form of, for example, solutions, syrups or suspensions, or they may be presented as a dry product for reconstitution with water or other suitable vehicles before use.

In an embodiment of the invention, a process for preparing herbal compositions for treatment or prevention of inflammatory disease, comprises the steps of,

a) washing a part of Coccinia indica;

b) sieving the part of Coccinia indica; and

c) preparing pharmaceutically acceptable formulation thereof.

In an embodiment of the invention, a process for preparing herbal compositions for treatment or prevention of inflammatory disease, comprises the steps of,

a) washing a part of Coccinia indica and a part of an additional herb; b) sieving the part of Coccinia indica and the part of the additional herb; c) mixing the part of Coccinia indica and the part of the additional herb; and d) preparing pharmaceutically acceptable formulation thereof.

In an embodiment of the invention, a process for preparing herbal compositions for treatment or prevention of inflammatory disease, comprises the steps of,

a) washing a part of Coccinia indica and a part of additional herb selected from Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia;

b) sieving the part of Coccinia indica and the part of additional herb selected from Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia; c) mixing the part of Coccinia indica and the part of additional herb selected from Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia;

d) heating the above mixture in a vessel containing a solvent; and

e) preparing pharmaceutically acceptable formulation thereof.

In an embodiment of the invention, a process for preparing herbal compositions for treatment or prevention of inflammatory disease, comprises the steps of,

a) washing a part of root of Coccinia indica and a part of additional herb selected from Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia;

b) sieving the part of root of Coccinia indica and the part of additional herb selected from Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia;

c) mixing 40 to 60% of the part of root of Coccinia indica and 50 to 60% of the part of additional herb selected from Acacia arabica, Diospyros peregrina, Mangifera indica, Arachis hypogeal, Sida cordifolia; and

d) heating the above mixture in a vessel containing a solvent; and

e) preparing pharmaceutically acceptable formulation thereof.

In an embodiment of the invention, the herbal compositions may be delivered as a semi-solid form or gelatinous solid, such as but not limited to paste, jelly, gel or chutney.

In an embodiment of the invention, the herbal compositions may be delivered as a gaseous form or in form of aerosols which includes but not limited to spray, fumes, inhalers or mist.

In an embodiment of the invention, the herbal compositions may also be formulated for parenteral administration by injection, which includes but is not limited to using conventional catheterization techniques or infusion.

In an embodiment of the invention, the herbal compositions may also be formulated for topical administration, in the form of solution, cream, gel, ointment, powder, paste, gum or lozenge, using techniques known to those skilled in the formulation field. As used herein, topical administration includes delivery of the compositions to mucosal tissue of the mouth, nose and throat by, for example, spray or mist application.

In an embodiment of the invention, the herbal compositions as an active ingredient may be used alone or in combination with other therapeutic agents, for treatment or prevention of inflammatory diseases such as mastitis.

In an embodiment of the invention, a part of Coccinia indica is added to or mixed with fodder provided to cattle and administered orally to the subject.

In an embodiment of the invention, a part of Coccinia indica is added to or mixed with water and administered orally to the subject.

In an embodiment of the invention, the herbal compositions of the present invention may be in the form of a decoction or may be prepared using a decoction process.

In an embodiment of the invention a part of Coccinia indica can be given chemical treatment or made to react with other chemical reagents to form mixtures or herbal compositions which are used for treatment or prevention of inflammatory diseases such as mastitis.

In an embodiment of the invention, the desirable dose of the compositions may vary depending on the condition and the weight of the subject, severity, drug form, route and period of administration.

In an embodiment of the invention, the herbal composition may be used for treatment or prevention of mastitis.

In an embodiment of the invention, the herbal composition may be used for treatment or prevention of a inflammatory condition other than mastitis that may be selected from the group consisting of, but not limited to inflammatory joint diseases, rheumatoid arthritis, osteoarthritis, polyarthritis, gout, chronic inflammatory connective tissue diseases, lupus erythematosus, scleroderma, Sjorgen's syndrome, dermatomyositis, vasculitis, mixed connective tissue disease, tendonitis, synovitis, bacterial endocarditis, osteomyelitis and psoriasis, chronic inflammatory lung diseases, chronic respiratory disease, pneumonia, fibrosing alveolitis, chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, emphysema, silicosis and other pneumoconiosis, tuberculosis, chronic inflammatory bowel, gastro-intestinal tract inflammatory diseases, chronic inflammatory demyelinating polyradiculoneuropathy, chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, Guillan-Barre Syndrome and myasthemia gravis, laminitis, laryngitis, chronic cholecystitis, Hashimoto's thyroiditis, chronic inflammation caused by an implanted foreign body in a wound, delayed onset muscle soreness, or any combination thereof.

It is observed that when more than one herb is used in the herbal compositions of the present invention, there is enhanced efficacy and the combination of herbs lead to synergistic effect.

The aim of this specification is to describe the invention without limiting the invention to any one embodiment or specific collection of features. A person skilled in the relevant art may realize the variations from the specific embodiments that will nonetheless fall within the scope of the invention, and such variations are deemed to be within the scope of the current invention.

It may be appreciated that various other modifications and changes may be made to the embodiment described without departing from the spirit and scope of the invention.

Example

Clinical cases were evaluated on bacterial proliferation, tissue irritation and nature of milk. The impact of the formulation was evaluated by isolating Bacterial culture and efficacy testing in affected quarter. Tissue irritation was studied by physical examination and clinical observation by quantifying parameters like swelling, erthema and pain/hot. The nature of milk was examined by including variables like not normal, apparently normal, hemorrhagic, curdled milk, flakes, serous, thelitis in-order of severity of infection. The medication relieved the affected animals within 2 days.