WO2012131643A1

WO2012131643A1 - Herbal compositions comprising pedilanthus tithymaloides for treatment prevention of gastrointestinal disorder

Info

Publication number: WO2012131643A1
Application number: PCT/IB2012/051566
Authority: WO
Inventors: Ananda Chandra RAULA
Original assignee: Raula Ananda Chandra
Priority date: 2011-04-01
Filing date: 2012-03-30
Publication date: 2012-10-04

Abstract

The present invention in a preferred embodiment provides for herbal compositions for treatment or prevention of gastrointestinal disorders. The present invention also provides for the methods of preparation and various forms of administration of the said compositions. The said compositions comprise of at least a part of Pedilanthus tithymaloides.

Description

HERBAL COMPOSITIONS COMPRISING PEDILANTHUS TITHYMALOIDES FOR TREATMENT OR PREVENTION OF GASTROINTESTINAL DISORDER

BACKGROUND:

Disorders or diseases related to the gastrointestinal tract which may be collectively referred to as gastrointestinal disorders (GI disorders), are common and often lead to severe pain and discomfort. There are various kinds of GI disorders including but not limited to constipation, gastrisis, fecal impaction, rectal prolapsed, gastrointestinal dysfunction, secretory diarrhea, gastroenteritis, GI bleeding, gastric and peptic ulcer, anorectal disorders, malabsorption syndromes, diverticular disease, tumors of GI tract, bezoars, dysentery, cholera, which have varied effects on the body or health of a subject.

Although, there are synthetic medicines and associated treatment methods available for addressing, gastrointestinal disorders, most of them 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 gastrointestinal disorders, there is a continuous requirement for medicines or compositions for their treatment, 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 gastrointestinal disorders, 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 gastrointestinal disorders, comprising of at least a part of Pedilanthus tithymaloides, 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 gastrointestinal disorders and is selected from but not limited to Pergularia daemia, Sida acuta root, Phyllanthus reticulatus leaf, Ipomoea obscura leaf, Phoenix

l sylvestris, Ximenia americana, Semecarpus anacardium, Annona squamosa, common salt, 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 gastrointestinal disorders, comprising of at least a part of Pedilanthus tithymaloides, 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 gastrointestinal disorders and is selected from but not limited to Pergularia daemia, Sida acuta root, Phyllanthus reticulatus leaf, Ipomoea obscura leaf, Phoenix sylvestris, Ximenia americana, Semecarpus anacardium, Annona squamosa, common salt, or any combination thereof.

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

In an embodiment of the invention, the parts of Pedilanthus tithymaloides 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 shrub or a tree or a plant 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 gastrointestinal disorders, comprise the steps of,

a) washing a part of Pedilanthus tithymaloides;

b) sieving the part of Pedilanthus tithymaloides; and

c) preparing pharmaceutically acceptable formulation thereof.

a) washing a part of Pedilanthus tithymaloides and a part of an additional herb; b) sieving the part of Pedilanthus tithymaloides and the part of an additional herb;

c) mixing the part of Pedilanthus tithymaloides and the part of an additional herb; and

d) preparing pharmaceutically acceptable formulation thereof.

a) washing a part of Pedilanthus tithymaloides, a part of Pergularia daemia, a part of Sida acuta root, a part of Phyllanthus reticulatus leaf, a part of Ipomoea obscura leaf, a part of Phoenix sylvestris, a part of Ximenia americana, a part of Semecarpus anacardium, and a part of Annona squamosa; b) sieving the part of Pedilanthus tithymaloides, the part of Pergularia daemia, the part of Sida acuta root, the part of Phyllanthus reticulatus leaf, the part of Ipomoea obscura leaf, the part of Phoenix sylvestris, the part of Ximenia americana, the part of Semecarpus anacardium, and the part of Annona squamosa;

c) mixing the part of Pedilanthus tithymaloides, the part of Pergularia daemia, the part of Sida acuta root, the part of Phyllanthus reticulatus leaf, the part of Ipomoea obscura leaf, the part of Phoenix sylvestris, the part of Ximenia americana, the part of Semecarpus anacardium, and the part of Annona squamosa;

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 gastrointestinal disorders. 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, the parts of Pedilanthus tithymaloides 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 gastrointestinal disorders.

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, a gastrointestinal disorder is selected from a set of but not limited to gastrointestinal dysfunction, diarrhea, gastroenteritis, GI bleeding, gastric and peptic ulcer, anorectal disorders, gastric hyperacidity, hypochlorhydria, malabsorption syndromes, diverticular disease, tumors of GI tract, bezoars, dysentery, cholera, flatulence, or any combination thereof.

In an embodiment of the invention, the herbal composition may be used for treatment or prevention of a gastrointestinal disorders that may be caused by one or more of cestodes, nematodes and trematodes, such as but not limited to roundworms, tapeworms, ringworms, pinworm, hookworm, Filariasis, Onchocerciasis, Schistosomiasis, Trichinella and Guinea Worm, or any combination thereof.

In an embodiment of the invention, the herbal composition may be used for treatment or prevention of a gastrointestinal disorders that may be caused by one or more of Protozoa, Spironucleus muris, Giardia muris, Tritrichomonas muris, Entamoeba muris, Helminths, Syphacia muris, Aspicularis tetraptera, Trichosomoides crassicauda, Strongyloides ratti, Nippostrongylus muris, Hymenolepis nana, Hymenolepis diminuta, Taenia taeniaeformis, Taenia seralis, Acanthocephala, Moniliformis moniliformis, Vibrio cholerae, or any combination thereof.

It is observed that when more than one herbs are 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 1:

lOOgm of leaves of Pedilanthus tithymaloides was mixed with 50gms of common salt and were subject to grinding together to make a paste. This paste was given to the subject suffering from stomach pain due to gastrointestinal disorder to eat after which the intensity of pain reduced considerably and the subject was in better medical condition.

Claims

I CLAIM:

1) Herbal compositions for treatment or prevention of gastrointestinal disorders, the herbal compositions comprising at least a part of Pedilanthus tithymaloides .

2) Herbal compositions as claimed in claim 1, wherein said herbal compositions is selected from a group comprising whole Pedilanthus tithymaloides, extracts of Pedilanthus tithymaloides, crushed Pedilanthus tithymaloides, pulverized Pedilanthus tithymaloides, severed Pedilanthus tithymaloides, chemical constituents of Pedilanthus tithymaloides, and any combination thereof.

3) Herbal compositions as claimed in any of the preceding claims, wherein said herbal compositions further comprise additional herbs.

4) Herbal compositions as claimed in any of the preceding claims, wherein said herbal compositions further comprise additional herbs selected from Pergularia daemia, Sida acuta root, Phyllanthus reticulatus leaf, Ipomoea obscura leaf, Phoenix sylvestris, Ximenia americana, Semecarpus anacardium, Annona squamosa, common salt, or any combination thereof.

5) Herbal compositions as claimed in any of the preceding claims, wherein the herbal compositions of the invention further comprises one or more of solvents, excipients, auxiliary agents, stabilizing agents, thickening agents, flavoring agents, fragrance, preservatives, fillers, coloring agents, and any combination thereof.

6) Herbal compositions as claimed in any of the preceding claims, wherein the herbal compositions of the invention treats or prevents gastrointestinal disorders selected from gastrointestinal dysfunction, diarrhea, gastroenteritis, GI bleeding, gastric and peptic ulcer, anorectal disorders, gastric hyperacidity, hypochlorhydria, malabsorption syndromes, diverticular disease, tumors of GI tract, bezoars, dysentery, cholera, flatulence, and any combination thereof.

7) An herbal composition as claimed in any of the preceding claims, wherein the herbal composition of the invention treats or prevents endoparasites selected from cestodes, nematodes, trematodes, roundworms, tapeworms, ringworms, pinworm, hookworm, Filariasis, Onchocerciasis, Schistosomiasis, Trichinella, Guinea Worm, Spironucleus muris, Giardia muris, Tritrichomonas muris, Entamoeba muris, Helminths, Nematodes, Syphacia muris, Aspicularis tetraptera, Trichosomoides crassicauda, Strongyloides ratti, Nippostrongylus muris, Cestodes, Hymenolepis nana, Hymenolepis diminuta, Taenia taeniaeformis, Taenia seralis, Acanthocephala, Moniliformis moniliformis, and any combination thereof.

8) Herbal compositions as claimed in any of the preceding claims, wherein the herbal compositions is in forms selected from a group comprising of injectable forms; solid tablets, pellets, granules, capsules, forms; oral usage form; topical application form; semi-solid form; gaseous form; and any combination thereof.

9) A process for preparing herbal compositions for treatment or prevention gastrointestinal disorders, comprise the steps of,

a) washing a part of Pedilanthus tithymaloides;

b) sieving the part of Pedilanthus tithymaloides; and

c) preparing pharmaceutically acceptable formulation thereof.

10) A process for preparing herbal compositions as claimed in any of the preceding claims, comprise the steps of,

d) preparing pharmaceutically acceptable formulation thereof.