WO2012137223A1

WO2012137223A1 - A synergistic herbal extract composition for use in treating bloating

Info

Publication number: WO2012137223A1
Application number: PCT/IN2012/000238
Authority: WO
Inventors: Jogi MAHAKUL
Original assignee: Mahakul Jogi
Priority date: 2011-04-04
Filing date: 2012-04-03
Publication date: 2012-10-11

Abstract

A synergistic herbal extract composition comprising therapeutically effective amounts of extracts of Phyllanthus fraterna, Paederia foetida, Anthocephalus chinensis, Balanites aegyptica, Helianthus annuus, Diplocyclos palmatus, and Cocculus hirsutus for use in treating bloating in a subject in need thereof. A process for the preparation of such composition is also provided.

Description

A SYNERGISTIC HERBAL EXTRACT COMPOSITION FOR USE IN TREATING BLOATING

FIELD OF THE INVENTION

The present invention relates to a novel synergistic herbal extract composition comprising therapeutically effective extracts of Phyllanth s fraterna, Paederia foetida, Anthocephalus chinensis, Balanites aegyptica, Helianthus annum, Diplocyclos palmatus, and Cocculus hirsutus for use in treating bloating in a subject in need thereof. The present invention also relates to a process for the preparation of such composition.

BACKGROUND OF THE INVENTION

Bloating is most often caused by trapped gas in the small intestine. This can cause flatulence (passing of excessive gas/wind) painful stomach ache and an uncomfortable feeling when wearing tight clothes. Bloating is any abnormal general swelling, or increase in diameter of the abdominal area. As a symptom, the patient feels a full and tight abdomen, which may cause abdominal pain sometimes accompanied by increased borborygmus (stomach growling) or more seriously the total lack of borborygmus.

There are a variety of causes for this bloating, including for example: Intestinal Gas, Constipation, Peptic Ulcers, Anorexia, Anxiety, Smoking, Water Retention, Trapped wind, Over eating, Indigestion, Dysmotility (a slow digestive system). Other conditions that may result in a bloated stomach include: Hypothyroidism (Hashimoto's Disease), Premenstrual Syndrome (PMS), Menopause, Candidiasis, Coeliac Disease, Irritable Bowel Syndrome (IBS).

Bloating can also occur as a result of food intolerance, insufficient Hydrochloric acid in the stomach, insufficient digestive enzymes in the stomach or lack of good intestinal flora (good bacteria normally present in the gut). Important, but uncommon causes of abdominal bloating, include large intraabdominal tumors, such as those arising from ovarian, liver, uterus and stomach cancer; and megacolon, an abnormal dilation of the colon, due to some diseases, such as Chagas disease, a parasitic infection. Gaseous bloating may be a consequence of cardiopulmonary resuscitation procedures, due to the artificial mouth-to-mouth insufflation of air.

The most common symptoms associated with bloating include pain in the abdominal cavity, chest pain, vomiting, diarrhea, constipation, and bloody or darkened stools. Others include difficulty swallowing or belching, abdominal fullness or indigestion, and excessive gas after eating or drinking. Unexplained weight loss can also be experienced as the amount of food ingested reduces due to a poor appetite and stomach discomfort. Stomach bloating also causes the body to feel fatigue, breathing problems, and pain.

Simethicone (mixture of polydimethylsiloxane and silica gel.) is widely used to reduce bloating. Simethicone causes gas bubbles to break up and is widely used to relieve gas, although its benefit is questionable. Activated charcoal is sometimes used although benefit of activated charcoal is unclear. Bismuth subsalicylate is used to reduce the odor of unpleasant smelling gas due to sulfur.

The conventional therapies have their own certain limitations and side effects.

As an alternative to conventional therapies, many people find comfort from various ailments from herbal formulations and extracts which are effective as well as have no side effects. Thus, there has always been awareness for the need of herbal formulations and extracts as an effective viable remedy.

Herbs such as Foeniculum Vulgare (Sweet Fennel) and Pulsatilla Vulgaris (Pasque

Flower) help to alleviate bloating. While research in the field of herbal medicines has increased, much remains to be learned about the effectiveness of such herbal remedies. In view of the above, there is a continuing need in the art to provide new, effective safe and economical pure herbal synergistic composition for use in treating bloating. The present invention satisfies these needs, as well as others, and generally overcomes the deficiencies found in the background art.

OBJECTS OF THE INVENTION

Thus, the main object of the present invention is to provide a novel synergistic herbal extract composition comprising therapeutically effective amounts of plant extracts of Phyllanthus fraterna, Paederia foetida, Anthocephalus chinensis, Balanites aegyptica, Helianthus annuus, Diplocyclos palmatus, and Cocculus hirsutus.

Another object of the invention is to provide a use of the novel herbal composition in treating and/or preventing bloating in a subject in need thereof.

A further objective of the present invention is to provide a process for the preparation of synergistic herbal extract composition of the present invention.

Another object of the present invention is to minimize side effects and toxicity, the limitations of the conventional therapeutic agents for treating and preventing bloating.

Another object of the present invention is to provide the novel herbal composition which is having economic significance in comparison to the commonly available allopathic and synthetic drugs. SUMMARY OF THE INVENTION

The present invention relates to a synergistic herbal extract composition comprising a therapeutically effective amount of extracts of:

• Phyllanthus fraternal;

• Paederia foetida;

• Anthocephahis chinensis

• Balanites aegyptica;

• Helianthus annum;

• Diplocyclos palmatus; and

• Cocculus hirsutus;

In an embodiment of the present invention, the composition of the present invention further comprises of black salt.

The herbal composition of the present invention can optionally contain at least one carrier.

The present invention also relates to a process for the preparation of the synergistic herbal extract composition of the present invention.

The present invention further relates to a use of the novel herbal composition in treating and/or preventing bloating, comprising administering a therapeutically effective amount of the composition of the present invention to a subject in need thereof.

The present invention also relates to a process for the preparation of the herbal extract composition of the present invention. DETAILED DESCRIPTION OF THE INVENTION

Thus, the present invention is directed to a novel synergistic anti bloating herbal extract composition comprising therapeutically effective amounts of extracts of:

• Phyllanthus fraterna,

• Paederia foetida,

• Anthocephalus chinensis,

• Balanites aegyptica,

• Helianthus annuus,

• Diplocyclos palmatus, and

• Cocculus hirsntus .

The term "Bloating" as used herein refers to a symptom of a number of conditions such as Intestinal Gas, Constipation, Peptic Ulcers, Anorexia, Anxiety, Smoking, Water Retention, Trapped wind, Over eating, Indigestion, Dysmotility Hypothyroidism (Hashimoto's Disease), Premenstrual Syndrome (PMS), Menopause, Candidiasis, Coeliac Disease, Irritable Bowel Syndrome (IBS) and the like. etc. The term "bloating" as used herein, refers to abnormal general swelling, or increase in diameter of the abdominal area, which may cause abdominal pain, accompanied by increased stomach growling. The term "bloating" as used further encompasses the bloating caused due to uncommon causes, for example, large intra-abdominal tumors such as those arising from ovarian, liver, uterus and stomach cancer; and megacolon, an abnormal dilation of the colon, and Chagas disease, a parasitic infection. The term "subject" as used herein refers to mammals including humans.

The term "black salt" as used herein refers to a mineral salt consisting primarily of sodium chloride and trace impurities such as sodium sulfate, iron sulfide, and hydrogen sulfide. It is known commonly in India as "kala namak".

In an embodiment of the present invention, the composition of the present invention comprises of 15 to 25 % by weight of an extract of Phyllanthus fraterna, 30 to 40 % by weight of an extract of Paederia foetida, 5 to 10% by weight of an extract of Anthocephalus chinensis, 5 to 10 % by weight of an extract of Balanites aegyptica; 1 to 5 % by weight of an extract of Helianthus annuus, 1 to 5 % by weight of an extract of Diplocyclos palmatus; 1 to 5 % by weight of an extract of Cocculus hirsutus.

In a further embodiment, the composition of the present invention comprises 10 to 20 % by weight of black salt.

Details of the herbal ingredients of the composition:

1) Phyllanthus fraterna :

Phyllanthus fraterna, also known by name of Bhumyamlaki is an herb found

throughout India. The whole plant possesses great medicinal values. It has been cited in Ayurvedic texts that bhumyamalaki increases the appetite, is digestant, laxative and a liver stimulant. It is beneficial in cough, asthma, urinary diseases, jaundice, malaria and enlargement of liver and spleen. The paste of its leaves is applied, externally, in the skin diseases, wounds and ulcers.

Botanical Classification

• Family: Phyllanthaceae • Genus: Phyllanthus

• Species: P. fraternal

2) Paederia foetida:

Paederia foetida is a species of plant, with common names that are variations of

Skunkvine; Stinkvine; or Chinese Fever Vine. It is native to temperate and tropical Asia. The plant is believed to be a laxative or bowel function regulator. The plant is used to relieve intestinal complaints, i.e., in dyspepsia, flatulence, gastritis, enteritis, stomachache, abdominal distension. It is also useful in treatment of colic, spasms, rheumatism, gout and many other diseases.

Botanical Classification

• Family: Rubiaceae

• Genus: Paederia

• Species: P. foetida

3) Anthocephalus chinensis:

Anthocephalus chinensis, a medium sized to tall deciduous tree known by common names of Kadam, Common bur-flower tree, Laran, Nauciea, Cadamba, Roghu, Kadwal . Fruits are edible. Bark and leaves are used for medicinal purposes. It is used as an Ayurvedic medicine for uterine disorders, blood diseases and leprosy. Juice prepared from the bark of Anthocephalus chinensis is given orally to lower body temperature and also used as a tonic and mouth gargle.

Botanical Classification

• Family: Rubiaceae

• Genus: Anthocephalus

• Species: A. chinensis 4) Balanites aegyptiaca:

Balanites aegyptiaca, found in most arid, semiarid to sub humid tropical savannahs, and hot dry areas, along watercourses and in woodlands. In English the fruit has been called desert date. Medicinal uses of this plant are many and have been used in the treatment of liver and spleen diseases, for abdominal pains and as a purgative. The oil is consumed for headache and to improve lactation.

Botanical Classification

• Family: Zygophyllaceae

• Genus: Balanites

• Species: B. aegyptiaca

5) Helianthus annuus:

Helianthns annuus, popularly known as Sunflower, is an annual plant native to the Americas. It possesses a large inflorescence (flowering head). Sunflower seeds are considered to have antioxidant, anti-inflammatory, diuretic and expectorant properties. They can help reducing the symptoms of asthma, osteoarthritis and rheumatoid arthritis and help in cases of bronchial, pulmonary and laryngeal problems. The flowering head and seeds are febrifuge, nutritive and stomachic. The seed is also considered to be diuretic and expectorant.

Botanical Classification

• Family: Asteraceae

• Genus: Helianthus

• Species: H. annuus ) Diplocyclos palmatus:

Diplocyclos palmatus known by common name as lollypop climber and striped cucumber is a perennial, slender, much-branched climber. It has been recorded in India as growing and spreading in the wild. Whole plant is medicinally useful. It pacifies vitiated vata, pitta, inflammation, cough, flatulence, skin diseases and general debility.

Botanical Classification:

• Family: Cucurbitaceae

• Genus: Diplocyclos

• Species: D. palmatus ) Cocculus hirsutus:

Cocculus hirsutus having various synonyms, locally known as Chireta in hindi, is a climbing shrub and found throughout India, in tropical and subtropical tracts.

The plant has great medicinal value and is used both, internally as well as externally for medicinal purpose. It alleviates abdominal pain, colic, flatulence, dyspepsia, general debility. It has digestive, carminative, demulcent, depurative, emollient, tonic and antipyretic properties and is widely used in Ayurvedic medicine.

Botanical Classification

• Family: Menispermaceae

• Genus: Cocculus

• Species: C. hirsutus

The plant extracts used in the composition of the present invention have been used individually for health promoting and varied therapeutic purposes. However, the herbal composition of the present invention is a unique combination that has been developed to provide therapeutic benefits in the treatment and/or prevention of bloating in subjects.

An important aspect of the herbal composition of the present invention is that the composition comprises of a mixture of herbal extracts, which provide more benefit than a single herb. An unexpected synergistic effect is exhibited by the combination of various ingredients in the present herbal composition. Strategic combination of herbal ingredients of the present invention exhibits beneficial pharmacological effects when optimally combined. Active ingredients of the herbs are preferably combined in such a manner as to optimize and enhance the pharmacological effects with minimal or no adverse toxic reactions (which become a distinct possibility if the herbs are used singly at a concentration of 100%).

The herbal composition described herein can be used as an alternative to conventional drugs or treatments and has been found to effectively treat or prevent bloating due to a wide range of medical conditions in subjects.

An embodiment of the present invention provides use of the herbal composition of the present invention for the treatment and/or prevention of bloating by administrating a therapeutically effective amount of the composition to a subject in need thereof.

Active compounds responsible for specific therapeutic activity can be found in higher concentrations in specific parts of medicinal plants and in lower concentrations in other specific parts. Specific part of a medicinal plant having higher concentration is selected and processed for preparing the extracts as used in the preparation of the composition of the present invention Preferably, extracts of Phyllanthus fraterna are obtained from leaves , extracts of Paederia foetida are obtained from leaves and extracts of Anthocephalus chinensis are obtained from leaves. In some embodiments, the herbal composition as described herein is prepared to be administered in a variety of ways, for example orally, or parenterally, using means known in the art.

In an embodiment, the herbal composition of the present invention optionally contains at least one carrier selected from a group comprising of diluent, binder, disintegrant, glidant, lubricant and the like. There may be one or more carriers used in the preparation of the composition of the present invention. The carrier employed can be solid or liquid. See, for example, Remington: The Science and Practice of Pharmacy , 1995, Gennaro ed.

The oral composition of the present invention can be selected from a group comprising of syrup, tablet, capsule, powder, beads, pellets, granules, solution, suspension, oleoresin, emulsion and the like.

The parenteral composition of the present invention can be administered by intravenous drip or by intraperitoneal, subcutaneous or intramuscular injection.

The herbal composition of the present invention can be formulated into a particular dosage form by using any common technique available in the art.

An exemplary and generalized process for preparing the herbal composition of the present invention is described below in a stepwise manner. a. Drying respective plant parts to remove excess moisture;

b. , Powdering and sieving respective plant parts through mesh to obtain fine powder; c. Adding a suitable solvent to the fine powder of step (b) to obtain a solution;

d. Allowing the solution to stand followed by continuous stirring; e. Optionally repeating step (d) more than once;

f. Filtering the solution obtained from step (e) to obtain the extract;

g. Evaporating excess solvent and lyophilizing to obtain fine powder.

In a preferred embodiment, the solution is allowed to stand for 2 to 3 hours in step (d) and continuously stirred for 30 minutes.

In one embodiment, the step (d) is repeated 4-5 times.

In a further embodiment, the powder as obtained from step (g) can either be directly administered to a subject or can be formulated into a particular dosage form using suitable carriers by using any common technique available in the art.

ADVANTAGES OF THE INVENTION

1. The present invention provides a novel synergistic Anti-bloating herbal extract composition comprising therapeutically effective amounts of plant extracts of Phyllanthus fraterna, Paederia foetida, Anthocephalus chinensis, Balanites aegyptica, Helianthus annuus, Diplocyclos pal atus, Cocculus hirsutus and black salt.

2. The present invention provides use of the novel herbal composition of the present invention for treating or preventing bloating in a subject in need thereof.

3. The present invention provides a process for the preparation of novel herbal composition of the present invention.

4. The present invention provides the novel herbal composition which is safe, effective and devoid of side effects.

5. The present invention provides the novel herbal composition which is having economic significance in comparison to the commonly available allopathic and synthetic drugs.

EXAMPLES

The present invention 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:

l OOOg of the composition of example 1 was made. Experimental animals with clinical signs of bloat were identified. Animals were administered l OOg twice daily for maximum 5 days. The therapeutic efficacy of the drug was evaluated based on the parameters viz., appetite, position of the animal, distention of the flank, ruminal waves, respiration (type), respiration (per minute), time required to relieve the gas, time required for restoration of rumen motility, time taken by animal to return to feed. The animals were found to be relieved of bloat within 7- 10 hour after administration of medicine.

Claims

1. An Anti-bloating herbal composition comprising therapeutically effective amounts of plant extracts of Phyllanthus fraterna, Paederia foetida, Anthocephalus chinensis, Balanites aegyptica, Helianthus annuus, Diplocyclos palmatus, and Cocculus hirsutus .

2. The composition of claim 1 , wherein said composition comprises of 15 to 25 % by weight of an extract of Phyllanthus fraterna, 30 to 40 % by weight of an extract of Paederia foetida, 5 to 10% by weight of an extract of Anthocephalus chinensis, 5 to 10 % by weight of an extract of Balanites aegyptica; 1 to 5 % by weight of an extract of Helianthus annuus, 1 to 5 % by weight of an extract of Diplocyclos palmatus; 1 to 5 % by weight of an extract of Cocculus hirsutus.

3. The composition of claim 1 , wherein said composition further comprises of black salt.

4. The composition of claim 3, wherein said composition comprises of 10 to 20 % by weight of black salt.

5. The composition of claim 1 , wherein said composition further comprises of at least one carrier.

6. Use of the composition of claim 1 , wherein said composition is used for treating and/or preventing bloating comprising administering a therapeutically effective amount of said composition to a subject in need thereof.

7. The composition of claim 1 , wherein said composition is administered orally, or parenteral ly.

8. A method for preparation of the Anti-bloating herbal composition of claim I, comprising the steps of: a. Drying respective plant parts to remove excess moisture; b. Powdering and sieving respective plant parts through mesh to obtain fine powder; c. Adding a suitable solvent to the fine powder of step (b) to obtain a solution; d. Allowing the solution to stand followed by continuous stirring; e. Optionally repeating step (d) more than once; f. Filtering the solution obtained from step (e) to obtain the extract; g. Evaporating excess solvent and lyophilizing to obtain fine powder.

9. The method of claim 8, wherein the powder as obtained from the step (g) is either directly administered to a subject or is formulated into a particular dosage form using suitable carriers by using a common technique available in the art.