WO2017145182A1 - Formulation à base d'herbes pour traiter des maladies de la bouche et maintenir une hygiène buccale - Google Patents

Formulation à base d'herbes pour traiter des maladies de la bouche et maintenir une hygiène buccale Download PDF

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Publication number
WO2017145182A1
WO2017145182A1 PCT/IN2017/050073 IN2017050073W WO2017145182A1 WO 2017145182 A1 WO2017145182 A1 WO 2017145182A1 IN 2017050073 W IN2017050073 W IN 2017050073W WO 2017145182 A1 WO2017145182 A1 WO 2017145182A1
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WO
WIPO (PCT)
Prior art keywords
formulation
herbal formulation
herbal
clerodendruminfortunatum
trianthemaportulacastrum
Prior art date
Application number
PCT/IN2017/050073
Other languages
English (en)
Inventor
Khatun REKHA
Pandit RAMSAGAR
Mahato TULSI
Original Assignee
Rekha Khatun
Ramsagar Pandit
Tulsi Mahato
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rekha Khatun, Ramsagar Pandit, Tulsi Mahato filed Critical Rekha Khatun
Publication of WO2017145182A1 publication Critical patent/WO2017145182A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/85—Verbenaceae (Verbena family)
    • A61K36/855—Clerodendrum, e.g. glorybower
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine

Definitions

  • gingivitis is associated with an increased risk of diabetes, heart attack, stroke, and lung disease. It also increases the risk of a woman giving birth to a premature or low birth weight infant.
  • Gingivitis can be caused by several factors.
  • One such factor is the formation of dental plaque.
  • Plaque is a thin film of bacteria that is constantly formed on the surface of teeth. As plaque advances, it hardens and becomes tartar leading to development of an infection.
  • Gingivitis can also be caused by trapping of food or other material in suculus - a space formed between the teeth and edges of the gum. Symptoms of gingivitis includes gums that are red, tender, or swollen, gums that bleed while brush or floss your teeth, gums that have pulled away from the teeth, loose teeth, pus between teeth and gums, pain when chewing, sensitive teeth, partial dentures that no longer fit, foul-smelling breath that does not go away after you brush your teeth.
  • Dental plaque is a complex biofilm that accumulates on the hard tissues (teeth) in the oral cavity.
  • Dental plaque formation is characterized by progression of microorganisms with Streptococci being the dominant 'pioneer' species followed by increasing proportions of actinomycetes and eventually the conversion of the plaque to a 'mature' community with high levels of Gram-negative anaerobic filamentous organisms.
  • Streptococcus mutans S. gordonii, Neisseria mucosa, Brevi bacterium liquefaciens and Moraxella sp.
  • a variety of adhesions and molecular interactions underlie these adhesive interactions and contribute to plaque development and ultimately to diseases such as gingivitis, caries and periodontal disease.
  • the main object of the present invention is to provide anherbal formulation comprising of therapeutically effective amounts of Clerodendruminfortunatum and Trianthemaportulacastrum.
  • Another object of the present invention is to provide an herbal formulation for treating and preventing toothache and tooth decay by administration of a therapeutically effective amount of the composition.
  • Another object of the present invention is to provide an herbal formulation having an antimicrobial activity against causative organisms of dental plaque.
  • a further object of the present invention is to provide anherbal formulation which is safe, biodegradable, effective and devoid of side effects.
  • an herbal formulation for the prevention and/or treatment of diseases of mouth comprising extracts of at least one part of Clerodendruminfortunatum and Trianthemaportulacastrum. It is another aspect of the present invention, wherein Clerodendruminfortunatum comprises about 0.5- 10 percent by weight.
  • Trianthemaportulacastrum comprises about 0.1- 0.4 percent by weight. It is another aspect of the present invention, wherein the parts of Clerodendruminfortunatum and Trianthemaportulacastrum preferably include whole plant of Clerodendruminfortunatum and leaves of Trianthemaportulacastrum.
  • the formulation further comprises of at least one of the pharmaceutically acceptable excipient selected from the group consisting of binder, diluent, sweetener, gelling agent, abrasive, foaming agent, flavouring agent and preservative.
  • the pharmaceutically acceptable excipient selected from the group consisting of binder, diluent, sweetener, gelling agent, abrasive, foaming agent, flavouring agent and preservative.
  • step (d) formulating the extract from step (d) into a particular dosage form using excipients to provide the herbal formulation.
  • the extract is formulated to an herbal formulation with or without carrier(s).
  • the suitable solvent preferably includes water and ethanol.
  • the present invention is thus directed to an herbal compositionfor the prevention and/or treatment of diseases of mouth comprising therapeutically effective amount of Clerodendruminfortunatum and Trianthemaportulacastrum.
  • plaque induced gingivitis includes gingivitis caused by accumulation of dental plaque and refers to a condition characterized by complex biofilm accumulation on the hard tissues (teeth) in the oral cavity leading to bleeding gums, swollen gums, bright red or purple gums, tenderness and pain in gums and bad breathandultimately to diseases such as caries and periodontal disease.
  • toothache refers to a condition associated with pain around the teeth or jaws primarily as a result of a dental condition.
  • toothaches are caused by tooth problems including but not limited to for example dental cavity, a cracked tooth, an exposed tooth root gum disease, damaged filling repetitive motions such as;chewing gum or grinding teeth and the like.
  • the symptoms of toothache are pain with chewing, hot or cold sensitivity, bleeding or discharge from around a tooth or gums, swelling around a tooth or swelling of your jaw, injury or trauma to the area.
  • subject refers to mammals more preferably humans.
  • terapéuticaally 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.
  • composition of the present invention comprises of about 0.5- 10% by weight of at least one part of Clerodendruminfortunatum, about 0.1- 0.4% by weight of at least one part of Trianthemaportulacastrum and optionally at least one of the pharmaceutically acceptable excipients.
  • the parts of Clerodendruminfortunatum and Trianthemaportulacastrum preferably include whole plant of Clerodendruminfortunatum and leaves of Trianthemaportulacastrum.
  • Clerodendruminfortunatum also known as Hill glory bower is a shrub collected from Bihar. It is a perennial flowering shrub belonging to the family Lamiaceae.
  • the leaves and roots of Clerodendruminfortunatum are used as herbal remedy for alopecia, asthma, cough, diarrhoea, rheumatism, fever and skin diseases. It is also known to have hepato-protective activity.
  • the roots and bark of stem of this plant are prepared as decoction and given for respiratory diseases, fever, periodic fever, cough, bronchial asthma, etc.
  • a paste of leaves and roots are applied externally over skin diseases especially fungal infections and alopecia. Fresh leaves are given for liver disorders and headache.
  • leaves and root are widely used as antidandruff, antipyretic, ascaricide, laxative, vermifuge, and in treatments of convulsion, diabetes, gravel, malaria, scabies, skin diseases, sore, spasm, scorpion sting, snake bite and tumor.
  • Trianthemaportulacastrum also known as desert horsepurslane, black pigweed, and giant pigweed, was collected from Bihar. It is a species of flowering plant belonging to the family Aizoaceae. The plant is alexiteric, analgesic, stomachic, laxative, alterative; cures bronchitis, heart diseases, anemia, inflammations, piles and ascites. The plant has been used in the indigenous system of medicine for the obstruction of the liver asthma, amenorrhea, dropsy, edema, ascites, and beri-beri. A decoction of the herb is used as a vermifuge and is useful in rheumatism; it is also an antidote to alcoholic person. The root is cathartic and abortifacient with irritant properties. An infusion of the roots is administered in jaundice, stranguary, and dropsy.
  • the formulation comprises of a mixture of extracts of two herbs which gives significant relief in multiple diseases associated with oral cavity. 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.
  • An embodiment of the present invention provides a use of the herbal composition of the present invention for the treatment and/or prevention of plaque, gingivitis, toothache, tooth decay by administrating a therapeutically effective amount of the composition to a subject in need thereof.
  • the herbal dental composition of the present invention optionally contains at least one pharmaceutically acceptable excipient.
  • the herbal dental formulation of the present invention can be formulated in a delivery system in any of the form that include paste, gel, solution, gargle, powder, lozenges, ointments, impregnated dental floss and the like.
  • the herbal composition of the present invention may further comprise of the pharmaceutically acceptable excipients selected from the group comprising of binder, diluent, sweetener, gelling agent, abrasive, foaming agent, flavoring agent and preservative as a carrier or otherwise.
  • the binder as used herein in the composition according to the present invention is selected from the group comprising of cellulose per se, esters of cellulose polymers, gelatins and/or traditional binders alone or in combination thereof preferably selected from sodium carboxymethylcellulose, hydroxypropyl cellulose, hydroxy propyl methylcellulose, methyl cellulose, polyvinyl pyrrolidone, polyethylene glycol, hydrolysed gelatin, natural gums, most preferably selected from hydroxy propyl methyl cellulose (HPMC), corn starch alone or in combination thereof.
  • HPMC hydroxy propyl methyl cellulose
  • the sweetener according to the present invention is selected from natural, artificial, water soluble, water insoluble or intense sweeteners preferably selected from sucrose, glucose, fructose, fructose syrup, glycyrrhizin, molasses, caramel, mono ammonium salt of glycyrrhizin, mono- di- or ti-sodium salt of glycyrrhizin, mono- di- or tri-potassium salt of glycyrrhizin, and calcium salt of glycyrrhizin, sugar alcohols such as mannitol, sorbitol, xylitol, maltitol alone or in combination thereof.
  • the abrasive according to the present invention is selected from the group comprising of natural and synthetic abrasive particulate materials alone or in combination thereof most preferably selected from calcium carbonate of natural origin.
  • the gelling agent according to the present invention is selected from the group comprising of natural or synthetic origin alone or in combinationthereof most preferably selected from xanthum gum of natural origin.
  • the diluent according to the present invention is selected from the group comprising spray- dried mannitol, methyl carboxy cellulose alone or in combination thereof.
  • the foaming agent according to the present invention is selected from the group comprising salts of lauroylsarcosinate.
  • the preservative according to the present invention is selected from the group comprising of citric acid, sodium benzoate, cetylpyridinium chloride, potassium sorbate and alkyl parabens alone or in combination thereof.
  • the flavoring agent according to the present invention is selected from the group comprising of essential oils, flavoring chemicals alone or in combination thereof.
  • the essential oils includes oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon lime, grapefruit and orange and flavoring chemical includes menthol, carvone and anethole.
  • the most preferable flavoring is selected from peppermint oil and menthol alone or in combination thereof.
  • composition of the present invention required to be used may vary from subject to subject depending on the age, general condition of the subject, severity of the condition and the like. An appropriate dose is readily determined by one of ordinary skills in the art.
  • the mixture prepared using extracts of whole plant of Clerodendruminfortunatum and leaves of Trianthemaportulacastrumare either directly administered to a subject or are formulated into a particular oral dosage form using carrier(s).
  • Clerodendruminfortunatum and Trianthemaportulacastrum were collected and dried in shade.
  • the dried material (1 Kg) was then powdered and extracted with 50% aqueous alcohol (3 L) for 5 days. At the end of this, the extract obtained was filtered and then concentrated under vacuum at less than 60° C. Then the extract was lyophilised to obtain the extract in powder form.
  • the extracts were mixed with menthol, ethanol, sodium saccharin, peppermint oil, SLS as per the quantity mentioned above. The solution prepared was used as mouthwash for studies.
  • a total of 60 volunteers including male and female of 18-30 years with clinical signs of mild to moderate gingivitis were selected and assigned to Group B (only scaling done-Placebo given) and Group A (scaling along with use of herbal mouthwash). After recoding the clinical parameters, the patients were instructed to use herbal mouthwash 10 ml for 30second twice daily after food in both groups and oral hygiene instructions were given to all patients. Plaque and gingivitis assessment were carried out using the plaque index, Gingival indexat baseline and at 21 days of herbal mouthwash use. The subjects were assigned randomly with 30 subjects in each of Group-A and Group-B. Group B was given placebo and Group A was provided herbal formulation as mouth wash.
  • the claimed herbal formulation was tested against key micro-organisms involved in dentalplaque formation.
  • the Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) of the herbal formulation against Streptococcus mutans, Streptococcus gordonii, Neisseria mucosa, Moraxella sp., and Brevi bacterium liquefaciens were determined as referred in Table 3.
  • Table 3 Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) of the formulation against micro-organisms involved in dental plaque initiation and formation

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cosmetics (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

La présente invention concerne une formulation à base d'herbes pharmaceutiquement acceptable pour traiter une maladie de la bouche et maintenir une hygiène buccale. La composition à base d'herbes, comprenant des extraits d'au moins une partie de Clerodendrum infortunatum et de Trianthema portulacastrum, comprend une plante entière de Clerodendrum infortunatum et des feuilles de Trianthema portulacastrum. La formulation comprend en outre au moins un de l'excipient pharmaceutiquement acceptable choisi parmi le groupe constitué de liant, de diluant, d'édulcorant, d'agent gélifiant, d'abrasif, d'agent moussant, d'agent aromatisant et de conservateur en tant que support. La formulation à base d'herbes est formulée dans un système d'administration dans l'une quelconque des formes comprenant une pâte, un gel, une solution, un gargarisme, une poudre ou un fil dentaire imprégné. Cette formulation à base d'herbes est utilisée pour traiter des maladies de la cavité buccale.
PCT/IN2017/050073 2016-02-25 2017-02-22 Formulation à base d'herbes pour traiter des maladies de la bouche et maintenir une hygiène buccale WO2017145182A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201631006537 2016-02-25
IN201631006537 2016-02-25

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WO2017145182A1 true WO2017145182A1 (fr) 2017-08-31

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PCT/IN2017/050073 WO2017145182A1 (fr) 2016-02-25 2017-02-22 Formulation à base d'herbes pour traiter des maladies de la bouche et maintenir une hygiène buccale

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WO (1) WO2017145182A1 (fr)

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BHATTACHARJEE D ET AL.: "Clerodendrum Infortunatum Linn.: A Review", JOURNAL OF ADVANCES IN PHARMACY AND HEALTHCARE RESEARCH, vol. 1, no. 3, 2011, pages 82 - 85, XP055412072 *
GADDEYYA G. ET AL.: "A Comprehensive Review on Ethnobotany and Photochemistry of an Herbal Weed Trianthema portulacastrum L.", JOURNAL OF PHARMACOGNOSY AND PHYTOCHEMISTRY, vol. 4, no. 4, 2015, pages 25 - 31, XP055412075 *
PANDITA V ET AL.: "Dentistry meets nature role of herbs in periodontal care: A systematic review", JOURNAL OF INDIAN ASSOCIATION OF PUBLIC HEALTH DENTISTRY, vol. 12, no. 3, 2014, pages 148 - 156, XP055412076 *

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