WO2006032091A2 - Herbal composition - Google Patents
Herbal composition Download PDFInfo
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- WO2006032091A2 WO2006032091A2 PCT/AU2005/001443 AU2005001443W WO2006032091A2 WO 2006032091 A2 WO2006032091 A2 WO 2006032091A2 AU 2005001443 W AU2005001443 W AU 2005001443W WO 2006032091 A2 WO2006032091 A2 WO 2006032091A2
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- herbal composition
- mis
- extract
- composition according
- herbal
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Classifications
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- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/287—Chrysanthemum, e.g. daisy
-
- 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)
- A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
-
- 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)
- A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
-
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
Definitions
- the invention relates to a herbal composition for treating a soft and/or hard tissue injury such as bruises.
- Sporting and recreational activities are a major part of people's lives. They promote fitness, fun and socialisation. However, there is also a risk of injury associated with many of these activities that results in damage to soft and/or hard tissue. Such injuries can also be sustained during activities of everyday life.
- a bruise or "contusion” is a traumatic injury to soft tissue underneath the skin resulting in breakage of the local capillaries and leakage of red blood cells into the soft tissue.
- a bruise will turn into a dark blue or purple color. As the bruise begins to heal, it changes colors. The color change is due to the biochemical breakdown of hemoglobin that is found in the blood. As the different components of the blood are broken down, different colors will appear in the bruise. The swelling associated with a bruise is the result of an excessive build-up of fluid in the damaged soft tissue.
- Muscle aches and pains are common and are most frequently related to tension, overuse, or muscle injury from exercise or physically demanding work. In these situations, the muscle pain tends to involve specific muscles and starts during or just after the activity. Muscle pain can also involve the connective soft tissue that surrounds the muscle. Connective soft tissue includes ligaments, tendons, and fascia (thick bands of tendons) .
- a strain which is also called a "pulled muscle" is caused when a muscle becomes overstretched and tears resulting in soft tissue damage. Excessive physical activity or effort, improper warming up before physical activity and poor flexibility can all cause this type of injury.
- a sprain which is an injury to the ligaments around a joint, occurs when a ligament is stretched too far or tears. When a ligament is damaged, there is pain and swelling around the joint.
- a herbal composition comprising extracts from:
- Arnica (Arnica montana) ; Comfrey ⁇ Symphytum spp) ; Witch Hazel (Hamamelis virginiana) ; Calendula (Calendula officinalis) ; Hypericum (Hypericum perfoliaturn) ; and
- Lavender (Lavender angustifolia) .
- the herbal composition may further comprise extracts from one or more of Aloe (Aloe sp) , Agrimony (Agrimonia enpatoria) , Nettles ( ⁇ rtica dioica) , Burdock (Arctium lappa) , Jamaican Dogwood (Piscidia erythrina) , Oats (Avena sativa) , Licorice (Glycyrrhiza glabra) , Chamomile (Matricaria recutita) , Albizzia (Albizza lebbeck) , Devil's Claw (Harpagophyt ⁇ im procumbens) , Golden seal (Hydrastis canadensis) , Kava (Piper mythisticum) , Corydalis (Corydalis ambigua) , Marshmallow (Althea officinalis) , Poke root (Phytolacca decandra) , Plantain spp (Plan
- Sarsaparilla (Smilax officinalis) , Sassafras (Sassafras albidum) , Red clover (Trifolium pretense) , Yarrow (Achillea millefolium) , Self heal (Prunella vulgaris) , American cranesbill (Geranium maculaturn) , Elder (Sambucus nigra) , Horsetail (Eguisetum spp) , Slippery Elm ( ⁇ lmnus fulva) , Hoheria (Hoheria populnea) , Sage (Salvia officinalis) , Bearberry (Arctostaphyllos uva ursi) , Sweet violet (Viola odorata) , Tormentil (Potentilla tormentilla) ,ssen mantle ⁇ Alchemilla mollis/vulgaris) , New Zealand Flax ⁇ Phormi ⁇ m spp)
- a second aspect of the invention provides a method of treating a soft and/or hard tissue injury or symptoms associated with the injury which comprises administering a therapeutically effective amount of the herbal composition as defined above to a subject in need thereof.
- a third aspect of the invention provides use of the herbal composition as defined above for the manufacture of medicament for treating a soft and/or hard tissue injury or symptoms associated with the injury.
- a fourth aspect of the invention provides use of the herbal composition as defined above for treating a soft and/or hard tissue injury or symptoms associated with the injury.
- a fifth aspect of the invention provides the herbal composition as defined above for use in treating a soft and/or hard tissue injury or symptoms associated with the injury.
- the herbal composition may conveniently be administered together with one or more carriers.
- a seventh aspect of the invention provides the herbal composition as defined above together with one or more carriers.
- the herbal composition is suitably administered topically.
- extract as used herein should be taken in the broadest possible sense. "Extracts” may include tinctures, fluid extracts or solid extracts, tars, cold pressed oils, infused oils, infusions, decoctions, tars, essential oils, and mucilage, for example.
- the herbal composition may include one or more different kinds of extracts. For example, extracts in the form of a tincture, an infused oil and an essential oil. Furthermore, the different herbs may be processed to form extracts by different means. Similarly, the herbal composition may comprise a mixture of two or more types of extracts of a particular herb.
- Tinctures may be formed from water-based infusions and decoctions.
- Alternative bases for the extract may include acetracts (to form a vinegar extract) , glycetracts (to form a glycerine extract) , meIs (to form a honey extract) , oxymels (honey and vinegar) , or syrups (to form a sugar extract) .
- Tinctures are prepared by methods well known in the art. Briefly, however, a fresh plant tincture is made by first obtaining a herb dried by air as known in the art. The dried herbs are then further dried in an oven at a temperature of between 60 0 C and 70 0 C. The oven dried herbs are then suspended in a solution in a storage container. In a preferred form, the solution is a mixture of alcohol and water. To make up a 1:5 tincture, 75 gms of oven dried herb is suspended in 375 ml of the solution (weight of herb x 5 to get 1:5 ratio) in a storage container. The storage container is allowed to stand for about 6 weeks and is shaken periodically. The mixture is then filtered and the solution withdrawn provides the tincture used.
- the tinctures may also be purchased from herbal suppliers such as MediHerb Fty Ltd, 124 McEvoy Street, Warwick, Queensland 4370, Australia in a ready-to-use formulation.
- An infused oil may be made by infusing or macerating the herb in an oil. Infusing or macerating a herb in an oil solubilises the herb, making the resulting infused oil particularly suitable for topical application.
- the oil used to prepare the infused oil may be a fixed or vegetable oil.
- a fixed oil is a non-volatile animal or plant based oil.
- fixed, fruit and vegetable oils examples include almond oil (including sweet almond oil) , coconut oil, corn oil, peanut oil, olive oil (including extra virgin olive oil) , safflower oil, sesame oil, soybean oil, castor oil, wheat germ oil, jojoba oil and cod-liver oil.
- Cold pressed oils are particularly preferred.
- Methods for preparing cold pressed oils are well known in the field. Generally, the process involves a simple crushing and filtering process.
- Steam-distillation is an example of one method that is used. Generally, steam-distillation involves passing steam throughout a particular part of the herb plant, which evaporates its oils. The steam is then condensed and the oils separate from the water. This method yields a high quality oil.
- a tar is a very strong decoction, which is further reduced by evaporation.
- Mucilage is a gelatinous substance, which is extracted from the herb plant, such as the root.
- the extracts may be prepared from any part of the herb plant such as, for example, foliage, leaves, the root, flowers, bark, stems or rhizome, seeds, and fruit. However, particular parts of the herb plant are usually used to prepare the extracts.
- An Arnica extract is usually made from the flowers.
- the Arnica extract is prepared as a tincture.
- the herbal composition preferably comprises from about 1 ml to about 100 mis of Arnica extract, more preferably from about 50 mis to about 70 mis of Arnica extract, and most preferably about 60 mis of Arnica extract.
- a Comfrey extract is usually made from the root.
- the Comfrey extract is prepared as a tincture.
- fresh mucilage extracted from the root may also be used.
- the herbal composition preferably comprises from about 1 ml to about 100 mis of Comfrey extract, more preferably from about 50 mis to about 70 mis of Comfrey extract, and most preferably about 60 mis of Comfrey extract.
- a Witch Hazel extract is usually made from the leaves.
- the Witch Hazel extract is prepared as a tincture.
- the Witch Hazel extract may also be prepared as an infusion or decoction.
- the herbal composition preferably comprises from about 1 ml to about 60 mis of Witch Hazel extract, more preferably from about 30 mis to about 50 mis of Witch Hazel extract, and most preferably about 40 mis of Witch Hazel extract.
- a Calendula extract is usually made from the flowers.
- the flowers In a preferred form of the invention, the
- Calendula extract is infused in an oil.
- the Calendula extract may also be prepared as a tincture.
- the herbal composition preferably comprises from about 1 ml to about 60 mis of Calendula extract, more preferably from about 30 mis to about 50 mis of Calendula extract, and most preferably about 40 mis of Calendula extract.
- a Hypericum extract is usually made from the flowers and aerial parts of the plant.
- the Hypericum extract is infused in an oil.
- the Hypericum extract may also be prepared as a tincture.
- the herbal composition preferably comprises from about 1 ml to about 60 mis of Hypericum extract, more preferably from about 30 mis to about 50 mis of Hypericum extract, and most preferably about 40 mis of Hypericum extract.
- a Lavender extract is usually made from the flowers.
- the Lavender extract is prepared as an essential oil.
- the Lavender extract may also be prepared as a tincture.
- the herbal composition preferably comprises from about 1 ml to about 60 mis of Lavender extract, more preferably from about 30 mis to about 50 mis of Lavender extract, and most preferably about 40 mis of Lavender extract.
- Table 1 illustrates a herbal composition of a preferred embodiment of the invention.
- the herbal composition may further comprise one or more additional herb extracts, which may also assist in treating a soft and/or hard tissue injury or symptoms associated with the injury.
- additional herb extracts include herb extracts of one or more of Aloe ⁇ Aloe sp) , Agrimony (Agrimon ⁇ a eupatoria) , Nettles (Urtica dioica) , Burdock (Arctium lappa) , Jamaican Dogwood (Piscidia erythr ⁇ na) , Oats (Avena sativa) , Licorice ⁇ Glycyrrhiza glabra) , Chamomile (Matricaria recutita), Albizzia (Albizza lebbeck) , Devil's Claw (Harpagophytum procumbens) , Golden seal (Hydrastis canadensis) , Kava (Piper mythisticum) , Corydalis
- the herbal composition may comprise from about 1 ml to about 100 mis, more preferably from about 20 mis to about 60 mis, and most preferably about 30 mis of each of the above-mentioned additional herb extracts.
- soft tissue is used herein in the broadest sense and includes structural tissue, areolar tissue, adipose tissue, aponeurosis, ligaments, tendons, fascia, muscles, cartilage, and the like.
- hard tissue is used herein to refer to bone.
- a “hard tissue injury” is a fracture to a bone.
- bone fractures There are several types of bone fractures, including the “greenstick” fracture, which is an incomplete fracture in which the bone bends, the “transverse” fracture, which is a fracture that goes across the bone's axis causing it to break, and the “simple” fracture, which is fracture that breaks the bone but does not break the skin.
- Another type of fracture is the “stress” fracture, which is a hairline crack in the bone that develops because of repeated or prolonged forces against the bone.
- Typical symptoms associated with a soft or hard tissue injury include, but are not limited to, skin discoloration, swelling, aches and pain.
- the inventor believes that the surprising and unexpected effects seen with the herbal composition results from synergism between the individual components.
- the synergy between the individual components in the herbal composition can be further enhanced by addition of one or more of these additional herb extracts in the herbal composition.
- subject refers to any animal that sustains a soft and/or hard tissue injury and requires treatment with the herbal composition to treat the soft and/or hard tissue injury or symptoms associated with the injury.
- the subject may be an animal, such as a mammal, preferably a human, or may be a non-human primate or non-primates such as used in animal model testing.
- the herbal composition is suitable for use in treatment of humans, it is also applicable to veterinary treatment, including treatment of companion animals such as dogs and cats, and domestic animals such as horses, ponies, donkeys, mules, llama, alpaca, pigs, cattle and sheep, or zoo animals such as primates, felids, canids, bovids, and ungulates.
- companion animals such as dogs and cats
- domestic animals such as horses, ponies, donkeys, mules, llama, alpaca, pigs, cattle and sheep
- zoo animals such as primates, felids, canids, bovids, and ungulates.
- treating means affecting a subject, tissue or cell to obtain a desired pharmacological and/or physiological effect.
- the effect may be prophylactic in terms of completely or partially treating the soft and/or hard tissue injury or symptoms associated with the injury.
- Treating covers any treatment of a soft and/or hard tissue injury or symptoms associated with the injury suffered by an animal such as a mammal, more particularly a human, and includes treating the effects, i.e. cause regression, of a soft and/or hard tissue injury or alleviating, relieving or ameliorating the symptoms associated with the injury.
- the term "effective amount” means an amount of the herbal composition to treat a soft and/or hard tissue injury or symptoms associated with the injury in order to yield a desired therapeutic response.
- terapéuticaally effective amount means an amount of the herbal composition to yield a desired therapeutic response. For example, treating a soft and/or hard tissue injury or symptoms associated with the injury.
- the herbal composition may conveniently be administered together with one or more carriers.
- Carriers include substances that are useful in preparing a formulation comprising the herbal composition, may be in co-administration with the herbal composition while allowing the individual components to perform their intended function, and are generally safe, non-toxic and are neither biologically or otherwise undesirable.
- carriers will include those suitable for veterinarian use as well as human use. Examples of carriers include dispersing agents, suspending agents, emulsifying agents, stabilising agents, wetting agents, binding agents, lubricants, disintegrants, solvents, media, delay agents, fillers, aqueous and oily bases, non ⁇ aqueous vehicles, and the like.
- the herbal composition may contain preserving agents, colouring agents, fragrances, thickening and/or gelling agents, buffers and the like. Those skilled in the art will be able to identify further additives that may be desirable for cosmetic reasons, for example.
- the herbal composition may be converted into customary formulations.
- formulations include, but are not limited to, solutions, emulsions, suspensions, powders, granules, natural and synthetic materials impregnated with the individual components of the herbal composition, pastes, ointments, creams, plasters, washes, lotions, transdermal patches, and sprays (atomiser, or aerosol) .
- the herbal composition is converted into a formulation suitable for topical administration.
- the choice of carriers and/or additives may be dictated to some extent by the intended dosage form of the herbal composition and the mode of administration of the herbal composition.
- Formulations comprising the herbal composition may be produced by a number of techniques standard in the art, for example, by mixing the herb extracts with one or more carriers and/or additives until all components are well blended.
- the formulations may be stored in suitable containers, receptacles, vessels and the like.
- the herbal composition may be formulated as an ointment, cream, compress, poultice, moisturiser, plaster, wash, lotion, or as a transdermal patch.
- Ointments and creams may, for example, be formulated with an aqueous or oily base with the addition of suitable thickening and/or gelling agents.
- oily bases include, but are not limited to, a vitamin E cream or lotion, glucate cream, extra virgin olive oil, sweet almond oil, jojoba oil, apricot oil, peanut oil, fruit and vegetable oils, beeswax, lanolin and honey.
- Lotions and washes may be formulated with an aqueous or oily base, and will in general also contain one or more emulsifying agents, stabilising agents, dispersing agents, suspending agents, thickening agents, or colouring agents.
- a topical formulation in the form of a cream may be prepared by adding about 60 mis of Arnica extract in the form of a tincture / about 60 mis of Comfrey extract in the form of fresh mucilage extracted from the root; about 40 mis of Witch Hazel extract in the form of a tincture; about 40 mis of Calendula extract in the form of an infused oil; about 40 mis of Hypericum extract in the form of an infused oil; and about 20 mis of Lavender extract in the form of an essential oil; to about 500 mis of a suitable cream base. These ingredients may be blended by mixing, agitation and/or heating, as known in the art. The cream based topical formulation may then be apportioned into suitable containers for use.
- the herbal composition would be administered to a subject as needed, as desired, or as advised by a medical practitioner, pharmacist, attendant physician, medical herbalist, naturopath, or veterinarian.
- the selection of additional herb extracts may also be made on the specific needs of the subject.
- the herbal composition is suitably applied directly to the affected area, but not to an affected area with broken skin.
- the dose administered, the period of administration, and the general administration regime may differ between subjects depending on variables such as their tolerance to certain active ingredients, weight, metabolism, the mode of administration chosen, the severity of the symptoms, and the age and/or general health of the subject.
- the general administration regime for topical treatment is application to the affected areas about 3 times daily.
- Treatment is preferably commenced at the time the soft and/or hard tissue injury is sustained and preferably continues until the injury or symptoms associated with the injury are no longer present.
- the subject After suffering a fall onto a hard surface, the subject sustained a fracture to both coccyx and sacrum and considerable bruising to the lumber and buttock regions.
- the herbal composition was prepared as a topical formulation in the form of a cream by mixing the following ingredients: about 60 mis of Arnica extract in the form of a tincture; about 60 mis of Comfrey extract in the form of fresh mucilage; about 40 mis of Witch Hazel extract in the form of a tincture; about 40 mis of Calendula extract in the form of an infused oil; about 40 mis of Hypericum extract in the form of an infused oil; about 20 mis of Lavender extract in the form of an essential oil; and about 500 mis of a glucate cream base.
- Subject B applied the cream to the injury. There was a noticeable decrease in the swelling and little sign of bruising. With rest and continued repeated applications of the cream, the injury healed well. There have been no reported complications resulting from the injury.
- Subject C After regularly applying the cream for a period of two weeks, Subject C was able to participate in sporting activities without suffering swelling or pain afterwards.
- Subject D repeatedly applied the cream as required resulting in a substantial improvement in 24 hours. All signs of the injury were gone within 60 hours.
- Subject E liberally applied the cream to the affected areas before bedtime. In the morning, there was no sign of swelling or pain and the subject was able to walk normally without restriction or pain.
Abstract
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AU2004905440A AU2004905440A0 (en) | 2004-09-21 | Herbal composition | |
AU2004905440 | 2004-09-21 |
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CN108042601A (en) * | 2018-01-19 | 2018-05-18 | 葵花药业集团(贵州)宏奇有限公司 | A kind of drug for treating acute and chronic soft tissue injury and preparation method thereof |
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GR1009331B (en) * | 2017-03-14 | 2018-07-31 | Ευαγγελια Παναγιωτη Λαγου | Muscle-relieving oil with herbs |
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