(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2003/0185918A1
`(43) Pub. Date:
`Oct. 2, 2003
`ROSenbloom
`
`US 2003O185918A1
`
`(54)
`
`(76)
`
`(21)
`(22)
`
`(60)
`
`NUTRITIONAL SUPPLEMENTS AND
`METHODS OF USING SAME
`
`Inventor: Richard A. Rosenbloom, Elkins Park,
`PA (US)
`Correspondence Address:
`KNOBLE & YOSHIDA
`EIGHT PENN CENTER
`SUITE 1350, 1628 JOHN F KENNEDY BLVD
`PHILADELPHIA, PA 19103 (US)
`Appl. No.:
`10/421,276
`Filed:
`Apr. 23, 2003
`Related U.S. Application Data
`Division of application No. PCT/US02/24794, filed
`on Aug. 6, 2002, which is a continuation of applica
`tion No. 09/923,090, filed on Aug. 6, 2001, now Pat.
`No. 6,592,896, and which is a continuation of appli
`cation No. 10/122,991, filed on Apr. 15, 2002, now
`Pat. No. 6,596,313.
`
`Publication Classification
`
`(51)
`
`Int. Cl. ................................................ A61K 35/78
`
`(52) U.S. Cl. ............................................ 424/755; 424/756
`
`ABSTRACT
`(57)
`A nutritional Supplement for providing, and for promoting
`the health of Salivary glands and/or Supporting normal or
`healthy Swallowing includes ingredients obtainable from
`turmeric, ginger, and horseradish. The nutritional Supple
`ment may also be used to treat Symptoms Such as Symptoms
`of a common cold, Sore throat, congestion, mucositis, lar
`yngitis, mucous membrane inflammation and Sialorrhea, as
`well as inflammation and viral infectin, or to inhibit or
`exterminate a virus. This nutritional Supplement can be
`orally administered a perSon. The nutritional Supplement
`may further include optional ingredients Such as ingredients
`obtainable from Slippery elm bark powder and green tea, as
`well as other optional ingredients. This nutritional Supple
`ment may further include a pharmaceutically acceptable
`carrier for oral administration.
`Also disclosed are methods of providing nutrition, for pro
`moting the health of Salivary glands and/or Supporting
`normal or healthy Swallowing, as well as methods for
`treating Symptoms of a common cold, Sore throat, conges
`tion, mucositis, laryngitis, mucous membrane inflammation
`and Sialorrhea. Methods of treating inflammation, and viral
`infections, as well as inhibiting or exterminating viruses are
`also disclosed.
`
`THORNE - EXHIBIT 1015
`
`

`

`US 2003/0185918 A1
`
`Oct. 2, 2003
`
`NUTRITONAL SUPPLEMENTS AND METHODS
`OF USING SAME
`
`BACKGROUND OF THE INVENTION
`0001 A. Field of the Invention
`0002 The present invention relates to a nutritional
`Supplement and methods of using it. More particularly, the
`present invention relates to a nutritional Supplement useful
`for promoting various health effects and to methods for
`administering the nutritional Supplement for at least these
`purposes.
`0003) B. Description of the Prior Art
`0004 Treatment of Sialorrhea
`0005 Sialorrhea, a symptom related to amyotrophic lat
`eral Sclerosis (ALS), and other causes Such as achalasia,
`acoustic neuroma, Bell's palsy, cerebral palsy, cerebrovas
`cular accident (stroke), glossopharyngeal neuralgia, Guil
`lain-Barre Syndrome, hypocalcemia, Ludwig's angina, men
`tal retardation, motor-neuron disease, muscular dystrophy,
`myasthenia gravis, myotonic dystrophy, paralytic poliomy
`elitis, polymyositis, Parkinson's disease, Radical Cancer
`Surgery, Seventh-nerve palsy, Shy-Drager Syndrome, and
`Wilson's disease, is the excessive drooling due to Salivary
`gland dysfunction Such as overproduction of Saliva from the
`Salivary glands. Sometimes, Sialorrhea may also be induced
`by drugs. Such as clonazepam, ethionamide, haloperidol, and
`transdermal nicotine among others. Sialorrhea may also be
`caused by abnormal or unhealthy Swallowing by a patient
`Suffering from diseaseS Such as ALS.
`0006 Much effort has been made to treat Sialorrhea.
`Newall et al. reported using beta antagonists to control
`excessive Secretions of the oral Salivary glands and reported
`a 75% success rate (J. Neurol. Sci., 1996, 139, 43-4). Mier
`et all have found that ingestion of glycopyrrolate is effective
`in treating sialorrhea in children. However, 20% of the
`children treated with glycopyrrolate experienced Substantial
`adverse effects, enough to require discontinuation of the
`medication (arch. Pediatr. Adolese. Med., 2000, 154, 1214
`1218). According to a recent study by Rettori et al. (Ann. N.
`Y. Acad. Sci., 2000; 917; 258-67), inhibitors of nitric oxide
`synthase (NOS) decrease stimulated salivary secretions
`whereas donors of NOS potentiate stimulated salivary secre
`tions. This indicates that nitric oxide exerts a Stimulatory
`role on Salivary Secretion.
`0007 Treatment of Inflammation
`0008. In modern non-herbal medicine, there are two
`major categories of anti-inflammatory medicines: Steroidal
`and non-Steroidal. Steroidal anti-inflammatory medicines
`are powerful medications, which are based on hormonal
`Substances, Such as cortisone. Steroidal medications have a
`Stronger anti-inflammatory response than non-Steroidal
`medicines. Steroidal medications can be taken as pills,
`injected into the bloodstream, or injected directly into a joint
`Space. There are many non-Steroidal anti-inflammatory
`medications. Acetaminophen, aspirin, ibuprofen, and
`naproxen are the most commonly used non-Steroidal anti
`inflammatory medications.
`0009 Non-steroidal anti-inflammatory drugs have three
`major actions, all of which are related to inhibition of
`cyclo-oxygenase resulting in decreased formation of proS
`
`tanoids. Firstly, an anti-inflammatory action can be achieved
`by reducing production of vasodilator prostaglandins
`(PGE2, PGI2), which means less vasodilation and, indirectly
`leSS Oedema. Secondly, an analgesic effect can be achieved
`by reduced prostaglandin production (less Sensitization of
`nociceptic nerve endings to the inflammatory mediators
`bradykinin and 5-hydroxytryptamine). Thirdly, an anti
`pyretic effect can produce an anti-inflammatory action,
`probably due to a decrease in the mediator PGE2 generated
`in response to inflammatory pyrogens, much as interleukin
`1.
`0010. There are side effects to both of these groups of
`medicines. They may include, among other things, Stomach
`upset, Stomach bleeding, or ulcers, kidney problems, hearing
`problems and ankle Swelling. Additionally, the Steroidal
`anti-inflammatory medications can have more Serious Side
`effects including: loSS of bone mass, cataracts, reduced
`ability to fight infection, Swelling and weight gain, mood
`changes, high blood pressure, and problems with the bone
`marrow where blood cells are produced.
`0011 Turmeric (Curcuma longa)
`0012 Turmeric, or Haldi in Hindi, is used very widely as
`medicine as well as a common ingredient in Indian cooking.
`The rhizome of turmeric is used in medicine and food as a
`fine powder.
`0013 Anti-inflammatory effects of curcumin isolated
`from Curcuma longa were reported in Srimal and Dhawan,
`Pharmacology of Diferuloyl Methane, a Non-steroidal Anti
`inflammatory Agent, J. Pharm. Pharmac., 25:447-452
`(1973). Significant anti-inflammatory activity for curcumin,
`comparable with phenylbutaZone and hydrocortisone, was
`observed by Arora et al. (Indian Journal of Medical
`Research, 1971, 59, 1289-1291). Curcumin, an alkaloid
`(diferuloyl methane) isolated from the alcoholic extract of
`turmeric, has been shown to be a potent anti-inflammatory
`agent. Further work on anti-inflammatory and anti-arthritic
`activity has also been carried out by Thatte et al. (Indian
`Journal of Pharmacology, 1986, 18 (1), 19-21). Turmeric
`has been found to have Significant anti-inflammatory activity
`both in acute and chronic models. The therapeutic dose of
`turmeric, for optimal activity if used alone, is reported to be
`in the range of 5 to 10 grams of dry powder daily (Patward
`han, U.S. Pat. No. 5,494.668). This dosage level, however,
`can produce a feeling of nausea.
`0014 Curcumin not only has anti-inflammatory proper
`ties but also has anti-oxidant, anti-tumor and other valuable
`properties. When used in low concentrations, curcumin can
`inhibit nitric oxide synthase (NOS) and, therefore, inhibit
`nitric oxide production. For example, Brouet et al. (Bio
`chem. BiophyS. Res. Commun., Jan. 17, 1995; 206 (2);
`533-40) have reported that NOS activity in soluble extracts
`of macrophages activated for 6-24 hours in the presence of
`curcumin (10 microM) was significantly lower that that of
`macrophages activated without curcumin. Northern-blot and
`immunoblotting analyses demonstrated that significantly
`reduced levels of the mRNA and 130-kDa protein of induc
`ible NOS were expressed in macrophages activated with
`curcumin, compared to those without curcumin activation.
`Inhibition of NOS induction was maximal when curcumin
`was added together with lipopolysaccharide (LPS) and inter
`feron-gamma (IFN-gamma) and decreased progressively as
`the interval between curcumin and LPS/IFN-gamma was
`increased to 18 hours.
`
`

`

`US 2003/0185918 A1
`
`Oct. 2, 2003
`
`0015) Ginger (Zingiber officinale)
`0016 Native to Southern Asia, ginger is a 2- to 4-foot
`perennial that produces grass-like leaves up to a foot long
`and almost an inch wide. Ginger root, as it is called in the
`grocery Store, actually consists of the underground Stem of
`the plant, with its bark-like outer covering Scraped off.
`0017 Chinese medical texts from the fourth century B.C.
`Suggest that ginger is effective in treating nausea, diarrhea,
`Stomach aches, cholera, toothaches, bleeding, and rheuma
`tism. Ginger was later used by Chinese herbalists to treat a
`variety of respiratory conditions, including coughs and the
`early Stages of colds.
`0.018
`Ginger's modern use dates back to the early 1880s,
`when a Scientist named D. Mowrey noticed that ginger-filled
`capsules reduced his nausea during an episode of flu.
`Inspired by this, he performed the first double-blind study of
`ginger. Germany's Commission E Subsequently approved
`ginger as a treatment for indigestion and motion Sickness.
`Ginger has become widely accepted as a treatment for
`nausea. Even Some conventional medical texts Suggest gin
`ger for the treatment of the nausea and Vomiting of preg
`nancy, although others are more cautious.
`0.019
`Ginger gives relief from muscular discomfort and
`pain. It inhibits prostaglandin and leukotriene biosynthesis
`and histamine release. Thus it acts as an anti-inflammatory
`as well as an antacid agent. It is a dual inhibitor of the
`lipoxigenase and cycloxigenase System. Ginger contains
`1-4% essential oil (oleoresin). Used alone fresh Ginger is
`required to be used in Substantially high doses (50 grams
`daily), which is not only inconvenient but can act as an
`irritant to the gastric mucosa. In dry form for any significant
`results, 7 to 10 grams of dry ginger powder has to be taken
`daily. Such large doses of ginger are extremely inconvenient
`for the patient and affect patient compliance on a daily basis.
`(See Potwardhan, U.S. Pat. No. 5,494,668.)
`0020 Horseradish (Armoracia rusticana)
`0021 Horseradish, a perennial herb (Armoracia rusti
`cana, but Sometimes classified in other genera) of the family
`Cruciferae (mustard family), is native to Central and South
`ern Europe where it has long been cultivated in gardens and
`naturalized in many parts of North America. It is grown
`mainly for its roots, which formerly were used medicinally,
`particularly as an antiscorbutic. Horseradish is also an
`excellent diuretic, and is good for digestion problems.
`Herbalists combine horseradish and honey for coughs and
`asthma treatments. Externally, it is Sometimes used to alle
`Viate the pain and Stiffness caused by rheumatism.
`0022. Friedman, U.S. Pat. Nos. 5,248,504 and 5,385.734,
`has used horseradish to treat nasal and Sinus dysfunction.
`Attempts have also been made to provide oral horseradish
`remedies for certain ailments. Mays, U.S. Pat. No. 98,875,
`relates to a medical compound for alleviating asthma,
`coughs and colds. The compound includes pulverized horse
`radish. Diets, U.S. Pat. No. 74,205, discloses a medical
`compound containing horseradish for the treatment of con
`Sumption.
`0023 Slippery Elm (Ulmus rubra)
`0024. Slippery elm trees are native to North America.
`Slippery Elm has been employed in traditional herbal medi
`cine for over 100 years. The dried inner portion of the
`
`slippery elm bark has been used both by Native Americans
`and early Settlers. Slippery Elm is a nutritious food that was
`made into a type of pudding for those who had weak
`Stomachs. Slippery Elm is Soothing to irritated tissues and
`has been used in poultices for its ability to encourage healing
`in wounds. Slippery Elm nourishes the adrenal glands,
`gastrointestinal tract, and respiratory System. It helps the
`body expel excess mucus. Other conditions, for which
`Slippery elm is used, include: abscess, broken bones, bums
`and Scalds, cholera, colitis, constipation in children, debility,
`diaper rash, diarrhea in children, diverticulitis, dysentery,
`hemorrhoids, hiatal hernia, indigestion, labor pain, leprosy
`and Sore throat.
`0.025 Green Tea (Camellia sinensis)
`0026 Green tea is the dried leaves and leaf buds of the
`shrub Camelia Sinensis. It is mainly produced in China and
`Japan. Dried tea leaves are composed mainly of phy
`tochemicals known as polyphenols (36%), principally fla
`vonols (including catechins), flavonoids, and flavondiols.
`The leaves also contain plant alkaloids (about 4%), includ
`ing caffeine, theobromine and theophylline. Much of the
`research on green tea has been focused on its potential to
`prevent cancer. Research Suggests that the polyphenols in
`green tea are responsible for a chemopreventive effect (E.
`Kaegi, Canadian Medical Association Journal, 1998, 158:
`1033-35).
`0027. It is an object of certain embodiments of the
`present invention to provide a nutritional Supplement to
`promote the health of Salivary glands and/or to Support
`normal or healthy Swallowing.
`0028. It is a further object of certain embodiments of the
`present invention to provide a composition for treating
`Sialorrhea.
`0029. It is still a further object of certain embodiments of
`the present invention to provide a composition for treating
`Some common types of inflammation Such as Sore throat,
`congestion, laryngitis and mucous membrane inflammation.
`0030. It is still a further object of certain embodiments of
`the present invention to provide a method to treat a Sore
`throat, congestion, laryngitis and mucous membrane inflam
`mation by administering a composition made from natural
`herbs.
`0031. It is still a further object of certain embodiments of
`the present invention to provide a method to treat Sialorrhea
`by administering a composition made from natural herbs.
`0032. It is a still further object of certain embodiments of
`the present invention to provide a nutritional Supplement
`with Virucidal and/or virustatic properties.
`0033. These and other objects of the present invention
`will be apparent from the Summary and detailed description
`of the invention, which follow.
`
`SUMMARY OF THE INVENTION
`In a first aspect, the present invention relates to a
`0034.
`nutritional Supplement. The nutritional Supplement of the
`invention may be used for providing nourishment, or,
`optionally for promoting the health of Salivary glands and/or
`Supporting normal or healthy Swallowing. The nutritional
`Supplement includes ingredients, which can be obtained
`
`

`

`US 2003/0185918 A1
`
`Oct. 2, 2003
`
`from turmeric, ginger and horseradish. It has been found that
`the combination of these ingredients provides a nutritional
`Supplement that provides a nutritional benefit and is effec
`tive in promoting the health of Salivary glands and/or
`Supporting normal or healthy Swallowing.
`0035) In a second aspect, the present invention relates to
`a method of promoting the health of Salivary glands and/or
`Supporting normal or healthy Swallowing, by administering
`an effective amount of the nutritional Supplement of the
`present invention.
`0036). In a third aspect, the present invention relates to a
`method to treat one or more of a common cold, and/or one
`or more Symptoms thereof, a Sore throat, congestion, laryn
`gitis, mucositis, mucous membrane inflammation and Sia
`lorrhea, by orally administering to a patient an effective
`amount of a composition including ingredients which can be
`obtained from turmeric, ginger and horseradish, which pro
`vides Substantial relief from one or more of these Symptoms
`or ailments.
`0037. In a fourth aspect, the present invention relates to
`a method of inhibiting the growth of a virus by administering
`to a carrier carrying the virus, a composition including
`ingredients which can be obtained from turmeric, ginger and
`horseradish.
`0.038. In a fifth aspect, the present invention relates to a
`method of treating viral infection by administering a com
`position including ingredients which can be obtained from
`turmeric, ginger and horseradish.
`0039. In a sixth aspect, the present invention relates to a
`method of treating inflammation by administering a com
`position including ingredients which can be obtained from
`turmeric, ginger and horseradish.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`0040. In a first aspect, the present invention relates to a
`nutritional Supplement. The nutritional Supplement may be
`employed for the purpose of providing nourishment. Alter
`natively, the nutritional Supplement of the present may
`provide Some additional benefits Such as promoting the
`health of Salivary glands and/or Supporting normal or
`healthy Swallowing. The nutritional Supplement of the
`present invention includes ingredients, which can be
`obtained from turmeric, ginger, and horseradish.
`0041. By “nutritional” or “nutritional supplement” as
`used herein is meant that the Supplements used in the
`practice of this invention provide a nourishing amount of
`one or more ingredients derived from turmeric, ginger and
`horseradish.
`0042. As used herein the term “flavors” includes both
`fruit and botanical flavors.
`0.043 AS used herein the term “Sweeteners' includes
`Sugars, for example, glucose, Sucrose and fructose. Sugars
`also include high fructose corn Syrup Solids, invert Sugar,
`Sugar alcohols including Sorbitol, and mixtures thereof.
`Artificial Sweeteners are also included within the Scope of
`the term, "Sweetener.”
`0044 As used herein, the term “pharmaceutically accept
`able” means a component that is Suitable for use with
`
`humans and/or animals without undue adverse side effects
`(Such as toxicity, irritation, and allergic responses), com
`menSurate with a reasonable risk/benefit ratio. Further, as
`used herein, the term "safe and effective amount” refers to
`the quantity of a component, which is Sufficient to yield a
`desired therapeutic response without undue adverse side
`effects (such as toxicity, irritation, or allergic responses),
`commensurate with a reasonable risk/benefit ratio when
`used in the manner described herein.
`004.5
`Each of turmeric, ginger, or horseradish contain
`active ingredients which may provide Some beneficial effect
`in promoting the health of Salivary glands, Supporting nor
`mal or healthy Swallowing, and/or treating one or more
`Symptoms including Symptoms of a common cold, a Sore
`throat, congestion, laryngitis, mucositis and mucous mem
`brane inflammation. Turmeric and ginger may further Serve
`as COX-2 inhibitors to treat certain types of inflammation
`Such as that due to arthritis. However, the taste of each of
`turmeric, ginger, or horseradish at an effective dosage level
`may be too overpowering for a patient. It has been found that
`the combination of materials, which can be obtained from
`turmeric, ginger and horseradish, in the nutritional Supple
`ment of the present invention provides a Substantial benefi
`cial effect, as well as favorable taste characteristics which
`make the nutritional Supplement palatable.
`0046) The first ingredient of the nutritional supplement of
`the present invention may be obtained from turmeric. The
`yellow pigment of the rhizome of turmeric is composed of
`three compounds known as curcuminoids. The three cur
`cuminoids are curcumin (diferuloylmethane), desmethoxy
`curcumin (hydroxycinnamoyl feruloylmethane), and bis
`deSmethoxycurcumin (dihydroxydicinnamoyl methane) (see
`Drug Analysis by Chromatography and MicroScopy, p. 169,
`Ann Arbor Science Inc., 1973). The essential oils of turmeric
`(curcuma longa) are primarily composed of the following
`compounds: d-camphor (1%), cyclo-isoprenemyrcene
`(85%), and p-tolylmethylcarbinol (5%), (see E. Gunther,
`The Essential Oil, pp. 123-4, Van Nostrand Co., 1955).
`0047 The first ingredient of the nutritional supplement of
`the present invention, obtained from turmeric, preferably
`includes curcuminoids, Such as curcumin (diferuloyl
`methane), desmethoxycurcumin (hydroxycinnamoyl feru
`loylmethane), and bis-desmethoxycurcumin (dihydroxydi
`cinnamoyl methane) and mixtures of two or more of these
`curcuminoids.
`0048 Methods for isolating curcuminoids from turmeric
`are known, (see Janaki and Bose, An Improved Method for
`the Isolation of Curcumin From Turmeric, J. Indian Chem.
`Soc. 44:985 (1967)). Alternatively, curcuminoids for use in
`the present invention can be prepared by Synthetic methods.
`0049. The first ingredient, which can be obtained from of
`turmeric, can be incorporated into the nutritional Supplement
`of the present invention in a variety of different forms. Those
`different forms preferably include extracts of turmeric Such
`as turmeric powder extracts, turmeric fluid extracts, one or
`more the curcuminoid compounds, and turmeric powder,
`parts of, or whole plants of turmeric, tinctures thereof, and
`mixtures thereof. More preferably, the first ingredient is a
`turmeric extract.
`0050. The second ingredient of the nutritional supple
`ment of the present invention may be obtained from ginger
`
`

`

`US 2003/0185918 A1
`
`Oct. 2, 2003
`
`(also commonly called ginger root). Ginger inhibits pros
`tanoid Synthesis and also products of 5-lipoxygenase. The
`potency of the ginger extract in the acute inflammation test
`appears to be comparable to that exhibited by acetyl Salicylic
`acid reported in the same study. (Mascolo N. et al Journal
`of Ethnopharmocology, 1989, 27, 129-140).
`0051 One of the features of inflammation is increased
`oxygenation of arachidonic acid, which is metabolized by
`two enzymic pathways—the cyclooxygenase (CO) and the
`5-lipoxygenase (5-LO)-leading to the production of pros
`taglandins and leukotrienes respectively. It is Suggested
`(Srivastava and Mustafa; Medical Hypotheses, 1992, 39
`342-348) that at least one of the mechanisms by which
`ginger shows its ameliorative effects could be related to
`inhibition of prostaglandin and leukotriene biosynthesis, i.e.
`it works as a dual inhibitor of eicosanoid biosynthesis.
`0.052 Ginger contains 1-4% essential oil (oleoresin).
`Many chemical investigations have been carried out on the
`constituents of the essential oil of ginger. All together more
`than 200 different volatiles have been identified in the
`essential oil of ginger. The essential oil of ginger contains a
`mixture of various terpenes as well as Some other non
`terpenoid compounds.
`0053. The active compounds of ginger which may be
`employed in the present invention include, but are not
`limited to, 1,8-cineole, 10-dehydrogingerdione, 10-gingerol,
`6-gingerdione, 6-gingerol, 6-shogaol, 8-B-17-epoxy-2-
`trans-12-ene-15, 16-diol, 8-gingerol, 8-shogaol, 9-OXO-ner
`olidol, acetaldehyde, acetic acid, alanine, C.-linolenic-acid,
`O-linolenic acid, C-phellandrene, C-piene, C-terpinene,
`C-terpineol, C-Zingiberene, ar-curcumene, arginine, ascor
`bic acid, asparagine, B-bisabolol, B-carotene, B-elemene,
`B-eudeSmol,
`B-ionone,
`B-myrcene,
`3-phellandrene,
`B-pinene, B-Selinene, B-SeSquiphellandrene, B-Sitosterol,
`B-thujone, bornyl-acetate, boron, caffeic acid, calcium, cam
`phene, camphor, capric acid, caprylic acid, capsaicin, caryo
`phyllene, chavicol, chlorogenic acid, chromium, citral, cit
`ronellal, citronellal, cobalt, copper, cumene, curcumin,
`cystine, delphinidin, 2-cadinene, elemol, ethyl acetate,
`ethyl-myristate, farnesal, farmesene, ferulic acid, furfural,
`Y-aminobutyric acid, Y-terpinene, geranial, geraniol, gera
`nyl-acetate, gingerenone, glutamic acid, glycine, hexahy
`drocurcumin, histidine, isogingerenone-B, isoleucine,
`kaernpferol, lecithin, limonene, linoleic acid, magnesium,
`manganese, methionine, mufa, myrecene, myricetin, myris
`tic acid, neral, nerol, nerolidol, niacin, nickel, oleic acid,
`Oxalic acid, p-coumaric acid, p-cymene, p-hydroxy-benzoic
`acid, palmitic acid, pantothenic acid, paradol, patchoulic
`alcohol, phenylalanine, quercetin, riboflavin, Selenium,
`Shikimic-acid, terpinen-4-ol, thiamin, tryptophan, Vanillic
`acid, Vanillin, Zinc, and Zingerone. Also, mixtures of two or
`more of these active compounds may be employed.
`0.054 The second ingredient of the nutritional supple
`ment of the present invention, which may be obtained from
`ginger, can be incorporated in the nutritional Supplement of
`the present invention in many different forms including
`extracts Such as ginger powder extracts, ginger fluid
`extracts, ginger powder including ginger root powder, and
`one or more active compounds of ginger, parts of, or whole
`ginger plants, tinctures thereof, and mixtures thereof. Also,
`for any Specific active compound of ginger for which
`Suitable Synthesis routes are known, the active compound
`
`can be prepared Synthetically. Preferably, the Second ingre
`dient of the nutritional Supplement of the present invention
`is Selected from ginger extract, and ginger root powder.
`0055 A third ingredient of the nutritional supplement of
`the present invention may be obtained from horseradish,
`also commonly called horseradish root. Horseradish's phar
`macological activities are mainly due to its active com
`pounds. The active compounds of horseradish which may be
`useful in the present invention include, but are not limited to,
`allyl-isothiocyanate, amylase, arginine, ascorbic acid, aspar
`agine, gentisic acid, kaempferol, limonene, niacin, p-hy
`droxy-benzoic acid, pectin, phenylpropyl-isothiocyanate,
`quercetin, raphanin, riboflavin, rutoside, Selenium, Sinapic
`acid, Sinigrin, tannin, thiamin, Vanillic acid and Zinc, as well
`as mixtures of two or more of these compounds.
`0056. The third ingredient of the nutritional Supplement
`of the present invention, which may be obtained from
`horseradish, can be included in the nutritional Supplement in
`many different forms. Those different forms include horse
`radish powder, horseradish extracts Such as horseradish
`powder extracts and horseradish fluid extracts, one or more
`active compounds of horseradish, parts of, or whole plants
`of horseradish, tinctures thereof, and mixtures thereof. For a
`particular active compound, for which a Synthetic route is
`known, the active compound may be obtained Synthetically.
`Preferably, the third ingredient of the nutritional Supplement
`of the present invention is Selected from horseradish powder
`and horseradish extract.
`0057 All active compounds of the present invention may
`be obtained from other sources, if available. Thus, the phrase
`“which can be obtained from' or the phrase “which may be
`obtained from' is meant to encompass compounds or nutri
`tional Supplements that are obtainable from turmeric, ginger,
`horseradish, slippery elm or green tea and therefore encom
`passes Synthetic forms of the same compounds and/or com
`positions as well as the same compounds and/or composi
`tions obtained from other Sources.
`0058. The ingredients of the nutritional supplement of the
`present invention, which may be obtained from turmeric,
`ginger and horseradish, may be used in the forms of turmeric
`powder, ginger powder, and horseradish powder, each of
`which may be ground from the rhizome of turmeric, ginger
`root and horseradish root respectively. Alternatively, tur
`meric powder, ginger powder, horseradish powder, and/or
`one or more of the active compounds contained therein may
`be purchased from commercial Sources Such as Delavau Co.
`Alternatively, the ingredients of the present invention can be
`used in the form of turmeric extract, ginger extract and
`horseradish extract, which may be extracted from each of
`turmeric rhizome, ginger root and horseradish roots using
`common extraction procedures. One Suitable extraction pro
`cedure is described below.
`0059. The extraction procedure comprises, generally, the
`Steps of
`0060) 1) cleaning the plant from which the pharma
`cologically or biologically active plant extract is to
`be obtained to remove any foreign matter thereon;
`0061) 2) particulating the plant to obtain a particu
`late mass having particle Size ranging from 0.001 to
`about 10 mm; and
`
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`US 2003/0185918 A1
`
`Oct. 2, 2003
`
`0062 3) subjecting the particulate mass to at least
`one polar and at least one non-polar Solvent to obtain
`Separate fractions of plant extract Soluble in the
`respective Solvents, and mixing the fractions. So
`obtained to obtain the beneficiated plant extract in
`accordance with this invention.
`For instance, in the case of turmeric, the process
`0.063
`comprises the Steps of:
`0064.
`1) cleaning the roots of turmeric to remove
`any foreign matter thereon;
`0065. 2) particulating the roots to obtain a particu
`late mass having particle Size ranging from 0.001 to
`about 10 mm;
`0066 3) subjecting the particulate mass to distilla
`tion to obtain a Volatile fraction, if any, from the
`particulate mass,
`0067 4) cooking the distilled particulate mass in a
`polar Solvent, Such as water to Solubulize material in
`the distillation-treated particulate mass to obtain first
`Solution and a first residue,
`0068 5) filtering the first solution from the first
`residue,
`0069. 6) evaporating the filtrate obtained from the
`first Solution to remove the Solvent and obtain a
`Solute designated as fraction A obtained from the
`particulate mass,
`0070 7) subjecting the first residue to treatment with
`a second polar solvent such as 75% to 95% ethanol
`for twelve to thirty-six hours to obtain a second
`Solution and a Second residue,
`0071) 8) filtering the second solution from the sec
`ond residue to obtain a Second filtrate;
`0072 9) evaporating the second filtrate to remove its
`Solvent and obtain a Solute designated as fraction B
`obtained from the particulate mass,
`0073 10) subjecting the second residue to less polar
`or non-polar Solvents, Such as petroleum ether, for
`twelve to thirty-six hours to obtain a third solution
`and a third residue, and filtering the third Solution
`from the third residue to obtain a third filtrate;
`0074 11) evaporating the third filtrate to remove its
`Solvent and obtain a Solute designated as fraction C
`obtained from the particulate mass, and
`0075) 12) homogeneously mixing the volatile frac
`tion, with fractions A, B and C from the particulate
`mass to obtain a beneficiated plant extract.
`0.076 The process is suitable for the preparation of phar
`macologically or biologically active plant extracts in a
`convenient, administrable dosage form from any of the
`plants mentioned above.
`0.077
`Solvents useful for extracting turmeric include
`water, ethanol, propanol, paraffin, hexane, petroleum ether,
`toluene, acetone, methyl ethyl ketone, and other common
`organic Solvents. Water, ethanol and petroleum ether are the
`preferred Solvents for extracting turmeric. Solvents useful
`for extracting ginger include water, ethanol, propanol, par
`affin, petroleum ether, hexane, toluene, acetone, methyl
`
`ethyl ketone, and other common organic Solvents. Ethanol,
`water and acetone are the preferred Solvents for extracting
`ginger. Solvents useful for extracting horseradish include
`water, ethanol, propanol, paraffin, petroleum ether, hexane,
`toluene, acetone, methyl ethyl ketone, and other common
`organic Solvents. Water and ethanol are the preferred Sol
`vents for extracting horseradish.
`0078 Most preferably, the nutritional Supplement of the
`present invention includes turmeric extract, ginger root
`powder, and horseradish root powder, each in a safe and
`effective amount to provide one or more of the beneficial
`effects described herein.
`0079 Each gram of the nutritional supplement of the
`present invention preferably contains 5 mg to 20 mg of
`turmeric powder extract. Most preferably, each gram of the
`nutritional Supplement contains 7 mg to 15 mg of turmeric
`powder extract.
`0080 Each gram of the nutritional supplement of the
`present invention preferably contains 30 mg to 150 mg of
`