WO2003026430A1 - Traitement de la rhinite allergique - Google Patents

Traitement de la rhinite allergique Download PDF

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Publication number
WO2003026430A1
WO2003026430A1 PCT/US2002/030178 US0230178W WO03026430A1 WO 2003026430 A1 WO2003026430 A1 WO 2003026430A1 US 0230178 W US0230178 W US 0230178W WO 03026430 A1 WO03026430 A1 WO 03026430A1
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WO
WIPO (PCT)
Prior art keywords
herbs
herb
extracts
disorder
allergic rhinitis
Prior art date
Application number
PCT/US2002/030178
Other languages
English (en)
Inventor
Ching-Hsiang Hsu
Original Assignee
Eastwest Pharmaceuticals International Llc
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 Eastwest Pharmaceuticals International Llc filed Critical Eastwest Pharmaceuticals International Llc
Publication of WO2003026430A1 publication Critical patent/WO2003026430A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284Atractylodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/238Saposhnikovia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/57Magnoliaceae (Magnolia family)
    • A61K36/575Magnolia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents

Definitions

  • One aspect of this invention relates to a nutraceutical composition containing extracts of at least three or four herbs, wherein the first herb, which is optional, is Hedysarum polybotrys Hand. -Mazz. ox Astragalus membranceus Bge. (e.g., its root), the second herb is the root of Atractylodes macrocephala kodiz (e.g., its root), the third herb is Ledebouriella seseloides (hoffm.) Wolff (e.g., its root), and the fourth herb is an anti-allergy herb.
  • An anti-allergy herb is one that, when used alone or in combination with other herbs, can exhibit activity in treating allergy.
  • the weight percentage of the herbal extracts in the nutraceutical composition ranges from 1% to 99%.
  • the fourth herb is Centipeda minimal (L.) A. Br. Et Aschers (e.g., its whole plant, "E-Bu-Shi-Cao" in Chinese). They include those wherein the weight ratio of the first, second, third, and fourth herbs is (0-1.5):(0.5-1.5):(0.5-1.5):(0.5-1.5). As indicated by this weight ratio, the first herb may not be included. In other words, the nutraceutical compositions may contain extracts of only three herbs.
  • weight refers to "dry weight,” i.e., the weight measured after the herb have been harvested and dried.
  • drying processes are specified by the regulations in herb-producing countries (e.g., P.R. China). Herbs so-obtained are suitable for transportation and long term storage.
  • the fourth herb is Magnolia lilifora Desr. (e.g., its flower; "Xin-Yi-Hua” in Chinese). They include those wherein the weight ratio of the first, second, third, and fourth herbs is (0-1.5):(0.5-1.5):(0.5- 1.5):(0.5-1.5); and those containing extracts of four herbs.
  • each composition contains extracts of exactly three or four herbs.
  • the weight ratio of the first, second, third, and fourth herbs can be (0-1.5):(0.5-1.5):(0.5-1.5):(0.5-1.5).
  • Another aspect of this invention relates to a method of treating a disorder related to excessive secretion of histamine or interleukin-4.
  • the method includes administering to a subject in need thereof a nutraceutical composition containing extracts of at least three or four herbs, wherein the first herb, which is optional, is Hedysarum polybotrys Hand.-Mazz. or Astragalus membranceus Bge. (e.g., the root), the second herb is Atractylodes macrocephala kodiz. (e.g., the root), the third herb is Ledebouriella seseloides (hoffm.) Wolff (e.g., the root), and the fourth herb is an anti- allergy herb.
  • the disorder to be treated include, but are not limited to, allergic rhinitis, asthma, and eczyma.
  • compositions used in the method of treating such a disorder include those wherein the fourth herb is Centipeda minimal (L.) A. Br. EtAschers (whole plant) or Magnolia lilifora Desr (flower); those wherein the weight ratio of the first, second, third, and fourth herbs is (0-1.5):(0.5-1.5):(0.5-1.5):(0.5-1.5); and those containing extracts of three or four herbs.
  • the improved herbal medicine includes extracts of at least three or four herbs, wherein the first herb, which is optional, is the root of Hedysarum polybotrys Hand.-Mazz. or Astragalus membranceus Bge., the second herb is the root of Atractylodes macrocephala kodiz., the third herb is the root of Ledebouriella seseloides (hoffm.) Wolff, and the fourth herb is an anti-allergy herb.
  • the first herb which is optional, is the root of Hedysarum polybotrys Hand.-Mazz. or Astragalus membranceus Bge.
  • the second herb is the root of Atractylodes macrocephala kodiz.
  • the third herb is the root of Ledebouriella seseloides (hoffm.) Wolff
  • the fourth herb is an anti-allergy herb.
  • a nutraceutical composition of this invention includes extracts of the root of Hedysarum polybotrys Hand.-Mazz. ox Astragalus membranceus Bge., the root of Atractylodes macrocephala kodiz., the root of Ledebouriella seseloides (hoffm.)
  • the weight ratio of the extracts of the first, second, third, and fourth herbs can be in the range of (0-1.5):(0.5-1.5):(0.5- 1.5):(0.5-1.5). Preferred ratios can be determined by efficacy-evaluating methods described below or analogous methods.
  • the nutraceutical composition is unexpectedly effective for the treatment of disorders related to excessive secretion of histamine or interleukin-4, such as allergic rhinitis, asthma, and eczyma.
  • the extracts of the herbs can be obtained by methods well known in the art. For instance, each herb is first soaked in water and then heated (e.g., at 100°C), or first soaked in a mixture of water and an organic solvent (e.g., ethanol) and then heated (e.g., at 55°C) for an extended period of time (e.g., 1-4 hours). The liquid phase, which contains active ingredients from the herbs, is then collected. The solvent (or the solvents) of the solution thus obtained, i.e., water (or a mixture of water and the organic solvent), is then removed under reduced pressure, yielding a residue (i.e., extracts of the herbs). The herbs can be handled together or individually to obtain their extracts.
  • each herb is first soaked in water and then heated (e.g., at 100°C), or first soaked in a mixture of water and an organic solvent (e.g., ethanol) and then heated (e.g., at 55°C) for an extended period of time (e.g.
  • the extracts thus obtained can be used to formulate a nutraceutical composition for treating (including preventing or ameliorating the symptoms of) a disorder related to excessive secretion of histamine or interleukin-4, such as allergic rhinitis, asthma, and eczyma.
  • the nutraceutical composition can be a dietary supplement (e.g., a capsule or tablet, or placed in a mini-bag), a food product (e.g., a soft drink, milk, juice, or confectionary, or placed in a herbal tea-bag), or a botanical drug.
  • the botanical drug can be in a form suitable for oral use, such as a tablet, a hard or soft capsule, an aqueous, or a syrup; or in a form suitable for parenteral use, such as an aqueous propylene glycol solution, or a buffered aqueous solution.
  • the amounts of the active ingredients in the nutraceutical composition depend to a large extent on a subject's specific need. The amount will also vary, as recognized by those skilled in the art, depending on administration route, and possible co-usage of other agents useful for treating the above-mentioned disorders.
  • Herbal extracts thus obtained in an effective amount can also be formulated with a pharmaceutically acceptable carrier into a pharmaceutical composition for treating the above-mentioned disorders.
  • “An effective amount” refers to the amount of the extracts which is required to confer therapeutic effect on the treated subject.
  • Effective doses will vary, as recognized by those skilled in the art, depending on the route of administration, the excipient usage, and the optional co-usage with other therapeutic treatments.
  • pharmaceutically acceptable carriers include colloidal silicon dioxide, magnesium stearate, cellulose, sodium lauryl sulfate, and D&C Yellow # 10.
  • the herbal extracts can be formulated into dosage forms for different administration routes utilizing conventional methods. For example, they can be formulated in a capsule, a gel seal, or a tablet for oral administration. Capsules may contain any standard pharmaceutically acceptable materials such as gelatin or cellulose. Tablets may be formulated in accordance with conventional procedures by compressing mixtures of the polysaccharide with a solid carrier and a lubricant. Examples of a suitable solid carrier include starch and sugar bentonite.
  • the herbal extracts can also be administered in the form of a hard shell tablet or a capsule containing a binder, e.g., lactose or mannitol, a conventional filler, and a tableting agent.
  • the pharmaceutical composition may be administered via a parenteral route, e.g., topically, intraperitoneally, and intravenously.
  • parenteral dosage forms include aqueous solutions, isotonic saline or 5% glucose of the active agent, or other well- known pharmaceutically acceptable excipient.
  • Cyclodextrins, or other solubilizing agents well known to those familiar with the art, can be utilized as pharmaceutical excipients for delivery of the therapeutic compound.
  • nutraceutical or pharmaceutical composition of this invention in inhibiting the secretion of histamine or interleukin-4 can be evaluated by an in vitro assay well known in the art. See, e.g., Cheng et al., M. Taiwan J. Med., 1998, 3:166- 173; and Cheng et al., J. of E.N.T. Medicine, 1998, 33: 431-441.
  • a nutraceutical composition of this invention can be further evaluated by clinical studies.
  • a group of patients suffering from allergic rhinitis (which is related to excessive excretion of histamine or interleukin-4) can be treated with the nutraceutical composition. Before the treatment, they exhibit some symptoms typical of allergic rhinitis including stuffy nose, sneezing, runny nose, itchy nose, itchy eyes, watery eyes, swollen eyes, and sore eyes.
  • the patients are then orally administered with the nutraceutical composition, e.g., by a dose of 800 mg/lOkg/day, for an extended period of time, e.g., 14 days.
  • Relief of the allergy can be observed, as characterized by reduced severity, and sometimes frequency, of the symptoms.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

L'invention concerne une composition nutraceutique contenant des extraits d'au moins trois ou quatre herbes. La première herbe, facultative, est Hedysarum polybotrys Hand.-Mazz. ou Astragalus membranceus Bge., la deuxième herbe est Atractylodes macrocephala kodiz, la troisième herbe est Ledebouriella seseloides (hoffm.) Wolff, et la quatrième herbe est une herbe anti-allergique. L'invention concerne également un procédé de traitement d'un trouble associé à une secrétion excessive d'histamine ou d'interleukine-4 au moyen des extraits selon l'invention.
PCT/US2002/030178 2001-09-25 2002-09-23 Traitement de la rhinite allergique WO2003026430A1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US32476101P 2001-09-25 2001-09-25
US60/324,761 2001-09-25
US35000402P 2002-01-17 2002-01-17
US60/350,004 2002-01-17
CA002438055A CA2438055A1 (fr) 2001-09-25 2003-08-22 Traitement de la rhinite allergique

Publications (1)

Publication Number Publication Date
WO2003026430A1 true WO2003026430A1 (fr) 2003-04-03

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ID=34426454

Family Applications (1)

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PCT/US2002/030178 WO2003026430A1 (fr) 2001-09-25 2002-09-23 Traitement de la rhinite allergique

Country Status (2)

Country Link
CA (1) CA2438055A1 (fr)
WO (1) WO2003026430A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102688314A (zh) * 2012-03-27 2012-09-26 荆金锁 一种治疗鼻炎的中药
CN110179908A (zh) * 2019-03-28 2019-08-30 曾子芸 一种鼻窍通香囊及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4460578A (en) * 1980-12-11 1984-07-17 Claude Marie Henri Cervelle Pharmaceutical composition for topical use based on a total extract of Hedysarum fructescens willd
US5133964A (en) * 1987-07-01 1992-07-28 Kim Young S Pharmaceutical liquid composition containing bezoar bovis and preparation for its manufacture
US5135010A (en) * 1991-08-09 1992-08-04 Fan Sophie S M Herbal smoking materials
US5942233A (en) * 1996-03-12 1999-08-24 Chang; Teh Shan Herbal composition for stimulating blood circulation
US6280751B1 (en) * 1997-03-10 2001-08-28 Jane Clarissa Fletcher Essential oil composition

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4460578A (en) * 1980-12-11 1984-07-17 Claude Marie Henri Cervelle Pharmaceutical composition for topical use based on a total extract of Hedysarum fructescens willd
US5133964A (en) * 1987-07-01 1992-07-28 Kim Young S Pharmaceutical liquid composition containing bezoar bovis and preparation for its manufacture
US5135010A (en) * 1991-08-09 1992-08-04 Fan Sophie S M Herbal smoking materials
US5942233A (en) * 1996-03-12 1999-08-24 Chang; Teh Shan Herbal composition for stimulating blood circulation
US6280751B1 (en) * 1997-03-10 2001-08-28 Jane Clarissa Fletcher Essential oil composition

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102688314A (zh) * 2012-03-27 2012-09-26 荆金锁 一种治疗鼻炎的中药
CN110179908A (zh) * 2019-03-28 2019-08-30 曾子芸 一种鼻窍通香囊及其制备方法

Also Published As

Publication number Publication date
CA2438055A1 (fr) 2005-02-22

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