WO2008119127A1 - Compositions à base d'herbes et méthodes destinées au traitement de la ménorragie - Google Patents

Compositions à base d'herbes et méthodes destinées au traitement de la ménorragie Download PDF

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Publication number
WO2008119127A1
WO2008119127A1 PCT/AU2008/000463 AU2008000463W WO2008119127A1 WO 2008119127 A1 WO2008119127 A1 WO 2008119127A1 AU 2008000463 W AU2008000463 W AU 2008000463W WO 2008119127 A1 WO2008119127 A1 WO 2008119127A1
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Prior art keywords
composition
menorrhagia
replaced
composition according
radix
Prior art date
Application number
PCT/AU2008/000463
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English (en)
Inventor
Mary Jane Lyttleton
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Medcina Group Pty Ltd
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
Priority claimed from AU2007901739A external-priority patent/AU2007901739A0/en
Application filed by Medcina Group Pty Ltd filed Critical Medcina Group Pty Ltd
Publication of WO2008119127A1 publication Critical patent/WO2008119127A1/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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481—Astragalus (milkvetch)
    • 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
    • A61K36/533—Leonurus (motherwort)
    • 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
    • A61K36/537—Salvia (sage)
    • 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)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704—Polygonum, e.g. knotweed
    • 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)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • 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)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • Herbal compositions and methods for treating menorrhagia are Herbal compositions and methods for treating menorrhagia
  • This invention relates to new medicinal compositions and methods for treating menorrhagia and conditions associated therewith.
  • Menorrhagia is defined as excessive blood loss associated with menstruation. There may be deluge bleeding during the normal course of the period or there may be an extended time (up to ten days) of menstrual bleeding or both. The cause of the heavy bleeding may be fibroids in the uterine cavity but often it is related to hormone imbalance, causing the uterine lining to thicken excessively. Continued menorrhagia leads to anaemia and debility. In young women it is sometimes treated with NSAID's used to treat period pain, but with limited effectiveness. Alternatively an implant such as an intrauterine device (IUD) impregnated with hormones may be required. In women past child bearing age, the treatment is surgical - either removal of fibroids, removal of the uterine lining or most commonly removal of the uterus itself.
  • IUD intrauterine device
  • the formulations of the present invention are designed to provide an effective treatment for menorrhagia in western women, without the risks inherent in the drug or surgical treatment options.
  • the formulations provide an effective treatment by regulating hormones, reducing the thickness of the uterine lining and controlling the amount of blood lost, and by improving or alleviating one or more other symptoms accompanying or associated with menorrhagia, such as anaemia like pallor and fatigue.
  • the present invention provides a composition for prophylactic or therapeutic treatment of menorrhagia, comprising the herbs: Huang Qi Radix astragali
  • Huang Qi could be replaced with Dang Shen, and/or Sheng Di could be replaced with Shu Di or Xuan Shen ⁇ Radix scrophulariae), and/or He Shou Wu could be replaced with Dang Gui or Shu Di, and/or Yi Mu Cao could be replaced with Yan Hu Suo, and/or Pu Huang could be replaced with Dan Shen.
  • the present invention provides a method of therapeutic or prophylactic treatment of menorrhagia, comprising administering to a subject requiring such treatment, a composition of the first aspect.
  • the present invention provides the use of a composition according to the first aspect, in the manufacture of a medicament for the prophylactic or therapeutic treatment of menorrhagia.
  • the present invention provides use of a composition according to the first aspect, as a medicament.
  • composition according to the invention treats or alleviates a symptom and/or condition accompanying or associated with menorrhagia.
  • compositions can be formulated as dry powdered herbs and taken loose, or can be encapsulated or tabletted.
  • the raw (un-powdered) herbs may also be provided and can be decocted for use by the patient.
  • the compositions of the present invention can also be formulated with aqueous, organic or aqueous/organic extracts of the herbs, as would be understood by those skilled in the art, which extracts may be dried and formulated by conventional means.
  • the composition may also be delivered in tablet or other solid dosage form, but it can also be delivered in a liquid or paste dosage form.
  • the composition may further include pharmaceutically acceptable excipients, adjuvants, solvents, disintegrators, carriers, flavours, colourings or coatings, and may be formulated in slow-release or controlled-release dosage formats.
  • the treatment of medical disorders, using herbal formulations differs from orthodox Western-style treatments in that the herbal formulations are intended to be tailored to meet the specific requirements of each patient.
  • the present invention provides base or core formulations that are effective in the treatment of menorrhagia. Moreover, the formulations of the present invention are more efficacious and have less side-effects than medications and formulations previously or currently available.
  • the components of a preferred formulation effective in the prophylactic or therapeutic treatment of menorrhagia comprise the herbs: Huang Qi Radix astragali
  • Certain herbs in the above composition may be replaced with other herbs that have a similar activity or function, should this be required for any reason.
  • Huang Qi could be replaced with Dang Shen, and/or Sheng Di could be replaced with Shu Di or Xuan Shen ⁇ Radix scrophulariae), and/or He Shou Wu could be replaced with Dang Gui or Shu Di, and/or Yi Mu Cao could be replaced with Yan Hu Suo .and/or and Pu Huang could be replaced with Dan Shen.
  • compositions of the present invention are primarily intended to be generic formulations that can be used without major changes for all female patients with menorrhagia.
  • a composition according to the invention treats or alleviates a symptom and/or condition accompanying or associated with menorrhagia.
  • the herbal formulation of the present invention can be administered orally or parenterally in any conventional form such as example granules, capsules, tablets, elixirs, powders, granules, suspensions in water or non-aqueous media, and sachets as additives to food or beverages.
  • the herbal formulation may be produced utilizing concentrated herbal extracts, either an extract of the total formulation, or by combining separate extracts of individual herbs. Such extracts may be employed as the base materials in the manufacture of tablets or powders.
  • Methods for preparing herbal formulations using herbal extracts are well known and are described in numerous texts and manuals, for example Bensky, D. and Barolet, R. "Chinese Herbal Medicine Formulas and Strategies", 1990 Eastland Press (pgs 18 - 24) and Bensky, D., Clavey, S. and Stoger E., Chinese Herbal Medicine", Materia Medica, 3 rd Ed. 2004 and the like, incorporated in their entirety herein by reference.
  • liquid preparations may take the form of, for example, solutions, syrups or suspensions or they may be presented as a dry powder for reconstitution with an appropriate liquid carrier, preferably water, for oral administration or for packaging in containers for example in ampoules or in multi-dose containers.
  • Such liquid preparations may be prepared by conventional means with pharmaceutically acceptable additives such as suspending agents, emulsifying agents, preservatives, non-aqueous vehicles example almond oil, oily esters or ethyl alcohol and artificial or natural colours and/or sweeteners.
  • the composition may also be delivered in a capsule or tablet dosage form, but it can also be delivered in a liquid or paste form.
  • tablet form the ingredients are mixed together and the tablets prepared according to methods well known in the art, for example the wet granulation method, the dry- granulation method or direct compression.
  • the composition may further include pharmaceutically acceptable excipients, adjuvants, solvents, disintegrators, carriers, flavours, colourings or coatings.
  • the tablets may be uncoated, or may be coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period.
  • the herbal formulations are preferably administered orally and in dosage units.
  • different daily doses can be used for treatment of a subject. Under certain circumstances, however, higher or lower doses may be appropriate.
  • the administration of the daily dose can be carried out both by single administration in the form of an individual dose unit or else several smaller dose units and also by multiple administration of subdivided doses at specific intervals. It will be appreciated that the formulation may also be administered via a slow release device.
  • the present invention is also directed to methods of therapeutic or prophylactic treatment of menorrhagia, comprising administering to a subject requiring such treatment, a composition according to the invention.
  • the present invention is also directed to use of composition according to the invention, in the manufacture of a medicament for the prophylactic or therapeutic treatment of menorrhagia.
  • the present invention is also directed to methods of treating or alleviating the symptoms and/or conditions accompanying or associated with menorrhagia, for example anaemia like pallor and fatigue.
  • the present invention is also directed to use of the composition as a medicament.
  • a preferred dose for treating or preventing menorrhagia and associated symptoms is in the range of 3g-15g (equivalent raw herb dosage) per day in a single does or multiple doses. More preferably it is 3g-5g (equivalent raw herb dosage) once or twice per day.
  • the exact dose depends to a great extent on the severity of menorrhagia, the general health of the patient and the presence of any accompanying symptoms.
  • the required dosage can be easily established by practitioners skilled in the art.
  • treating is used herein to mean 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 preventing menorrhagia, and/or may be therapeutic in terms of a partial or complete cure of a disorder.
  • Treating covers any therapy of, or prevention of, menorrhagia in a mammal, particularly a human, and includes preventing the disorder from occurring in a subject who may be predisposed to the disorder, but has not yet been diagnosed as having it; inhibiting the disorder, i.e. arresting its development.
  • the herbs were used in the dried powdered form. If desired the herbs may be encapsulated before administration. If sufficiently dry, the herbs were powdered using a grinder or similar device. If the moisture content of the herbs was high, the herbs were baked before being powdered. Although fresh or dried herbs can be used, the herbs may also be formulated by one of the following methods:
  • all the raw herbs can be boiled together and then concentrated by spray drying or other known methods into a dry granulated formulation.
  • the extracts can be concentrated before or after combining and may be processed into tablets or capsules.
  • the formula when using granules the formula is constructed typically with 3-15 g of each herb. A typical dose in the range of 3-5 g (about a teaspoon) of the formula is then taken twice a day in form of a tea.
  • the formula makes use of approximately the same amount of each herb (i.e. typically 3-15 g) and the entire formula is then boiled together in 2-3 cups of water until it is reduced to an amount of about one cup (approximately 45 minutes but the time can range from about 20 to about 60 minutes). This is then drunk at once or in divided doses over the course of the day.
  • the same herbs can be decocted a second time the following day with the addition of 2 cups of water and boiled down to about one cup. This cup can be drunk at once or in divided doses over the course of the day. These herbs are then discarded.
  • Table 1 Base formulation Chinese name Pharmaceutical name Amount (gm)
  • Periods - flow lasts for 7 days. Flow is very heavy for 3 days - flooding of bright red blood with large clots. She experiences dragging pain, which can be excruciating, requiring painkillers.
  • Pu Huang Pollen typhae 9 Her next two periods were shorter (i.e. stopped soon after day 3) but the first day was still very heavy. By the third cycle of treatment she reported her period was remarkably improved. The flow was much lighter and she did not feel as exhausted and sick. The dragging pain was also gone. She was instructed to continue the formula for another 2 cycles to consolidate the result.

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

Abstract

La présente invention concerne une composition destinée à la prévention ou au traitement thérapeutique de la ménorragie, comprenant les herbes suivantes: du Huang qi (radix astragali) (qui peut être remplacé par du dang shen) - du Yi mu cao (herba leonuri hétérophylli) (qui peut être remplacée par du yan hu suo) - du Sheng di (radix rehmanniae) (qui peut être remplacée par du shu di ou du xuan shen) - du San qi (radix pseudoginseng) - du He shou wu (radix polygoni multiflori) (qui peut être remplacé par du dang gui ou du shu di) - du Pu huang (pollen typhae) qui peut être remplacé par du (dan shen).
PCT/AU2008/000463 2007-04-02 2008-04-02 Compositions à base d'herbes et méthodes destinées au traitement de la ménorragie WO2008119127A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2007901739A AU2007901739A0 (en) 2007-04-02 Methods and compositions for treatment of menorrhagia
AU2007901739 2007-04-02

Publications (1)

Publication Number Publication Date
WO2008119127A1 true WO2008119127A1 (fr) 2008-10-09

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102526641A (zh) * 2012-03-20 2012-07-04 南宁市品迪生物工程有限公司 一种外源性治疗子宫肌瘤的药物和方法
CN102552869A (zh) * 2012-03-20 2012-07-11 南宁市品迪生物工程有限公司 三合一综合治疗子宫肌瘤
CN102920834A (zh) * 2012-11-23 2013-02-13 深圳市佳泰药业股份有限公司 绿茸益血胶囊及其制备方法
CN110882313A (zh) * 2019-12-09 2020-03-17 西安千禾药业股份有限公司 一种治疗月经不调、急慢性盆腔炎和宫颈炎的药物及其应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2343832A (en) * 1998-11-17 2000-05-24 Lenrys Associates Limited Biscuits containing herbs for horses
CN1298692A (zh) * 1999-12-06 2001-06-13 冷辑光 海泥、火山岩为分散剂的天然药物化妆品

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2343832A (en) * 1998-11-17 2000-05-24 Lenrys Associates Limited Biscuits containing herbs for horses
CN1298692A (zh) * 1999-12-06 2001-06-13 冷辑光 海泥、火山岩为分散剂的天然药物化妆品

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Derwent World Patents Index; AN 2001-515147 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102526641A (zh) * 2012-03-20 2012-07-04 南宁市品迪生物工程有限公司 一种外源性治疗子宫肌瘤的药物和方法
CN102552869A (zh) * 2012-03-20 2012-07-11 南宁市品迪生物工程有限公司 三合一综合治疗子宫肌瘤
CN102920834A (zh) * 2012-11-23 2013-02-13 深圳市佳泰药业股份有限公司 绿茸益血胶囊及其制备方法
CN110882313A (zh) * 2019-12-09 2020-03-17 西安千禾药业股份有限公司 一种治疗月经不调、急慢性盆腔炎和宫颈炎的药物及其应用

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