WO2008119133A1 - Compositions à base d'herbes et méthodes destinées au traitement de l'avortement spontané - Google Patents

Compositions à base d'herbes et méthodes destinées au traitement de l'avortement spontané Download PDF

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Publication number
WO2008119133A1
WO2008119133A1 PCT/AU2008/000472 AU2008000472W WO2008119133A1 WO 2008119133 A1 WO2008119133 A1 WO 2008119133A1 AU 2008000472 W AU2008000472 W AU 2008000472W WO 2008119133 A1 WO2008119133 A1 WO 2008119133A1
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Prior art keywords
rhizoma
miscarriage
sheng
semen
composition
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PCT/AU2008/000472
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English (en)
Inventor
Mary Jane Lyttleton
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Medcina Group Pty Ltd
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Filing date
Publication date
Priority claimed from AU2007901740A external-priority patent/AU2007901740A0/en
Application filed by Medcina Group Pty Ltd filed Critical Medcina Group Pty Ltd
Publication of WO2008119133A1 publication Critical patent/WO2008119133A1/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)
    • A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
    • 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
    • A61K36/539—Scutellaria (skullcap)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9064—Amomum, e.g. round cardamom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/06—Antiabortive agents; Labour repressants

Definitions

  • This invention relates to new medicinal compositions and methods for treating miscarriage and conditions associated therewith.
  • Miscarriage is pregnancy loss that occurs before 20 weeks, before the fetus is able to survive outside the womb. Most miscarriages occur in the first trimester or 12 weeks of pregnancy. As many as 50 percent of all pregnancies may end in miscarriage, because many losses occur before a woman realizes she is pregnant.
  • miscarriage causes of miscarriage are not thoroughly understood. When a woman has a first-trimester miscarriage, her healthcare provider often cannot determine the cause. However, most miscarriages occur when a pregnancy is not developing normally, either due to chromosomal defects in the embryo or problems with implantation or placenta development or immune factors.
  • hormonal problems such as poorly controlled diabetes, systemic lupus erythematosus, or thyroid disease.
  • maternal health problems such as poorly controlled diabetes, systemic lupus erythematosus, or thyroid disease.
  • D&C dilation and curettage
  • the formulations of the present invention are designed to provide a prophylactic treatment for miscarriage in western women where there is no chromosomal ahnormality in the embryo.
  • the present invention provides a composition for prophylactic or therapeutic treatment of miscarriage, comprising the herbs: Tu Si Zi Semen cuscata
  • the present invention provides a composition for the prophylactic or therapeutic treatment of miscarriage, comprising the herbs:
  • the present invention provides a composition for the prophylactic or therapeutic treatment of miscarriage, comprising the herbs:
  • the present invention provides a composition for the prophylactic or therapeutic treatment of miscarriage, comprising the herbs:
  • the present invention provides a composition for the prophylactic or therapeutic treatment of miscarriage, comprising the herbs:
  • the present invention provides a composition for the prophylactic or therapeutic treatment of miscarriage, comprising the herbs:
  • any of Tu Si Zi or Du Zhong could be replaced with Ba Ji Tian, Xu Duan or Yin Yang Huo, and/or Bai Zhu could be replaced with Dang Shen or Sheng
  • One or more herbs from the following group may also be added to the formulations of the first to sixth aspects, to generate additional formulations effective in the treatment of miscarriage and associated symptoms.
  • Sheng Jiang Rhizoma zingiberis officinalis may also be added to the formulations of the first to sixth aspects, to generate additional formulations effective in the treatment of miscarriage and associated symptoms.
  • the above supplementary herbs may be conveniently grouped into subsets.
  • One or more herbs from one or more subsets may be included in formulations of any one of the first to sixth aspects, if not already included, to enhance treatment of one or more symptoms and/or conditions accompanying and/or associated with miscarriage.
  • the preferred subsets are as follows:
  • Subset a Miscarriage prevention and relief of nausea.
  • Subset b Miscarriage prevention and relief of lower back pain.
  • Subset c Miscarriage prevention and treatment of pallor and fatigue.
  • Subset e Miscarriage prevention in presence of bloating, digestive upsets, or bearing down abdominal discomfort.
  • Subset f Miscarriage prevention in presence of anxiety and sleeplessness.
  • the present invention provides a method of therapeutic or prophylactic treatment of miscarriage, comprising administering to a subject requiring such treatment, a composition of the first, second, third, fourth fifth or sixth aspects.
  • the present invention provides the use of composition according to the first, second, third, fourth fifth or sixth aspects in the manufacture of a medicament for the prophylactic treatment of miscarriage.
  • the present invention provides the use of a composition according to any one of the first to sixth aspects as a medicament.
  • formulations of the present invention may be suitably used, and be effective, in the treatment of symptoms and/or conditions accompanying and/or associated with miscarriage. These are, for example, nausea, lower back pain, pallor and fatigue, spotting of blood, bloating, digestive upsets, bearing down abdominal discomfort, anxiety and/or sleeplessness.
  • formulations useful in the treatment of miscarriage it is intended that such formulations are also useful in the treatment of miscarriage in combination with any one of the symptoms and/or conditions outlined above.
  • Formulations for treatment of the accompanying symptoms and/or associated conditions will include, in addition to the core herb formulation, one or more herbs suitable for treatment of such symptoms and/or conditions.
  • 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.
  • 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 and prevention of miscarriage.
  • expanded formulations which include the core formulations and additional herbs for effective treatment or alleviation of associated symptoms that may manifest in a patient who has miscarried or is danger of miscarrying.
  • formulations of the present invention are more efficacious and have less side-effects than what has been available previously, or is currently available.
  • the components of a preferred formulation effective in the prophylactic or therapeutic treatment of miscarriage comprises the herbs:
  • the components of another preferred formulation effective in the prophylactic or therapeutic treatment of miscarriage comprises the herbs:
  • He Huan Hua Flos albizziae julibrissin The components of another preferred formulation effective in the prophylactic or therapeutic treatment of miscarriage, comprises the herbs:
  • the components of another preferred formulation effective in the prophylactic or therapeutic treatment of miscarriage comprises the herbs: Tu Si Zi Semen cuscata
  • He Huan Hua Flos albizziae julibrissin The components of another preferred formulation effective in the prophylactic or therapeutic treatment of miscarriage, comprises the herbs:
  • the components of another preferred formulation effective in the prophylactic or therapeutic treatment of miscarriage comprises the herbs: Tu Si Zi Semen cuscata Du Zhong Cortex eucommiae
  • the formulations of the present invention are primarily intended to be generic formulations that can be used without major changes for all female patients who have miscarried or are in danger of miscarrying, the only changes to the formulation being those that allow treatment of certain symptoms associated with miscarriage in addition to miscarriage itself.
  • specific tailored formulations comprising the core and additional supplementary herbs, which may usefully be prescribed for treatment, are also included as individual embodiments of the present invention.
  • One or more herbs from the following group may be added to the above formulations, to generate additional useful formulations in the treatment of miscarriage and associated symptoms and/or conditions.
  • Sheng Jiang Rhizoma zingiberis officinalis may be added to the above formulations, to generate additional useful formulations in the treatment of miscarriage and associated symptoms and/or conditions.
  • One or more herbs from one or more subsets of herbs below may be included in formulations that do not already include them, to enhance treatment of symptoms and/or conditions accompanying and/or associated with miscarriage.
  • Such subsets may be chosen from:
  • Subset a Miscarriage prevention and relief of nausea.
  • Subset b Miscarriage prevention and relief of lower back pain.
  • Subset d Miscarriage prevention in presence of uterine bleeding.
  • Subset e Miscarriage prevention in presence of bloating, digestive upsets, or bearing down abdominal discomfort.
  • Subset f Miscarriage prevention in presence of anxiety and sleeplessness.
  • the present invention is also directed a composition, wherein the composition treats or alleviates a symptom and/or condition accompanying and/or associated with miscarriage
  • 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, suspensions in water or non-aqueous media, and sachets as additives to food or beverages.
  • the herbal formulation may be produced utilizing concentrated herbal extract, 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
  • 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.
  • liquid preparations may be prepared by conventional means with pharmaceutically acceptable additives such as suspending agents, emulsifying agents, preservatives, non-aqueous vehicles, for 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 dosage 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 formulation For treatment of a subject, depending on activity of the herbal formulation, manner of administration, nature and severity of the disorder, age and body weight of the subject, different daily doses can be used. 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 miscarriage.
  • the present invention is also directed to the use of composition according to the invention in the manufacture of a medicament for the prophylactic treatment of miscarriage.
  • the present invention is also directed to methods of treating or alleviating the symptoms and/or conditions accompanying and/or associated with miscarriage, for example, nausea, lower back pain, pallor and fatigue, spotting of blood, bloating, digestive upsets, bearing down abdominal discomfort, anxiety and/or sleeplessness.
  • the present invention is also directed to use of the composition according to the invention as a medicament.
  • a preferred dose for preventive treatment of miscarriage and/or accompanying symptoms and/or associated conditions is in the range of 3g-15g (equivalent raw herb dosage) per day in a single dose or multiple doses.
  • the exact dose depends to a great extent on the frequency, severity and state of the condition, the general health of the patient and the presence of any accompanying symptoms and/or conditions.
  • 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 miscarriage or accompanying symptoms and/or associated conditions, and/or may be therapeutic in terms of a partial or complete cure of a disorder leading to miscarriage.
  • Treating covers any therapy of, or prevention of, miscarriage 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.
  • 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:
  • the formula when using granules the formula is constructed typically with 3g-15 g of each herb. A typical dose in the range of 3g-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 (Le. typically 3g-15g) 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 The components of a preferred formulation for treatment of miscarriage is set out in Table 1 below.
  • Table 1 Preferred formulation
  • One or more such additional herbs can be also be chosen from one or more of the following subsets:
  • Subset c Miscarriage prevention and treatment of pallor and fatigue.
  • Subset e Miscarriage prevention in presence of bloating, digestive upsets, or bearing down abdominal discomfort.
  • Subset f Miscarriage prevention in presence of anxiety and sleeplessness.
  • Example 2 Case Study 1
  • This patient had a history of three miscarriages and one live birth. Each miscarriage occurred at 10 to 12 weeks. Two of the miscarriages required a D&C after which the embryos were analysed and found to be chromosomally normal. The patient had been investigated for immune or genetic factors which might increase her risk of miscarriage. It was found that she carried one allele of the MTHR gene and to remedy this she bad taken a large dose of Folic acid daily for the last couple of years. She had also been prescribed Progesterone pessaries and low dose aspirin during her last two pregnancies, however these measures had not been successful in preventing miscarriage.
  • This patient (age 34 years) had five miscarriages in two years. The miscarriages occurred between 6 weeks to 8 weeks. Several embryos had been analysed and were of normal karyotype. She had been prescribed various treatments during her last three pregnancies including heparin, aspirin, steroids and progesterone.
  • the patient (age 40 years) was diagnosed with PCOS at 18 years of age. She had irregular infrequent menstrual cycles since puberty.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
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Abstract

La présente invention concerne une composition destinée à la prévention ou au traitement thérapeutique de l'avortement spontané, comprenant les herbes suivantes: du Tu si zi (semen cuscata), du Du zhong (cortex eucommiae), du Sang ji sheng (ramulus sangjisheng), du Bai zhu (rhizome atroctylodes macrocephala), ainsi qu'au moins une des herbes suivantes: - du Sha ren (fructus seu semen amomi), du Huang qin (radix Scutellaria bidentate), du Xiang fu (rhizome cyperi rotundi) et éventuellement d'autres herbes.
PCT/AU2008/000472 2007-04-02 2008-04-02 Compositions à base d'herbes et méthodes destinées au traitement de l'avortement spontané WO2008119133A1 (fr)

Applications Claiming Priority (2)

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AU2007901740 2007-04-02
AU2007901740A AU2007901740A0 (en) 2007-04-02 Compositions and methods for treatment of miscarriage

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WO2008119133A1 true WO2008119133A1 (fr) 2008-10-09

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102406918A (zh) * 2011-11-30 2012-04-11 宋爱民 治疗神经性呕吐的中药制剂
CN102526231A (zh) * 2012-01-17 2012-07-04 王秀云 一种治疗习惯性流产的中药制剂
CN102716368A (zh) * 2012-06-23 2012-10-10 乌艳霞 一种治疗胚胎停育的中药组合物
CN103405643A (zh) * 2013-07-26 2013-11-27 屈力军 一种治疗子宫内膜病、不孕症及习惯性流产的中草药剂
CN103479992A (zh) * 2013-10-14 2014-01-01 张桂赫 治疗伴消化道症状的焦虑性神经症的中药丸及其制备方法
CN104435952A (zh) * 2014-11-14 2015-03-25 王萍 一种安胎的中药制剂
CN108578570A (zh) * 2018-04-16 2018-09-28 胡碧原 一种治疗习惯性流产的中药

Citations (1)

* 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

Patent Citations (1)

* 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

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102406918A (zh) * 2011-11-30 2012-04-11 宋爱民 治疗神经性呕吐的中药制剂
CN102526231A (zh) * 2012-01-17 2012-07-04 王秀云 一种治疗习惯性流产的中药制剂
CN102716368A (zh) * 2012-06-23 2012-10-10 乌艳霞 一种治疗胚胎停育的中药组合物
CN103405643A (zh) * 2013-07-26 2013-11-27 屈力军 一种治疗子宫内膜病、不孕症及习惯性流产的中草药剂
CN103479992A (zh) * 2013-10-14 2014-01-01 张桂赫 治疗伴消化道症状的焦虑性神经症的中药丸及其制备方法
CN104435952A (zh) * 2014-11-14 2015-03-25 王萍 一种安胎的中药制剂
CN108578570A (zh) * 2018-04-16 2018-09-28 胡碧原 一种治疗习惯性流产的中药

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