EP1874326A2 - Utilisation d'extraits de racines de griffe du diable (harpagophytum procumbens) pour traiter l'endometriose - Google Patents

Utilisation d'extraits de racines de griffe du diable (harpagophytum procumbens) pour traiter l'endometriose

Info

Publication number
EP1874326A2
EP1874326A2 EP06754854A EP06754854A EP1874326A2 EP 1874326 A2 EP1874326 A2 EP 1874326A2 EP 06754854 A EP06754854 A EP 06754854A EP 06754854 A EP06754854 A EP 06754854A EP 1874326 A2 EP1874326 A2 EP 1874326A2
Authority
EP
European Patent Office
Prior art keywords
endometriosis
extracts
devil
claw
use according
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP06754854A
Other languages
German (de)
English (en)
Inventor
Detlef Arndt
Katja Bobermien
Dagmar Braun
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Esteve Pharmaceuticals GmbH
Original Assignee
Riemser Arzneimittel AG
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 Riemser Arzneimittel AG filed Critical Riemser Arzneimittel AG
Publication of EP1874326A2 publication Critical patent/EP1874326A2/fr
Withdrawn legal-status Critical Current

Links

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)
    • 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

Definitions

  • the present invention presents a new possibility for endometriosis therapy. More particularly, the invention relates to a novel use of extracts of devil's claw roots (Harpagophytum procumbens), in particular dry extracts from the secondary storage root of the devil's claw for the treatment of endometriosis and / or endometriosis-induced proliferative and / or inflammatory processes and / or endometriosis-related pain therapy.
  • extracts of devil's claw roots Hardpagophytum procumbens
  • dry extracts from the secondary storage root of the devil's claw for the treatment of endometriosis and / or endometriosis-induced proliferative and / or inflammatory processes and / or endometriosis-related pain therapy.
  • Endometriosis is a widespread chronic disease of women.
  • the name “endometriosis” derives from the medical term for the lining of the uterus (endometrium). It is currently reported at a frequency of up to 10% of women of childbearing age.
  • Endometriosis is a chronic condition in which tissue, which is very similar in structure and function to the lining of the uterus, settles outside the uterus. It is considered to be a proliferative disease that can expand to a considerable extent without therapy. It can occur in all parts of the body, the uterine lining parts.
  • endometrial tissue is subject to the woman's hormonal menstrual cycle. It mimics, so to speak, the function of the uterine lining and naturally responds to the hormones of the ovary.
  • the endometriotic tissue can grow and bleed according to the cycle. Endometrial implants form cysts and adhesions. They can form small red or whitish nodules, or large black-brown cysts. This different appearance is a handicap in the diagnosis.
  • Endometriosis is a chronic disease that, if left untreated, often progresses.
  • the resulting cysts and adhesions are benign.
  • the risk of malignant deterioration is very low and less than one percent. So far, endometriosis is considered not completely curable, because recurrences can occur again.
  • the symptoms can disappear completely by a targeted treatment and the fertility of the affected women can be improved, the disease can break out again.
  • Endometriosis is most commonly used to treat pain, with prostaglandin synthesis inhibitors or antispasmodic drugs.
  • Various analgesics e.g. Acetylsalicylic acid or ibuprofen are the drugs of choice.
  • An operation is i.d.R. the most effective therapy.
  • Drug hormonal treatment is often used as adjunctive treatment before or after surgery. However, it is also possible as a sole therapy. Its goal is a blockade of the hormonal cycle, which leads to a regression of endometrial implants.
  • the medication must generally be taken for six months. They often show good results in smaller Endometrioseherden. However, in many cases they lead to a number of unpleasant side effects such as weight gain, fatigue, insomnia, mood changes and sweating.
  • DE 196 03 788 A1 a process for the preparation of highly concentrated extracts of devil's claw is described, wherein a crude aqueous extract is brought into contact with a non-ionic adsorbent resin and the active ingredients bound thereto in a second stage by treatment with preferably an alcohol dissolved and the Extract is concentrated afterwards.
  • This extract is used to treat painful discomforts of the human or animal musculoskeletal system.
  • DE 197 16 660 C2 discloses the use of devil's claw root extracts for inhibiting the growth of Helicobacter pylori bacteria.
  • the object of the invention was to search for and / or develop pharmaceutical preparations which are suitable on the basis of natural active substances for endometriosis therapy. It has been found that devil's root extract (Harpagophytum procumbens) can be administered effectively and safely in endometriotherapy.
  • devil's root extract Hardpagophytum procumbens
  • prostaglandin E2 is highly formed in the endometrial stromal cells. This is primarily induced by various cytokines (IL-1 ⁇ , TNF-) and estradiol-17ß and triggered an inflammatory process. Prostaglandin is the strongest inducer of aromatase activity in endometrial stromal cells. An increase in cyclooxygenase-2 (COX-2) expression additionally leads to an increase in the rate of biosynthesis of prostaglandin E2.
  • COX-2 cyclooxygenase-2
  • the invention is based on the surprising finding that extracts of the devil's claw inhibit the prostaglandin and cytokine (leukotriene) biosynthesis analogous to the synthetic cyclooxygenase-2 inhibitors and thus the o.g. interrupt positive feedback mechanism.
  • the prostaglandin E2 as an inducer of the aromatase activity is not present or is not present in sufficient quantity.
  • the use of the extracts causes regression of endometrial implants, suppresses endometriosis-induced proliferative and / or inflammatory processes and reduces and eliminates associated pain as well as to overcome other endometriosis-related disorders, such as bleeding, bleeding disorders or dyspareunia.
  • Endometriosis-related pain is understood to mean in particular gynecological pain of the lower abdomen, dysmenorrhea and cyclically independent pain.
  • dry extracts from the secondary storage root of the devil's claw are preferably used for endometriosis therapy, in particular for suppressing endometriosis-related proliferative and / or inflammatory processes, for reducing and eliminating associated pain and for overcoming other endometriosis-related disorders.
  • Extracts of various origins are used in the first place.
  • the extracted dry extract is not a chemically unified substance as a plant extract.
  • effective main ingredients of the secondary storage root are iridoids and iridoid glycosides; including especially harpagoside, procumbid and harpagid.
  • flavonoids, 2-phenylethanol derivatives, various sugars, sterols, alkanes, fats and waxes and essential oils are present.
  • the European Pharmacopoeia requires a minimum content of 1.2% harpagoside as an effective substance determining substance.
  • the extracts according to the present invention are preferably administered orally, in solid or liquid form.
  • capsule and tablet preparations which contain simple aqueous or aqueous-alcoholic extracts of devil's claw roots.
  • the dry extracts of devil's claw roots preferably used in accordance with the invention are prepared in such a way that storage roots of devil's claw with water or extracted from a mixture of ethanol and water, the extract obtained is concentrated, the insoluble fraction is separated and the resulting soluble fraction is dried.
  • the dry extract is turbidly soluble in water and has a drug extraction ratio (DEV) of 1.5 to 5: 1 and has a harpagoside content as measured by HPLC of at least 2.10 to 3.10% by weight.
  • DEV drug extraction ratio
  • Dry extracts of devil's claw roots which are particularly preferred, are used
  • the extracts used according to the invention can be processed and applied in a known manner preferably to orally administered solid and liquid pharmaceutical preparations with the addition of known pharmaceutical auxiliaries and additives.
  • the drugs have active substance contents (drug contents) of 100 to 3000 mg, preferably 200, 375, 400, 410, 480, 2000 mg.
  • the extract can be used alone or in combination with other therapeutic agents.
  • individual ingredients of the extract preferably harpagoside (at least 1.2 mg / capsule) and Procumbid and Harpagid in sufficient dosage can be processed and applied in known manner to orally administered solid and liquid pharmaceutical preparations with the addition of known pharmaceutical excipients and additives ,
  • the use of extracts of devil's claw has the great advantage that the preparations used according to the invention are well tolerated and therefore risk-free to use.
  • the analgesic effect leads to the immediate relief of pain in endometriosis-related pain to pain relief in long-term effect.
  • the inflammatory process in the endometrial foci leading to increased production of cytokines (IL-1 ⁇ , TNF-) by monocytes and macrophages is effectively suppressed. Endometrial foci form back.
  • the extracts used according to the invention suppress estrogen production in the endometriotic foci, ie outside the uterus, without influencing the normal estrogen production in the ovaries. This has the great advantage compared to a standard hormone therapy that these preparations are much better tolerated.
  • Dried secondary storage root of devil's claw is crushed and extracted with 30% ethanol / water for 0.5 to 5 hours at 40 0 C to 60 0 C.
  • the extract solution is concentrated and the primary extract is stirred at room temperature with ethanol.
  • the soluble fraction is separated from the insoluble and dried. The result was a harpagosidreicher dry extract with a harpagoside content of 2.10 to 3.10% (determined by HPLC).
  • Film-coated tablets containing 400 mg and 2000 mg of drug equivalent (total possible amount of drug (s)) Dry extract of devil's claw roots have, for example, the following compositions:
  • the ingredients are mixed and compressed into tablets.
  • the tablets are coated with a film coating based on methylhydroxypropylcellulose.

Landscapes

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

Abstract

L'invention concerne une nouvelle utilisation d'extraits de racines de griffe du diable (harpagophytum procumbens) pour traiter l'endométriose. L'invention concerne en particulier l'utilisation d'extraits secs du tubercule secondaire de la griffe du diable pour traiter l'endométriose et/ou des processus prolifératifs et/ou inflammatoires liés à l'endométriose et/ou pour traiter des douleurs liées à l'endométriose.
EP06754854A 2005-04-26 2006-04-26 Utilisation d'extraits de racines de griffe du diable (harpagophytum procumbens) pour traiter l'endometriose Withdrawn EP1874326A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005020330A DE102005020330B3 (de) 2005-04-26 2005-04-26 Verwendung von Extrakten aus Teufelskrallewurzeln (Harpagophytum procumbens) zur Endometriosetherapie
PCT/EP2006/061831 WO2006114422A2 (fr) 2005-04-26 2006-04-26 Utilisation d'extraits de racines de griffe du diable (harpagophytum procumbens) pour traiter l'endometriose

Publications (1)

Publication Number Publication Date
EP1874326A2 true EP1874326A2 (fr) 2008-01-09

Family

ID=36677229

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06754854A Withdrawn EP1874326A2 (fr) 2005-04-26 2006-04-26 Utilisation d'extraits de racines de griffe du diable (harpagophytum procumbens) pour traiter l'endometriose

Country Status (3)

Country Link
EP (1) EP1874326A2 (fr)
DE (1) DE102005020330B3 (fr)
WO (1) WO2006114422A2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITRM20130501A1 (it) * 2013-09-10 2015-03-11 Aboca Spa Societa Agricola Nuovi estratti di artiglio del diavolo e loro usi.

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2006114422A2 *

Also Published As

Publication number Publication date
DE102005020330B3 (de) 2006-09-28
WO2006114422A3 (fr) 2007-03-15
WO2006114422A2 (fr) 2006-11-02

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