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WO2009043671A1 - Utilisation d'un extrait de silybum marianum - Google Patents

Utilisation d'un extrait de silybum marianum Download PDF

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Publication number
WO2009043671A1
WO2009043671A1 PCT/EP2008/061647 EP2008061647W WO2009043671A1 WO 2009043671 A1 WO2009043671 A1 WO 2009043671A1 EP 2008061647 W EP2008061647 W EP 2008061647W WO 2009043671 A1 WO2009043671 A1 WO 2009043671A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
silybum marianum
extract
use according
radiodermatitis
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.)
Ceased
Application number
PCT/EP2008/061647
Other languages
English (en)
Inventor
Assumpta Bruna Floris
Ricardo Gavilan Lopez
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.)
Madaus SA
Original Assignee
Madaus SA
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 Madaus SA filed Critical Madaus SA
Publication of WO2009043671A1 publication Critical patent/WO2009043671A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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
    • A61P17/00—Drugs for dermatological disorders

Definitions

  • the present invention relates to a novel use of a composition with a Silybum marianum extract, as well as to the use of a composition containing the mentioned extract for topical administration.
  • Silymarin a bioflavonoid formed by three structural isomers: silybin, silydianin and silychristin, is extracted from Silybum marianum, commonly known as milk thistle. Since the Middle Ages the extract of Silybum marianum seeds has been used as a potent liver protector. Its action as a liver cell protector against the toxicity of certain drugs, for example against acetaminophen-induced toxicity, is currently being demonstrated, as described in "Acetaminophen-induced Toxicity to Human Epidermoid Cell Line A431 and Hepatoblastoma Cell Line Hep G2, in vitro, Is diminished by Silymarin" Skin Pharmacological 1995;8:279-291.
  • Silymarin is also used as a liver protector of patients for the treatment of chronic hepatitis caused by antiviral drugs in patients with acquired immunodeficiency syndrome.
  • Other extended uses of silymarin are the treatment of alcoholic cirrhosis and the treatment of mushroom poisoning.
  • the application of silymarin in all these indications furthermore has the advantage that it has no side effects.
  • the silymarin of the Silybum marianum seed extract is also used in cosmetics as an antioxidant, especially in body creams and lotions, for the treatment of delicate skin, skin exposed to the sun or exposed to other oxidizing agents.
  • compositions comprising the extract of Silybum marianum seeds.
  • WO0234275 describes a pharmaceutical preparation, comprising milk thistle extract or an active ingredient therefrom, and one or several terpenes, as well as the most suitable excipients. Said preparation is indicated for liver diseases, specifically cirrhosis of the liver.
  • DE 4226866 describes another plant preparation comprising milk thistle seeds, which have been irradiated with infrared radiation, then immediately being subjected to fermentation. This preparation is used as an anti-inflammatory medium in the form of capsules, granules, powder or tablets. It can also be added as a nutritional supplement.
  • JP 2000136124 describes a composition that is able to keep the skin fresh, elastic and young, skin cell differentiation as well as proliferation being controlled by means of elastase activity inhibition.
  • the composition comprises oligopeptides and an extract selected from multiple plant species, including Silybum marianum.
  • BG105507 describes a composition applicable as an antioxidant in the prevention of the effects of chemotherapy and in treatment with irradiation, or any other condition in which cell oxidation-reduction is compromised.
  • the composition comprises vitamins, a Rosmarinus officinalis extract, Silybum marianum extract, phytocyanins, Ginko biloba, as well as synthetic nitroxyl radical products.
  • radiodermatitis Due to the increase of the treatment of diseases by means of radiation therapy, the number of people affected by a skin disease known by the name of radiodermatitis is increasing more and more.
  • the radiodermatitis is a disease that especially affects doctors and healthcare professionals who give diagnoses by means of applying X-rays to patients.
  • doctors and healthcare professionals who give diagnoses by means of applying X-rays to patients.
  • radiodermatitis Some of the effects of radiodermatitis are the onset of erythema, papules or vesicles, lesions with exudation, glossy skin, and in extreme cases, the onset of tumors.
  • Radiodermatitis can also have a psychological repercussion on the patient who is being treated for another disease upon observing that a second disease is acquired and the treatment must be stopped.
  • lotions or creams For the purpose of alleviating symptoms of this disease, lotions or creams generally comprising calcium and sodium salts, such as sodium alginate, are often topically administered to those patients to whom radiation therapy is applied. These lotions or creams on many times cause allergic or intolerance reactions which further aggravate the problem. Different formulations are also necessary according to the symptomatology of the radiodermatitis, therefore the cost of treatment is high and multiple formulations must be available in order to treat the different skin manifestations.
  • compositions with a Silybum marianum extract are very beneficial for alleviating the symptoms of radiodermatitis. They are furthermore compositions which are effective in all manifestations of the disease. Disclosure of the Invention
  • the object of the present invention is the use of a composition comprising a Silybum marianum extract or an active ingredient therefrom, at a concentration by weight of 0.05% to 1.00%, for the preparation of a medicament for the prevention and/or the treatment of radiodermatitis.
  • the active ingredient of the Silybum marianum extract is silymarin.
  • composition for the preparation of a medicament for the prevention and/or the treatment of radiodermatitis is characterized in that the Silybum marianum extract has a silymarin content of 80% by weight.
  • the composition for the preparation of a medicament for the prevention and/or the treatment of radiodermatitis further comprises an Epilobium angustifolium extract, at least one vitamin, preferably vitamin E, procyanidines, linoleic acid, moisturizing sugars, natural moisturizers and bisabolol.
  • Another object of the present invention is the use of a composition for topical administration, comprising a Silybum marianum extract or an active ingredient therefrom, at a concentration by weight of 0.05% to 1 .00%, for the preparation of a medicament for the prevention and/or the treatment of radiodermatitis.
  • composition for topical administration comprises at least one compound for solubilizing the active ingredients of the Silybum marianum extract and at least one compound for reducing the systemic absorption of said active ingredients.
  • the compounds for solubilizing and for reducing the systemic absorption of active ingredients are ethoxydiglycol, hydrogenated castor oil or a mixture of both. - A -
  • compositions containing a Silybum marianum extract or an active ingredient therefrom for the preparation of a medicament for the prevention and/or the treatment of radiodermatitis
  • compositions with Silybum marianum extract are described below, which compositions comprise from 0.05% by weight to 1 .00% by weight of extract or active ingredient therefrom, which have been used in clinical trials by the inventors.
  • Composition 1 Cream with Silybum marianum extract.
  • Silybum marianum extract (80% by 0 25 weight of silymarin)
  • Flavonoids (catechin and epicatechin) 0 5 from grape seed.
  • excipients used in the composition are all those excipients that a person skilled in the art of formulations would use to obtain a creamy consistency.
  • Composition 2 Gel with Silybum marianum extract.
  • the gel of composition 2 has a pH of 5.50 ⁇ 0.30, and a viscosity at 20 Q C of 1.000 ⁇ 500 cps
  • these compositions which must be administered topically further comprise a compound for solubilizing silymarin.
  • Silymarin is a molecule that is not very soluble in water; therefore the inventors have developed a formulation which allows providing large amounts of the same in the compositions for topical administration.
  • an agent for solubilizing silymarin in the composition allows assuring that the same will be in conditions for being applied on the skin and that aggregates, which would reduce its efficacy, will not be formed.
  • topical compositions object of the invention with Silybum marianum extract which are used for the preparation of a medicament for the prevention or the treatment of radiodermatitis, further comprise a compound for reducing the systemic absorption of silymarin or any active ingredient of the Silybum marianum extract.
  • Said agents for solubilizing silymarin, as well as compounds for reducing the systemic absorption the active ingredients are preferably ethoxydiglycol, hydrogenated castor oil or a mixture of both.
  • Silybum marianum extract with 80% silymarin is therefore gradually released and acts on the skin, which is where it is to perform its function, before or after treatment with radiation therapy.
  • the purpose was to evaluate acute radiodermatitis, pigmentation, pruritus and subjective comfort. A baseline evaluation was conducted before the treatment. Then evaluations were conducted in weekly controls and at the end of treatment.
  • Radiodermatitis has been classified according to the toxicity scale of the RTOG (Radiation Therapy Oncology Group) and the pigmentation, pruritus and subjective comfort by means of an EVA scale (0-10).
  • the following table shows the percentages and degree of radiodermatitis depending on the week of treatment.
  • the pruritus, pigmentation and subjective comfort recordings have indicated low EVAs, with a median score of 3.
  • Topical medication was used in nine patients: four patients were given hyaluronic acid and four other patients were given silver sulphadiazine, and one patient was given corticoids.

Landscapes

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

Abstract

L'invention porte sur l'utilisation d'une composition comprenant un extrait de Silybum marianum ou un ingrédient actif de celui-ci, pour la préparation d'un médicament lors de la prévention et/ou du traitement d'une radiodermatite. L'invention porte également sur l'utilisation de la composition pour une administration topique.
PCT/EP2008/061647 2007-10-04 2008-09-03 Utilisation d'un extrait de silybum marianum Ceased WO2009043671A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES200702600A ES2325291B1 (es) 2007-10-04 2007-10-04 "uso de un extracto de silybum marianum"
ESP200702600 2007-10-04

Publications (1)

Publication Number Publication Date
WO2009043671A1 true WO2009043671A1 (fr) 2009-04-09

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ID=39838713

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/061647 Ceased WO2009043671A1 (fr) 2007-10-04 2008-09-03 Utilisation d'un extrait de silybum marianum

Country Status (2)

Country Link
ES (1) ES2325291B1 (fr)
WO (1) WO2009043671A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014008361A2 (fr) 2012-07-05 2014-01-09 Nutramax Laboratories, Inc. Compositions comprenant un sulforaphane ou un précurseur de sulforaphane et un extrait ou une poudre de chardon marie
CN105796831A (zh) * 2016-04-19 2016-07-27 北京欣普迪生物科技有限公司 医用射线防护剂及其制备方法
CN106176845A (zh) * 2016-08-30 2016-12-07 青海民族大学 柳兰抑制cdc25酶有效部位及制法和应用
CN106176843A (zh) * 2016-08-30 2016-12-07 青海民族大学 柳兰抑制hdac1酶有效部位及制法和应用
CN106344631A (zh) * 2016-08-30 2017-01-25 青海民族大学 柳兰有效部位及其制备方法和应用

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999048386A1 (fr) * 1998-03-24 1999-09-30 Stueckler Franz Produit a base de substances naturelles
WO2002072051A2 (fr) * 2001-03-02 2002-09-19 Indena S.P.A. Compositions pharmaceutiques et cosmetiques destinees a proteger la peau des dommages causes par les rayonnements solaires
JP2003171310A (ja) * 2002-05-02 2003-06-20 Noevir Co Ltd 皮膚バリア機能強化剤
WO2003088986A1 (fr) * 2002-04-16 2003-10-30 Isis Innovation Limited Curcumine utilisee dans la prevention et/ou le traitement de dommages tissulaires
WO2007041327A1 (fr) * 2005-10-01 2007-04-12 Elc Management Llc Préparation comprenant un extrait de hypsizygus ulmarius

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6524599B2 (en) * 2001-02-21 2003-02-25 Skinceuticals, Inc. Use of milk thistle extract in skin care compositions

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999048386A1 (fr) * 1998-03-24 1999-09-30 Stueckler Franz Produit a base de substances naturelles
WO2002072051A2 (fr) * 2001-03-02 2002-09-19 Indena S.P.A. Compositions pharmaceutiques et cosmetiques destinees a proteger la peau des dommages causes par les rayonnements solaires
WO2003088986A1 (fr) * 2002-04-16 2003-10-30 Isis Innovation Limited Curcumine utilisee dans la prevention et/ou le traitement de dommages tissulaires
JP2003171310A (ja) * 2002-05-02 2003-06-20 Noevir Co Ltd 皮膚バリア機能強化剤
WO2007041327A1 (fr) * 2005-10-01 2007-04-12 Elc Management Llc Préparation comprenant un extrait de hypsizygus ulmarius

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ABASCAL K ET AL: "The many faces of Silybum marianum (milk thistle): Part 1 - Treating cancer and hyperlipidemia and restoring kidney function", ALTERNATIVE AND COMPLEMENTARY THERAPIES, MARY ANN LIEBERT, LARCHMONT, NY, US, vol. 9, no. 4, 1 January 2003 (2003-01-01), pages 170 - 175, XP009107569, ISSN: 1076-2809 *
DATABASE WPI Week 200406, Derwent World Patents Index; AN 2004-055898, XP002500694 *
LI L H ET AL: "Silymarin prevents UV irradiation-induced A375-S2 cell apoptosis", 20041201, vol. 26, no. 6, 1 December 2004 (2004-12-01), XP018001494 *
MCDOUGALL CAROL J ET AL: "Management of radiation dermatitis in a patient after mastectomy", JOURNAL OF WOUND, OSTOMY AND CONTINENCE NURSING, MOSBY-YEAR BOOK, ST. LOUIS, MO, US, vol. 32, no. 5, 1 September 2005 (2005-09-01), pages 337 - 340, XP009107567, ISSN: 1071-5754 *

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014008361A2 (fr) 2012-07-05 2014-01-09 Nutramax Laboratories, Inc. Compositions comprenant un sulforaphane ou un précurseur de sulforaphane et un extrait ou une poudre de chardon marie
EP3409280A1 (fr) 2012-07-05 2018-12-05 Nutramax Laboratories, Inc. Compositions comprenant un sulforaphane et un extrait ou poudre de chardon-marie
EP3821895A1 (fr) 2012-07-05 2021-05-19 Nutramax Laboratories, Inc. Compositions comprenant du sulforaphane ou un extrait de brocoli et un extrait ou une poudre de chardon-marie
CN105796831A (zh) * 2016-04-19 2016-07-27 北京欣普迪生物科技有限公司 医用射线防护剂及其制备方法
CN106176845A (zh) * 2016-08-30 2016-12-07 青海民族大学 柳兰抑制cdc25酶有效部位及制法和应用
CN106176843A (zh) * 2016-08-30 2016-12-07 青海民族大学 柳兰抑制hdac1酶有效部位及制法和应用
CN106344631A (zh) * 2016-08-30 2017-01-25 青海民族大学 柳兰有效部位及其制备方法和应用

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Publication number Publication date
ES2325291B1 (es) 2010-04-22
ES2325291A1 (es) 2009-08-31

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