WO2014118040A1 - Extrait d'indigo tinctoria pour le traitement topique et la prophylaxie d'affections cutanées - Google Patents

Extrait d'indigo tinctoria pour le traitement topique et la prophylaxie d'affections cutanées Download PDF

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Publication number
WO2014118040A1
WO2014118040A1 PCT/EP2014/051181 EP2014051181W WO2014118040A1 WO 2014118040 A1 WO2014118040 A1 WO 2014118040A1 EP 2014051181 W EP2014051181 W EP 2014051181W WO 2014118040 A1 WO2014118040 A1 WO 2014118040A1
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WO
WIPO (PCT)
Prior art keywords
extract
solvent
indigo
tinctoria
leaves
Prior art date
Application number
PCT/EP2014/051181
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English (en)
Inventor
Axel Brattstroem
Original Assignee
Axel Brattstroem
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 Axel Brattstroem filed Critical Axel Brattstroem
Publication of WO2014118040A1 publication Critical patent/WO2014118040A1/fr

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    • 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)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315—Isatis, e.g. Dyer's woad
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D11/00—Solvent extraction
    • B01D11/02—Solvent extraction of solids
    • B01D11/0203—Solvent extraction of solids with a supercritical fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine

Definitions

  • the present invention relates to an extract of leaves from Indigo tinctoria for the treatment and prophylaxis of skin disorders, preferably skin inflammation, more preferably psoriasis.
  • the invention also teaches pharmaceutical compositions comprising such extracts as well as methods for preparing these extracts.
  • Indigo naturalis is a dark blue powder prepared from the leaves of dye plants including Baphicacanthus cusia (Acanthaceae), Polygonum tinctorium (Polygonaceae), Isatis indigotica (Brassicaceae) and Indigofera suffrutticosa (Fabacea).
  • Indigo naturalis also known as Quing Dai is used in traditional Chinese medicine as a hemostatic,
  • Baphicacanthus cusia (Acanthaceae).
  • the blue powder of Indigo naturalis is produced by crushing, fermenting and adding calcium to the plant.
  • the main active agent is the alkaloid
  • Ban GmbH (Radix Isatidis) is another traditional Chinese medicine prepared from the roots of Isatis indigotica (Brassicaceae). It is mainly sold in Hebei, Jiangxi, Zhejiang, Fujian, Anhui and Gansu in China and has been used as plant remedy mainly for its alleged antiviral, antibacterial, anti-endotoxin, anti-inflammatory and immunregulatory effects. It is the objective of the present invention to provide alternative and improved medical preparations. It is a further preferred objective to provide improved medicaments for the treatment and prophylaxis of skin disorders, in particular skin inflammation, preferably atopic dermatitis, acne or psoriasis.
  • skin disorder as used herein is defined as dermatose.
  • the preferred skin disorder for treatment by the extract of the invention is skin inflammation, preferably selected from the group consisting of atopic dermatitis, acne and psoriasis, more preferably psoriasis.
  • the extracts from the leaves of Indigo tinctoria also comprise glucosinolates in amounts much higher than for example the amounts of glucosinolates found in preparations of Isatis indigotica.
  • the glucosinolates add to the anti-inflammatory effect of the extract and aid the solubilization of the extremely insoluble alkaloids to an extent that they reach an effective concentration in the extract.
  • glucosinolates possess additionally antioxidative and immunmodulating entities.
  • glucosinolates refers to a group of water-soluble glucoside compounds that contain sulfur and nitrogen and are derived from glucose and an amino acid. They occur as secondary metabolites in almost all plants of the order Brassicaceae.
  • the concentration of indirubin in the extracts of the present invention is preferably at least 0.5, more preferably at least 0.75, most preferably at least 1.0 wt.-%.
  • the concentration of tryptanthrin in the extracts of the present invention is preferably at least 0.05, more preferably at least 0.075, most preferably at least 0.1 wt.-%.
  • the extract solvent for producing the extract of the present invention is supercritical carbon dioxide, preferably together with at least one organic, more preferably hydrophilic, most preferably alcoholic co-solvent.
  • the alcoholic co-solvent is ethanol, preferably in an amount of 2 to 50, more preferably 5 to 40 or 10 to 30, most preferably 10 to 20 Vol.-% relative to the volume of the supercritical carbon dioxide.
  • the extracts of the present invention have utility for the topical treatment and prophylaxis of skin disorders.
  • treatment and prophylaxis of skin disorders relates to the treatment of an existing skin disorder for alleviating, reducing or getting rid of the disorder or at least one or more of its symptoms as well as the treatment of future skin disorders for preventing their occurrence, recurrence or the occurrence or recurrence of symptoms thereof.
  • the present invention relates to the use of an extract of the present invention for the preparation of a medicament for the treatment and prophylaxis of skin disorders, preferably skin inflammation, more preferably selected from the group consisting of atopic dermatitis, acne or psoriasis, most preferably psoriasis.
  • a further aspect of the present invention relates to a pharmaceutical composition
  • a pharmaceutical composition comprising an extract of the present invention.
  • the pharmaceutical composition further comprises at least one extract selected from the group of extracts produced from Mahonia aquifolium and/or Azadirachta indica.
  • the present invention relates to a method for preparing an indigo tinctoria extract of the invention, comprising the steps of:
  • step b1 drying the leaves of step a) to produce indirubin and tryptanthrin by
  • step b2) extracting the leaves of step a) using a suitable solvent
  • step c2) fermenting the extract of step b2) to produce indirubin and tryptanthrin, d) optionally further processing the raw extract to make it suitable for topical administration.
  • the extract solvent for the method of the invention is an aqueous and/or alcoholic solvent, preferably an aqueous ethanolic solvent, preferably an aqueous solvent having 30 to 90, preferably 40 to 80, more preferably 50 to 75, most preferably 65 to 75 Vol.-% alcohol, preferably ethanol.
  • the extract of the present invention is produced exclusively from Indigo tinctoria leaves excluding any other Isatis plant material.
  • the extracts of the invention may be administered topically in any conventional dosage form in any conventional manner.
  • the preferred mode of administration is preferably in a solid or liquid dosage form.
  • dosage forms of the extracts described herein include
  • ion exchangers alumina, aluminium stearate, lecithin, serum proteins, buffer substances, water, salts or electrolytes and cellulose-based substances.
  • maltodextrin can be used to produce a free- flowing dry extract which is particularly suitable for further processing.
  • Preferred dosage forms include liquid, solution, suspension, emulsion, reconstitutable powder and transdermal patch. Controlled release dosage forms with or without immediate release portions are also envisaged. Methods for preparing such dosage forms are known (see, for example, H. C. Anse! and N. G.
  • the administered Indigo tinctoria extract of the invention contains at least 0.5% preferably at least 1%, more preferably at least 5 wt-% dry solids or liquid equivalents from Indigo tinctoria. Although one dose per day may be sufficient, up to 5 or more doses per day may be applied topically. More preferably up to 3 doses per day are
  • the extracts of the present invention can be administered the same way as other chemical drugs or plant extracts and pharmaceutical compositions thereof.
  • Example 3 Clinical use of extracts from leaves of Indigo tinctoria for the topical
  • the prepared ointment was tested in 8 patients suffering for at least already 2-4 years from psoriasis. The diagnosis was confirmed by a dermatologist. The patients were advised to treat the affected skin areas one or two times per day with the ointment. The results were documented by photographs. Remission started within one week and completed after another 3-5 weeks. After stop of the treatment the skin affections reappeared within a couple of weeks. If the treatment started again the identical time course of remission was observed.

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

Abstract

La présente invention concerne un extrait de feuilles d'Indigo tinctoria pour le traitement et la prophylaxie d'affections cutanées, de préférence de l'inflammation de la peau, plus préférablement du psoriasis. L'invention concerne également des compositions pharmaceutiques comprenant ces extraits ainsi que des procédés de préparation de ces extraits.
PCT/EP2014/051181 2013-01-29 2014-01-22 Extrait d'indigo tinctoria pour le traitement topique et la prophylaxie d'affections cutanées WO2014118040A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13000428.6 2013-01-29
EP13000428 2013-01-29

Publications (1)

Publication Number Publication Date
WO2014118040A1 true WO2014118040A1 (fr) 2014-08-07

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PCT/EP2014/051181 WO2014118040A1 (fr) 2013-01-29 2014-01-22 Extrait d'indigo tinctoria pour le traitement topique et la prophylaxie d'affections cutanées

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016162488A1 (fr) * 2015-04-09 2016-10-13 Galderma Sa Traitement de la dermatite atopique par de l'extrait d'indigo naturel ou par de l'extrait de plante produisant de l'indigo
WO2016162485A1 (fr) * 2015-04-09 2016-10-13 Galderma Sa Composition pharmaceutique et son utilisation
US9861673B2 (en) 2015-04-09 2018-01-09 Galderma S.A. Extract from indigo naturalis and a process for preparing the same
CN108938724A (zh) * 2018-08-24 2018-12-07 云南希康生物科技有限公司 一种印楝叶提取物及其制备工艺、应用
US10668120B2 (en) 2015-04-09 2020-06-02 Galderma Sa Antibacterial indigo naturalis or indigo-producing plant extract and use thereof
CN115154378A (zh) * 2021-04-07 2022-10-11 艾沐外株式会社 一种防脱发及促进生发的组合物

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EP1495763A1 (fr) * 2002-04-15 2005-01-12 Tetsuo Santo Creme therapeutique contre la dermatite
FR2850580A1 (fr) * 2003-02-04 2004-08-06 Innadev Pharm Composition a base de plantes et d'acides gras polyinsatures en omega-3 pour la prevention et le traitement des verrues, keratoses et autres desordres de la peau
US20080279902A1 (en) * 2007-05-09 2008-11-13 Henry Steven Luria Delivery System And Method To Deliver Homeopathic Complexes Comprising Homeopathic Colored Pigment Products For Cosmetic Use
CN101396382A (zh) * 2007-09-27 2009-04-01 上海市脑血管病防治研究所 一种复方板蓝根口腔崩解片及其制备方法
US20120196841A1 (en) * 2009-10-05 2012-08-02 Kao Corporation Ceramide Production Enhancer and Moisturizer
KR20120036011A (ko) * 2010-10-07 2012-04-17 재단법인 한국한방산업진흥원 대청엽 추출물을 함유하는 미백 및 주름개선용 조성물
KR101191919B1 (ko) * 2012-02-20 2012-10-17 재단법인나주시천연염색문화재단 쪽 초임계 추출물을 유효성분으로 함유하는 치약 조성물 및 이의 제조방법

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Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190160128A1 (en) 2015-04-09 2019-05-30 Galderma S.A. Pharmaceutical composition comprising refined indigo naturalis extracts and the use thereof
US10232006B2 (en) 2015-04-09 2019-03-19 Galderma S.A. Pharmaceutical composition comprising refined indigo naturalis extract and the use thereof
US9833438B2 (en) 2015-04-09 2017-12-05 Galderma S.A. Treatment of atopic dermatitis with indigo naturalis or indigo producing plant extract
CN107466234A (zh) * 2015-04-09 2017-12-12 盖尔德玛公司 药用组合物及其用途
WO2016162488A1 (fr) * 2015-04-09 2016-10-13 Galderma Sa Traitement de la dermatite atopique par de l'extrait d'indigo naturel ou par de l'extrait de plante produisant de l'indigo
US11116811B2 (en) 2015-04-09 2021-09-14 Galderma S.A. Pharmaceutical composition comprising refined indigo naturalis extracts and the use thereof
WO2016162485A1 (fr) * 2015-04-09 2016-10-13 Galderma Sa Composition pharmaceutique et son utilisation
US10251926B2 (en) 2015-04-09 2019-04-09 Galderma S.A. Extract from indigo naturalis and a process for preparing the same
US9861673B2 (en) 2015-04-09 2018-01-09 Galderma S.A. Extract from indigo naturalis and a process for preparing the same
US10555985B2 (en) 2015-04-09 2020-02-11 Galderma S.A. Pharmaceutical composition comprising refined Indigo naturalis extracts and the use thereof
US10668120B2 (en) 2015-04-09 2020-06-02 Galderma Sa Antibacterial indigo naturalis or indigo-producing plant extract and use thereof
US10695391B2 (en) 2015-04-09 2020-06-30 Galderma S.A. Extract from Indigo Naturalis and a process for preparing the same
TWI737602B (zh) * 2015-04-09 2021-09-01 瑞士商高德美公司 藥學組合物及其製劑
CN108938724B (zh) * 2018-08-24 2021-06-18 云南希康生物科技有限公司 一种印楝叶提取物及其制备工艺、应用
CN108938724A (zh) * 2018-08-24 2018-12-07 云南希康生物科技有限公司 一种印楝叶提取物及其制备工艺、应用
CN115154378A (zh) * 2021-04-07 2022-10-11 艾沐外株式会社 一种防脱发及促进生发的组合物

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