WHO monographs on selected medicinal plants Volume 4 WHO monographs on selected medicinal plants VOLUME 4 WHO Library Cataloguing-in-Publication Data WHO monographs on selected medicinal plants. Vol. 4. 1. Plants, Medicinal. 2. Angiosperms. 3. Medicine, Traditional. I. WHO Consultation on Selected Medicinal Plants (4th: 2005: Salerno-Paestum, Italy) II. World Health Organization. ISBN 978 92 4 154705 5 (NLM classification: QV 766) © World Health Organization 2009 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). 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Printed in Spain Contents Acknowledgements v Introduction 1 General technical notices 5 Monographs (inalphabetical order of plant name) Fructus Agni Casti 9 Cortex Berberidis 30 Gummi Boswellii 48 Semen Cardamomi 61 Fructus Chebulae 71 Semen Cucurbitae 83 Folium Cynarae 92 Cortex Granati 108 Pericarpium Granati 117 Folium Guavae 127 Lichen Islandicus 140 Fructus Macrocarponii 149 Cortex Magnoliae 167 Herba Millefolii 179 Fructus Momordicae 192 Fructus Myrtilli 210 Radix Panacis Quinquefolii 226 Cortex Phellodendron 244 Rhizoma Picrorhizae 258 Oleum Ricini 271 Aetheroleum Rosmarini 284 Folium Rosmarini 294 Cortex Salicis 309 Fructus Tribuli 323 Flos Trifolii 335 iii Contents Ramulus cum Uncis Uncariae 353 Cortex Viburni Prunifolii 364 Radix Withaniae 373 Annex 1 Participants of the Fourth WHO Consultation on Selected Medicinal Plants Salerno-Paestum, Italy, 3–6 October 2005 392 Annex 2 Cumulative index (in alphabetical order of plant name) 395 Annex 3 Cumulative index (in alphabetical orderof plant material of interest) 397 Annex 4 Cumulative index of medicinal plants (in alphabetical order of Latin binomial plant name) 400 Annex 5 Cumulative index of major chemical constituents (by compound namein alphabetical order) 406 Annex 6 Cumulative index of major chemical constituents (ordered by CAS number) 430 Annex 7 Cumulative index of major chemical constituents (ordered by molecular formula) 437 iv Acknowledgements Special acknowledgement is due to Professor Norman R. Farnsworth, Professor Harry H.S. Fong, and Professor Gail B. Mahady of the WHO Collaborating Centre for Traditional Medicine, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA, for drafting and re- vising the monographs. Special acknowledgement is also due to Dr Ray- mond Boudet-Dalbin of the Laboratoire de Chimie Thérapeutique, Uni- versity of René Descartes, Paris, France, for drawing the chemical structures and for compiling the index of major chemical constituents in- cluding information on their molecular formula and CAS numbers. The photograph for the front cover was kindly provided by the Research Center for Medicinal Plant Resources, National Institute of Biomedical Innovation, Tsukuba City, Japan. WHO also acknowledges with thanks the valuable work of the ap- proximately 200 experts including 81 national health authorities, who provided comments and advice on the draft texts; those who submitted comments through the World Self-Medication Industry (a nongovern- mental organization in official relations with WHO) and the Internation- al Federation of Pharmacists (a nongovernmental organization in official relations with WHO); and those who participated in the Fourth WHO Consultation on Selected Medicinal Plants held in Salerno-Paestum, Italy, in October 2005 to review the monographs (see Annex 1). Sincere appreciation is extended to the Ministry of Health of Italy, the Government of the Province of Campagna, Italy, the Municipal Govern- ment of Salerno, Italy, and the State University of Salerno, who hosted the above-mentioned Fourth WHO Consultation and supported it financial- ly. Finally, WHO wishes to express thanks to Mr Raymond Tsai, Boston, USA, Dr Hermann Garden, Basel, Switzerland, Ms Lynn Morra, Abu Dhabi, United Arab Emirates, and Ms Tina Lu, Rochester, USA, for their indispensable assistance in finalizing and editing the manuscripts. v Introduction Increasing role of the WHO monographs on selected medicinal plants Over the past two decades, there has been a tremendous increase in the use of herbal medicine; however, there is still a significant lack of research data in this field. Therefore since 1999, WHO has published three vol- umes of the WHO monographs on selected medicinal plants: volume 1 includes 28 monographs; volume 2 contains an additional 30 monographs; and volume 3 provides 31 monographs. Including the 28 new monographs published in this volume, a total of 118 monographs in four volumes are now available on the WHO web site (http://www.who.int/medicinedocs/ en/m/abstract/Js14213e/). Due to the diversity of medicinal plants and herbal medicines, it is dif- ficult for WHO to continue to develop more monographs on commonly used medicinal plants. One of the objectives of WHO monographs is to provide a model that will support countries in developing their own na- tional or regional monographs on medicinal plants or national formular- ies on herbal medicines. Experts can be trained through the process of developing country-specific or regional monographs, and national capac- ity in this field can thus be built up. For example, at WHO’s regional training workshop on regulation of herbal medicines held for the WHO European Region, in September 2003, the participating national drug regulatory authorities of many of the Newly Independent States (NIS) submitted their request to WHO di- rectly, for assistance in the development of monographs on medicinal plants commonly used in NIS. In order to respond to their urgent need, WHO initiated a new project to develop a set of regional (NIS) monographs on commonly used me- dicinal plants, based on available scientific information relating to their safety, efficacy and quality, which will facilitate the creation of effective and practical regulatory and quality assurance measures on herbal medi- cines. WHO has been working with 15 national drug regulatory authori- ties interested in this publication in NIS, Countries of Central and Eastern 1 Introduction Europe (CCEE) and their neighbouring countries, in close collaboration with the WHO Regional Office for Europe. The 13 new monographs on commonly used medicinal plants in NIS have been drafted based on the format of the WHO monographs by the experts in NIS and CCEE coun- tries with the support of experts, national health authorities and NGOs within and also outside the NIS and CCEE countries. The WHO mono- graphs on medicinal plants commonly used in NIS have been completed and will be published soon. Based on the NIS countries model, in the fu- ture, WHO would like to cooperate with more countries or regions to develop their monographs on commonly used medicinal plants. Preparation of monographs for volume 4 Selection of medicinal plants The selection of medicinal plants for inclusion in the WHO monographs is based on worldwide use. The medicinal plants selected must meet two major criteria: (1) they must be in common use in at least two WHO Re- gions; and (2) there must be sufficient scientific data available to satisfy the requirements of the various sections in the monograph format. The recommended selection criteria discussed at the Third WHO Consultation on Selected Medicinal Plants (Ottawa, Canada, July 2001) were applied to the preparation of volume 4 of the WHO monographs. Preparation During the preparation of volume 4, more than 200 experts were involved in addition to members of WHO’s Expert Advisory Panel on Traditional Medicine, a significant expansion compared to the numbers involved in the previous three volumes. National drug regulatory authorities in 81 countries participated in the process, again a greater number than for the previous volumes. This global network of active players facilitated wider access to the available scientific references and information, in terms of both quality and quantity. This considerable level of support contrib- uted greatly to the efficiency of the preparation process. The Fourth WHO Consultation on Selected Medicinal Plants was held in Salerno-Paestum, Italy, in October 2005 to review and finalize the draft monographs. Thirty-four experts and drug regulatory authorities from WHO Member States participated (Annex 1). Following extensive dis- cussion, 28 of the 32 draft monographs were adopted for inclusion. Changes in format in volume 4 A description of selected sections of the monographs is given in the General technical notices, which reflect the above-mentioned format 2