Bulbus Allii Cepae WHO monographs on selected medicinal plants VOLUME 1 World Health Organization Geneva 1999 i WHO monographs on selected medicinal plants WHO Library Cataloguing in Publication Data WHO monographs on selected medicinal plants.—Vol. 1. 1.Plants, Medicinal 2.Herbs 3.Traditional medicine ISBN 92 4 154517 8 (NLM Classification: QV 766) The World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and enquiries should be addressed to the Office of Publications, World Health Organization, Geneva, Switzerland, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available. © World Health Organization 1999 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. 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Designed by WHO Graphics Typeset in Hong Kong Printed in Malta 97/11795-Best-set/Interprint-6500 ii Bulbus Allii Cepae Contents Acknowledgements v Introduction 1 Monographs (in alphabetical order of plant name) Bulbus Allii Cepae 5 Bulbus Allii Sativi 16 Aloe 33 Aloe Vera Gel 43 Radix Astragali 50 Fructus Bruceae 59 Radix Bupleuri 67 Herba Centellae 77 Flos Chamomillae 86 Cortex Cinnamomi 95 Rhizoma Coptidis 105 Rhizoma Curcumae Longae 115 Radix Echinaceae 125 Herba Echinaceae Purpureae 136 Herba Ephedrae 145 Folium Ginkgo 154 Radix Ginseng 168 Radix Glycyrrhizae 183 Radix Paeoniae 195 Semen Plantaginis 202 Radix Platycodi 213 Radix Rauwolfiae 221 Rhizoma Rhei 231 Folium Sennae 241 Fructus Sennae 250 Herba Thymi 259 iii WHOContents monographs on selected medicinal plants Radix Valerianae 267 Rhizoma Zingiberis 277 Annex Participants in the WHO Consultation on Selected Medicinal Plants 288 iv Bulbus Allii Cepae Acknowledgements Special acknowledgement is due to Professors Norman R. Farnsworth, Harry H. S. Fong, and Gail B. Mahady of the WHO Collaborating Centre for Tradi- tional Medicine, College of Pharmacy, University of Illinois at Chicago, USA, for drafting and revising the monographs. WHO also acknowledges with thanks the members of the advisory group that met in Beijing, China, in 1994, to draw up a list of medicinal plants for which monographs should be prepared, the more than 100 experts who pro- vided comments and advice on the draft texts, and those who participated in the WHO Consultation held in Munich, Germany, in 1996 to review the monographs (see Annex). Finally, WHO would like to thank the Food and Agriculture Organization of the United Nations and the United Nations Indus- trial Development Organization for their contributions and all those who submitted comments through the World Self-Medication Industry, a nongov- ernmental organization in official relations with WHO. v WHO monographs on selected medicinal plants vi Bulbus Allii Cepae Introduction During the past decade, traditional systems of medicine have become a topic of global importance. Current estimates suggest that, in many developing coun- tries, a large proportion of the population relies heavily on traditional practi- tioners and medicinal plants to meet primary health care needs. Although modern medicine may be available in these countries, herbal medicines (phytomedicines) have often maintained popularity for historical and cultural reasons. Concurrently, many people in developed countries have begun to turn to alternative or complementary therapies, including medicinal herbs. Few plant species that provide medicinal herbs have been scientifically evaluated for their possible medical application. Safety and efficacy data are available for even fewer plants, their extracts and active ingredients, and the preparations containing them. Furthermore, in most countries the herbal medi- cines market is poorly regulated, and herbal products are often neither regis- tered nor controlled. Assurance of the safety, quality, and efficacy of medicinal plants and herbal products has now become a key issue in industrialized and in developing countries. Both the general consumer and health-care professionals need up-to-date, authoritative information on the safety and efficacy of medici- nal plants. During the fourth International Conference of Drug Regulatory Authorities (ICDRA) held in Tokyo in 1986, WHO was requested to compile a list of medicinal plants and to establish international specifications for the most widely used medicinal plants and simple preparations. Guidelines for the as- sessment of herbal medicines were subsequently prepared by WHO and adopted by the sixth ICDRA in Ottawa, Canada, in 1991.1 As a result of ICDRA’s recommendations and in response to requests from WHO’s Member States for assistance in providing safe and effective herbal medicines for use in national health-care systems, WHO is now publishing this first volume of 28 monographs on selected medicinal plants; a second volume is in preparation. Preparation of the monographs The medicinal plants featured in this volume were selected by an advisory group in Beijing in 1994. The plants selected are widely used and important in 1 Guidelines for the assessment of herbal medicines. In: Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 1. Geneva, World Health Organization, 1997:31–37. 1 WHOIntroduction monographs on selected medicinal plants all WHO regions, and for each sufficient scientific information seemed available to substantiate safety and efficacy. The monographs were drafted by the WHO Collaborating Centre for Traditional Medicine at the University of Illinois at Chicago, United States of America. The content was obtained by a systematic review of scientific literature from 1975 until the end of 1995: review articles; bibliographies in review articles; many pharmacopoeias—the International, African, British, Chinese, Dutch, European, French, German, Hungarian, Indian, and Japanese; as well as many other reference books. Draft monographs were widely distributed, and some 100 experts in more than 40 countries commented on them. Experts included members of WHO’s Expert Advisory Panels on Traditional Medicine, on the International Pharmacopoeia and Pharmaceutical Preparations, and on Drug Evaluation and National Drug Policies; and the drug regulatory authorities of 16 countries. A WHO Consultation on Selected Medicinal Plants was held in Munich, Germany, in 1996. Sixteen experts and drug regulatory authorities from Member States participated. Following extensive discussion, 28 of 31 draft monographs were approved. The monograph on one medicinal plant was re- jected because of the plant’s potential toxicity. Two others will be reconsidered when more definitive data are available. At the subsequent eighth ICDRA in Bahrain later in 1996, the 28 model monographs were further reviewed and endorsed, and Member States requested WHO to prepare additional model monographs. Purpose and content of the monographs The purpose of the monographs is to: • provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States; • provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and • facilitate information exchange among Member States. Readers will include members of regulatory authorities, practitioners of ortho- dox and of traditional medicine, pharmacists, other health professionals, manu- facturers of herbal products, and research scientists. Each monograph contains two parts. The first part consists of phar- macopoeial summaries for quality assurance: botanical features, distribution, identity tests, purity requirements, chemical assays, and active or major chemi- cal constituents. The second part summarizes clinical applications, pharmacol- ogy, contraindications, warnings, precautions, potential adverse reactions, and posology. In each pharmacopoeial summary, the Definition section provides the Latin binomial pharmacopoeial name, the most important criterion in quality assur- ance. Latin pharmacopoeial synonyms and vernacular names, listed in the 2 Bulbus IntroductionAllii Cepae sections Synonyms and Selected vernacular names, are those names used in com- merce or by local consumers. The monographs place outdated botanical no- menclature in the synonyms category, based on the International Rules of Nomenclature. For example, Aloe barbadensis Mill. is actually Aloe vera (L.) Burm. Cassia acutifolia Delile and Cassia angustifolia Vahl., often treated in separate mono- graphs, are now believed to be the same species, Cassia senna L. Matricaria chamomilla L., M. recutita L., and M. suaveolens L. have been used for many years as the