Evaluation of Herbal Medicinal Products Evaluation of Herbal Medicinal Products Perspectives on quality, safety and efficacy Edited by Pulok K Mukherjee Director, School of Natural Product Studies, Jadavpur University, Kolkata, India Peter J Houghton Emeritus Professor in Pharmacognosy, Pharmaceutical Sciences Division, King’s College London, London, UK London • Chicago Published by the Pharmaceutical Press An imprint of RPS Publishing 1 Lambeth High Street, London SE1 7JN, UK 100 South Atkinson Road, Suite 200, Grayslake, IL 60030-7820, USA © Pharmaceutical Press 2009 is a trade mark of RPS Publishing RPS Publishing is the publishing organisation of the Royal Pharmaceutical Society of Great Britain First published 2009 Typeset by J&L Composition, Scarborough, North Yorkshire Printed in Great Britain by Cromwell Press Group, Trowbridge ISBN 978 0 85369 751 0 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the prior written permission of the copyright holder. The publisher makes no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made. The right of Pulok K Mukherjee and Peter J Houghton to be identified as the editors of this work has been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988. A catalogue record for this book is available from the British Library Contents Preface viii Contributors ix Glossary xiii Part 1 Overview of various types of traditional medicine 1 1 The worldwide phenomenon of increased use of herbal products: opportunities and threats 3 2 Developing herbal medicinal products with quality, safety and efficacy: from field to bedside, with particular reference to the situation in India 13 3 Natural remedies from Turkey: perspectives of safety and efficacy 28 4 Traditional Chinese medicines: the challenge of acceptance by Western medicine 42 5 Traditional Chinese medicines: evaluation of botanical extracts and dietary supplements 62 6 Synergy and polyvalence: paradigms to explain the activity of herbal products 85 7 From clinical evidence to mechanism of action: the development of standardised phytomedicines 95 Part 2 Pharmacological evaluation for some therapeutic areas 105 8 Herbal medicines for functional gastrointestinal disorders: study methods for quality, safety and efficacy 107 9 Therapy and prevention of hepatocellular carcinoma using herbal drugs 122 vi | Contents 10 Testing of herbal products used to treat infections 133 11 Natural products research in Helicobacter pylori infections 149 12 Evaluation of the efficacy of herbal medicinal products used to treat cardiovascular diseases 160 13 Herbal medicinal products as antiangiogenic agents: perspectives and evaluation 174 14 Herbs affecting the central nervous system 187 15 Herbs used to treat respiratory conditions other than infections 203 16 Immunomodulatory herbal medicinal products: establishing standards and activity, with particular reference to herbs used in Ayurveda 215 17 Tests on Indian and Peruvian medicinal plants used for wound healing 228 18 Evidence of the efficacy of herbal medicinal products used for conditions associated with inflammation 243 19 Tests for antioxidant activity and their relevance to herbal medicinal products 261 20 Herbal medicinal products affecting memory and cognitive disorders 282 21 Evaluation of herbal medicinal products against herpes virus diseases 295 22 Herbal medicinal products for tinnitus: perspectives and evaluation 314 23 Traditional herbs for healthcare – turmeric: a case history 322 24 Safety and efficacy of Hachimi-jio-gan: a Chinese preparation to counteract oxidative damage 340 Part 3 Product development 357 25 Essential oils in the treatment of skin diseases: aspects of efficacy and toxicology 359 26 Shelf-life of herbal remedies: challenges and approaches 369 Contents | vii Part 4 Evaluation of quality and safety 381 27 Authentication and quality assessment of botanicals and botanical products used in clinical research 383 28 Quality control of Chinese herbal drugs 393 29 Clinical trials as signposts to efficacy 426 30 Toxicological evaluation of herbal medicines: approaches and perspectives 444 31 Safety evaluation of herbal medicines 457 Index 479 Preface It would be impossible in one book to cover every However, we hope that this collection of articles possible aspect of the evaluation of herbal medicinal gives a sufficient overview of approaches to the eval- products. Apart from the large number of plant uation of herbal medicinal products to enable others species used throughout the world for medicinal to produce similar articles to make the picture more purposes, there are many disease states, geographical complete. regions and cultural considerations. Our aim is to improve the level of understanding Consequently, some will be disappointed that a of the various avenues that are needed to provide a topic has not been included, which they think impor- fully rounded evaluation of these materials, so that tant, while others will think that a particular they can be used with greater confidence, because geographical area, disease state or analytical method of improved quality and an increasing scientifically has been overemphasised or neglected! sound evidence base. We make no pretence of claiming that this volume is comprehensive, and recognise that there Pulok K Mukherjee are many interesting and exciting developments in Peter J Houghton analytical approaches and biological studies which are barely mentioned. Contributors Bolanle A Adeniyi Cees J Beukelman Departments of Pharmacy Practice, and Medicinal Section Medicinal Chemistry and Chemical Biology, Chemistry and Pharmacognosy, UIC PAHO/WHO Department of Pharmaceutical Sciences, Faculty of Collaborating Center for Traditional Medicine, Sciences, Utrecht University, Utrecht, The Netherlands and b PhytoGeniX BV, Utrecht, The Netherlands University of Illinois at Chicago, College of Pharmacy, 833 South Wood Street, Chicago, IL 60612, USA Sujit K Bhattacharya O P Agarwal ICMR Virus Unit, I D & B G Hospital Campus, Beliaghata, Kolkata 700 010, India Indian Council of Medical Research, Ansari Nagar, New Delhi 110 029, India Tuhin Kanti Biswas J B Roy State Ayurvedic Medical College and K F H Nazeer Ahmed Hospital, 170–172, Raja Dinendra Street, Kolkata School of Natural Product Studies, Department of 700 004, India Pharmaceutical Technology, Jadavpur University, Shrabana Chakrabarti Kolkata 700 032, India S N Pradhan Centre for Neurosciences, University of Stanley O Aniagu Calcutta, 244B Acharya J C Bose Road, Kolkata 700 020, India Molecular Pathobiology Group, School of Biosciences, University of Birmingham, Birmingham, Sekhar Chakraborty UK ICMR Virus Unit, I D & B G Hospital Campus, Beliaghata, Kolkata 700 010, India Rudolf Bauer Institute of Pharmaceutical Sciences, Department of Debprasad Chattopadhyay Pharmacognosy, Universitätsplatz 4/1, 8010 Graz, ICMR Virus Unit, I D & B G Hospital Campus, Austria Beliaghata, Kolkata 700 010, India Ezra Bejar Raymond Cooper Herbalife International, Century City, CA 90067, PhytoScience Inc, PO Box 1935, Los Altos CA 94023, USA USA Larry H Danziger Albert J J van den Berg Departments of Pharmacy Practice, and Medicinal Section Medicinal Chemistry and Chemical Biology, Chemistry and Pharmacognosy, UIC PAHO/WHO Department of Pharmaceutical Sciences, Faculty of Collaborating Center for Traditional Medicine, Sciences, Utrecht University, Utrecht, The Netherlands University of Illinois at Chicago, College of Pharmacy, and b PhytoGeniX BV, Utrecht, The Netherlands 833 South Wood Street, Chicago, IL 60612, USA x|Contributors Cynthia L Darlington K B Harikumar Department of Pharmacology and Toxicology, Amala Cancer Research Centre, Thrissur 680 555, School of Medical Sciences, University of Otago Kerala, India Medical School, Dunedin, New Zealand P J Houghton Sonali Das Department of Pharmacy, King’s College London, ICMR Virus Unit, I D & B G Hospital Campus, Franklin Wilkins Building, 150 Stamford Street, Beliaghata, Kolkata 700 010, India London SE1 9NH, UK Rajendra M Dobriyal Tianan Jiang Herbal Research Labs, Hindustan Unilever Research Life Extension Inc, 1100 West Commercial Boulevard, Center, 64 Main Road, Whitefield, Bangalore 560 Fort Lauderdale, FL 33309, USA 066, India Ki Sung Kang Brian J Doyle Institute of Natural Medicine, University of Toyama, Departments of Pharmacy Practice, and Medicinal 2630 Sugitani, Toyama, 930-0194, Japan Chemistry and Pharmacognosy, UIC PAHO/WHO Collaborating Center for Traditional Medicine, David O Kennedy University of Illinois at Chicago, College of Pharmacy, Brain, Performance and Nutrition Research Centre, 833 South Wood Street, Chicago, IL 60612, USA Northumbria University, Newcastle upon Tyne NE1 8ST, UK Cristobal Fraga Department of Physiology, University of Santiago de Arif-ullah Khan Compostela, Spain Natural Product Research Division, Department of Biological and Biomedical Sciences, Aga Khan A Gantait University, Karachi 74800, Pakistan School of Natural Product Studies, Department of Pharmaceutical Technology, Jadavpur University, Burt H Kroes Kolkata 700 032, India Medicinal Chemistry and Chemical Biology Section, Department of Pharmaceutical Sciences, Faculty of Anwarul Hassan Gilani Sciences, Utrecht University, Utrecht, The Netherlands Natural Product Research Division,