MEDICINE
Quaiity Controi of Herbs and Herbai Material
Chief Editor
Ping-Chung Leung
The Chinese University of Hong Kong
Editors Harry Fong
University of lliinois at Chicago, USA
Charlie Changli Xue
RMIT University, Australia
Published by
World Scientific Publishing Co Pte Ltd
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USA office: 27 Warren Street, Suite 401-402, Hackensack, NJ 07601
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British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library
Annals of Traditional Chinese Medicine — Vol. 2 CURRENT REVIEW OF CHINESE MEDICINE Quality Control of Herbs and Herbal Material
Copyright © 2006 by World Scientific Publishing Co. Pte. Ltd.
All rights reserved. This book, or parts thereof, may not be reproduced in anyform or by any means, electronic or mechanical, including photocopying, recording or any information storage and retrieval system now known or to be invented, without written permission from the Publisher.
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ISBN 981-256-707-0
Editorial Board of the Annals of Traditional Chinese Medicine
Special Advisors:
Ke-Ji Chen (China)
Seung-Hoon Choi (Philippines)
David Eisenberg (USA)
Shi-Long Lai (Hong Kong)
Shichen Zhang (Hong Kong)
Xiaorui Zhang (Switzerland)
Chief Editors:
Ping-Chung Leung (Hong Kong)
Harry H.-S. Fong (USA)
Charlie Changli Xue (Australia)
Executive Editors:
William King-Fai Cheng (Hong Kong)
Sim-Kim Cheng (Singapore)
Chye-Tee Goh (Singapore)
Associate Editors:
Alan Bensoussan (Australia)
Paul Pui-Hay But (Hong Kong)
Bao-Cang Cai (China)
Kelvin K.-C. Chan (Hong Kong)
Timothy M. Chan (USA)
Pui-KwongChan(C/&4)
Wai-Yee Chan (USA)
Il-Moo Chang (Korea)
Yung-Hsien Chang (Taiwan)
Chun-Tao Che (Hong Kong)
Chieh-Fu Chen (Taiwan)
Yung-Chi Cheng (USA)
Moses Sing-Sum Chow (Hong Kong)
Kwok-Pui Fung (Hong Kong)
Ji-Sheng Han (China)
Joseph Tak-Fai Lau (Hong Kong)
Chun-Guang Li (Australia)
Liang Liu (Hong Kong)
David Story (Australia)
Frank Thien (Australia)
Ling-Ling Wang (China)
Kenji Watanabe (Japan)
Kin-Ping Wong (USA)
PeishanXie (China)
Ping Xu (China)
Bing Zhang (China)
Zhong-Zhen Zhao (Hong Kong)
Contents
Contributors xi
Preface to Series xix
Chapter 1 The Basic Requirement for Modernisation of 1 Chinese Herbal Medicine
Peishan Xie
Chapter 2 Evidence-Based Herbal Medicine: Challenges in 11 Efficacy and Safety Assessments
Harry H.-S. Fong, Guido F. Pauli, Judy L. Bolton, Richard B. van Breemen, Suzanne Banuvar, Lee Shulman, Stacie E. Geller & Norman R. Farnsworth
Chapter 3 Good Agricultural Practice — GAP 27 Does it Ensure a Perfect Supply of Medicinal Herbs for Research and Drug Development?
Ping-Chung Leung
Chapter 4 Supply and Cultivation of Medicinal Plants 59 in Japan
Zhongzhen Zhao, Zhijun Yang & Osamu Iida
Chapter 5 Organic Produce of Medicinal Herbs in Australia 73
S.-J. Sheng, C.C.-L. Xue, E. Pang, D.F. Story & C.-G. Li Vll
Chapter 6 Quality Control of Herbs: Principles and 87 Procedures, Using Panax as an Example
Aik-Jiang Lau & Hwee-Ling Koh
Chapter 7 DNA Profiling for Quality Control of Medical 117 Herbs, Utilities and Issues
Yan Hong & Baolin Guo
Chapter 8 Modern FT-IR Spectroscopy and Quality 139 Control of Traditional Chinese Medicines
Suqin Sun
Chapter 9 GLP Requirements and Herbal Medicines 155
King-Fai Cheng, Mavis Y.-H. Lee & Kwok-Pui Fung
Chapter 10 The Recognition and Challenge of Drug 173 Metabolism and Pharmacokinetics in Modernisation Research in Traditional Chinese Medicine
Changxiao Liu
Chapter 11 Intestinal Metabolism of Traditional Chinese 199 Medicine and Its Pharmacological and Toxicological Significance
Guozhu Han
Chapter 12 Observation on the Effect of a Herbal 219 Formula in Anti-metastasis of Post-operation Colorectal Cancer
Han-Chen Shen, Xian-Ru Zhu & Shen-Biao Luo
Chapter 13 Evaluation of Research on Diabetes with 229 Combined TCM and WM
Lan Ling & Qing Ni
Chapter 14 Research on Depth and Angle of Dangerous 247 Acupoints
Zhengguo Yan, Jue Bai, Baishui Shao & Jianhua Zhang
Chapter 15 Acupuncture in Cancer Patient Care
265 Gary Deng, Andrew Vickers, K. Simon Yeung & Barrie R. Cassileth
Contributors
Jue Bai Anatomy Department
Shanghai University of Traditional Chinese Medicine Shanghai, China
Suzanne Banuvar
UIC/NIH Center for Botanical Dietary Supplements Research Northwestern University Feinberg School of Medicine Chicago, USA
Judy L. Bolton
Program for Collaborative Research in the Pharmaceutical Sciences
UIC/NIH Center for Botanical Dietary Supplements Research Department of Medicinal Chemistry and Pharmacognosy College of Pharmacy, University of Illinois at Chicago Chicago, USA
Barrie R. Cassileth
Integrative Medicine Service Memorial Sloan-Kettering Cancer Center New York, USA
King-Fai Cheng Institute of Chinese Medicine
The Chinese University of Hong Kong Hong Kong, China
Gary Deng
Integrative Medicine Service
Memorial Sloan-Kettering Cancer Center
New York, USA
Norman R. Farnsworth
Program for Collaborative Research in the Pharmaceutical Sciences
UIC/NIH Center for Botanical Dietary Supplements Research Department of Medicinal Chemistry and Pharmacognosy
WHO Collaborating Center for Traditional Medicine
College of Pharmacy, University of Illinois at Chicago Chicago, USA
Harry H.-S. Fong
Program for Collaborative Research in the Pharmaceutical Sciences
UIC/NIH Center for Botanical Dietary Supplements Research Department of Medicinal Chemistry and Pharmacognosy
WHO Collaborating Center for Traditional Medicine
College of Pharmacy, University of Illinois at Chicago Chicago, USA
Kwok-Pui Fung
Institute of Chinese Medicine
The Chinese University of Hong Kong
Hong Kong, China
Stacie E. Geller
UIC/NIH Center for Botanical Dietary Supplements Research Department of Obstetrics and Gynecology
College of Medicine, University of Illinois at Chicago Chicago, USA
Baolin Guo
Institute of Medicinal Plant Development
Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China
Contributors
Guozhu Han
Department of Pharmacology
Dalian Medical University
Dalian, China
Yan Hong
Temasek Life Sciences Laboratory
National University of Singapore
Osamu Iida
Research Center for Medicinal Plant Resources
National Institute of Biomedical Innovation
Ibaraki, Japan
Hwee-Ling Koh
Department of Pharmacy, Faculty of Science
National University of Singapore
Aik-Jiang Lau
Department of Pharmacy, Faculty of Science
National University of Singapore
Mavis Y.-H Lee
Institute of Chinese Medicine
The Chinese University of Hong Kong
Hong Kong, China
Ping-Chung Leung
Institute of Chinese Medicine
The Chinese University of Hong Kong
Hong Kong, China
Chun-Guang Li
The RMIT Chinese Medicine Research Group
Division of Chinese Medicine, School of Health Sciences
World Health Organization Collaborating Center for Traditional Medicine
RMIT University
Victoria, Australia
Lan Ling
Department of Endocrinology
Quang An Men Hospital
Traditional Chinese Medicine Research Institute of China
Beijing, China
Changxiao Liu
Tianjin State Key Laboratory of Pharmacokinetics and Pharmacodynamics
Tianjin Institute of Pharmaceutical Research
Tianjin, China
Shen-Biao Luo
Zhijiang Academy of Traditional Chinese Medicine
Hangzhou, China
Qing Ni
Department of Endocrinology
Quang An Men Hospital
Traditional Chinese Medicine Research Institute of China
Beijing, China
E. Pang
The RMIT Chinese Medicine Research Group
Division of Chinese Medicine, School of Health Sciences
World Health Organization Collaborating Center for Traditional Medicine
RMIT University
Victoria, Australia
Guido F. Pauli
Program for Collaborative Research in the Pharmaceutical Sciences
UIC/NIH Center for Botanical Dietary Supplements Research Department of Medicinal Chemistry and Pharmacognosy College of Pharmacy, University of Illinois at Chicago Chicago, USA
Lee Schulman
UIC/NIH Center for Botanical Dietary Supplements Research Northwestern University Feinberg School of Medicine Chicago, USA
Baishui Shao
Anatomy Department
Shanghai University of Traditional Chinese Medicine Shanghai, China
Han-Chen Shen
Zhijiang Academy of Traditional Chinese Medicine Hangzhou, China
S.-J Sheng
The RMIT Chinese Medicine Research Group
Division of Chinese Medicine, School of Health Sciences
World Health Organization Collaborating Center for Traditional Medicine
RMIT University Victoria, Australia
David F. Story
The RMIT Chinese Medicine Research Group
Division of Chinese Medicine, School of Health Sciences
World Health Organization Collaborating Center for Traditional Medicine
RMIT University
Victoria, Australia
Suqin Sun
Department of Chemistry
Tsinghua University Beijing, China
Richard B. van Breemen
Program for Collaborative Research in the Pharmaceutical Sciences
UIC/NIH Center for Botanical Dietary Supplements Research
Department of Medicinal Chemistry and Pharmacognosy College of Pharmacy, University of Illinois at Chicago Chicago, USA
Andrew Vickers
Integrative Medicine Service
Memorial Sloan-Kettering Cancer Center
New York, USA
Peishan Xie
Guangzhou Institute for Drug Control
Guangdong, China
Charlie Chang-Li Xue
The RMIT Chinese Medicine Research Group
Division of Chinese Medicine, School of Health Sciences
World Health Organization Collaborating Center for Traditional Medicine
RMIT University Victoria, Australia
Zhengguo Yan
Anatomy Department
Shanghai University of Traditional Chinese Medicine
Shanghai, China
Zhijun Yang
School of Chinese Medicine
Hong Kong Baptist University
Hong Kong, China
K. Simon Yeung
Integrative Medicine Service
Memorial Sloan-Kettering Cancer Center
New York, USA
Jianhua Zhang
Anatomy Department
Shanghai University of Traditional Chinese Medicine
Shanghai, China
Zhongzhen Zhao
School of Chinese Medicine
Hong Kong Baptist University
Hong Kong, China
Xian-Ru Zhu
Zhijiang Academy of Traditional Chinese Medicine
Hangzhou, China
The Basic Requirement for Modernisation of Chinese Herbal Medicine
Peishan Xie
Abstract
Authentication and consistent quality are the basic requirements for TCHM and its commercial products, regardless of the kind of research conducted to modernise the TCM The complexities of TCHM challenge the current official quality control mode, for which only a few markers were selected for identification and quantitative assay. Referring to too many unknown factors existed in TCHM, it is impossible and unnecessary to pinpoint qualitatively and quantitatively every single component contained in the herbal drug Chromatographic fingerprinting is a rational option to meet the need for more effective and powerful quality assessment to TCHM The optimised chromatographic fingerprint is not only an alternative analytical tool for identification, but also an approach to express the various pattern of chemical ingredients distribution in the herbal drugs and preserve such "database" for further multi-faceted sustainable studies Some examples demonstrated the role of fingerprinting in quality control and assessment
Keywords: Chromatographic Fingerprint; Sustainable Quality Assessment Mode
The paradigms of traditional Chinese herbal medicine (TCHM) are featured as holistic system; the common clinical use of Chinese medicines requires the complex recipes and formulae derived from historical and anecdotal evidence of Chinese medicinal practitioners. Based on ancient Chinese philosophy, a typical therapeutic formula is symbolised as an active "cabinet" consisted of "Monarch" drug, "ministers" drug, "assistants"
drug and "messengers" or "servants" drug, which work together harmoniously and serve various functions respectively to adjust, balance, and restore the body's function guided by Chinese ancient philosophy and culture. Consequently, no single active constituent is responsible for the overall efficacy of the whole formula, even single herbal drugs, which usually contain numerous chemical compounds with holistic efficacy rather than a single active compound. It is definitely different from the Western single chemical drug, and is also distinguished from Western herbal/ botanical medicine because TCHM is the carriers loading the information of the philosophy and culture of traditional Chinese medicine. Hence, we should keep in mind it will be nothing different from Western herbal drugs once the TCM information is unloaded from TCHM matrices. On the new wave of modernisation of TCM under the economic globalisation environment, there is a trend towards the seeking of TCHM as a source for discovery of new chemical drugs without considering the synergic effect of all of the ingredients in the herbal drugs. That means such an approach is mostly concerned with only the interested single target and ignores the total quality of the herbal drug itself. The consequence would lead to a loss of ancestors' wisdom (the culture and philosophy of TCM and exclusive clinical experiences) accumulated through generations. Referring to the complexity and difficulty in merging ancient Chinese culture and modern Western science, the first step in the process of TCM modernisation, we should preserve the total information loaded in the TCHM as much as possible in order to avoid any rash affirmation on the pros and cons of TCM without discreet study. From the viewpoint of chemistry and biology, the total chemical ingredients pattern in every entity of TCHM should be preferably expressed in the appropriate chromatograms — chromatographic fingerprint consisted of detectable ingredients. The optimised fingerprints can serve as "chemical signatures" of the TCHM for consecutive multi-faceted research The following examples illustrate the role of chromatographic fingerprints in TCHM.
1.1 Authentication of the Species Prone to Confusion
Ginseng (root of Panax ginseng) and American ginseng (root of Panax quinqueefolium) are two close species containing very similar chemical
Ebl
Fig 1.1 HPTLC fingerprints of Ginseng and American ginseng
ingredients. The functions of the two species are different according to TCM in clinical use. It is difficult to distinguish them by only selecting single ginsenosides, but the HPTLC images with digital scanning profiles as a whole can easily differentiate between them (Xie, 2005a) (Fig. 1.1).
1.2 Quality Evaluation of the Crude Drugs
There are two species of Ge Gen (Kudzu root) in Chinese Pharmacopoeia Ye Ge {Radix Pueraria lobatae) and Gan Ge (Radix R thomsonii), which were used as the same herbal drag for a long time (Xiao, 2002). But the content determination of main isoflavonoid, Puerarin and HPTLC
Jmarkm gmssrsgroot
fingerprint analysis showed the great disparity of the content of puerarin, and the total chemical pattern expressed by the fingerprint revealed that the puerarin content and the chemical components concentration distribution in the Gan Ge, fingerprint was eight to 15 times lower than that of Ye Ge (Figs. 1.2 and 1.3), thus, it is impossible that both species are bio-equivalent. Hence, Ye Ge should be the appropriate candidate for Ge Gen (Kudzu root) in the prescription by TCM practitioners.
Comparison of total peak area and the main components between the P. lobata and P. thomsonii
of total peak area and the main components
Fig. 1.2. HPTLC fingerprints of Ye Ge (root of Puemriae lobatae) and Gan Ge (root of Puerarae thomsonii). Left: Isoflavonoides, Right: Aglycones, PRL: Root of Pueraria lobata, PRT: Root of Pueraria thomsonii.
Fig. 1.3. Comparison of the discrepancy
between Ye Ge (black bar) and Gan Ge (grey bar).
