QUALITY CONTROL OF HERBAL MEDICINES AND RELATED AREAS pdf

QUALITY CONTROL
OF HERBAL MEDICINES
AND RELATED AREAS

Edited by Yukihiro Shoyama













Quality Control of Herbal Medicines and Related Areas
Edited by Yukihiro Shoyama


Published by InTech
Janeza Trdine 9, 51000 Rijeka, Croatia

Copyright © 2011 InTech
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of the use of any materials, instructions, methods or ideas contained in the book.

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Technical Editor Teodora Smiljanic
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Image Copyright Imagestalk, 2010. Used under license from Shutterstock.com

First published October, 2011
Printed in Croatia

A free online edition of this book is available at www.intechopen.com
Additional hard copies can be obtained from



Quality Control of Herbal Medicines and Related Areas, Edited by Yukihiro Shoyama
p. cm.
ISBN 978-953-307-682-9

Contents

Preface IX
Part 1 Basic Analytical Methodology 1
Chapter 1 Method Development and
Validation of Analytical Procedures 3
Kapil Kalra
Chapter 2 Validation of an Analytical Procedure 17
Ahmed Badr Eldin
Chapter 3 Stability Indicating Methods 25
Ana Paola Cione, Edivan Tonhi and Paulo Silva
Part 2 Quality Control of Food for Safety 37
Chapter 4 Application of the Software e-SAFES®
(Based on SAFES Methodology) to Control Disinfection in
the Sugar Extraction from Sugar Beet (Beta vulgaris L.) 39
Marek Bennár, Ester Betoret, Noelia Betoret, Lucía Seguí,
Luis Mayor López, David Arce, Ignacio Blanquer,
Vicente Hernández, Tatiana Bojnanská and Pedro Fito
Chapter 5 Procedures of Food Quality Control:
Analysis Methods, Sampling and Sample Pretreatment 63
Nancy Ornelas-Soto, Oracio Barbosa-García and
Pedro L. Lopez-de-Alba
Chapter 6 Improvement of Food Safety and Quality by Statistical
Process Control (SPC) in Food Processing Systems:
A Case Study of Traditional Sucuk (Sausage) Processing 91
A. Coskun Dalgiç, Hasan Vardin and K. Bülent Belibagli
Part 3 Quality Control of Drugs 117

Chapter 7 Allergen Extract Analysis and Quality Control 119
Samuele E. Burastero
VI Contents

Chapter 8 Quantitative Determination of Drugs in
Dosage Forms as a Tool of Quality Control Studies 145
Sigrid Mennickent, Marta de Diego,
Mario Vega and Carmen Gloria Godoy
Chapter 9 Manufacture, Structure Confirmation
and Quality Control of the Chiral Drugs 161
Zhang Zhen and Bi Kaishun
Part 4 Quality Control of Herbal Medicine 169
Chapter 10 Quality Control Method for Herbal
Medicine - Chemical Fingerprint Analysis 171
Zhang Yongyu, Sun Shujun, Dai Jianye,
Wang Wenyu, Cao Huijuan, Wu Jianbing and Gou Xiaojun
Chapter 11 Processing and Quality Control of
Herbal Drugs and Their Derivatives 195
José Otávio Carréra Silva Júnior, Roseane Maria Ribeiro Costa,
Francisco Martins Teixeira and Wagner Luiz Ramos Barbosa
Chapter 12 Quality Control of Cordyceps sinensis
Teleomorph, Anamorph, and Its Products 223
Chih-Sheng Chen, Ruey-Shyang Hseu and Ching-Tsan Huang
Chapter 13 Quality Control by Immunoaffinity
Concentration Using Monoclonal Antibody 239
Takuhiro Uto and Nguyen Huu Tung
Chapter 14 Quality Control of Bupleurum
Species by Newly Established Eastern Blotting 255
Osamu Morinaga, Xiao-Wei Li and Shunsuke Fujii
Chapter 15 Quality Control of Panax Species by

Monoclonal Antibody and DNA Analysis 269
Hiroyuki Tanaka










Preface

This issue has been born from the editor’s hope that the readers will be able to obtain
the different kinds of knowledge from many contributors. The term “Quality Control”
covers a wide and global range in different fields. Therefore, the authors invited were
experts from a wide variety of areas. The authors of this thematic issue provide a
comprehensive summary of most recent knowledge and references on quality control
in a varety of fields. Quality control is essential for natural products like natural
medicine and related food products. Since the concentration varies for bioactive
components in natural medicines or natural product extracts, and is dependent on the
place of collection, the season of its collection, the method of extraction and subsequent
treatment, the standardization of quality is necessary. Therefore, the methodology of
quality control for several natural medicines and chemically synthesized drugs has
been incorporated and discussed in this issue. The quality control of food primarily
implies safety for human beings and therefore has to be based on multidisciplinary
approaches. This is the reason why the editor selected the appropriate terms of
technology for the quality control of food production. Since new technology for not
only diagnosis, but also therapy is always required, these areas are included in the

book. It becomes evident that water conditions, including quality and quantity, have
recently deteriorated in the world. In order to bring recent water environment issues
to attention, the quality control of water was also incorporated as a topic in this book.
In this issue fifteen chapters have been included as described above, discussing in
detail various aspects of quality control. It might be argued that the notions presented
in this book can be widely applied in the field of quality control. Moreover, more than
700 references found at the end of the chapters will make this thematic issue useful not
only for phytochemical researchers, but also many scientists working in numerous
fields, emphasizing high scientific standing of the issue.
Much effort has been invested by the contributors to share current information.
Without their efforts and input this issue, “Quality Control of Herbal Medicine and
Related Areas” could not exist. The editor sincerely appreciates the time spent and the
wisdom shared in bringing this book to fruition.
Yukihiro Shoyama
Faculty of Pharmaceutical Science, Nagasaki International University,
Japan

Part 1
Basic Analytical Methodology