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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 All chapters are Open Access articles distributed under the Creative Commons Non Commercial Share Alike Attribution 3.0 license, which permits to copy, distribute, transmit, and adapt the work in any medium, so long as the original work is properly cited. After this work has been published by InTech, authors have the right to republish it, in whole or part, in any publication of which they are the author, and to make other personal use of the work. Any republication, referencing or personal use of the work must explicitly identify the original source. Statements and opinions expressed in the chapters are these of the individual contributors and not necessarily those of the editors or publisher. No responsibility is accepted for the accuracy of information contained in the published articles. The publisher assumes no responsibility for any damage or injury to persons or property arising out of the use of any materials, instructions, methods or ideas contained in the book. Publishing Process Manager Niksa Mandic Technical Editor Teodora Smiljanic Cover Designer Jan Hyrat 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 orders@intechweb.org 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 Chapter 7 Quality Control of Drugs 117 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