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About the Authors:
Jieqiang Zhu
Affiliation: Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China
Xiaohui Fan
* E-mail: [email protected] (XF); [email protected] (RA); [email protected] (WT)
Affiliation: Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China
Yiyu Cheng
Affiliation: Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China
Rajiv Agarwal
* E-mail: [email protected] (XF); [email protected] (RA); [email protected] (WT)
Affiliation: Office of New Drug Quality Assessment, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, Maryland, United States of America
Christine M. V. Moore
Affiliation: Office of New Drug Quality Assessment, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, Maryland, United States of America
Shaw T. Chen
Affiliation: Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, Maryland, United States of America
Weida Tong
* E-mail: [email protected] (XF); [email protected] (RA); [email protected] (WT)
Affiliation: National Center for Toxicological Research (NCTR), US Food and Drug Administration, Jefferson, Arkansas, United States of America
Introduction
In recent years, there has been increased interest in the United States in developing botanical preparations as pharmaceutical products and not only as dietary supplements. Since it is known that different plant parts of a herbal medicine may possess different treatment effects, one hurdle has been to develop analytical methods to adequately identify the source, i.e., different plant parts, of the botanical raw material to ensure that the botanical drug substance and drug product can be reproducibly manufactured to provide the same safety and efficacy as the clinical trial supplies,. A typical example for dramatic differences in therapeutic activity is Ephedrae herba and Ephedrae Radix et Rhizoma. Ephedrae herba is the herbaceous stem part of Ephedra which can elevate blood pressure and Ephedrae Radix et Rhizoma is the root part, which can lower blood pressure [1]. In order to avoiding medication errors with herbal preparations, regulatory agencies, such as the US FDA [2], EMA [3]and China SFDA [4], recommend that herbal medicines are prepared from specific parts of the botanical raw material.
There are many reports about fingerprint techniques to address the identity and quality of botanicals, which are mainly chromatographic analysis, including high performance liquid chromatography (HPLC) [5], [6],...