Quality Control and Safety Evaluation of Natural Products


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Series: Public Health in the 21st Century
BISAC: LAW046000

Natural medicines are derived from natural sources such as plants, animals and/or mineral origins. The use of traditional natural products is an empirical healthcare system based on thousands of years of human experience. Over the past few decades, quality control and safety evaluation methods for natural products, though sophisticated and technologically advanced, still lack comprehensiveness and practicability to some extent. Generally, those methods fully satisfy the modern scientific requirements for extraction, identification, purity, quality and pharmacological effects in the assessment of chemical drugs. However, they are not suitable for handling the complex chemical characteristics of natural products. Therefore, a better understanding of the basic properties of natural medicines and advanced chemical, pharmacological and biological techniques would facilitate the application of the natural products in public health.

The purpose of this book is to address the issues mentioned above and present related solutions. The book covers the below topics:
•Advanced analytical technologies in the application of the natural medicines (e.g. mass spectrometry, gas or liquid chromatography, and NMR).
•Recent advances in biochemistry research of natural medicines (e.g. gene expression microarray, tissue microarray, and chromatin-precipitation assay)
•Innovations in analytical chemistry of natural products
•Quality control and safety evaluation of traditional medical material and finished products
•Detection of low quality and adulterants of natural product
•Identification of the plant by various analytical techniques
•Regulations and management of natural products from foreign countries
•Novel cell-based models used for the high-throughput screening for drug discovery in natural products
•Pharmacological effects of natural products in vitro and in vivo
•Advanced modeling techniques used in pharamcokinetic and pharmacodynamic properties of natural products (e.g. Pharsight WINNONLIN, Simcyp, and Gastroplus)

(Imprint: Nova)

Table of Contents

Table of Contents


Chapter 1
A Review on the Application of High Performance Liquid Chromatography-Mass Spectrometry in the Quality Control of Traditional Chinese Medicines
(Xian-Long Cheng, Ling-Yun Ma, Ming-Hua Li, Wei Liu, Wen-Juan Zhang, Feng Wei and Shuang-Cheng Ma, National Institutes for Food and Drug Control, China Food and Drug Administration, Beijing, China)

Chapter 2
The Application of DNA Molecular Techniques in Identification of Traditional Chinese Medicine
(Wen-Juan Zhang, Xian-Long Cheng, Feng Wei, and Shuang-Cheng Ma, National Institutes for Food and Drug Control, China Food and Drug Administration, Beijing, China)

Chapter 3
Phytochemicals from Honey¡ªA Review for the Roles in Floral Identification and Authentification
(Shi Shen and Shuang-Qing Zhang, National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China)

Chapter 4
Implementation and Practice of Safety Evaluation of Natural Products
(Zhi-Jian Li, Guo-Lin Zhao, Lan-Lan Zhang, Qin Dou, Ming Yan, Aibai Silafu, Institute of Xinjiang Traditional Uighur Medicine, Xinjiang Laboratory of Uighur Medical Prescription, Urumqi, Xinjiang, China, and others)

Chapter 5
Issues to be Considered about Safety Evaluation of Natural Products
(Shi-Fen Dong, Shuo-Feng Zhang and Hui Zhao, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China, and others)

Chapter 6
Clinical Pathology in Safety Evaluation of Natural Products
(Yu-Fa Miao, Yan Huo, Xing-Chao Geng, Jian-Jun Lv and Bo Li, National Institutes for Food and Drug Control, Beijing, China)

Chapter 7
Registration Regulations Requirements for Safety Evaluation of Natural Products
(Xiao-Yu Fan, Jing-Yi Feng, Tian-Tian Liu, Gen-Bei Wang, Xiao-Hui Ma, Hong-Tao Jin, Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, and others)

Chapter 8
Pharmacokinetics Based Herb-Drug Interactions£ºMechanism, Prediction and Management
(Yingfei Li, Shuai Yuan, Suyun Li and Guoxin Ji, Institute of Chinese Materia Medica, China Academy of Chinese MedicalSciences, Beijing, China, and others)

Chapter 9
Safety Evaluation of Phytosterols
(Lifang Gao, Center for Food and Drug Safety Evaluation, Capital Medical University, Beijing, China)


The book “Quality Control and Safety Evaluation of Natural Products” is targeted at chemists, biologists, pharmacologists, students, and researchers in related fields to appreciate the current available methodologies and regulations for natural product characteristic, safety evaluation and toxicology and so on.

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