Quantitative Methods for Traditional Chinese Medicine Development

Chapter 4

Reference Standards and Product Specifications

4.1 Introduction

As discussed in Chapter 1, most TCMs consist of a number of active and/or inactive ingredients (components). These components may be extracted from natural resources such as plants. In practice, however, some components may not be able to be fully characterized even with advanced technology. Thus, many of their pharmacological activities may remain unknown. In this case, it is almost impossible to evaluate the effectiveness and safety of the TCM under investigation following the process of pharmaceutical development the Western way. For commonly used Chinese herbal medicines, the Pharmacopoeia of the People’s Republic of China (Chinese Pharmacopoeia) is an official and ...