| Quality control, safety and efficacy assessment are the three crucial research fields in the modernization of the Traditional Chinese Medicine (TCM). In Chapter one, we give a brief explanation on the importance of the modernization of TCM and its current research areas. At present, fingerprint become vital tool for modern chemistry and modernization of TCM. Especially, fingerprint technique is recognized by the Food and Drug Administration (FDA) as one of the effective approaches to evaluate the quality of TCM. Discussions on quality control of TCM utilizing fingerprint techniques are detailed made. Precision of the fingerprint test methods is very important, which relates to chemical research, clinical effect, experimental research and safety of TCM. In current status, FDA, British Herb Pharmacopoeia, Indian Herb Pharmacopoeia, Botanical Society of German and Botanical Society of Canada all employ fingerprint to control the quality of herb medicine. And the repeatability and re-producibility of fingerprint are the basis for the feasibility of this approach. In Chapter two, we generalize the determination method of repeatability and re-producibility from univariate test outcome to multivariate fingerprint data. The proposed general statistical method is illustrated by Herb Houttuyniae fingerprint data.Building a scientific quality assessment system of TCM is a key issue on TCM modernization. Currently, fingerprint become an effective tool to build this system. Similarity comparison between the test fingerprint and the standard fingerprint has been adopted to control the quality of TCM. However, how to determine the lower bound or the critical value for quality assessment is a focus in the community of TCM and chemistry. People often argue traditional methods which are subjective determining a lower bound for quality assessment for different TCM and different experiment methods. Thus, how to give a more objective method to determine the lower bound of similarity, as a benchmark,...
|
PDF Full Text Request