Foreword

Zhitong Huazheng capsule, which has been awarded ‘Jilin Province Name-brand Products’, ‘Top 10 Products for Gynecology Diseases’(2011), ‘Industry Model, Public Safe Medication’(National Health and Family Planning Commission of China（NHFPC, 2012) and ‘Industrial Brand Trustworthy Products’ (NHFPC, 2013), is a A variety with large sales of traditional Chinese medicine. However, the development and the application of this drug shares the five common issues known as the bottleneck of the traditional Chinese medicinal products: lack of focus clinical target, ambiguous pharmacophore, unclear mechanism, low-grade production process, low-level quality control. Thus, revisit the properties of this drug in depth is extreme necessary.

This book focuses on the issues of the Zhitong Huazheng capsule in terms of ambiguous pharmacophore, low-level quality control, uncertain mechanism, unclear clinical target and non-prominent advantages. We employs state-of-art technologies and methodologies of modern drug development to study the pharmacy, pharmacodynamics, plasma composition of the drug metabolites and clinical revaluation. In order to improving the quality of the Zhitong Huazheng capsule, we screened the formulation, properly set the process quality control point and index, precisely controlled the process parameters and successfully achieved reproduction among different batches. While incorporating the chemical composition, pharmacophore, plasma component and fingerprint spectra, the quality control standard of the drug was improved significantly. This protocol may provide support for further improving the quality of the traditional Chinese medicine. Pharmacodynamics studies revealed the synergistic regulation mechanism of the Zhitong Huazheng capsule involving multi-component, multi-pathway, multi-target and multi-function. We also determined the proper clinical target through clinical trials of large samples.

This book provides scientific evidences of understanding and applying the Zhitong Huazheng capsule for the investigators of traditional Chinese medicine and clinical doctors. We sincerely hope the reader benefit from this book.

Editor

Changchun, October 2018