Development and Application of New Traditional Chinese Medicine Preparations (Second Edition)

Author: Xie Xiujiong
Publisher:
Publishing Date: 2003-09-01
Features: This book is a comprehensive and thorough revision by the author, based on the relevant provisions and spirit of the "New Drug Approval Measures" issued by the State Food and Drug Administration and implemented on May 1, 1999, combined with the current research and development of traditional Chinese medicine (TCM) new preparations, as well as the author's extensive experience in TCM research and participation in national drug evaluation work. The revised edition has the following characteristics: ① It basically reflects the current regulations and spirit of the state regarding the research and application of new TCM drugs, as well as the current technical level of TCM new drug research and development, with a strong sense of the times; ② It significantly enriches the content on research ideas, methods, and the application of new technologies in new drug research in each chapter, and provides numerous examples of successful or unsuccessful cases. The discussions on the issues involved are more in-depth and specific, significantly enhancing the readability and practicality of the book. The book consists of 13 chapters, with the main chapters including:
Basis for Research and Development of TCM New Preparations (including the provisions for TCM preparations in the "New Drug Approval Measures," as well as the "Technical Requirements for TCM New Drug Research"), Topic Selection and Design, Process Research of TCM New Preparations (including prescription, dosage form, process route, process condition screening, packaging design, and examples), Pilot Production, Establishment of Quality Standards and Stability Testing (including the principles for establishing quality standards and the procedures in application work, content of quality standards, content and methods of stability testing, and research on quality standards for TCM injectables), Pharmacological Research (including major pharmacological studies, general pharmacological studies, and pharmacokinetic studies, with examples), Toxicological Research (including acute and chronic toxicity tests, mutagenicity and carcinogenicity tests, toxicity tests for topical and mucosal administration, drug dependence tests, and examples), Clinical Research and Protocol Design (selection of clinical trial subjects, choice of clinical research methods, clinical efficacy evaluation, clinical research protocol design, and examples), Application for Clinical Trials, Clinical Trials, Application for New Drug Certification (Production), Construction of TCM Pharmaceutical Factories, and Examples of Clinical Trial Applications. Among them, Chapters 3, 5, 6, 7, and 8 are particularly rich in content and have great reference value. The book is approximately 900,000 words in total.
In summary, the revised new edition is more suitable for medical, scientific research, and pharmaceutical production personnel engaged in the research and development of TCM new drugs for learning and reference, and can also serve as a good teaching material for higher medical and pharmaceutical colleges.