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

Author: Xie Xiujiong
Publisher:
Publish Date: 2006-01-15
Features: The third edition of this book is a comprehensive revision based on the second edition, incorporating the relevant regulations and guidelines issued by the State Food and Drug Administration (SFDA) and implemented on May 1, 2005, such as the Measures for Drug Registration. It also integrates the current research and development of traditional Chinese medicine (TCM) new formulations, as well as the author's extensive experience in new drug research and participation in provincial and national drug review processes. The book has the following characteristics:
① Reflects the current national policies and regulations, particularly the new provisions and requirements for the research and application of TCM new drugs under the Measures for Drug Registration (implemented on May 1, 2005), as well as new technologies and achievements in TCM new drug research and development, giving it a contemporary focus.
② Enriches the content on new dosage forms, new technology applications, and case studies, adds animal models and key pharmacological research methods for new diseases, and includes clinical research data on TCM new drugs for new diseases, thereby enhancing the reference and practical value of the book. As a result, the book is more up-to-date and easier to read. The book consists of 13 chapters, primarily covering the basis for TCM new formulation research and development (including regulations under the Measures for Drug Registration), topic selection and design, process research for TCM new formulations (including prescription, dosage form, process route, process condition screening, and packaging design), pilot production, quality standard establishment and stability testing (including principles for establishing quality standards and procedures in the application process, content of quality standards, content and methods of stability testing, quality standards for TCM injectables, and fingerprint research), new TCM dosage forms (including research and case studies on disperse tablets, injectables, oral pellets, sustained-release formulations, and nanoscale drug delivery systems), pharmacological research (including major pharmacological studies, general pharmacological studies, and pharmacokinetic studies, with case studies), toxicological research (including acute and chronic toxicity tests, mutagenicity and carcinogenicity tests, toxicity tests for topical and mucosal administration, drug dependence tests, and case studies), clinical research and protocol design (selection of clinical trial subjects, choice of clinical research methods, evaluation of clinical efficacy, clinical research protocol design, and case studies), clinical application application, clinical trials, application for new drug certificates, conversion of trial standards to formal standards, supplementary applications for new drugs, and GMP. 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 formulations for learning and reference. It can also serve as a teaching material for undergraduate and graduate students in medical colleges and universities.