Development and Application of New Traditional Chinese Medicine Preparations

Author: Xie Xiujiong
Publisher:
Publish Date: 2006-01-01
Features: The third edition of this book is a comprehensive revision based on the second edition, developed by the author according to the relevant regulations and guidelines issued by the State Food and Drug Administration (SFDA) and implemented on May 1, 2005, such as the "Drug Registration Administration." It also incorporates 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 work. The book has the following characteristics: ① Reflects the current national policies and regulations, especially the new provisions and requirements for the research and application of TCM new drugs under the "Drug Registration Administration" (implemented on May 1, 2005), as well as new technologies and achievements in TCM new drug research and development, thereby embodying a contemporary focus. ② Enriches the content on new dosage forms, new technology applications, and case studies, adds animal models and main pharmacological research methods for new diseases, as well as clinical research data on TCM new drugs for new diseases, thereby enhancing the reference and practical value of the book. Therefore, the book is more timely and has better readability. The book consists of 13 chapters, mainly including the basis for the research and development of TCM new formulations (including the relevant provisions of the "Drug Registration Administration"), topic selection and design, process research on TCM new formulations (including prescription, dosage form, process route, process condition screening, and packaging design), pilot production, quality standard establishment and stability testing (including the principles for establishing quality standards and the procedures in the application process, content of quality standards, content and methods of stability testing, quality standards for TCM injectables, and fingerprint research), new dosage forms of TCM (including research and case studies on dispersible tablets, injectables, oral liquid pills, sustained-release formulations, and nanocarrier delivery systems), pharmacological research (including main pharmacological studies, general pharmacological studies, and pharmacokinetic studies, with case studies), toxicological research (including acute and chronic toxicity tests, mutagenicity tests, carcinogenicity tests, toxicity tests for dermal and mucosal administration, drug dependence tests, and case studies), clinical research and protocol design (selection of clinical trial subjects, choice of clinical research methods, clinical efficacy evaluation, clinical research protocol design, and case studies), clinical application application, clinical trials, application for new drug certificates, conversion of trial drug 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, and can also serve as teaching material for undergraduate and graduate students in medical colleges and universities.