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

Author: Xie Xiujiong
Publisher:
Publish Date: 1994-06-01
Features: The third edition of this book is a comprehensive revision based on the second edition, developed by the author according to the relevant provisions and spirit of the "Drug Registration Management Measures" promulgated by the State Food and Drug Administration and implemented on May 1, 2005, combined with the actual research and development of new Chinese medicine preparations today, as well as the author's many years of experience in new drug research and participation in provincial and national drug review work. It has the following characteristics: ① Reflects the current national policies and regulations, especially the new provisions and requirements for the research and application of new Chinese medicine drugs under the "Drug Registration Management Measures" (implemented on May 1, 2005), as well as new technologies and achievements in the research and development of Chinese medicine drugs, thus embodying an up-to-date style. ② Enriches the research and application of new dosage forms and technologies, adds animal models for new diseases and main pharmacological research methods, as well as clinical research data for new Chinese medicine drugs for new diseases, thereby enhancing the reference and practical value of the book. Therefore, the book has stronger timeliness and readability. The book consists of 13 chapters, mainly including the basis for the research and development of new Chinese medicine preparations (including the relevant provisions of the "Drug Registration Management Measures"), topic selection and design, process research of Chinese medicine preparations (including prescription, dosage form, process route, process condition screening, and packaging design), pilot production, quality standard formulation and stability testing (including the principles for formulating quality standards and the procedures in the application process, content of quality standards, content and methods of stability testing, quality standards for Chinese medicine injections, and fingerprint map research), new dosage forms of Chinese medicine (including research and examples of dispersed tablets, injections, oral drops, sustained-release preparations, and nanotechnology-based delivery systems), pharmacological research (including main pharmacological studies, general pharmacological studies, and pharmacokinetic studies, with examples), toxicological research (including acute and chronic toxicity tests, mutagenicity tests, carcinogenicity tests, toxicity tests for topical and mucosal administration, drug dependence tests, and examples), clinical research and protocol design (selection of clinical subjects, selection of clinical research methods, clinical efficacy evaluation, clinical research protocol design, and examples), application for clinical trials, clinical trials, application for new drug certificates, conversion of trial standards to formal standards, supplementary applications for new drugs, and GMP. In short, the revised new edition is more suitable for medical, scientific research, and pharmaceutical production personnel engaged in the research and development of new Chinese medicine preparations for learning and reference, and can also serve as teaching materials for undergraduate and graduate students in medical colleges and universities.