Chen Zhangmei, Vong Chi Teng, Zhang Tiejun, Yao Chun, Wang Yitao, Luo Hua
Macau Centre for Research and Development in Chinese Medicine, State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, 999078, People's Republic of China.
State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research Co., Ltd, Tianjin, 300462, People's Republic of China.
Chin Med. 2023 Sep 30;18(1):126. doi: 10.1186/s13020-023-00836-3.
Traditional Chinese medicine (TCM) is increasingly getting attention worldwide, as it has played a very satisfactory role in treating COVID-19 during these past 3 years, and the Chinese government highly supports the development of TCM. The therapeutical theory and efficacies of Chinese medicine (CM) involve the safety, effectiveness and quality evaluation of CM, which requires a standard sound system. Constructing a scientific and reasonable CM quality and safety evaluation system, and establishing high-quality standards are the key cores to promote the high-quality development of CM. Through the traditional quality control methods of CM, the progress of the Q-marker research and development system proposed in recent years, this paper integrated the research ideas and methods of CM quality control and identified effective quality parameters. In addition, we also applied these effective quality parameters to create a new and supervision model for the quality control of CM. In conclusion, this review summarizes the methods and standards of quality control research used in recent years, and provides references to the quality control of CM and how researchers conduct quality control experiments.
中医药在全球范围内日益受到关注,因为在过去三年抗击新冠疫情中发挥了非常令人满意的作用,且中国政府高度支持中医药发展。中医药的治疗理论和疗效涉及中药的安全性、有效性及质量评价,这需要一个规范完善的体系。构建科学合理的中药质量与安全评价体系,建立高质量标准是推动中医药高质量发展的关键核心。通过中药传统质量控制方法、近年来提出的Q-标志物研发体系的进展,本文整合了中药质量控制的研究思路与方法,识别出有效的质量参数。此外,我们还应用这些有效质量参数创建了一种新的中药质量控制监管模式。总之,本综述总结了近年来质量控制研究的方法和标准,为中药质量控制以及研究人员如何进行质量控制实验提供参考。