摘要
中药复方新药是在我国传统医药理论指导下,利用现代科学技术研究开发的新药,是最能体现中医药特色和优势的新药类别。药学研究作为中药复方新药临床前研究的主要内容之一,既是药品均一、稳定的有效保证,又是安全性实验和有效性实验的基础。通过查阅文献并结合笔者在新药研究中的实践和体会,从药材的基原与产地、工艺研究、质量标准、稳定性等方面探讨了中药复方新药药学研究中应重点关注的问题,并提出一些建议与解决措施,以期为中药复方新药的研发提供参考与借鉴。
The new drug of traditional Chinese medicine(TCM) compound is a category of new drug which is developed in the basis of the guidance of traditional Chinese medicine theory with modern science and technology. It can embody the characteristics and advantages of TCM adequately. Pharmaceutical research is one of the main contents of preclinical research on the new drug of TCM compound. It can not only ensure the "uniformity and stability" of drugs, but also is the premise basis of safety test and effectiveness test. By consulting the literature and combining with our own practice and experience in the new drug research field, the present paper discussed some key issues in the pharmaceutical researches and proposed some suggestions and solutions from the following aspects including the origins and habitats, technological research, quality standard, and stability, etc., which will provide some useful references for the development of the new drug of TCM compound.
作者
郭静
玄振玉
谢燕
GUO Jing;XUAN Zhen-yu;XIE Yan(School of Public Health,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;SuZhou Youseen New Drug R&D Co.,Ltd.,Suzhou 215125,China)
出处
《中草药》
CAS
CSCD
北大核心
2020年第8期2267-2272,共6页
Chinese Traditional and Herbal Drugs
基金
上海市科委“生物医药领域”科技支撑项目(18401930800)。
关键词
中药复方新药
药学研究
中医药
药材基原
质量标准
new drug of traditional Chinese medicine compound
pharmaceutical research
traditional Chinese medicine
origin of medicinal materials
quality standard
