摘要
目的:探讨已上市民族药品种的再研究路径。方法:对已上市民族药品种的临床、药学及药理毒理研究情况进行分析。结果与结论:民族药品种的上市前研究因科学发展水平、监管历史、民族政策等原因存在诸多先天不足,有必要进行上市后再研究;研究应先理清存在的关键性问题,再结合品种实际特点,在民族医药理论的指导下分阶段开展。
Objective： To discuss the supplementary research modes for the on-sale ethnic medicinal products. Methods： The status about the clinical study, pharmaceutical study, and pharmacological as well as toxicological study of on-sale ethnic medicinal products was analyzed. Results and Conclusion： Many inherent deficiencies exist in the research on pre-sale ethnic medicinal products due to the underdevelopment of science, regulatory history, national policies and the like, thus it is necessary to conduct supplementary research on the products being on-sale. It is proposed herein that we identify the key problems firstly, and then carry out the research in stages with the guidance of the ethnic medicine theory in conjunction with the actual characteristics of the products.
作者
韦晓瑜
吴娜
龙继红
Wei Xiaoyu Wu Na Long Jihong(National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products, Beijing 100070, China)
出处
《中国药事》
CAS
2017年第1期27-31,共5页
Chinese Pharmaceutical Affairs
关键词
民族药品种
临床研究
药学研究
药理毒理研究
民族医药理论
上市后再研究
ethnic medicinal products
clinical study
pharmaceutical study
pharmacological and toxicological study
ethnic medicine theory
supplementary research on the products being on-sale
