桑枝总生物碱片研发历程回顾(二):现代药理学理念诠释中药的药效特点及药理作用机制  

Review of the research and development of Ramulus Mori(Sangzhi)alkaloids(Ⅱ):modern pharmacological concepts interpret the characteristics of pharmacological effects and mechanisms of traditional Chinese medicines

作　　者：刘率男[1] 刘泉[1] 刘玉玲[1] 金毅群 谢明智[1] 申竹芳[1] LIU Shuainan;LIU Quan;LIU Yuling(Institute of Materia Medica,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100050,China)

机构地区：[1]中国医学科学院北京协和医学院药物研究所,100050 [2]北京五和博澳药业有限公司

出　　处：《中国糖尿病杂志》2020年第8期635-640,共6页Chinese Journal of Diabetes

基　　金：“十二五”国家科技重大专项课题资助项目(2013ZX09101005);“十三五”国家科技重大专项课题资助项目(2018ZX09711-001-009-014);北京市自然科学基金面上项目(7202137);北京市科技计划“十病十药”研发资助项目(Z111100059011010)。

摘　　要：2020年3月,我国原创降血糖天然药物"桑枝总生物碱片"获批上市,成为10几年来我国首个获批的中药创新药,也是糖尿病治疗领域唯一有效组分天然药物。在桑枝总生物碱的研发秉承中药传统理论并结合现代药理学研究方法,以确定桑枝中具有降血糖作用的有效组分及评价其药效特点及药理作用机制,故桑枝总生物碱具有其他中药不可比拟的作用靶点清晰、物质基础明确和降血糖作用显著等特点,其广泛的糖尿病治疗综合获益优于单纯糖苷酶抑制剂,具有天然药物独特的多重药理作用优势。本文从药理学研究角度,回顾利用现代药理学研究手段从"中药宝库"中寻找降糖药物过程,以及采用现代药理学手段及理念完善药效学评价体系,并广泛挖掘桑枝总生物碱多重药理作用特点及潜在机制。评述利用现代药理学研究理念,从天然药物中获取有效活性成分和新药研究中需要突破的技术瓶颈和理念创新,旨在为创新中药发展的"传承精华、守正创新"提供参考。In March 2020,an innovative hypoglycemic natural drug"Sangzhi alkaloids tablet"was approved,becoming the first approved innovative traditional Chinese medicine in China in more than a decade,and the only effective components drug in the field of diabetes treatment.It is the development direction of the modernization of traditional Chinese medicine research to take the theory of traditional Chinese medicine as the guidance,closely combine with clinical practice,and use modern pharmacological methods to investigate traditional Chinese medicine.The successful development of"Sangzhi alkaloids tablet"is not only the combination of traditional medicine and modern medicine,but also a successful example of the combination of traditional medicine and modern pharmacology.In the process of research and development of"Sangzhi alkaloids tablet",we have been adhering to the traditional theory of traditional Chinese medicine,combined with its clinical pharmacodynamic basis,using modern pharmacological research technology to determine the effective components with hypoglycemic effect,evaluate its pharmacodynamic characteristics and explore the mechanisms.Since the last century,pharmacology has developed from studying the mechanism of action of known drugs to the new stage of mainly studying new drugs.Pharmacological research has always run through the whole process of new drug research and development.It is the use of a variety of modern pharmacological research methods,innovative natural drug"Sangzhi alkaloids tablet"can’t be reached by other traditional Chinese medicine.Specific target,material basis and hypoglycemic effects are clearly.From the perspective of pharmacology research,this paper reviews the process of searching for hypoglycemic traditional Chinese medicine from the"treasure house of traditional Chinese medicine"by modern pharmacological research methods,improving the pharmacodynamic evaluation system to clarify the preclinical pharmacodynamic characteristics of total alkaloids of Ramulus Mori,and uses network/i

关 键 词：桑枝总生物碱 糖尿病 2型 餐后血糖 药理学研究 综合获益 

分 类 号：R285[医药卫生—中药学]