经典名方完带汤复方制剂关键质量属性及量值传递研究

Research on Key Quality Attributes and Quantity Transfer of Classical Formula Wandai Tang Compound Preparation

目的:探讨完带汤复方制剂中化学成分及关键质量属性,以关键质量属性为指标进行药材、饮片、中间体与复方制剂的相关性研究。方法:通过紫外可见分光光度法、高效液相色谱法以及液质联用方法测定完带汤中的主要成分;并以芍药苷、橙皮苷总量和转移率、指纹图谱为指标研究复方制剂制备过程中的量值传递过程。结果:完带汤中主要成分包括多糖类、总黄酮、总皂苷、无机盐类,并以芍药苷、橙皮苷为主要含量控制指标;主要化学成分从药材-饮片-中间体-复方制剂逐级传递,且归属关系清晰。结论:此研究结果对后续的制剂制备工艺与质量控制具有较好的指导意义。

Objective:To discuss the chemical component and critical quality attributes of Wandai Tang compound preparation,and to perform the correlation study between crude drugs,decoction pieces,intermediate object and compound preparation by taking critical quality attributes as the indexes.Methods:The main components of Wandai Tang were determined by ultraviolet-visible spectrophotometry,HPLC and LC-MS method;quantity transfer process in the preparation of compound preparation were studied by taking paeoniflorin,hesperidin aggregate,transfer rate and fingerprint as the indicators.Results:The main ingredients of Wandai Tang contained polysaccharides,total flavonoids,total saponins,inorganic salts,by taking paeoniflorin and hesperidin as the control indicators for the main content;the main chemical ingredients transmitted gradually from crude drugs,decoction pieces,intermediate object to compound preparation,showing clear attribution.Conclusion:The finding has good guiding significance for the subsequent preparation technology and quality control.