肝苏颗粒质量标准提升研究  

Study on quality standard improvement for Gansu granules

作　　者：陶朝阳 史鹏杰 周鑫 孙连娜 TAO Chaoyang;SHI Pengjie;ZHOU Xin;SUN Lianna(Pharmaceutical Preparation Research Center of General Hospital of Tibet Military Region,Lhasa 850007,China;School of Pharmacy,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]西藏军区总医院药物制剂研究中心,西藏拉萨850007 [2]上海中医药大学中药学院,上海201203

出　　处：《药学实践与服务》2022年第6期546-549,共4页Journal of Pharmaceutical Practice and Service

基　　金：国家重点研发计划资助(2019YFC1711000)。

摘　　要：目的建立肝苏颗粒质量标准,有效控制药品质量。方法以乔松素-7-O-β-D-葡萄糖苷为指标性成分,改进肝苏颗粒的薄层鉴别方法;采用Agilent ZORBAX SB-C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.5%甲酸水溶液为流动相,以280nm检测波长,建立乔松素-7-O-β-D-葡萄糖苷的HPLC含量测定方法。结果采用所建立的TLC方法鉴别肝苏颗粒时,特征斑点分离度良好、清晰;定量分析结果显示乔松素-7-O-β-D-葡萄糖苷的质量浓度在2.4~240μg/ml范围内与峰面积呈良好线性关系(r=0.9999),平均加样回收率为100.76%,RSD为0.66%,准确度良好。结论本实验所建立的TLC鉴别方法和HPLC含量测定方法专属性强、重现性好,可以作为肝苏颗粒质量控制的提高标准。Objective To establish the quality standard of Gansu granules(GGs)and effectively control the quality of GGs.Methods TLC identification method of Gansu granules was improved by using pinocembrin-7-O-β-D-glucoside as the indicator.In HPLC analysis,Agilent ZorbaxSB-C18(4.6 mm×250 mm,5μm)was used as a chromatographic column,and acetonitrile-0.5%formic acid solution was used as the mobile phase.The detection wavelength of 280 nm was used to analyze the content of pinocembrin-7-O-β-D-glucoside in GGs.Results The separation of characteristic spots was good and clear when the established TLC method was used to identify Gansu granules.Quantitative analysis showed that the concentration of pinocembrin-7-O-β-D-glucoside has a good linear relationship with the peak area in the range of 2.4-240μg/ml(r=0.9999).The average sample recovery rate of pinocembrin-7-O-β-D-glucoside is 100.76%with RSD value of 0.66%.The accuracy was good.Conclusion The TLC identification method and HPLC content determination method established in this experiment have strong specificity and good reproducibility,and can be used as an improved standard for the quality control of Gansu granules.

关 键 词：肝苏颗粒 质量标准 薄层色谱法 乔松素-7-O-β-D-葡萄糖苷 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]