童康片检测方法的修订研究  

Study on revision of test methods for Tongkang Tablets

作　　者：毕福钧[1] 位翠杰 林彤[1] 江英桥[1] BI Fujun;WEI Cuijie;LIN tong;JIANG Yingqiao(Guangzhou Institute for Drug Control,Guangzhou 510160,China;Jinan University,Guangzhou 510632,China)

机构地区：[1]广州市药品检验所,广州510160 [2]暨南大学,广州510632

出　　处：《中国药品标准》2020年第1期62-68,共7页Drug Standards of China

基　　金：国家药典委员会《中国药典》2016年度药品标准提高任务(中药17号)

摘　　要：目的:对童康片的质量标准进行提高,完善其质量评价方法。方法:采用显微鉴别法对童康片中山药和陈皮进行鉴别,采用薄层色谱法对童康片中黄芪、白术、防风和陈皮进行定性鉴别,采用HPLC-ELSD法,Thermo Hypersil Gold C 18色谱柱(4.6 mm×250 mm,5μm),以乙腈-水(35∶65)为流动相,流速1.0 mL·min^-1,对童康片中黄芪甲苷进行了含量测定。结果:山药和陈皮粉末显微特征明显;黄芪、白术、防风和陈皮薄层鉴别斑点清晰,专属性强,阴性无干扰。黄芪甲苷在0.026618~1.703526μg范围内线性关系良好(r=0.9993,n=7);平均加样回收率为:96.5%,RSD为1.9%。测定样品11批,黄芪甲苷的含量在58~106μg·片^-1之间。结论:经方法学验证,提高后的质量标准可更全面有效地用于童康片的质量控制。Objective:To improve the specification and optimize the test methods of Tongkang Tablets.Methods:Dioscoreae Rhizoma and Citri Reticulatae Pericarpium were identified by microscopic identification.Astragali Radix,Atractylodis Macrocephalae Rhizoma,Saposhnikoviae Radix and Citri Reticulatae Pericarpium were identified by TLC.The content of astragaloside in Tongkang Tablets was determined by HPLC-ELSD.A Thermo Hypersil Gold C 18 column(4.6 mm×250 mm,5μm)was adopted,the mobile phase consisted of acetonitrile-water(35∶65),and the flow rate was 1.0 mL·min^-1.Results:Dioscoreae Rhizoma and Citri Reticulatae Pericarpium had the microscopic characteristics.The TLC chromatograms of Astragali Radix,Atractylodis Macrocephalae Rhizoma,Saposhnikoviae Radix and Citri Reticulatae Pericarpium had the clear and specific spots without the negative interference.The linear range of astragaloside fell into 0.026618-1.703526μg(r=0.9993,n=7),and the average recovery was 96.5%(RSD as 1.9%,n=6).The contents of astragaloside in 11 batches of samples were 58-106μg per tablet.Conclusion:The methodological validation showed that the improved specification can be used for the comprehensive and effective quality control of Tongkang Tablets.

关 键 词：童康片 黄芪甲苷 TLC HPLC-ELSD 

分 类 号：R921.2[医药卫生—药学]