茵苓退黄合剂的质量标准研究  

Studies on Quality Specification of Yin Ling TuiHuang mixture

作　　者：赖宏强 夏丽珍[1] 丰文杰 赖增发 LAI Hong-qiang;XIA Li-zhen;FENG Wen-jie;LAI Zeng-fa(Sanming City Integrated Traditional and Western Hospital,Sanming 365001,China;Inspection center of Sanming Cify,Sanming 365000,China)

机构地区：[1]福建省三明市中西医结合医院,福建三明365001 [2]福建省三明市检验检测中心,福建三明365000

出　　处：《海峡药学》2022年第1期53-56,共4页Strait Pharmaceutical Journal

基　　金：三明市科技计划项目(2019-Y-3)。

摘　　要：目的建立茵苓退黄合剂的质量标准。方法采用薄层色谱法(TLC)定性鉴别茵苓退黄合剂中大黄、栀子;采用高效液相色谱法(HPLC)测定该制剂中的栀子苷含量,色谱柱为Ultimate XB-C_(18)柱(4.6 mm×250 mm,5μm),流动相为乙腈:水(15:85),柱温:35℃;流速:1.0 mL·min^(-1);检测波长:238 nm,进样量为10μL。结果大黄、栀子的TLC图斑点清晰,分离度较好,阴性样品无干扰。栀子苷在0.212μg~1.697μg范围内,线性关系良好(r=0.9995);栀子苷的加样回收率为99.40%,RSD为0.7%(n=5)。结论该方法简便可行,专属性、重复性好,可作为茵苓退黄合剂的内控标准。OBJECTIVE To establish quality specification of Yinling Tuihuang mixture.METHODS Rhubarb and Gardenia in Yinling Tuihuang Mixture were qualitatively identified by the thin layer chromatography(TLC).The content of geniposide in the Mixture was determined by the high performance liquid chromatography(HPLC).The chromatographic column was Ultimate XB C_(18) column(4.6 mm×250 mm,5μm)with mobile phase of acetonitrile-water(15∶85)flowing at 1 mL·min^(-1) in a gradient elution,the detection wavelength was 238 nm,the column temperature was 35℃,and the injection volume was 10μL.Results TLC images of Rhubarb and Gardenia showed clear spots,good separation and no interference from the negative samples.The linear ranges of protocatechuic aldehyde were 0.212μg~1.697μg(r=0.9995).The average recoveryies were 99.40% for Geniposide,and the RSDs were 0.7%(n=5).Conclusion The method is simple and feasible with good specificity and repeatability,which can be used for the inner quality standard of Yinling Tuihuang Mixture.

关 键 词：茵苓退黄合剂 薄层色谱法 高效液相色谱法 栀子苷 

分 类 号：R927[医药卫生—药学]