利尿合剂的质量标准分析  

An analysis of the quality standard of diuretic mixture

作　　者：陈向英 杨志华 洪美华 CHEN Xiangying;YANG Zhihua;HONG Meihua(Pharmaceutical Department,Zhongshan Hospital of Traditional Chinese Medicine,Guangdong,Zhongshan 528401,China)

机构地区：[1]广东省中山市中医院药学部,广东中山528401

出　　处：《中国医药科学》2020年第16期245-248,共4页China Medicine And Pharmacy

基　　金：广东省中山市医学科研项目(2017A020042)。

摘　　要：目的建立利尿合剂的质量标准。方法采用薄层色谱(TLC)法对利尿合剂中白花蛇舌草、叶下珠进行薄层色谱鉴别研究;同时应用高效液相色谱(HPLC)法测定制剂中甘草酸的含量,色谱柱:Agilent ZORBAX XDB-C18柱(4.6mm×250mm 5μm);流动相:甲醇-0.2mol/L醋酸铵溶液-冰醋酸(55∶45∶1)梯度洗脱;检测波长:250nm;流速:1.00mL/min;柱温:40℃;进样量:20μL。结果白花蛇舌草、叶下珠的薄层色谱斑点清晰,阴性无干扰。甘草酸在0.2162~1.081μg(r=0.9997)线性范围内,呈良好的线性关系,平均回收率为98.60%,RSD为0.522%(n=5)。结论该方法简单,稳定性,重现性好,可作为利尿合剂的质量控制方法。Objective To establish the quality standard for diuretic mixture.Methods Thin layer chromatography(TLC)was used to conduct the study on TLC identifications of hedyotis diffusa willd and phyllanthus urinaria L in diuretic mixture.Meanwhile,high performance liquid chromatography(HPLC)was used to determine the content of glycyrrhizic acid in the preparation.As far as HPLC was concerned,the chromatographic column was Agilent ZORBAX XDB-C18(4.6 mm×250 mm 5μm);the mobile phase was methanol-0.2 mol/L ammonium acetate solutionglacial acetic acid(55∶45∶1)in gradient elution;the detection wavelength was 250 nm;the flow rate was 1.00 mL/min;the column temperature was 40℃;the injection volume was 20μL.Results The TLC spots of hedyotis diffusa willd and phyllanthus urinaria L were clear and the blank test showed no interference.The glycyrrhizic acid showed a good linear relationship within the linear range of 0.2162-1.081μg(r=0.9997),with an average recovery of 98.60%and RSD of 0.522%(n=5).Conclusion The method is simple and with good stability and reproducibility.It can be used for the quality control of diuretic mixture.

关 键 词：利尿合剂 质量标准 薄层色谱法 高效液相色谱法 甘草酸 

分 类 号：R286.0[医药卫生—中药学]