小儿和胃利脾颗粒质量标准研究

Quality Standard of Xiao'er Hewei Lipi Granules

目的建立小儿和胃利脾颗粒(鸡内金,山药,三七,黄芪等)质量标准。方法采用薄层色谱法对小儿和胃利脾颗粒中三七、黄芪进行定性鉴别;采用高效液相色谱法测定小儿和胃利脾颗粒中三七皂苷R1、人参皂苷Rb1、人参皂苷Rg1、黄芪甲苷,色谱柱为C18柱,乙腈-水为流动相,检测器分别为紫外检测器、蒸发光散射检测器。结果薄层色谱鉴别方法专属性强,斑点清晰,且阴性无干扰;三七皂苷R1、人参皂苷Rb1、人参皂苷Rg1、黄芪甲苷线性范围分别为0.42～4.20μg,r=0.999 7;0.76～7.60μg,r=0.999 8;0.70～7.00μg,r=0.999 7及1.52～7.60μg,r=0.999 9。结论本质量标准方法结果准确、重复性好,可有效控制该制剂的质量。

AIM To establish the quality standard of Xiao＇er Hewei Lipi Granules（Galligigerii endothelium corneum,Dioscoreae Rhizoma,Notoginseng Radix et Rhizoma,Astragali Radix,etc）.METHODS Identifications of Notoginseng Radix et Rhizoma and Astragali Radix were carried out by TLC.HPLC methods were used for the determination of notoginsenoside R1 and ginsenoside Rb1,ginsenoside Rg1 and astragoloside IV in Xiao＇er Hewei Lipi Granules.A C18 column was used with the mobile phase of acetonitrile-water,the detectors were UV-detector,evaporative light-scattering detector（ELSD）.RESULTS Notoginseng Radix et Rhizoma and Astragali Radix could be identified by TLC with high specificity.The TLC spots were clear without the interference of the blank control.The linear ranges were in the range of 0.42-4.20 μg（r=0.999 7） for notoginsenoside R1,0.76-7.60 μg（r=0.999 8）for ginsenoside Rb1,0.70-7.00 μg（r=0.999 7）for ginsenoside Rg1,1.52-7.60 μg（r=0.999 9）for astragaloside IV,respectively.CONCLUSION This quality standard is accurate and reproducibly,which can be used for quality control of Xiao＇er Hewei Lipi Granules.