复方杏仁片质量标准研究

目的 :制订复方杏仁片的质量标准。方法 :采用薄层色谱法对处方中黄芪和紫菀进行了定性鉴别 ;用反相高效液相色谱法测定其中苦杏仁含有的苦杏仁苷的含量 ,采用色谱柱KromasiLC18柱 ,以甲醇 -乙腈 -水 -四氢呋喃 (14∶10∶75∶1)为流动相 ,流速 :1 0ml/min ,检测波长 2 15nm。结果 :以羧甲基纤维素钠为黏合剂制备的硅胶G薄层板 ,以氯仿 -甲醇 -水 (13∶7∶2 )的下层液为展开剂进行黄芪甲苷的鉴别研究 ;以石油醚 (6 0～ 90℃ ) -醋酸乙酯 (9:1)为展开剂进行紫菀的鉴别研究 ;苦杏仁苷在 0 6～ 3 4 μg范围内线性关系良好 (r =0 9997) ,平均回收率为 98 34% ,RSD为 0 73%。结论 :该方法准确可靠地进行定性、定量检测 ,能有效地控制制剂的质量。

Study on quality standard for almond compound pill

Objective:To establish the method for quality control of almond compound pill (Semen Armeniacae,Radix astragali,Radix asteris).Methods:Radix astragali and Radix asteris were identified by TLC,and the content of amygdalin in Semen Armeniacae was determined by RP-HPLC.Kromasil C 18 column was used.The mobil phase consisted of methanol-aceton itrile-water-tetrahydro (14∶10∶75∶1)with flow rate 1.0ml·min -1 .The detection wavelength was set at 215nm.Results:The underneath Layer of chloroform-methanol-water(13∶7∶2)was applied as the developer for the identification of Astragaloside IV on silica gel G coating plate.Thepetroleum(60～90℃)-ethyl acetate(9∶1)was applied as the developer for the identification of Radix asteris on silica gel G coating plate.The method was Liner within the range of 0.6～3.4μg (r=0.9997).The average recovery of assay was 98.34% and RSD was 0.73% (n=5).Conclusion:The method appeared to be simple and rapid,highly accurate and precise.It can control the quality of this preparation effectively.