缩泉丸质量标准的初步研究

Study on Quality Standard of Suoquan Pills

目的通过对缩泉丸进行薄层色谱及高效液相色谱鉴别,对其质量标准进行初步研究。方法采用薄层色谱法,对缩泉丸方中的益智仁、乌药、山药进行定性鉴别,并采用高效液相色谱对方中的乌药醚内酯进行含量检测。结果在薄层色谱中均能检测出益智仁、乌药、山药的特征性成分,阴性对照无干扰。高效液相色谱中,乌药醚内酯在0.0005-0.02 mg·m L^-1范围内呈良好线性关系（r=0.9998）,平均加样回收率为96.07%,RSD为1.62%。结论该法专属性强、重复性好。为方中的山药提供新的薄层色谱鉴别方法,可用于缩泉丸的定性鉴别;高效液相色谱法可对缩泉丸中乌药醚内酯进行定量分析,为缩泉丸的质量标准制订提供依据。

Objective To establish high performance liquid chromatography（HPLC） and thin layer chromatography（TLC） methods for the quality control of Suoquan pills.Methods Fructus Alpiniae Oxyphyllae,Radix Linderae,and Rhizoma Dioscoreae of Suoquan pills were identified by TLC.HPLC was performed on Hypersil ODS C18（5μm,4.0 mm×150 mm） with the mobile phase being acetonitrile and water.The flow rate was 1 ml/min,the column temperature was 25 ℃,and ultraviolet wave-length was 235 nm.Results Fructus Alpiniae Oxyphyllae,Radix Linderae,and Rhizoma Dioscoreae of Suoquan pills had been identified without interference in negative control.The results of HPLC showed that linderane presented good linearity in the range of 0.0005 -0.02 mg·m L^-1（r=0.9998）.The average recovery of linderane was 96.07 % with RSD being 1.62 %.Conclusion The established methods are specific and with good reproducibity,and can be used for the qualitative identification and quantitative determination of Suoquan pills.