参味合剂质量控制研究

摘要

目的：建立参味合剂的质量控制方法。方法采用TLC法对制剂中五味子、麦冬、甘草进行定性鉴别；采用HPLC法测定制剂中五味子醇甲含量，色谱柱为Diamonsil C18柱（5μm，250 mm ×4．6 mm）；流动相为甲醇-水（58∶42）；检测波长为250 nm。结果在TLC色谱中检出五味子、麦冬和甘草，阴性对照无干扰；五味子醇甲进样量在0．3012～3．012μg范围内与峰面积呈良好的线性关系，r＝0．99999，平均加样回收率为98．55％，RSD＝1．05％（n＝6）。结论所建立TLC鉴别方法和HPLC含量测定方法专属性强，结果准确，重现性好，可作为参味合剂的质量控制。%Objective To formulate a method for quality control of Shenwei Mixture.Methods Radix codonopsis,fructus schisandrae and licorice were identified by thin layer chromatography.Schisandrol was determined by high performance liquid chromatography,with diamonsil C18 column (5 μm,4.6 mm ×250 mm)as chromatographic column.The mobile phase consisted of methanol∶water(58∶42). The detection wavelength was 250nm.Results Radix codonopsis,fructus schisandrae and licorice were detected by TLC.And negative control was without interference.Schisandrol showed a good linear relationship within a range of 0.301 2~3.012 μg (r=0.999 99). The average recovery was 98.55%.RSD was 1.05%(n=6).Conclusions The established methods are specific,accurate,reproduci-ble,which can be used for quality control of Shenwei Mixture.