滋阴沐足散质量标准控制研究

Study on the Quality Standard of Ziyin Muzu Powder

目的建立滋阴沐足散的质量标准。方法采用薄层色谱鉴别法对处方中的当归、蒺藜进行了定性鉴别;用高效液相色谱法测定蛇床子素的含量,色谱柱：Hypersil ODS2（5μm,4.6mm×250mm,）;流动相：乙腈—水（43：57）;流速1.0m L/min;检测波长为330nm,柱温：35℃。结果薄层色谱鉴别方法分别检出当归、蒺藜,阴性样品无干扰。蛇床子素在0.192~1.916μg范围内与峰面积积分值有良好线性关系,回归方程为Y=3 203.7X-42.662,r=0.999 8（n=6）。结论所建立方法专属性强、灵敏度高、重复性好,可作为该制剂的质量控制方法。

Objective To establish quality standard of Ziyin Muzu Powder. Methods Danggui and Jili were identified by TLC.HPLC method was used to determine osthole in this preparation. Chromatographic condition was as follows： the Hypersil C18 column ODS2 （5μm, 4.6mm ×250mm）; the mobile phase was acetonitrile-water （43：57）; the flow rate was 1.0mL/min; the detecting wavelength was 330nm, the column temperature was at 35 ℃. Results Danggui and Jili could be identified by TLC and there was no interference of the negative contro 1 .The method showed a good linear relationship in the range of 0.192-1.916μg. The regression equation was： Y=3 203.7X- 42.662, r=0.999 8（n=6）.Conclusion This method is practicable, convenient,precise and reliable, which can be used for the quality control of Ziyin Muzu powder.