和胃平肝丸的质量标准研究

Studies on Quality Standard of Hewei Pinggan Pills

目的建立和胃平肝丸的质量控制方法。方法分别采用显微鉴别法、薄层色谱法对11味中药材进行了定性鉴别;采用HPLC法测定了厚朴酚与和厚朴酚的含量,色谱柱为ZORBAX SB-C18(250mm×4.6mm,5μm)分析柱;流动相:乙腈-0.05%磷酸溶液(54∶26);检测波长:294nm;流速:1.0ml/min;柱温:40℃。结果定性鉴别方法专属性强;厚朴酚与和厚朴酚分别在0.202～2.02、0.05025～0.603μg·ml-1范围内浓度与峰面积呈良好的线性关系(均r=0.9999,n=6),平均回收率分别为100.06%、98.56%,RSD分别为2.00%、1.74%(n=6);结论本方法可准确地进行定性、定量,可用于控制和胃平肝丸的质量。

Aim To establish a quality control standard of Hewei Pinggan Pills. Methods 11 herb drugs were identified by Micro-distinguish and TLC. Magnolol and Honokiol were determined by HPLC. Agilent Zorbax SB-C18 （4.6mm × 250 mm,5μm） was used as the chromatographic column and acetonitrile-0.05% phosphoric acid solution（54：26） as the mobile phase. The detection wavelength was 294nm;the flow rate was 1.0ml/min,and the column temperature was 40℃. Results The qualitative identifications with Micro - distinguish and TLC were specific. Liner ranges of both Magnolol and Honokiol were 0. 202 - 2.02 and 0. 05025 -0. 603μg·ml^-1 （ average r =0. 999 9, n =6）, The average recovery of magno- lol and honokiol was 100. 06% ,98.56%, RSD was 2. 00%, 1.74% （ n = 6） ; Conclusion The result showed that this method could identify and detemine accurately and could be used for quality control of Hewei pinggan Pills.