和中理脾丸的质量标准研究

Studies on Quality Standard of Hezhong Lipi Pills

目的建立和中理脾丸的质量控制方法。方法分别采用显微鉴别法，薄层色谱法对7味中药材进行了定性鉴别；采用高效液相色谱法测定了厚朴酚与和厚朴酚的含量，色谱柱为AgilentExtend-C18（250mm×4．6mm，5μm）分析柱；流动相：乙腈-0．05％磷酸水（39：61）；检测波长：222nm；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0.0770-0.770、0.0352-0.352μg范围内浓度与峰面积呈良好的线性关系（r=0.9998，n=6），平均回收率分别为97．8％、97．6％，RSD分别为1．2％，0．8％（n=6），结论本方法可准确地进行定胜、定量、可用于控制和中理脾丸的质量。

Aim To establish a quality standard of Hezhong Lipi Pills. Methods Seven herbal drugs were identified by Micro-distinguish and TLC. Magnolol and honokiol were determined by HPLC. Agilent Extend C18（250mm×4.6mm,5μm） was used as the chromatographic column and acetonitrile-0.05% phosphoric acid solution （39：61） as the mobile phase. The detection wavelength was 222nm; the flow rate was 1.0ml/min, and the column temperature was 40℃. Results The qualitative identification with Micro-distinguish and TLC was specific. Liner ranges of both magnolol and honokiol were 0.0770-0.770μg,0.0352-0.352μg（ average r =0.9998, n = 6）. The average recovery of magnolol and honokiol was 97.8% ,97.6%. RSD was 1.2% ,0.8% （ n = 6） ; Conclusion This method could be used for quality control of Hezhong Lipi Pills.