健脾和中颗粒的质量控制方法研究

Quality Control Methods for Jianpi Hezhong Granules

目的建立适宜的健脾和中颗粒质量控制方法。方法采用薄层色谱法鉴别健脾和中颗粒中苍术、厚朴、山楂等,并采用高效液相色谱法建立方中厚朴酚、和厚朴酚的含量测定方法。色谱柱：Agilent XDB-C18（4.6 mm×250 mm,5μm）;流动相：乙腈-水（55∶45）;检测波长：295 nm;流速：1.0 mL/min;柱温：25℃。结果薄层色谱中斑点清晰,供试品和对照药材色谱斑点对应良好,阴性无干扰;Y厚=1585.19479X＋1.34427;Y和=1578.885 99X＋4.44212,表明厚朴酚在浓度范围32.8-164.0μg/mL内呈良好的线性关系,r=0.999 99;厚朴酚在浓度范围19.2-96.0μg/mL内呈良好的线性关系,r=0.99997。厚朴酚平均回收率为99.23%,RSD为1.06%（n=6）;和厚朴酚平均回收率为98.95%,RSD为1.63%（n=6）。结论该方法简便、准确、可靠,可作为健脾和中颗粒的质量控制方法。

OBJECTIVE To establish quality control methods for Jianpi Hezhong granules. METHODS TLC was used to distinguish Atractylodis rhizoma,Magnoliae officinalis cortex and Crataegi fructus in Jianpi Hezhong granules. HPLC was used for the determination of Magnolol and Honokiol. The column was Agilent XDB-C18（ 4.6mm×250 mm,5 μm）; mobile phase were acetonitrile-water（ 55 ∶ 45）; the detection wavelength was at 295 nm;flow rate was 1.0 mL / min and column temperature at 25 ℃. RESULTS The TLC spots were clear and negative samples were non-interference in TLC,the chromatography spots of test drug were correspond with the reference drug; Magnolol shows a good linear relationship in the range of 32. 8-164. 0 μg / mL,r = 0. 999 99,the average recovery was 99.23% with RSD = 1.06%（ n = 6）; Honokiol showed a good linear relationship in the range of 19.2-96.0 μg / mL,r = 0.999 97,the average recovery was 98.95% with RSD = 1.63%（ n = 6）. CONCLUSION This method is simple,accurate,and reliable,and it can be used for the quality control for Jianpihezhong granules.