提高蒙药伊赫汤质量标准的研究

Study on improvement of the quality standard of Mongolian medicine Yihetang

目的提高蒙药伊赫汤的质量标准,为有效控制该制剂的内在质量提供实验依据。建立蒙药伊赫汤中化学成分的定性鉴别及含量测定方法。方法增加木香、栀子、紫花地丁、没食子酸和红花的TLC鉴别。建立测定制剂中秦皮乙素含量的HPLC法。色谱柱为Shiseido C 18色谱柱(250 mm×4.6 mm,5μm);以甲醇-1 mL·L^-1磷酸(14∶86)为流动相进行梯度洗脱;流速为1.0 mL·min^-1;检测波长为345 nm;柱温为30℃;进样量为10μL。结果TLC鉴别中,木香、栀子、紫花地丁、没食子酸和红花的图谱清晰,与相邻斑点分离较好,阴性对照无干扰;HPLC含量测定中,秦皮乙素的质量浓度在1.25~20.00μg·mL^-1范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为101.2%,RSD值为1.43%。结论所建立的TLC鉴别方法和HPLC含量测定方法简便、可靠、重复性好、专属性强,可作为蒙药伊赫汤的质量控制方法。

Objective To improve the quality standard,provide experimental basis for effective control of the intrinsic quality of the preparation,and to establish a qualitative identification and content determination method for the chemical constituents of Mongolian medicine Yihetang.Methods TLC identification of Aucklandia,Gardeniae Fructus,Viola philippica,gallic acid and safflower was added.An HPLC method for determining the content of quercetin in the preparation was established.The column was a Shiseido C 18 column(250 mm×4.6 mm,5μm),and a gradient elution with methanol-1 mL·L^-1 phosphoric acid(14∶86)as the mobile phase.The flow rate was 1.0 mL·min^-1,and the detection wavelength was 345 nm.The temperature was 30℃and the injection volume was 10μL.Results In the TLC identification,the spots of Aucklandia,Gardeniae Fructus,Viola philippica,gallic acid and safflower were clear,and separated well.The negative control showed no interference.In the HPLC content determination,the mass concentration of quercetin in the range of 1.25-20.00μg·mL^-1 showed a good linear relationship with the peak area(r=0.9999),and the average recovery was 101.2%,RSD was 1.43%.Conclusion The TLC identification method and HPLC content determination method established in this paper are simple,reliable,reproducible and specific,and can be used as a quality control method for Mongolian medicine Yihetang.