经断调理丸的质量标准

Quality Standard of Rougan Yangxue Pills

目的经断调理丸质量标准的建立。方法显微鉴别墨旱莲、合欢皮;薄层色谱鉴别女贞子、丹参。高效液相色谱法(HPLC)检测丹皮酚含量,色谱柱为Agilent TC-C_(18)(250 mm×4.6 mm,5μm);以水-甲醇(62∶38)为流动相;检测波长:274 nm;流速:1.0 ml/min;柱温:30℃。结果显微鉴别特征明显;薄层色谱鉴别斑点清晰,阴性对照对鉴别无干扰;丹皮酚在4.99~74.88μg/ml范围内呈良好的线性关系(r=0.9999),平均加样回收率102.35%,相对标准偏差(RSD)为0.2%。结论该测定方法简单可靠,可用于经断调理丸的质量控制。

Objective To establish the quality standard of Jingduan Tiaoli Pills.Methods Microscopic identification method was used to identify Ecliptae herba and Albiziae cortex.TLC method was used to identify Ligustri lucidi fructus and Salviae miltiorrhizae radix et rhizoma.The content of paeonol was detected by high performance liquid chromatography,the column was Agilent TC-C_(18)(250 mm×4.6 mm,5μm);the mobile phase was methanol-water(38:62);detection wavelength:274 nm;flow rate:1.0 ml/min;column temperature:30℃.Results The characteristics of microscopic identification were obvious;the TLC spots were clear and the negative control had no interference.Paeoniflorin showed a good linear relationship in the range of 4.99~74.88μg/ml(r-0.9999).The average recovery of hesperidin was 102.35%,with RSD of 0.2%.Conclusion The method is simple and available,and it can be used for the quality control of Jingduan Tiaoli Pills.