乌梅透骨口服液的质量控制

Quality Control of Wumei Tougu Oral Liquid

目的:建立乌梅透骨口服液的质量控制方法。方法:采用TLC法对组方中的川续断、当归、五味子进行鉴别:用柱层析方法处理样品,用HPLC法测定样品中川续断皂苷Ⅵ的含量。结果:在薄层色谱中能检出川续断、当归、五味子;川续断皂苷Ⅵ在0.05～1.5 mg·ml^(-1)范围内线性关系良好(r=0.999 9),平均回收率为96.99%,RSD为2.10%(n=9)。结论:所建立的定性方法专属性强,定量方法准确,重复性好,可有效控制该制剂质量。

Objective： To establish a method for quality control of wumei tougu oral liquid. Method： Dipsacus asperoides ,Angelica sinensis and Schisandra chinensis were identified by TLC;The samples were treated with column chromatography, and Asperosaponin Ⅵ were determined by HPLC, the Diamonsil（R） diamond C 18 column （250 mm ×4. 6 mm,5 μm）was used, acetonitrile-water（ 30：70） as mobile phase, detecting wavelength was 212 nm, flow rate was 1 ml·min^-1, column temperature was 25 ℃. Result： Dipsacus asperoides ,Angelica sinensis and Schisandra chinensis could be detected by TLC. Linear correlation of Asperosaponin Ⅵ was good in the range of 0. 05-1.5 mg·ml^-1 （r =0. 999 9） ,and the mean recovery was 96. 99% ,RSD =2. 10% （n =9）. Conclusion： The qualitative and quantitative methods are accurate and suitable for quality control of wumei tougu oral liquid.