培土清心颗粒质量标准研究

Study on Quality Standard of Peitu Qingxin Granules

目的:建立培土清心颗粒的质量标准。方法:采用高效液相色谱法测定处方中连翘苷的含量。以依利特Hypersil ODS2(4.6 mm×250 mm,5μm)柱为色谱柱,柱温25℃,以乙腈-水(25∶75)为流动相,流速1.0 mL.min-1,检测波长277 nm。结果:白茅根、连翘、白鲜皮和甘草分离度好,阴性对照无干扰;连翘苷在0.179～4.29μg线性关系良好,其回归方程Y=7 316.648X-2 807.941(r=0.999 97),加样回收率为100.67%,RSD 1.03%(n=9)。结论:该方法简便、准确、重复性好,可作为培土清心颗粒的质量控制方法。

Objective： To establish the quality standard of Peitu Qingxin granules. Method： TLC was used for the qualitative identification of Imperatae Rhizoma, Forsythiae Fructus, Dictamni Cortex and Glycyrrhizae Radix et Rhizoma. HPLC was used to determine the content of phillyrin, which was obtained by a Yilite Hypersil ODS2 （4. 6 mm ×250 mm, 5 μm） column with the mobile phase composed of acetonitrile-water （25： 75）, and the column temperature was maintained at 25 ℃. The flow rate was 1.0 mL·min-1. The detection wavelength was set at 277 nm. Result： TLC spots were clear and well-separated without negative interference. The linear range of phillyrin was 0. 179-4.29 μg （ r = 0. 999 97 ） with an average recovery of 100.67% （ RSD 1.03% , n = 9）. Conclusion： The method is simple, accurate and reproducible, which can be used for the quality control for Peitu Qingxin granules.