通脑液的质量标准研究

Quality standard studies of Tongnaoye

目的:建立通脑液的质量标准。方法:采用薄层色谱法(TLC)对处方中西红花进行定性鉴别;采用HPLC法测定西红花中西红花苷Ⅰ和西红花苷Ⅱ的含量,色谱柱:Agilent ZORBAX SB-C_(18)柱(250 mm×4.6 mm,5μm),甲醇-水(48∶52)为流动相,流速1.0 mL·min^(-1),柱温30℃,检测波长440 nm,进样量10μL。结果:薄层鉴别专属性强,分离效果好。西红花苷Ⅰ在9.66~57.94μg·m L-1呈良好的线性关系(r=1),西红花苷Ⅱ在5.91~35.48μg·mL^(-1)呈良好的线性关系(r=0.999 9),平均回收率分别为98.4%(RSD=1.21%,n=9),99.4%(RSD=1.70%,n=9)。结论:该方法简便、准确、重复性好,可作为通脑液的质量控制方法。

Objective：To establish the quality standard of Tongnaoye.Methods：Thin layer chromatography（TLC） was used to identify crocus sativus in the prescription.High performance liquid chromatography（HPLC） was used to determine the content of crocin Ⅰ and crocin Ⅱ.Chromatographic conditions were as follows：Agilent ZORBAX SB-C18 column（250 mm × 4.6 mm,5 μm） was used,the mobile phase consisted of methanol-water（48 ：52） with the flow rate of 1.0 mL·min^-1,the detection wavelength was set at 440 nm,the temperature was 30 ℃ and the sample volume was 10 μL.Results：The TLC method showed good specificity and separation effect.Crocin Ⅰ showed a good linear relationship（r = 1） in the range of 9.66-57.94 μg·mL^-1,while crocin Ⅱ showed a good linear relationship（r = 0.999 9） in the range of 5.91-35.48 μg·mL^-1.Their average recovery rates were 98.4%（RSD = 1.21%,n = 9） and 99.4%（RSD = 1.70%,n = 9） respectively.Conclusion：This method was simple,accurate and reproducible,which could be used to control the quality of Tongnaoye.