摘要:
目的 建立新脑灵颗粒的质量标准。 方法 采用薄层色谱（TLC）法对该处方中的延胡索、白芷、厚朴、甘草、当归、川芎、五味子和菊花进行鉴别；采用高效液相色谱（HPLC）法测定丹酚酸B的含量，色谱柱：Agilent Eclipse XDB-C18（4.6 mm×250 mm，5μm）；流动相：0.5%甲酸水溶液（A）-乙腈（B），梯度洗脱（0～5 min，24%B；5～6 min，24%～19%B；6～25 min，19%～20% B）；流速：1.0 ml/min；柱温：25℃；检测波长：286 nm；进样量：10μl。 结果 TLC图中特征斑点清晰，专属性强。丹酚酸B在20～1280μg/ml范围内线性关系良好，其回归方程为Y=13.304X-117.50（r=0.9999，n=7），平均回收率96.17%（RSD=1.10%）。 结论 该方法简便可行、准确可靠、重复性好，可用于新脑灵颗粒的质量控制。
Abstract:
Objective To establish quality control of Xinnaoling granules. Methods Thin layer chromatography (TLC) methods were used to identify Rhizoma Corydalis, Radix Angelicae dahuricae, Cortex Magnoliae officinalis, Radix Glycyrrhizae, Rhizoma Ligusticum, Ligusticum wallichii, Schisandra Chinensis, Dendranthema morifolium. The concentration of salvianolic acid B was determined by high performance liquid chromatography (HPLC). The method employed a column of Agilent Eclipse XDB-C18 (4.6 mm×250 mm,5 μm) with a mobile phase of 0.5% formic acid (A)-acetonitrile (B) at a temperature 25℃. The gradient elution program was as follow:0~5 min 24% B, 5~6 min 24%~19% B, 6~25 min 19~20% B. The flow rate was 1.0 ml/min, and the injection volume was 10 μl and the detection wavelength was 286 nm. Results The spots in TLC plates were clear and specific. As for salvianolic acid B, the linear range was 20-1280 μg/ml and the equation of linear regression of salvianolic acid B was Y=13.304 X-117.50 (r=0.9999, n=7). The average recovery rate was 96.17% (RSD=1.10%). Conclusion The method was proved to be simple, reliable, reproducible, and could be used in the quality control of Xinnaoling granules.
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