苦杏仁配方颗粒中苦杏仁苷的定量分析及特征图谱研究

摘要

目的：建立苦杏仁配方颗粒中苦杏仁苷的高效液相色谱分析方法及苦杏仁配方颗粒高效液相色谱特征图谱。方法采用反相高效液相色谱法，色谱柱为Dionex C18（4.6 mm×250 mm，5μm），流动相为乙腈-0.1%磷酸溶液（8∶92），检测波长为207 nm，流速为0.6 mL/min，进样量10μL，柱温为30℃，测定苦杏仁配方颗粒中苦杏仁苷的含量，并以苦杏仁苷峰为参照峰分析10批苦杏仁配方颗粒样品，采用《中药色谱指纹图谱相似度评价系统（2004 A）》进行相似度评价。结果苦杏仁苷的线性方程为Y＝6.176×10-7X－3.058×10-3，在0.1225～1.225μg范围内呈良好的线性关系（r＝0.9998），平均回收率为98.75%（RSD＝1.30%）。苦杏仁配方颗粒的特征图谱由6个共有峰构成，10批样品的相似度≥0.981。结论该方法简便、准确、重复性良好，可用于苦杏仁配方颗粒的质量控制。%ObjectiveTo establish an HPLC analytic method for amygdalin inKuxingrenFormula Granules and HPLC characteristic chromatogram.MethodsRP-HPLC method was adopted. The determination was performed on Dionex C18 column (4.6 mm×250 mm, 5μm) with acetonitrile-0.1% phosphoric acid solution (8:92) at the flow rate of 0.6 mL/min. The detection wavelength was set at 207 nm and sample size was 10μL. The column temperature was 30℃. The peak of amygdalin was set as refernce, and 10 batches of samples were analyzed. TCM Chromatogram Fingerprint Similarity Evaluation System (2004 A) was adopted to evaluate similatity.Results The linear equation of amygdalin wasY=6.176×10-7X−3.058×10-3, with a good linear relationship in the range of 0.122 5–1.225μg (r= 0.999 8). The average recovery rate was 98.75% (RSD=1.30%). There were 6 common peaks in the characteristic chromatogram ofKuxingrenFormula Granules, and the similarity of 10 batches of samples was higher than 0.981. ConclusionThe HPLC method is simple, accurate and reproducible, which can be used for the quality control of Kuxingren Granules.