苦杏仁配方颗粒中苦杏仁苷的定量分析及特征

苦杏仁配方颗粒中苦杏仁苷的定量分析及特征图谱研究

作者：王迎春 麻景梅 李斯 李军山 李振江 牛丽颖

来源：《中国中医药信息》2016年第05期

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，5 μm)，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10 μL，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0.122 5～1.225 μg范围内呈良好的线性关系(r=0.999 8)，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。

关键词：苦杏仁配方颗粒;高效液相色谱法;苦杏仁苷;含量测定;特征图谱

中图分类号：R284.1 文献标识码：A 文章编号：1005-5304(2016)05-0087-04

Quantitative Analysis of Amygdalin in Kuxingren Formula Granules and Study on Characteristic Chromatogram WANG Ying-chun1，2，3， MA Jing-mei1，2，3， LI Si1， LI Jun-shan2，3，4， LI Zhen-jiang2，3，4， NIU Li-ying1，2，3 (1. Hebei University of Chinese Medicine，

Shijiazhuang 050091， China; 2. Hebei TCM Formula Granule Engineering & Technology Research Center， Shijiazhuang 050091， China; 3. TCM Formula Granule Research Center of Hebei Province University， Shijiazhuang 050091， China; 4. Shineway Pharmaceutical Group Ltd， Shijiazhuang 051430， China)

Abstract： Objective To establish an HPLC analytic method for amygdalin in Kuxingren

Formula Granules and HPLC characteristic chromatogram. Methods RP-HPLC method was adopted. The determination was performed on Dionex C18 column (4.6 mm×250 mm， 5 μm) 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 10 μL. 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 was Y=6.176×10-7X−3.058×10-3， with a good linear relationship in the range of 0.122 5–1.225 μg (r= 0.999 8). The average recovery rate was 98.75% (RSD=1.30%). There were 6 common peaks in the characteristic chromatogram of Kuxingren Formula Granules， and the similarity of 10 batches of samples was higher than 0.981.