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目的:建立超高效液相色谱法同时测定通脉颗粒中丹参素、原儿茶醛、葛根素、大豆苷和丹酚酸B含量,并通过灰色关联度分析法对5种成分进行分析评价。方法:采用XBridge~(TM) C_(18)色谱柱(4.6 mm×75 mm,2.5μm),以乙腈(A)-0.2%磷酸(B)为流动相,梯度洗脱,流速0.7 m L·min~(-1),测定波长280 nm。结果:通脉颗粒中丹参素、原儿茶醛、葛根素、大豆苷和丹酚酸B进样量分别在0.011~0.106μg(r=0.999 9),0.004~0.043μg(r=0.999 9),0.019~0.193μg(r=0.999 8),0.008~0.084μg(r=0.999 9),0.005~0.048μg(r=0.999 9)范围内呈良好线性关系,平均回收率(n=9)分别为99.5%、95.0%、96.8%、97.6%、100.8%;含量测定结果分别在0.18~18.45、0.01~0.78、0.04~9.75、0.01~1.80、0.05~1.58 mg·g~(-1)之间。通过灰色关联度方法分析,结果在0.25~0.72之间,表明各生产企业之间产品质量差异较大。结论:该方法为通脉颗粒的质量控制和评价奠定了基础。
OBJECTIVE: To establish a method for the simultaneous determination of Danshensu, protocatechuic aldehyde, puerarin, daidzin and salvianolic acid B in Tongmai Granules by ultra performance liquid chromatography (HPLC). The five components were analyzed and evaluated by gray relational analysis. Methods: The gradient elution was performed on a XBridge C18 column (4.6 mm × 75 mm, 2.5 μm) using acetonitrile-A (0.2% phosphoric acid) as mobile phase with a flow rate of 0.7 mL · min ~ (-1), the determination wavelength of 280 nm. Results: The injection volume of Danshensu, protocatechuic aldehyde, puerarin, daidzin and salvianolic acid B in Tongmai Granule were 0.011-0.106μg (r = 0.999 9), 0.004-0.043μg (r = 0.999 9) (R = 0.999 8), 0.008 ~ 0.084 μg (r = 0.999 9) and 0.005 ~ 0.048 μg (r = 0.999 9) respectively. The average recoveries (n = 9) 99.5%, 95.0%, 96.8%, 97.6% and 100.8%, respectively. The determination results of contents were between 0.18 ~ 18.45,0.01 ~ 0.78,0.04 ~ 9.75,0.01 ~ 1.80,0.05 ~ 1.58 mg · g ~ (-1) respectively. Through the method of gray relational analysis, the result is between 0.25 and 0.72, indicating that there is a great difference in product quality among various manufacturing enterprises. Conclusion: This method laid the foundation for the quality control and evaluation of Tongmai granules.