UPLC法同时测定通脉颗粒中5个主成分的含量及其灰色关联度分析

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 C₁₈色谱柱（4.6 mm×75mm，2.5 μm），以乙腈（A）-0.2%磷酸（B）为流动相，梯度洗脱，流速0.7 mL·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0.011~0.106 μg（r=0.999 9），0.004~0.043 μg（r=0.999 9），0.019~0.193 μg（r=0.999 8），0.008~0.084 μg（r=0.999 9），0.005~0.048 μg（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 UPLC method for simultaneous determination of danshensu,protocatechuic aldehyde,puerarin,daidzin and salvianolic acid B in Tongmai granules. To analyze and evaluate the 5 components with grey relational analysis. Methods: Separation was performed on a XBridge^TM C₁₈ column(4.6 mm×75 mm, 2.5 μm). And the mobile phase consisted of acetonitrile(A) and 0.2% phosphoric acid(B) with gradient elution at a flow rate of 0.7 mL·min^-1. The detection wavelength was 280 nm. Results: Danshensu, protocatechuic aldehyde,puerarin,daidzin and salvianolic acid B showed good linearity in the ranges of 0.011-0.106 μg(r=0.999 9), 0.004-0.043 μg(r=0.999 9), 0.019-0.193 μg(r=0.999 8), 0.008-0.084 μg(r=0.999 9), 0.005-0.048 μg(r=0.999 9), respectively. The average recoveries(n=9) were 99.5%, 95.0%, 96.8%, 97.6%, 100.8%, respectively. Their contents in samples were between 0.18-18.45 mg·g^-1,0.01-0.78 mg·g^-1,0.04-9.75 mg·g^-1, 0.01-1.80 mg·g^-1, 0.05-1.58 mg·g^-1, respectively. Results of grey relational analysis were between 0.25 and 0.72, illustrating that the quality of the products from different manufacturing enterprises was greatly different. Conclusion: The method offered the foundation for the quality control and evaluation of Tongmai granules.

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