一测多评法测定保心宁片中6个丹参类指标性成分的含量

目的：建立同时测定保心宁片中6个指标性成分的高效液相色谱分析方法。方法：采用Capcell C₁₈色谱柱（4.6 mm×250 mm，5 μm），以乙腈-0.05%磷酸水作为流动相进行梯度洗脱，流速0.8 mL·min^-1，柱温30℃，检测波长270 nm；以丹酚酸B为内参物，建立其与迷迭香酸、二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮Ⅱ_A之间的相对校正因子（f_k/s）；采用外标法测定保心宁片中丹酚酸B的量，通过f_k/s计算保心宁片中其他5种成分的量，并将采用一测多评测定的实验结果与采用外标法测定的结果进行t检验。结果：各成分f_k/s重现性良好，采用f_k/s计算的含量与外标法实测值无显著性差异。结论：本实验所建立的f_k/s重复性良好，可用于保心宁片中多个成分的定量分析质量评价。

Objective: To develop a method for simultaneous determination for six active components in Baoxinning tablets.Methods: An HPLC method was used and the analysis was performed on Capcell C₁₈(4.6 mm×250 mm,5 μm)column. The mobile phase was acetonitrile-0.05% H₃PO₄ solution with gradient elution. The flow rate was 0.8 mL·min^-1; the column temperature was 30℃ and the detection wavelength was 270 nm. The relative correction factors(f_k/s)of salvianolic acid B as internal reference to rosmarinic acid, dihydrotanshioneⅠ, crytotanshinone, tanshinoneⅠ, tanshinone Ⅱ_A, were calculated, respectively. The content of salvianolic acid B was determined by external standard method and the contents of above five components were calculated by f_k/s in Baoxinning tablets. The results between external standard method(ESM)and quantitative analysis of multi-components bya single marker(QAMS)method were compared with t-test.Results: The reproducibility of f_k/s from each component was good. No significant differences were found in the results between QAMS and ESM.Conclusion: The method for f_k/s is reproducible and suitable to evaluate the quality of Baoxinning tablets.