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目的:建立以丹参酮ⅡA内参物,同时测定冠心丹颗粒中丹参素钠、原儿茶醛、丹酚酸B、丹参酮ⅡA的一测多评HPLC法。方法:以丹参酮ⅡA为内参物,确定其他3种成分相对于丹参酮ⅡA的校正因子,通过相对校正因子(RCF)对丹参素钠、原儿茶醛、丹酚酸B进行定量,实现一测多评(计算法);同时采用外标法测定冠心丹参粒中4种成分的含量(实测法),并比较一测多评法与外标法测定结果的差异。结果:在一定的线性范围内,丹参酮ⅡA与丹参素钠、原儿茶醛、丹酚酸B的相对校正因子分别为0.299 9,1.991 7,0.424 4;且在不同实验条件下重复性良好(RSD分别为1.33%、1.44%、4.00%);3批冠心丹参颗粒中4种成分按一测多评方法与外标法测定结果基本一致(RSD<3.0%)。结论:可有效地控制冠心丹参颗粒的内在质量。
OBJECTIVE: To establish a multiplex HPLC assay for the determination of tanshinone ⅡA, protocatechuic aldehyde, salvianolic acid B and tanshinone ⅡA in Guanxin Dan granules. Methods: Tanshinone Ⅱ A was used as an internal control to determine the calibration factors of the other three components relative to tanshinone ⅡA. The relative calibration factors (RCFs) were used to quantify sodium danshensu, protocatechuic aldehyde and salvianolic acid B, (Calculation method). At the same time, the contents of four components in Guanxin Danshen Granules were measured by external standard method (actual measurement), and the difference between the results of multiple test and external standard test was compared. Results: The relative calibration factors of tanshinone ⅡA and sodium danshensu, protocatechuic aldehyde and salvianolic acid B were 0.299 9, 1.991 7 and 0.424 4, respectively, within a certain linear range. And the repeatability was good under different experimental conditions RSD were 1.33%, 1.44% and 4.00%, respectively). The results of the four components of the three batches of Danshen Danshen Granules were basically consistent with the external standard method (RSD <3.0%). Conclusion: It can effectively control the intrinsic quality of Danshen Danshen granules.