目的 建立以葛根素为内标物，测定葛根芩连丸中大豆苷、药根碱、巴马汀、大豆苷元、黄芩素、汉黄芩素等多个指标性成分量的一测多评法（QAMS）。方法 采用Waters超高效液相色谱系统，以Acquity BEH C₁₈色谱柱，流动相甲醇-0.1%冰醋酸水溶液梯度洗脱，检测波长260 nm，体积流量0.3 mL/min，柱温30℃进行测定。以葛根素作为内标物，建立制剂中其他6种指标成分的相对校正因子（f_s/x），从而计算各待测成分的量，并将QAMS计算值与外标法（ESM）实测值进行比较，以验证QAMS的准确性和方法适宜性。结果 在各待测成分线性范围内，葛根芩连丸中的葛根素与大豆苷、药根碱、巴马汀、大豆苷元、黄芩素、汉黄芩素6种有效成分的f_s/x重现性良好，分别为1.02、1.07、1.05、1.32、0.62、0.90；采用QAMS测定的10个批次葛根芩连丸样品中7种指标成分量与外标法（ESM）的实测值之间无显著性差异；其中7种指标性成分葛根素、大豆苷、药根碱、巴马汀、大豆苷元、黄芩素和汉黄芩素在10个批次中的质量分数分别为8.923~10.746 mg/g、2.231~2.988 mg/g、0.825~1.197 mg/g、1.274~1.522 mg/g、2.330~2.713 mg/g、0.836~0.951 mg/g、0.901~1.092 mg/g。结论 以葛根素为内标物，建立的QAMS方便快捷，结果准确可靠，可用于葛根芩连丸多指标成分质量控制，为葛根芩连丸的质量评价提供参考。

Objective To develop a quantitative analysis multi-components by single marker (QAMS) method for the quantification of multiple characteristic components, namely, puerarin, daidzin, jatrorrhizine, palmatine, soybean glycol, wogonoside, wogonin, in Gegen Qinlian Pills (GQP) with puerarin as the internal reference. Methods Samples were analyzed by Waters ultra-high efficiency liquid chromatography (UPLC) system, equipped with a reverse phase Acquity BEH C₁₈ chromatographic column, with the mobile phase of methanol-0.1% phosphoric acid solution at a flow rate of 0.3 mL/min. The column temperature and the detection wavelength set at 30℃ and 260 nm respectively. Based on puerarin as the internal reference, the relative correction factors (RCFs) with other six characteristic components were calculated, then compared with the external standard method. This result benefits to verify the accuracy and advantages of the established QAMS method. Results Under the linear range of determination, RCFs of daidzin, jatrorrhizine, palmatine, soybean glycol, wogonoside, wogonin with reference to puerarin, were 1.02, 1.07, 1.05, 1.32, 0.62, and 0.90 in GQP, respectively. And the repeatability was good in different experimental conditions. Moreover, there was no significant difference on the quantitative results of seven characteristic components, derived from between external standard method and QAMS method in the 10 batches of GQP samples. The range of seven characteristic components contents in the 10 batches of GQP samples, namely puerarin, daidzin, jatrorrhizine, palmatine, soybean glycol, wogonoside and wogonin, were 8.923-10.746 mg/g, 2.231-2.988 mg/g, 0.825-1.197 mg/g, 1.274-1.522 mg/g, 2.330-2.713 mg/g, 0.836-0.951 mg/g, and 0.901-1.092 mg/g, respectively. Conclusion In present study, a feasible, convenient and accurate QAMS method with puerarin as the internal reference was established. Therefore, it is suitable to quantify multiple characteristic components in GQP and provide a useful approach for the quality control of GQP.

四川省教育厅高校科研创新团队（17TD0010）；药食同源植物资源开发四川省高校重点实验室（10Y201703）