目的 建立测定蒙药扎冲十三味丸中8种成分（没食子酸、绿原酸、沉香四醇、鞣花酸、丁香酚、α-细辛脑、β-细辛醚、甘草酸铵）含量的一测多评（QAMS）方法。方法 采用HPLC法，以Inertsil ODS-3色谱柱（250 mm×4.6 mm，5 μm），甲醇-0.1%磷酸水溶液为流动相，梯度洗脱，柱温30℃，体积流量1.0 mL/min，检测波长：0~7 min，271 nm；7~20 min，252 nm；20~28 min，254 nm；28~33 min，281 nm；33~45 min，257 nm；45~55 min，237 nm；以丁香酚为内参物，建立与其他7种待测成分的相对校正因子（f_s/i），并采用2台不同高效液相色谱仪和3根不同色谱柱对所建立的f_s/i进行耐用性考察，从而用QAMS法测定各待测成分的含量。同时采用外标法测定3个批次蒙药扎冲十三味丸中8种成分的含量，比较2种方法测定的结果，并验证所建立一测多评法的准确性。结果 蒙药扎冲十三味丸中没食子酸、绿原酸、沉香四醇、鞣花酸、α-细辛脑、β-细辛醚、甘草酸铵7种成分的f_s/i重现性良好，分别为0.433 4、1.068 3、0.505 6、0.141 6、0.429 0、0.346 2、1.748 8。一测多评法与外标法测定结果无显著性差异。结论 以丁香酚为内参物，所建立的一测多评法方便快捷，结果准确可靠，可用于蒙药扎冲十三味丸多指标成分质量控制，为蒙药扎冲十三味丸的质量评价提供参考。

Objective Using eugenol as internal reference material to establish a method for the determination of eight components (gallic acid, chlorogenic acid, agarotetraol, ellagic acid, eugenol, β-asarone, α-asarone, and ammonium glycyrrhizinate) in Mongolian medicine Zhachong Shisanwei Pills (ZSP) by QAMS method. Methods An inertsil ODS-3 column (250 mm×4.6 mm, 5 μm), methanol-0.1% phosphoric acid solution as mobile phase, gradient elution, column temperature of 30℃, flow rate of 1.0 mL/min, detection wavelength:0-7 min, 271 nm; 7-20 min, 252 nm; 20-28 min, 254 nm; 28-33 min, 281 nm; 33-45 min, 257 nm; 45-55 min, 237 nm. The relative correction factors (f_s/i) were established with the other 7 components to be measured using eugenol as the internal reference, and the durability of the established f_s/i was investigated by using two different HPLC instruments and three different columns, so that the content of each component to be measured could be determined by QAMS method. At the same time, the external standard method was used to determine the contents of eight components in three batches of ZSP. The results of the two methods were compared, and the accuracy of the established one-test-multi-assessment method was verified. Results The relative correction factors of gallic acid, chlorogenic acid, agar tetraol, ellagic acid, β-asarone, α-asarone and ammonium glycyrrhizinate in ZSP were reproducible with good reproducibility, which were 0.433 4, 1.068 3, 0.505 6, 0.141 6, 0.429 0, 0.346 2, and 1.748 8, respectively. There was no significant difference between the results of multiple evaluation method and external standard method. Conclusion With eugenol as the internal reference material, the established method is convenient, rapid, accurate and reliable, which can be used for the quality control of Mongolian medicine ZSP.

R286.02

国家重点研发计划项目：蒙医防治优势病种经典方药研发平台及质量体系建设和示范研究（2018YFC1708200）；内蒙古自治区科技重大专项（2019ZD004）；内蒙古自治区人民政府蒙医药标准化项目（2020-MB019）