目的 采用UPLC-MS/MS法测定麦冬Ophiopogonis Radix多指标成分结合偏最小二乘法-判别分析（partial least squares-discriminant analysis，PLS-DA）、熵权-TOPSIS法对不同厂家参麦颗粒质量进行综合评价。方法 采用UPLC-MS/MS法同时测定3家厂家85批参麦颗粒中麦冬苷元-3-O-α-L-吡喃鼠李糖-β-D-吡喃葡萄糖苷、龙脑7-O-[β-D-呋喃芹菜糖基-(1→6)]-β-D-吡喃葡萄糖苷、麦冬皂苷C、麦冬皂苷D、短葶山麦冬皂苷C、山麦冬皂苷B、甲基麦冬高黄酮A、甲基麦冬高黄酮B、甲基麦冬黄烷酮A、甲基麦冬黄烷酮B、麦冬黄烷酮A和对香豆酸12个麦冬成分的含量，运用PLS-DA及熵权-TOPSIS法建立参麦颗粒中投料用麦冬饮片综合质量优劣评价方法。结果 12个成分分别在考察的质量浓度范围内线性关系良好（r＞0.998 9），加样回收率为95.3%～105.3%，RSD值均小于2.9%，精密度、重复性、稳定性考察均符合分析要求。85批样品差异明显，甲基麦冬黄烷酮B、麦冬皂苷D、甲基麦冬高黄酮B、甲基麦冬黄烷酮A、甲基麦冬高黄酮A、麦冬苷元-3-O-α-L-吡喃鼠李糖-β-D-吡喃葡萄糖苷和麦冬皂苷C是影响参麦颗粒中麦冬质量的主要潜在标志物；熵权-TOPSIS法可用于不同厂家参麦颗粒中投料用麦冬的质量优劣的评价。结论 建立的多指标成分定量测定方法操作便捷、结果准确，结合PLS-DA及熵权-TOPSIS法可用于参麦颗粒中投料用麦冬的质量的综合评价。

Objective To comprehensively evaluate the quality of Shenmai Granules (参麦颗粒, SG) from different manufacturers by using UPLC-MS/MS method to determine the multi-indicator components of Maidong (Ophiopogonis Radix) combined with partial least squares discriminant analysis (PLS-DA) and entropy weight (EW)-TOPSIS mothod. Methods The UPLC-MS/MS method was used to simultaneously determine the contents of 12 Ophiopogon japonicus components, including ophiogenin-3-O-α-L-rhamnopyranosyl-(1→2)-β-D-glucopyranoside, borneol 7-O-[β-D-apiofuranosyl-(1→6)]-β-D-glucopyranoside, ophiopojaponin C, ophiopojaponin D, liriope muscari baily saponins C, liriopesides B, methylophiopogonone A, methylophiopogonone B, methylophiopogonanone A, methylophiopogonanone B, ophiopogonanone A and p-coumaric acid in 85 batches of SG from three manufacturers. A comprehensive quality evaluation method for the Ophiopogon japonicus in SG was established using PLS-DA and EW-TOPSIS. Results The 12 components showed good linear relationships in their own ranges. The average recovery were 95.3%—105.3%, the RSDs were all less than 2.9%, and the precision, repeatability, and stability tests met the analytical requirements. The samples showed significant differences, methylophiopogonanone B, ophiopojaponin D, methylophiopogonone B, methylophiopogonanone A, methylophiopogonone A, ophiogenin 3-O-α-L-rhamnopyranosyl-(1→2)-β-D-glucopyranoside and ophiopojaponin C were the main potential markers affecting the quality. The EW-TOPSIS method can be used to evaluate the quality of O. japonicus used in different manufacturers’ SG. Conclusion The established multi-index ingredients quantitative determination method is convenience and accuracy, and the combination of PLS-DA and EW-TOPSIS method can be used for the comprehensive evaluation of the quality of Ophiopogonis Radix for feeding in SG.

R283.6

中国药品监管科学行动计划第二批重点项目（NMPAJGKX-2023-024）;国家药品抽检计划（2022-38）