目的 采用UPLC-MS/MS法測定麥冬Ophiopogonis Radix多指標成分結合偏最小二乘法-判別分析（partial least squares-discriminant analysis，PLS-DA）、熵權-TOPSIS法對不同廠家參麥顆粒質量進行綜合評價。方法 采用UPLC-MS/MS法同時測定3家廠家85批參麥顆粒中麥冬苷元-3-O-α-L-吡喃鼠李糖-β-D-吡喃葡萄糖苷、龍腦7-O-[β-D-呋喃芹菜糖基-(1→6)]-β-D-吡喃葡萄糖苷、麥冬皂苷C、麥冬皂苷D、短葶山麥冬皂苷C、山麥冬皂苷B、甲基麥冬高黃酮A、甲基麥冬高黃酮B、甲基麥冬黃烷酮A、甲基麥冬黃烷酮B、麥冬黃烷酮A和對香豆酸12個麥冬成分的含量，運用PLS-DA及熵權-TOPSIS法建立參麥顆粒中投料用麥冬飲片綜合質量優(yōu)劣評價方法。結果 12個成分分別在考察的質量濃度范圍內線性關系良好（r＞0.998 9），加樣回收率為95.3%～105.3%，RSD值均小于2.9%，精密度、重復性、穩(wěn)定性考察均符合分析要求。85批樣品差異明顯，甲基麥冬黃烷酮B、麥冬皂苷D、甲基麥冬高黃酮B、甲基麥冬黃烷酮A、甲基麥冬高黃酮A、麥冬苷元-3-O-α-L-吡喃鼠李糖-β-D-吡喃葡萄糖苷和麥冬皂苷C是影響參麥顆粒中麥冬質量的主要潛在標志物；熵權-TOPSIS法可用于不同廠家參麥顆粒中投料用麥冬的質量優(yōu)劣的評價。結論 建立的多指標成分定量測定方法操作便捷、結果準確，結合PLS-DA及熵權-TOPSIS法可用于參麥顆粒中投料用麥冬的質量的綜合評價。

Objective To comprehensively evaluate the quality of Shenmai Granules (參麥顆粒, 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

中國藥品監(jiān)管科學行動計劃第二批重點項目（NMPAJGKX-2023-024）;國家藥品抽檢計劃（2022-38）