目的 建立HPLC-一测多评（QAMS）法同时检测乳宁颗粒中柴胡皂苷a、柴胡皂苷d、二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮Ⅱ_A、王不留行环肽A、王不留行环肽B的含量。方法 采用Agilent HC-C₁₈（250 mm×4.6 mm，5 μm）色谱柱，柱温30℃；乙腈-0.1%磷酸为流动相，梯度洗脱，体积流量1.0 mL/min，检测波长分别为210 nm（检测柴胡皂苷a和柴胡皂苷d）和280 nm（检测二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮Ⅱ_A、王不留行环肽A和王不留行环肽B）。以丹参酮Ⅱ_A为内参物，建立其与柴胡皂苷a、柴胡皂苷d、二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、王不留行环肽A、王不留行环肽B的相对校正因子（RCF），计算各成分含量，同时与外标法（ESM）实测值进行比较，以验证HPLC-QAMS法的可行性。结果 柴胡皂苷a、柴胡皂苷d、二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮Ⅱ_A、王不留行环肽A、王不留行环肽B分别在4.08～102.00、2.97～74.25、0.74～18.50、1.56～39.00、1.98～49.50、3.69～92.25、0.66～16.50、0.54～13.50 μg/mL（r≥0.999 1）线性关系良好，平均加样回收率（RSD）分别为100.08%（0.54%）、99.68%（0.67%）、97.85%（1.64%）、98.99%（0.92%）、98.81%（1.35%）、100.06%（0.62%）、96.81%（0.73%）、97.79%（1.41%），乳宁颗粒中各成分一测多评法计算值与外标法实测含量值无显著性差异。结论 所建立的HPLC-QAMS法为乳宁颗粒提供了一种准确可行的多指标质量控制模式。

Objective To establish an HPLC-QAMS method for the determination of saikosaponin a, saikosaponin d, 15, 16-dihydrotanshinone I, cryptotanshinone, tanshinone I, tanshinone II_A, segetalin A and segetalin B in Runing granule. Methods The samples were separated on an Agilent HC-C₁₈ (250 mm×4.6 mm,5 μm),gradient elution conditions were the mobile phase using acetonitrile-0.1% phosphoric acid solution at a flow rate of 1.0 mL/min.The detection wavelength were 210 nm for saikosaponin a and saikosaponin d,and 280 nm for 15,16-dihydrotanshinone I,cryptotanshinone,tanshinone I,tanshinone II_A,segetalin A and segetalin B,the column temperature was 30 ℃.Using tanshinone II_A as an internal standard,the relative correction factors of saikosaponin a, saikosaponin d, 15, 16-dihydrotanshinone I, cryptotanshinone, tanshinone I, segetalin A and segetalin B were calculated, after which the content determination was made.The method was validated by comparison of the quantitative results between external standard method (ESM) and HPLC-QAMS method. Results Saikosaponin a,saikosaponin d, 15, 16-dihydrotanshinone I, cryptotanshinone, tanshinone I, tanshinone II_A, segetalin A and segetalin B showed good linear relationships within the ranges of 4.08 — 102.00, 2.97 — 74.25, 0.74 — 18.50, 1.56 — 39.00, 1.98 — 49.50, 3.69 — 92.25, 0.66 — 16.50 and 0.54 — 13.50 μg/mL (r ≥ 0.999 1), whose average recoveries (RSD) were 100.08% (0.54%), 99.68% (0.67%), 97.85% (1.64%), 98.99% (0.92%), 98.81% (1.35%), 100.06%(0.62%),96.81% (0.73%), 97.79%(1.41%), respectively. No significant differences were found in the quantitative analysis of components by ESM and HPLC-QAMS method. Conclusions The HPLC-QAMS method can provide a accurate and feasible method with determination to establish multi-index component quality evaluation model for Runing granule.

山东省中医药科技发展计划项目（2019-0449）