目的 建立HPLC波长切换法同时测定益安宁丸中7种活性成分的方法。方法 采用HPLC法，同时测定益安宁丸中三七皂苷R₁、五味子醇甲、丹酚酸B、五味子酯甲、人参皂苷Rg₁、人参皂苷Rb₁、丹参酮Ⅱ_A的含量，采用Shim-pack GIST-C₁₈色谱柱（250 mm×4.6 mm，5μm），流动相为乙腈-0.1%磷酸水溶液，梯度洗脱：0～5 min，5%乙腈；5～12 min，5%～12%乙腈；12～17 min，12%～20%乙腈；17～30 min，20%乙腈；30～36 min，20%～50%乙腈；36～45 min，50%～80%乙腈；45～70 min，80%乙腈；检测波长203 nm（三七皂苷R₁、人参皂苷Rg₁、人参皂苷Rb₁）、220 nm（五味子酯甲）、250 nm（五味子醇甲）、268 nm（丹酚酸B）和270 nm（丹参酮Ⅱ_A），体积流量1.0 mL/min，柱温35℃，进样量10 μL。结果 三七皂苷R₁、五味子醇甲、丹酚酸B、五味子酯甲、人参皂苷Rg₁、人参皂苷Rb₁、丹参酮Ⅱ_A检测质量浓度的线性范围分别为0.015～0.150、0.077～0.766、0.006～0.062、0.009～0.092、0.050～0.503、0.067～0.670、0.011～0.108 mg/mL；平均加样回收率分别为99.5%、99.8%、99.2%、98.9%、96.9%、98.8%、97.1%。结论 该方法简单、有效、结果准确，可用于益安宁丸中上述7种活性成分的同时测定。

Objective To establish an HPLC method for the simultaneous content determination of seven constituents in Compound Yi’anning Pills (CYP). Methods The determination was performed on Shim-pack GIST C₁₈ column with mobile phase consisted of acetonitrile-0.1% phosphoric acid (gradient elution: 0—5 min, 5% acetonitrile; 5—12 min, 5%—12% acetonitrile; 12—17 min, 12%—20% acetonitrile; 17—30 min, 20% acetonitrile; 30—36 min, 20%—50% acetonitrile; 36—45 min, 50%—80% acetonitrile; 45—70 min, 80% acetonitrile) at the flow rate of 1.0 mL/min. The detection wavelength was set at 203 nm for notoginsenoside R₁, ginsenoside Rg₁, and ginsenoside Rb₁, 220 nm for schisantherrin A, 250 nm for schisandrin, 268 nm for salvianolic acid B, and 270 nm for tanshinone Ⅱ_A. The column temperature was set at 35 ℃ and the injection volume was 10 μL. Results The linear range of detection concentration was 0.015—0.150 mg/mL for notoginsenoside R₁, 0.077—0.766 mg/mL for schisandrin, 0.006—0.062 mg/mL for salvianolic acid B, 0.009—0.092 mg/mL for buddleodide, 0.050—0.503 mg/mL for ginsenoside Rg₁, 0.067—0.670 mg/mL for ginsenoside Rb₁, and 0.011—0.108 mg/mL for tanshinone Ⅱ_A. Average recoveries respectively were 99.5%, 99.8%, 99.2%, 98.9%, 96.9%, 98.8%, and 97.1%. Conclusion The method is simple, effective, and accurate, which can be used for simultaneous determination of seven active constituents in CYP.

河南省高等学校重点科研项目（13A360587）