目的 建立同时测定枣仁安神胶囊中五味子醇甲、五味子醇乙、隐丹参酮、丹参酮I、丹参酮II_A、五味子乙素的方法，为枣仁安神胶囊的质量控制提供科学的方法。方法 采用HPLC法，选用Thermo 120Å-C₁₈色谱柱（250 mm×4.6 mm，5 μm）；以乙腈-0.1%冰醋酸水溶液为流动相梯度洗脱，对枣仁安神胶囊中6种主要指标性成分的含量进行同时分析测定；检测波长：五味子醇甲、五味子醇乙、五味子乙素为250 nm，隐丹参酮、丹参酮I、丹参酮II_A为270 nm；体积流量1.0 mL/min，柱温为30℃。结果 五味子醇甲在4.7～3 153.6 ng（r=0.999 9）、五味子醇乙在7.864～314.500 ng（r=0.999 9），隐丹参酮在14.4～1 256.9 ng（r=0.999 9）、丹参酮I在15.1～1 103.8 ng（r=0.999 9）、丹参酮II_A在15.3～1 532.0 ng（r=0.999 9）、五味子乙素在6.134～204.500 ng（r=0.999 9）内呈良好的线性关系。平均加样回收率分别为五味子醇甲为100.4%、五味子醇乙为98.7%、隐丹参酮为99.4%、丹参酮I为100.0%、丹参酮II_A为99.3%、五味子乙素100.2%，RSD分别为1.4%、2.7%、2.2%、2.2%、2.5%、2.1%；8批样品中各指标成分的质量分数分别为五味子醇甲1.545 7～1.909 9 mg/g、五味子醇乙0.129 8～0.235 1 mg/g、隐丹参酮0.508 4～0.523 4 mg/g、丹参酮I 0.111 7～0.122 3 mg/g、丹参酮II_A 0.755 8～0.874 4 mg/g、五味子乙素0.120 2～0.190 1 mg/g。结论 建立的含量测定分析方法灵敏度高、专属性强，可很好地控制枣仁安神胶囊质量。

Objective To establish a method for determining the contents of schisandrin, schisandrol B, cryptotanshinone, tanshinone I and tanshinone II_A, γ-schisandrin in Zaoren Anshen Capsules (ZAC), and provide scientific method for quality control of ZAC. Methods HPLC was used by using Thermo 120Å-C₁₈ column, with the mobile phase consisted of acetonitrile and 0.1% acetic acid solution with gradient elution for simultaneous determination of six main index components. The detection wavelengths were set at 250 nm for schisandrin, schisandrol B, γ-schisandrin and 270 nm for cryptotanshinone, tanshinone I, and tanshinone II_A, flow rate was 1.0 mL/min, and column temperature was 30 ℃. Results Schisandrin, schisandrol B, γ-schisandrin, cryptotanshinone, tanshinone I, and tanshinone II_A showed good the linear ranges relationships in the range of 4.7—3 153.6 ng (r=0.999 9), 7.864—314.500 ng (r=0.999 9), 14.4—1 256.9 ng (r=0.999 9), 15.1—1 103.8 ng (r=0.999 9), 15.3—1 532.0 ng (r=0.999 9) and 6.134—204.500 ng (r=0.999 9), respectively. The average recoveries were 100.4%, 98.7%, 99.4%, 100.0%, 99.3% and 100.2%, RSD were 1.4%, 2.7%, 2.2%, 2.2%, 2.5% and 2.1%, respectively. The contents of each index component in 8 batches of sample were schisandrin 1.545 7—1.909 9 mg/g, schisandrol B 0.129 8—0.235 1 mg/g, cryptotanshinone 0.508 4—0.523 4 mg/g, tanshinone I 0.111 7—0.122 3 mg/g, tanshinone II_A 0.755 8—0.874 4 mg/g, γ-schisandrin 0.120 2—0.190 1 mg/g. Conclusion The established analytical method is highly sensitive with strong specificity and it can be used efficiently in the quality control of ZAC.

R286.02

河北省自然科学基金-石药集团医药联合基金（C2011320007）