Objective To establish the quality standard of Zishen capsule. Methods Paeoniae Radic Alba, Ziziphi Spinosae Semen, Lilii Bulbus and Polygoni Multiflori Caulis in Zishen capsule were identified by TLC. Super high performance liquid chromatography (UPLC) was used to determine the content of paeoniflorin, the main active ingredient of Paeoniae Radic Alba. The chromatography column was ACQUTTY UPLC BEH C18 (2.1 mm×50 mm, 1.7 μm). The mobile phase was acetonitrile-water (16 : 84), flow rate was 0.250 mL/min, column temperature was 30 ℃, and the detection wavelength was 230 nm. Results TLC spots were clear and easy to identify. Paeoniflorin showed a linear relationship in the range of 0.031—0.248 μg, r=0.999 9. The average recovery rate was 99.30%, and RSD was 0.99% (n=6). Conclusion This method is rapid, simple, and greatly reduces the time of analysis. It can be used as the qualitative and quantitative research methods of Zishen capsule.%目的 建立紫参胶囊的质量控制的方法.方法 采用薄层色谱法对方中的白芍、酸枣仁、百合、首乌藤进行定性鉴别.采用超高效液相色谱法对方中白芍的主要活性成分芍药苷进行含量测定.色谱柱:ACQUITY UPLC BEH C18(2.1mm×50mm,1.7 μm)；流动相:乙腈-水(16∶84)；流速:0.250mL/min;柱温:30℃；检测波长:230 rm.结果 薄层色谱鉴别斑点清晰,易于鉴别.芍药苷在0.031 ～ 0.248 μg范围内线性关系良好,r=0.999 9；平均加样回收率为99.30％,RSD=0.99％(n=6).结论 本方法快速、简单,大大缩短了分析时间,可用于紫参胶囊定性定量研究.
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