目的 对复方酸枣仁颗粒的质量标准进行研究.方法 采用薄层色谱法(TLC)对制剂中的酸枣仁、知母、甘草三味药材进行专属性鉴别;采用高效液相色谱法(HPLC)对处方中药材知母的有效成分芒果苷进行含量测定.色谱柱为Welchrom C18 HPLC Column(4.6 mm×200 mm,5μm);流动相为甲醇-乙腈-0.5％的乙酸水(7∶7∶86),检测波长为258 nm,进样量为10μL,流速为1.0 mL/min,柱温为30℃.结果 酸枣仁、知母、片草三味药材的TLC特征斑点清晰,分离度好,阴性没有干扰.芒果苷在1.072～167.5 μg/mL的浓度范围内呈良好的线性关系,回归方程为Y=42 888X-30 400,r=0.999 9.平均加样回收率为99.15％,RSD=2.82％(n=6).3批样品中芒果苷的含量分别为0.1690、0.2473、0.2735 mg/g,符合要求.结论 所建立的质量标准准确、重复性良好,可用于复方酸枣仁颗粒的质量控制.%Objective To establish the quality standard for Fufang Suanzaoren Granules.Methods Ziziphi spinosae semen,Anemarrhenae rhizome,Glycyrrhizae radix et rhizoma were identified by TLC.The contents of mangiferin were determined by HPLC.HPLC method on mangiferin was adopted on a Welchrom C18 (4.6 mm×200 mm,5 μm) column with Methanol-acetonitrile-0.5％ acetic acid (7∶7∶86) as the mobile phase,the flow rate was 1.0 mL/min,the detection wavelength was 258 nm,the column temperature was 30℃ and the injection volum was 10 μL.Results TLC spots of Ziziphi spinosae semen,Anemarrhenae rhizome,Glycyrrhizae radix et rhizoma were clear with good resolution and without interference of negative samples.There was a good linearity within the range of 1.072-167.5 μg/mL,with the linear equation of Y=42 888X-30 400,r =0.999 9.The average recovery of berberine hydrochloride was 99.15％ and the RSD was 2.82％ (n =6).The content of Mangiferin in three batchs samples were satisfactory.Conclusion The method is simple,accurate and reproducible.It can be used as the quality control method of Fufang Suanzaoren Granules.
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