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目的:建立生津益气口服液的质量标准。方法:采用薄层色谱法对生津益气口服液合剂中的黄芪、五味子、黄连、赤芍进行鉴别,采用HPLC-ELSD法测定黄芪甲苷的含量,色谱柱为Agilent C18柱,流动相为乙腈-水(32∶68),流速为1.0 ml·min-1,进样量为10μL,柱温为35℃,ELSD检测器漂移管温度为100℃,载气流量为2.7 L.min-1。结果:在TLC色谱中黄芪、五味子、黄连、赤芍均能检出;黄芪甲苷在0.11～0.90 mg·ml-1范围内呈良好的线性关系,r=0.999 3。平均加样回收率为97.3%,RSD为1.13%(n=6)。结论:该法简便,准确,专属性强,能有效控制生津益气口服液的质量。
Objective: To establish the quality standard of Shengjin Yiqi Oral Liquid. Methods: Astragalus, Schisandra chinensis, Coptis Chinensis and Radix Paeoniae Rubra in Shengjin Yiqi Oral Liquid Mixture were identified by TLC. The content of Astragaloside Ⅳ was determined by HPLC-ELSD. The mobile phase consisted of acetonitrile - water (32:68) at a flow rate of 1.0 ml · min-1. The injection volume was 10 μL and the column temperature was 35 ° C. The ELSD detector drift tube temperature was 100 ° C and the carrier gas flow was 2.7 L.min-1. Results: Astragalus, Schisandra chinensis, Coptis Chinensis and Radix Paeoniae Rubra were all detected by TLC. Astragaloside showed a good linearity in the range of 0.11-0.90 mg · ml-1, r = 0.999 3. The average recovery was 97.3% with a RSD of 1.13% (n = 6). Conclusion: The method is simple, accurate and specific, and can effectively control the quality of Shengjin Yiqi Oral Liquid.