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目的:制订清肺止咳糖浆的质量标准。方法:采用薄层色谱法对处方中麻黄、桔梗进行定性鉴别;采用高效液相色谱法测定样品中黄芩苷的含量,色谱条件为:Lichrospher C18(4.6mm×150mm,5μm)柱为分析柱;甲醇-0.2%磷酸溶液(44∶56)为流动相;流速1mL·min-1;检测波长280nm;柱温35℃。结果:薄层色谱法鉴别方法专属性强,阴性对照无干扰;含量测定结果表明,黄芩苷进样量在0.06～0.45μg范围内与峰面积响应值呈良好线性关系(r=0.9998),平均回收率为98.52%(RSD为0.61%,n=6)。结论:本方法准确、简便,专属性、重现性好,可用于清肺止咳糖浆的质量控制。
Objective: To establish the quality standards for Qingfei Zhike Syrup. Methods: The qualitative identification of ephedra and Platycodon grandiflorum in the formulation was determined by TLC. The content of baicalin in the sample was determined by high performance liquid chromatography. The chromatographic conditions were as follows: Lichrospher C18 (4.6 mm × 150 mm, 5 μm) was the analytical column. Methanol-0.2% phosphoric acid solution (44:56) was used as mobile phase; flow rate was 1 mL·min-1; detection wavelength was 280 nm; column temperature was 35°C. RESULTS: The TLC identification method was highly specific and the negative control was not interfered. The results of the content determination showed that there was a good linear relationship (r=0.9998) between the range of 0.06-0.45 μg injection of baicalin and the peak area response value. The recovery was 98.52% (RSD 0.61%, n=6). Conclusion: The method is accurate, simple, specific and reproducible, and can be used for quality control of Qingfei Zhike syrup.