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目的建立愈宁心软胶囊的质量标准。方法采用薄层色谱法对葛根进行定性鉴别。采用高效液相色谱法测定葛根素的含量,色谱柱为Agilent HC-C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-水-磷酸(47∶53∶0.2),检测波长为250 nm,流速为1.0 m L/min,柱温为室温,进样量为10μL。结果在选定的薄层色谱条件下,层析斑点清晰,分离效果好,阴性对照无干扰。含量测定时,葛根素质量浓度在84.4~422.0μg/m L范围内与峰面积线性关系良好(r=0.999 3),平均回收率为95.13%,RSD为3.09%(n=6)。结论该方法简便、准确、可靠,可作为愈宁心软胶囊的质量控制方法。
Objective To establish the quality standard of Yu Ningxin Soft Capsule. Methods The kudzu roots were identified by TLC. The content of puerarin was determined by HPLC. The column was Agilent HC-C18 column (150 mm × 4.6 mm, 5 μm). The mobile phase was methanol-water-phosphoric acid (47:53:0.2) and the detection wavelength was 250 nm, the flow rate was 1.0 m L / min, the column temperature was room temperature, the injection volume was 10 μL. Results In the selected TLC conditions, the chromatographic spots were clear and the isolation effect was good. The negative control had no interference. The content of puerarin in the range of 84.4-422.0 μg / mL was linear with the peak area (r = 0.999 3). The average recovery was 95.13% and the RSD was 3.09% (n = 6). Conclusion The method is simple, accurate and reliable and can be used as quality control method of Yu Ning Xin soft capsules.