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目的建立甘麦宁心胶囊的质量标准。方法采用薄层色谱法(TLC)对麦冬、桂枝和人参成分进行定性鉴别;采用高效液相色谱法(HPLC)对梓醇的含量测定方法,色谱柱:SHISEIDO C_(18)(4.6 mm×250 mm,5μm),流动相为乙腈:0.1%磷酸水溶液(1:99),检测波长为210 nm,流速为1.0 mL/min,柱温为30℃。结果薄层色谱中,斑点清晰,易于识别,重复性好;含量测定中,梓醇在0.02~0.6μg范围内线性关系良好(r=0.9999),平均回收率为99.43%(RSD=1.21%,n=6)。结论该质量控制方法简单,精密度高,重复性好,专属性强,可用于甘麦宁心胶囊的质量控制。
Objective To establish the quality standard of Ganmai Ningxin capsule. Methods The contents of Radix Ophiopogonis, Guizhi and Ginseng were identified by TLC. The content of catalpol was determined by high performance liquid chromatography (HPLC). The chromatographic column was SHISEIDO C 18 (4.6 mm × 250 mm, 5μm). The mobile phase was acetonitrile: 0.1% phosphoric acid (1:99), the detection wavelength was 210 nm, the flow rate was 1.0 mL / min and the column temperature was 30 ℃. Results In TLC, the spots were clear and easy to identify with good repeatability. The determination of catalpol in the range of 0.02-0.6 μg showed good linearity (r = 0.9999) with an average recovery of 99.43% (RSD = 1.21% n = 6). Conclusion The quality control method is simple, high precision, reproducibility, specificity, and can be used for quality control Ganmaining capsule.