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目的:建立以高效液相色谱法测定神安颗粒中斯皮诺素含量的方法,建立神安颗粒多指标质量控制体系中水溶性成分的控制指标。方法:色谱柱为Kromasil C18柱,流动相以乙腈和水进行梯度洗脱,检测波长为335 nm,流速为1.0 mL/min,柱温为室温,进样量为10μL。结果:斯皮诺素进样量在0.024～0.192μg范围内与峰面积积分值线性关系良好(R2=0.9995),平均回收率为98.85%(RSD=1.72%)。结论:本方法简便、快捷、专属性强、重现性好,可用于神安颗粒水溶性成分的质量控制。
OBJECTIVE: To establish a HPLC method for the determination of spinosin in Shenan granules, and to establish a control index for the water-soluble components in the multi-index quality control system of Shen’an granules. METHODS: The column was Kromasil C18. The mobile phase was eluted with acetonitrile and water gradient. The detection wavelength was 335 nm, the flow rate was 1.0 mL / min, the column temperature was room temperature and the injection volume was 10 μL. Results: The injection volume of spinosyn had a good linear relationship with the integral of peak area (R2 = 0.9995) in the range of 0.024-0.1992 μg with an average recovery of 98.85% (RSD = 1.72%). Conclusion: The method is simple, rapid, specific, reproducible, and can be used for quality control of water-soluble components of Shen’an granules.