神安颗粒多指标质量控制体系的研究分析——HPLC法建立神安颗粒中斯皮诺素含量测定的研究

Study and Analysis on Multitude Index Quality Control System of Shenan Granules——Study on Setup Content Determination of Spinosin in Shenan Granules by HPLC Method

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 content determination of Spinosin in Shenan Granules and to establish water -soluble constituent controlling index of multitude index quality control system of Shenan Granules. Methods ： HPLC was performed on Kromasil C- 18 column, the mobile phase consisted of acetonitrile and water mach gradient elution, the detection wavelength was 203 nm, flow rate was 1.0 mL/min, column temperature room temperature, sample size was 10 μL. Results ： Spinosin was linear with the peak area in the range of 0.030 ～ 0. 240 μg （ R2 = 0. 9995 ）, the average recovery was 98.85 % （ RSD = 1. 72% ）. Conclusion：The established method.is simple, shortcut, well specificity and reproducible. And thus it can be used for the quality control of water - solubility constituent quality of Shenan Granules.