清肠栓中没食子酸、靛蓝和靛玉红含量测定

Content Determination of Gallic Acid and Indigo and Indirubin in Intestine-Clearing Suppository

目的:建立清肠栓中没食子酸、靛蓝、靛玉红的含量测定方法。方法:采用UPLC法测定没食子酸、靛蓝和靛玉红的含有量,没食子酸:流动相0.5%磷酸水溶液乙腈=973;检测波长203 nm;体积流量0.3 mL·min^(-1);柱温30℃。靛蓝、靛玉红:流动相水乙腈=3565;检测波长290 nm;体积流量0.3 mL·min^(-1);柱温30℃。结果:没食子酸在0.21～2.10μg范围内线性关系良好,平均回收率大于95%;靛蓝在0.29～2.90μg范围内线性关系良好,平均回收率大于95%;靛玉红在0.02～0.21μg范围内线性关系良好,平均回收率大于95%。结论:据此建立的含量测定方法比较稳定,可以控制清肠栓的质量,同时也可以一定程度通过指标成分含量的多少,反映其疗效。

Objective:To establish a method for the content determination of gallic acid,indigo and indirubin in Intestine-Clearing Suppository.Methods:The contents of gallic acid,indigo and indirubin were determined by HPLC method.In terms of gallic acid content determination:Mobile phase 0.5% phosphoric acid aqueous solution:acetonitrile = 97:3;detection wavelength 203 nm;volume flow rate 0.3 mL·min-1;column temperature 30 ℃.In terms of content determination of indigo and indirubin:Mobile phase water:acetonitrile = 35:65;detection wavelength 290 nm;volume flow rate 0.3 ml/min;column temperature 30 ℃.Results:The linear relationship of gallic acid was good in the range of 0.21-2.10 μg,and the average recovery was more than 95%.The linear relationship of indigo was good in the range of 0.29-2.90 μg,and the average recovery was more than 95%.The linear relationship of indirubin was good in the range of 0.02-0.21 μg,and the average recovery was more than 95%.Conclusion:The content determination method is stable,can control the quality of Intestine-Clearing Suppository,and reflect its curative effect by the content of index components to a certain extent.