摘要
目的 建立小儿咽扁颗粒多指标含量测定方法,结合化学计量学分析,评价小儿咽扁颗粒质量。方法采用Waters XTERRA C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈与0.3%磷酸水溶液为流动相,梯度洗脱,流速1.0 ml/min,切换波长220 nm及326 nm,柱温35℃,进样量10μl。结果 小儿咽扁颗粒中绿原酸、异绿原酸C、异绿原酸A、古伦宾、哈巴苷、哈巴俄苷、射干苷、次野鸢尾黄素的色谱峰分离度好,线性关系良好,平均回收率分别为100.09%,98.41%,98.88%,98.19%,98.93%,99.09%,98.99%,99.27%,RSD均小于1.5%。该方法的精密度、稳定性、重复性均较好。12批小儿咽扁颗粒中上述8个成分的含量测定结果分别为0.2076~0.2866,0.0721~0.1061,0.0712~0.1019,0.0402~0.0619,0.0817~0.1081,0.0401~0.0645,0.0314~0.0612,0.0505~0.0768 mg/g。化学计量学分析表明不同厂家小儿咽扁颗粒质量存在一定差异,区分各类样品的质量差异标志物为绿原酸、古伦宾、射干苷和次野鸢尾黄素。结论 建立的综合质量评价方法准确、专属,可用于小儿咽扁颗粒的质量控制。
Objective To establish a method for overall quality evaluation of Xiaoer Yanbian Granules by multicomponent determination and chemometric analysis.Methods The analysis was carried out on a Waters XTERRA C_(18)(250 mm×4.6 mm,5 μm) column,using acetonitrile-0.3 % phosphoric acid solution at a fiow rate of 1.0 ml/min as mobile phase of gradient elution.The detection wavelength were 220 nm and 326 nm.The column temperature was 35 ℃ and the injection volume was 10 μl.Results The chromatographic peaks of chlorogenic acid,isochlorogenic acid C,isochlorogenic acid A,columbin,harpagide,harpagoside,belamcandin and irisflorentin in Xiaoer Yanbian Granules showed good resolution.All the components showed good linear relationship.The average recoveries were 100.09 %,98.41 %,98.88 %,98.19 %,98.93 %,99.09 %,98.99 % and 99.27 %,respectively,with RSDs less than 1.5 %.Precision,stability and reproducibility of the method were satisfactory.The contents of the above eight components in 12 batches of samples were 0.2076-0.2866,0.0721-0.1061,0.0712-0.1019,0.0402-0.0619,0.0817-0.1081,0.0401-0.0645,0.0314-0.0612 and 0.0505-0.0768 mg/g,respectively.Chemometric analysis showed that there were some differences in the quality of Xiaoeryanbian Granules from different manufacturers.The quality difference markers for distinguishing various samples were chlorogenic acid,columbin,belamcandin and irisfiorentin.Conclusion The method is accurate and specific,which can be used for the quality control of Xiaoer Yanbian Granules.
作者
曹春歌
房凌云
CAO Chun-ge;FANG Ling-yun(Department of Traditional Chinese Medicine,Shandong Heze Chinese Medicine Hospital,Heze 274000,China)
出处
《食品与药品》
CAS
2022年第6期531-538,共8页
Food and Drug
