【作者】 杨晓莹； 潘成成； 窦桃艳； 邵晓玮； 吕延英； 赵兴； 王嗣岑； 卢闻；

【Author】 YANG Xiao-ying;PAN Cheng-cheng;DOU Tao-yan;SHAO Xiao-wei;LV Yan-ying;ZHAO Xing;WANG Si-cen;LU Wen;School of Pharmacy,Health Science Center,Xi’an Jiaotong University;Xi’an Shiji Shengkang Pharmaceutical Industry Co.,Ltd.;

【机构】 西安交通大学医学部药学院； 西安世纪盛康药业有限公司；

【摘要】 目的建立肾康颗粒HPLC-DAD-ELSD联用的分析方法,科学评价其质量。方法采用Diamonsil?C₁₈色谱柱,以0.1%甲酸溶液-乙腈为流动相梯度洗脱;检测波长为:大黄素和大黄酚254 nm,丹酚酸B 288 nm,羟基红花黄色素A 403 nm;黄芪甲苷采用ELSD检测,参数为漂移管温度90℃,气压1.5 Bar。结果所建立的肾康颗粒的HPLC-DAD-ELSD指纹图谱方法的专属性、精密度、重现性和稳定性均良好;采用中药色谱指纹图谱相似度评价系统2004A对10批肾康颗粒进行相似度评价,结果表明肾康颗粒指纹图谱的相似度值在0.855～0.996之间,批间差异较小;颗粒样品的定量分析表明5种指标成分在10批肾康颗粒中的含量基本一致。结论所建立的HPLC-DAD-ELSD方法可用于肾康颗粒的质量控制,其提供了一种既能整体定性,又可指标成分定量的简便易行的质量评价模式。更多还原

【Abstract】 OBJECTIVE To establish the HPLC-DAD-ELSD fingerprint for scientific control of Shenkang granules’ quality. METHODS The chromatographic separation was performed on a Diamonsil? C18 column by gradient elution with 0.1% formic acid solution and acetonitrile as mobile phase. The detection wavelength of the emodin and chrysophanol was 254 nm, salvianolic acid B was 288 nm, HYSA was 403 nm, astragaloside IV was detected by ELSD, for the parameters of ELSD, the tempreture of the drift tube was 90℃ and air pressure was 1.5 Bar. RESULTS The established HPLC-DAD-ELSD fingerprint of Shenkang granules was specific, precise, reproducible and stable. Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica 2004 A was adopted for the similarity analysis on the 10 batches of Shenkang granules’ fingerprint. The results showed that the similarity values ranged from 0.855 to 0.996, the differences between the batches were small. The quantitative analysis of the granules showed that the five index components were almost the same in 10 batches of Shenkang granules. CONCLUSION The method of HPLC-DAD-ELSD fingerprint can be used for the quality control of Shenkang granules. This method was simple and convenient, which can realize the whole characterization and the quantification of index components.更多还原