UPLC同时测定金欣口服液中8种指标成分的含量.doc

  UPLC 同时测定金欣口服液中 8 种指标成分 的含量# 单进军1，徐建亚1，徐珊1，狄留庆2，汪受传1** 5 10 （1. 南京中医药大学，第一临床医学院，南京 210046； 2. 南京中医药大学，药学院，南京 210046） 摘要：目的：利用梯度洗脱，建立同时测定金欣口服液中芥子碱硫氰酸盐、虎杖苷、野黄芩 苷、白藜芦醇、黄芩苷、大黄素-8-O-β-葡萄糖苷、黄芩素、汉黄芩素 8 种指标成分的含量。 方法：采用 UPLC 法，ACQUITY UPLC BEH C18 色谱柱（2.1 mm×100 mm, 1.7μm），乙腈 -0.1%甲酸水溶液为流动相，流速为 0.4 mL·min-1，梯度洗脱：检测波长 280nm；柱温：35。 试验分别对线性关系、精密度、重复性、稳定性及加样回收率进行了考察。结果：被测定的 8 个指标成分分别在选定的范围内线性关系良好，平均加样回收率在 95%~105%。结论：本 方法操作简便，测定结果准确可靠，可用于金欣口服液的质量控制。 关键词：金欣口服液；多指标成分；超高效液相色谱法（UPLC）；双波长；含量测定 15 Simultaneous determination of eight components in Jinxin Oral Liquid by ultra performance liquid chromatography (UPLC) method SHAN Jinjun1, XU Jianya1, XU Shan1, DI Liuqing2, WANG Shouchuan1 20 25 30 35 (1. The First Medicine College, Nanjing University of Chinese Medicine, NanJing 210046; 2. College of Pharmacy, Nanjing University of Chinese Medicine, NanJing 210046) Abstract: In this study, a UPLC-PDA method for simultaneous determination of in Jinxin Oral Liquid was developed. The seperation was performed on a ACQUITY UPLC BEH C18 column (2.1 mm×100 mm, 1.7μm). The mobile phase was composed of acetonitrile and 0.1% formic acid with gradient elution. The flow rate was 0.4 mL·min-1 and the temperature was 35℃.The detection wavelength at 280nm. The method validation proved that the linearity, precision, repeatability, stability and recovery accorded with the requirement for anassay. The established method had been used for determination above eight components in three lots of Jinxin Oral Liquid, and the results showed that this method was simple, accurate and very suitable to the quality control of Jinxin Oral Liquid. Keywords: Jinxin Oral Liquid; multi-index composition; UPLC; double wavelength; content determination 0 引言 金欣口服液（原名清肺口服液）是由黄芩、虎杖、杏仁、葶苈子、桑白皮等八味药物组 成，根据儿科用药特殊性研制而成的中药 6.1 类新药（已完成临床研究），具有宣肺开闭、 清热解毒、化痰止咳之功效。临床和实验研究均证实金欣口服液治疗小儿病毒性肺炎疗效肯 定，具有抗病毒、调整免疫功能、抗炎、解热、止咳、化痰、平喘、化瘀等作用 [1-3] 。为进 一步提高该制剂的质量标准，本实验采用梯度洗脱超高效液相色谱法（UPLC）同时测定金 40 欣口服液中芥子碱硫氰酸盐、虎杖苷、野黄芩苷、白藜芦醇、黄芩苷、大黄素-8-O-β-葡