摘要
目的建立中药复方蒲地蓝消炎片的HPLC指纹图谱,对其进行质量控制。方法采用Agilent C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-体积分数为0.1%的磷酸水溶液为流动相,进行梯度洗脱,流速1.0 m L·min-1,柱温35℃,检测波长289 nm;运用"中药色谱指纹谱图相似度评价软件(2009版)"对不同厂家共20批样品进行相似度评价。结果建立了蒲地蓝消炎片对照指纹图谱并确定了21个共有色谱峰;蒲地蓝消炎片HPLC指纹图谱方法精密度、重复性、稳定性均良好;20批样品的指纹图谱与对照指纹图谱相似度值为0.933~0.998。结论上述建立的HPLC指纹图谱为蒲地蓝消炎片的质量评价提供了科学依据。
Objective To establish the HPLC fingerprints of Pudilan Xiaoyan tablets for the quality standard of traditional Chinese medicine. Methods A agilent C18 column（ 250 mm × 4. 6 mm,5 μm） was used for separation and the mobile phase acetonitrile-water（ containing 0. 1 %（ φ） phosphoric acid） in a gradient mode. The flowrate was 1. 0 m L·min-1,the column temperature was 35 ℃,and the detection wavelength was set at 289 nm. The similarity evaluation of 20 batches of samples from different manufacturers was carried out by using the similarity evaluation software（ 2009） of traditional Chinese medicine chromatographic fingerprints. Results The HPLC standard fingerprints of Pudilan Xiaoyan tablet were established and a total of 21 common chromatographic peaks were defined. The established HPLC fingerprint of Pudilan Xiaoyan tablets was precise,reproducible and stable. The similarity range of 20 samples was0. 933-0. 998. Conclusion The established HPLC fingerprint can provide the experimental basis to improve overall quality control of Pudilan Xiaoyan tablets.
作者
李艳娇
杨钒
宋洋
吕重宁
贾凌云
路金才
LI Yanjiao;YANG Fan;SONG Yang;LU Chongning;JIA Lingyun;LU Jincai(School of Traditional Chinese Meteria Medica, Shenyang Pharmaceutical University, Shenyang 110016, China;Heilongjiang Nuojie Pharmaceutical Co., Ltd., Suihua 152000, China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2018年第5期381-383,389,共4页
Journal of Shenyang Pharmaceutical University
基金
国家中医药管理局项目(201407002)
