小儿扶脾颗粒指纹图谱研究  

A fingerprint analysis of Xiaoer Fupi granules

作　　者：管志美[1] 彭艳梅[2] 龚年春 谭电波[2] GUAN Zhi -mei;PENG Yan -mei;GONG Nian -chun;TAN Dian -bo(Hunan Center for Drug Evaluation and ADR Monitoring,Changsha 410013,Hunan,China;Institute of Material Medica,Hunan Academy of Chinese Medicine,Changsha 410013,Hunan,China)

机构地区：[1]湖南省药品审评认证与不良反应监测中心,湖南长沙410013 [2]湖南省中医药研究院中药研究所,湖南长沙410013

出　　处：《湖南中医杂志》2018年第11期148-151,共4页Hunan Journal of Traditional Chinese Medicine

基　　金：湖南省传统中药制剂质量评价和溯源工程技术研究中心资助项目(编号:2018TP2035)

摘　　要：目的:建立湖南时代阳光药业股份有限公司小儿扶脾颗粒的高效液相色谱法(HPLC)指纹图谱分析方法。方法:采用反相高效液相色谱法,Ulimate-XB C18色谱柱(4. 6mm×250mm,5μm),乙腈-0. 1%磷酸溶液梯度洗脱,柱温30℃,检测波长330nm。结果:以橙皮苷为参照峰,建立了小儿扶脾颗粒HPLC指纹图谱,确立了12个共有峰,10批样品之间的共有峰相似度>0. 9。结论:该方法准确,精密度、重复性较好,可作为湖南时代阳光药业股份有限公司小儿扶脾颗粒质量控制的依据。Objective:To establish the high -performance liquid chromatography(HPLC)method for the fingerprint analysis of Xiaoer Fupi granules manufactured by Hunan Timesun Pharmaceutical Co.,Ltd.Methods:Reversed - phase HPLC was performed on an Ulimate-XB C18 column(4.6mm×250mm,5μm)with acetonitrile-0.1%phosphoric acid solution for gradient elution at a column temperature of 30℃ and a detection wavelength of 330nm.Results:The HPLC fingerprint of Xiaoer Fupi granules was established with hesperidin as the reference peak,and a total of 12common peaks were identified.The similarity of the common peaks of 10batches of samples was higher than 0.9.Conclusion :This method is accurate and hasgood precision and repeatability.Therefore,it can be used as the basis for the quality control of Xiaoer Fupi granules manufactured by Hunan Timesun Pharmaceutical Co.,Ltd.

关 键 词：小儿扶脾颗粒 高效液相色谱法 指纹图谱 

分 类 号：R284.1[医药卫生—中药学]