HPLC指纹图谱对五味子肠溶微球的质量评价  

HPLC fingerprinting evaluation of quality of Wuweizi enteric microspheres

作　　者：张宏梅[1] 崔佰吉[1] 张秀荣[1] 

机构地区：[1]吉林医药学院药学院,吉林132013

出　　处：《药物分析杂志》2011年第5期821-825,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：吉林省教育厅"十一五"科学技术研究项目(吉教科合字[2008]第263号)

摘　　要：目的:建立五味子肠溶微球HPLC指纹图谱,以此作为该制剂质量评价的指标。方法:采用DIKMA Platisil ODS(4.6mm×250 mm,5μm)色谱柱,流动相为乙腈-水,梯度洗脱(0→20→25→55→70 min,48%→48%→65%→65%→48%乙腈),流速0.8 mL.min-1,二极管阵列检测器(DAD),检测波长254 nm,柱温40℃,进样量40μL。以五味子醇甲为参照物建立五味子肠溶微球的HPLC指纹图谱。结果:图谱中有21个共有峰,确定为其指纹峰。采用国家药典委员会"中药色谱指纹图谱相似度评价系统(2004A版)"自动处理,10批样品的相似度均大于0.99。结论:该方法简便、稳定,重现性好,适于作为五味子肠溶微球质量评价的指标。Objective：To establish the HPLC fingerprint analysis for evaluation of quality of Wuweizi enteric microspheres.Methods：DIKMA Platisil ODS（4.6 mm×250 mm,5 μm） was adopted;The mobile phase was acetonitrile-water with a gradient elution（0→20→25→55→70 min,48%→48%→65%→65%→48% acetonitrile）,at the flow rate of 0.8 mL·min^-1;and photodiode array detector（DAD） was used,and the detection wavelength was 254 nm;The column temperature was maintained at 40 ℃.Results：There were 21 common peaks appeared in the fingerprints.The fingerprints peaks were defined by software which were published by the committee of pharmacopeia of China.The similarity degree was above 0.99.Conclusion：The method is simple,accurate and sensitive,and it is suitable to be used for evaluation of quality of Wuweizi enteric microspheres.

关 键 词：五味子 肠溶微球 指纹图谱 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]