高效液相色谱法测定六味地黄浓缩丸特征图谱及4种主要成分的含量  

Simultaneous determination of specific chromatogram and four main components of Liuwei-Dihuang concentrated pills by HPLC

作　　者：罗云[1] 郝伟伟[1] 王洁[1] 王木生[1] 赵海平[1] 张婧[1] 杨明[1] 廖正根[1] 

机构地区：[1]江西中医学院现代中药制剂教育部重点实验室,江西南昌330004

出　　处：《中国医院药学杂志》2012年第10期748-751,共4页Chinese Journal of Hospital Pharmacy

基　　金：国家"重大新药创制"科技重大专项(编号:2009ZX09310-005)

摘　　要：目的:采用高效液相色谱法建立六味地黄浓缩丸的特征图谱,并同时测定4种主要成分的含量。方法:以没食子酸、马钱苷、芍药苷、丹皮酚为对照,采用Kromasil C18柱(250 mm×4.6 mm,5μm),乙腈-0.015%磷酸溶液梯度洗脱,流速1.0mL·min-1,检测波长238 nm,柱温35℃进行试验,用国家药典委员会"中药色谱指纹图谱相似度评价系统2004A"处理分析。结果:不同厂家的六味地黄浓缩丸特征图谱相似度较高,但没食子酸、马钱苷、芍药苷、丹皮酚含量差异较大。结论:该方法快速简便、准确可靠、重复性好,六味地黄浓缩丸特征图谱专属性强,可结合4种主要成分的含量测定全面控制六味地黄浓缩丸的质量,为六味地黄浓缩丸的质量评价提供科学依据。OBJECTIVE To establish the HPLC specific chromatogram and determine four main components of Liuwei-Di huang concentrated piills. METHODS GalLic acid, loganin, paeoniflorin, and paeonol were the reference substances. HPLC a nalysis was performed on a Kromasil C18 column （250 mm×4.6mm,5μm） with temperature of 35℃. The mobile phase was acetonitrile-0. 015% phosphoric acid solution with gradient elution. The flow rate was 1.0 mL.min t and the detection wave- length was 238 nm. Similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine （2004A） was used in data analysis. RESULTS HPLC specific chromatograms of Liuwei-Dihuang concentrated pills from different samples were of high similarity, but there were obvious differences in contents of gallic acid, loganin, paeoniflorin, and paeonol. CONCLUSlON The HPLC specific chromatogram combined with determination of four main components can be used for the quality control of Liuwei-Dihuang concentrated pills. This method was rapid, accurate, convenient, reliable and reproducible. This pa per provided scientific basis to evaluate the quality of Liuwei-Dihuang concentrated pills.

关 键 词：高效液相色谱法 六味地黄浓缩丸 特征图谱 含量测定 

分 类 号：R927.2[医药卫生—药学]