高效液相色谱法同时测定补肾壮阳类中成药及保健食品中非法添加7种化药成分  

Simu taneous determination of 7 illegal components illegally added in traditional Chinese medicine and health food by HPLC

作　　者：邢俊波[1] 曹红[1] 张炯[1] 单婷婷[1] 水彩红[1] 陈玉敏[1] 胡丹[1] 

机构地区：[1]中国人民解放军总后勤部卫生部药品仪器检验所,北京100071

出　　处：《时珍国医国药》2014年第2期451-453,共3页Lishizhen Medicine and Materia Medica Research

基　　金：国家重大科学仪器设备开发专项项目(No.2012YQ18013208)

摘　　要：目的建立高效液相色谱法同时分析测定补肾壮阳类中成药及保健食品中非法添加7种西药成分（豪莫西地那非、羟基豪莫西地那非、红地那非、伐地那非、伪伐地那非、他达那非、氨基他达那非）。方法采用SHIMADZUVP—ODS（150L×4．6，5μm）色谱柱；流动相为乙腈-0．25mol·L^-1三乙胺溶液；流速：1．0ml·min^-1；检测波长为290nm；柱温：35℃。结果7种成分在相应的浓度范围内，峰面积和浓度有良好的线性关系（r≥0．9999）。检出限为2．8～10．5ng，定量限为8．2—33．4ng。结论该方法简便快速准确，重复性好，适用于基层药检机构，可作为补肾壮阳类中成药及保健食品中非法添加上述7种西药成分的快速筛查方法。Objective To develop a method for the dete ruination of seven components （ Homosildenafil, hydroxyhomosildenafil, aeetildenafil ,vardenafil, pseudovardenafil, tadalafil, aminotadalafil） in traditional Chinese medicine （TCM） and health food by HPLC - DAD. Methods The SHIMADZU VP - ODS （ 150 L × 4.6,5 μm） column was used. A mixture of aeetonitrile - 0.25 mol. L^-l triethylamine solution was used as the mobile phase under the program of gradient elution at a flow rate of 1.0 ml . mim^-1. The detection wavelength was set at 290 nm and the column temperature was 35 ℃. Results Good linearity was obtained for the 7 components in a wide range and the correlation was greater than 0. 999 9. The LOD and LOQ were from 2.8 to 10.5 ng and from 8.2 to 33.4 ng,respeetively. Conclusion The method is simple and repeatable. It can identify the seven illegal compo- nents in TCM and health food at the same time.

关 键 词：中成药 保健食品 高效液相色谱 非法添加 

分 类 号：R286[医药卫生—中药学]