HPLC法测定复方益肝灵片中水飞蓟宾的含量.doc

HPLC法测定复方益肝灵片中水飞蓟宾的含量
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作者:古海锋,张小茜,常增荣,傅欣彤,郭洪祝
【摘要】目的建立复方益肝灵片中水飞蓟宾的含量测定方法。方法采用HPLC法;流动相:甲醇-水-冰醋酸(48∶52∶1);检测波长:286 nm。 0~ μg范围内线性关系良好,其回归方程为:Y=×106X+×103,r= 9,%,RSD=%。结论该方法简单、准确、重复性好,可作为复方益肝灵片的质量控制方法。
【关键词】高效液相色谱法;复方益肝灵片;水飞蓟宾
Determination of Silybin in Fufang Yiganling Tablet by HPLC GU Hai-feng, ZHANG Xiao-qian, CHANG Zeng-rong, et al Beijing Institute for Drug Control, Beijing 100035, China Abstract:Objective To establish a method for the determination of silybin in Fufang Yiganling tablet. Methods RP-HPLC was used and the mobile phase was consisted of methanol-water-glacial acetic acid (48∶52∶1). The detection wavelength was 286 nm. Res
ults The calibration curve of Silybin was linear in the range of 0~ μg, linear equation:Y=×106X+×103, r= 9, with average recovery of % (RSD=%). Conclusions The method is simple, accurate and with good reproducibility. It can be used to control the quality of silybin in Fufang Yiganling tablet. Key words:HPLC;Fufang Yiganling tablet;Silybin 复方益肝灵片由水飞蓟素、五仁醇浸膏加工而成,具有益肝滋肾、解毒祛湿等作用,为临床治疗急慢性肝炎的常用药。其中水飞蓟素的主要成分是水飞蓟宾,水飞蓟宾有两种异构体:水飞蓟宾A(silybin A)、水飞蓟宾B(silybin B)[1]。原质量标准收载于《卫生部药品标准?中药成方制剂》(第12册),其含量测定方法采用UV法测定水飞蓟素含量(以水飞蓟宾计),对于控制产品质量具有一定作用,但方法专属性不强。本试验建立了HPLC法测定复方益肝灵片中水飞蓟宾含量的方法,该方法简便、准确、重现性好,可作为该制剂的质量控制方法。
1 仪器与试药
岛津L