糖肝煎浓缩丸的质量控制  

Quality standard of Tangganjian concentrated pills

作　　者：张义生[1] 吴莹[2] 范彦博[1] 何志伟[2] 

机构地区：[1]武汉市中医医院,湖北武汉430014 [2]湖北中医药大学,2014级研究生湖北武汉430065

出　　处：《中国医院药学杂志》2017年第19期1896-1899,共4页Chinese Journal of Hospital Pharmacy

基　　金：湖北省中西医结合项目"糖肝煎浓缩丸的制备及药效学研究"(编号:2013Z-Y25);"2015年黄鹤英才资助项目"编号:武人才[2016]1号

摘　　要：目的:建立糖肝煎浓缩丸的质量标准。方法:采用薄层色谱法对当归、白术、虎杖、黄连、柴胡、茵陈进行定性鉴别;采用显微鉴别法对茯苓和五味子进行定性鉴别;采用高效液相色谱法对芍药苷和阿魏酸进行含量测定,色谱条件:色谱柱:WondaSil C18(250 mm×4.6 mm,5μm);流动相:乙腈-0.1%磷酸溶液;梯度洗脱;流速:1 mL·min-1;柱温:35℃;检测波长:230nm和316 nm。结果:薄层色谱法可对当归、白术、虎杖、黄连、柴胡、茵陈进行定性鉴别,而且重复性较好;显微鉴别法可对茯苓和五味子进行定性鉴别;在该色谱条件下,芍药苷和阿魏酸分别在0.192 5~3.85μg和0.04~0.80μg范围内呈良好的线性关系,芍药苷和阿魏酸的平均回收率分别为101.5%和99.6%,RSD为1.70%和1.35%(n=6)。结论:该质量标准方法简便可靠,专属性强,重复性好,可有效控制该制剂的质量。OBJECTIVE To establish the quality standard of Tangganjian concentrated pills, lVlETItODS TLC methods were established to identify Angelicae Sinensis Radix, Atractylodis Macrocephalae Rhizome and Polygoni Cuspidati Rhizoma ET Radix, Coptidis Rhizome, Bupleuri Radix and Artemisiae Scopariae Herba. Poria and Schisandrae Chinensis Fructus were identified by microcopical identification. High performance liquid chromatography was used to determine the contents of peoni- florin and ferulic acid under the following chromatographic conditions： column chromatography, WondaSil C18 column （250 mm × 4. 6 mm, 5μm） ; mobile phase, acetonitrile-0. 1 % phosphoric acid solution; gradient elution; velocity, l mL.min ~ ; column temperature： 30 ℃; detection wavelengths, 230 nm and 216 nm. RESULTS TLC methods were used to indentify Angelicae Sinensis Radix, Atractylodis Macrocephalae Rhizome and Polygoni Cuspidati Rhizoma ET Radix, Coptidis Rhizome, Bupleuri Radix and Artemisiae Scopariae Herba. Microcopical identification can be used to indentify Poria and Schisandrae Chinensis Fructus. Under the chromatographic conditlons, paeoniflorin and ferulic acid showed a good linear relationship in the ranges of 0. 192 5-3.85μg and 0. 04-0. 80μg. The average recovery rates of paeoniflorin and ferulic acid were 101.5% and 99. 6%, RSD were 1.70% and 1. 35% （n = 6）. CONCLUSION This quality standard method is simple and reliable, with good specificity and repeatability, and can be used to control the quality of the preparation.

关 键 词：质量标准研究 糖肝煎浓缩丸 芍药苷 阿魏酸 

分 类 号：R943[医药卫生—药剂学]