吴茱萸降压颗粒的质量标准研究  

Study on the quality control standard of Wuzhuyu Jiangya granules

作　　者：刘毅[1] 张丽艳[1] 杨玉琴[1] 李健[1] 钟正灵[1] 谢宇[1] 

机构地区：[1]贵阳中医学院,贵阳550002

出　　处：《药物分析杂志》2009年第1期16-20,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：贵州省中药现代化科技产业研究开发专项项目(黔科合中药专字[2004]13号)

摘　　要：目的:建立吴茱萸降压颗粒的质量控制方法。方法:采用TLC方法对制剂中吴茱萸、人参、泽泻、大枣进行定性鉴别;采用HPLC法对制剂的主药吴茱萸中吴茱萸次碱、吴茱萸碱进行含量测定。采用SHIMADZU C18柱(150mm×4.6mm,5μm),以甲醇-水(70:30)为流动相,流速1.0mL.min-1,柱温25℃,检测波长225nm。结果:吴茱萸、人参、泽泻、大枣的定性鉴别方法专属性强,阴性无干扰;吴茱萸次碱、吴茱萸碱加样回收率(n=5)分别为100.2%和101.2%,RSD为1.3%和1.0%;吴茱萸次碱、吴茱萸碱进样量在0.33～1.64μg和0.24～1.18μg范围内与峰面积呈良好的线性关系。结论:本法简便可行,重复性好,可用于该制剂的质量控制。Objective：To establish the quality control standard of Wuzhuyu Jiangya granules. Methods：Fructus Evodiae, Radix et Rhizoma Ginseng, Rhizoma Alismatis, and Fruetus Jujubae were identified by TLC. The content of rutaeearpine,evodiamine in Wuzhuyu Jiangya granules were determined by HPLC. SHIMADZU C18 column （150 mm ×4. 6 mm,5 μm）was used,with methanol -water（70： 30）as mobile phase,the flow rate was 1.0 mL ·min^-1 , the detective wavelength was 225 nm and the column temperature was 25℃. Results：The TLC identification methods for the Fructus Evodiae, Radix et Rhizoma Ginseng, Rhizoma Alismatis, and Fructus Jujubae was high specificity, the negative sample didn＇t interfere the identification of TLC. The average recoveries（ n = 5 ）of rutaecarpine and evodiamine were 100. 2% and 101.2% ,RSD were 1.3% and 1.0% respectively. The linear ranges of rutaecarpine and evodiamine were 0. 33 - 1.64 μg and 0. 24 - 1.18 μg. Conclusion： The method is simple, reproducible and may be used for the quality control of Wuzhuyu Jiangya granules.

关 键 词：吴茱萸降压颗粒 吴茱萸次碱 吴茱萸碱 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]