十二味菝葜颗粒质量标准研究  

Quality Standard for Shi'erwei Baqia Particles

作　　者：胡春晓[1,2] 庞建云[1,2] 汪小涵[1,2] 沈成英[2] 袁海龙[2] HU Chunxiao PANGJlanyun WANG Xiaohan SHEN Chengying YUAN Hailong(College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Sichuan Chengdu 11137, China Dept. of Pharmacy, Air Force General Hospital of PLA, Beijing 100142, China)

机构地区：[1]成都中医药大学药学院,四川成都611137 [2]空军总医院药学部,北京100142

出　　处：《中国医院用药评价与分析》2017年第4期438-441,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：军队医疗机构制剂标准提高科研专项(No.13ZJZ12-5)

摘　　要：目的:建立十二味菝葜颗粒的质量标准。方法:采用薄层色谱法对十二味菝葜颗粒中的菝葜、槐花、丹参、苦参进行定性鉴别;采用高相液相色谱法对菝契和土茯苓的共同有效成分落新妇苷进行含量测定,色谱柱为Inertsil~? ODS-3色谱柱(250 mm×4.6 mm,5μm),乙腈-0.1%磷酸(V∶V=16∶84)为流动相,检测波长为291 nm。结果:薄层色谱斑点清晰,分离度好。落新妇苷进样量在0.015 3~0.306 0μg范围内线性关系良好(r^2=0.999 9)。精密度、稳定性与重复性试验的RSD均<2%。平均回收率为100.22%(RSD为0.53%,n=6)。结论:薄层色谱法及高效液相色谱法易于操作、重复性好,可有效控制十二味菝葜颗粒的质量。OBJECTIVE：To establish the quality standard for Shi＇erwei Baqia particles. METHDS： TLC was implemented to identify Chinaroot greenbier rhizome, Sophorae flos, Salviae mihiorrhizae radix et rhizoma and Sophorae flavescentis radix; and the common active ingredients in Chinaroot greenbier rhizome and Rhizoma smilacis glabrae was determined by HPLC method. The chromatographic column was Inertsil ODS-3 column （ 250 mm× 4. 6 mm,5 μm） , the mobile phase was acetonitrile-0. 1% phosphoric acid（ V： V = 16：84） , with detection wavelength of 291 nm. RESULTS： Diagnostic and clear spots were showed in TLC chromatogram. Astilbin showed a good linear relationship in the range of 0. 015 3-0. 306 0 μg（ r2 = 0. 999 9）. The relative standard deviation values of precision, stability and repeatability were less than 2%. The average recovery was 100. 22% （ RSD = 0.53% , n = 6 ）. CONCLUSIONS ： The method iseasy to carry out with a good reproducibilty, and could be used to control the quality of Shierwei Baqia particles.

关 键 词：十二味菝葜颗粒 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]