复方夏枯草膏质量标准研究  

Study on Quality Standard of Complex Prescription of Extractum Prunellae Spica

作　　者：高咏莉[1] 李国锋 叶奕芬[1] 王淑红[1] 王铁杰[1] 

机构地区：[1]深圳市药品检验所,广东深圳518057 [2]葛兰素史克(中国)投资有限公司,广东广州510000

出　　处：《中国中医药信息杂志》2013年第6期53-55,共3页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家药品标准提高研究(795)

摘　　要：目的建立复方夏枯草膏的质量标准。方法采用薄层色谱法,对夏枯草、甘草、玄参进行定性鉴别。采用反相高效液相色谱法测定制剂中迷迭香酸的含量,以甲醇-0.1%三氟乙酸(40∶60)为流动相,检测波长为330 nm。结果薄层色谱法专属性强、阴性无干扰。迷迭香酸在0.049 9～0.998 0μg范围内线性关系良好,平均回收率为100.99%(RSD=1.11%)。结论本方法简便、准确、稳定,且无干扰,可作为该制剂的质量控制方法。Objective To establish the quality standard for Complex Prescription of Extractum Prunellae Spica.Methods Prunellae Spica,Glycyrrhizae Radix et Rhizoma and Scrophulariae Radix were identified by TLC.HPLC was performed for the determination of rosmarinci acid with the mobile phase of methanol-0.1% trifluoroacetic acid（40∶60）,and the detection wavelength was 330 nm.Results The methods of TLC were distict and highly specific.Rosmarinci acid showed a good linear relationship within the range of 0.049 9-0.998 0,the average recovery rate was 100.99%（RSD=1.11%）.Conclusion The method is simple,sensitive and stable,and can be used as the quality control method for Complex Prescription of Extractum Prunellae Spica.

关 键 词：复方夏枯草膏 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]