康泌安片质量标准研究  

STUDY ON QUALITY STANDARD FOR KANGMI’AN TABLETS

作　　者：刘艳[1] 付超美[2] 付秀娟[1] 胡慧玲[2] 

机构地区：[1]泸州医学院药学院药物研究所,四川泸州646000 [2]成都中医药大学药学院药剂教研室

出　　处：《泸州医学院学报》2010年第3期254-257,共4页Journal of Luzhou Medical College

摘　　要：目的:建立康泌安片的质量标准。方法:采用薄层色谱法对康泌安片中四季红、连翘、三颗针进行定性鉴别研究。采用高效液相色谱法,测定康泌安片中没食子酸的含量,色谱柱为Kromasil(250mm×4.6mm,5μm),流动相为甲醇-水-N,N-二甲基甲酰胺-冰醋酸(1∶81∶15∶3),紫外检测波长为272nm,流速为0.5ml/min。结果:在TLC图谱中可检测出四季红、连翘、三颗针的特征斑点。没食子酸线性范围为0.051～0.255μg,平均回收率为97.78%。结论:所建立的方法简便、准确,可用于康泌安片的质量控制。Objective：To establish a quality standard for Kangmi’an tablets. Methods： Herba Polygoni Capitati, Fructus Forsythiae, and Berberis were identified by TLC and the content for gallic acid in Kangmi＇an tablets was determined by HPLC. The chromatographic column was Kromasil （250mm×4.6mm,5μm）,the mobile phase was a mixture of methanol-water-N,N-dimethylformamide-acetic acid glacial （1：81：15：3）, detective wavelength was 272nm,the flow rate was 0.5ml/min. Results： Herba Polygoni Capitati,Fructus Forsythiae,and Berberis could be identified by TLC,gallic acid showed a good linear relationship at a range of 0.051～0.255μg,the average recovery was 97.78%. Conclusion： The Method is simple, accurate, and can be used for quality control of Kangmi＇an tablets.

关 键 词：康泌安片 质量标准 薄层色谱法 没食子酸 高效液相色谱法 

分 类 号：R944.4[医药卫生—药剂学]