紫金散质量标准研究  

Study on the Establishment of the Criteria of Zijinsan

作　　者：李宁[1] 姚令文[2] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100045 [2]中国药品生物制品检定所

出　　处：《中国药事》2010年第7期684-686,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立紫金散中红大戟的薄层鉴别方法及五倍子中没食子酸的高效液相含量测定方法。方法采用phenomenex Luna5μC18(2)100A色谱柱;流动相为甲醇-0.1%磷酸溶液(7:93);流速:1.0mL.min-1;检测波长:273nm,柱温:30℃。结果没食子酸在0.082～0.818μg范围内呈良好的线性关系,r=0.9999,平均回收率99.1%,RSD=1.68%(n=9)。结论该方法操作简捷,重复性好,结果准确可靠,适用于该药的质量控制。Objective To identify Angelica.,RADIX KNOXIAE by TLC method and to determine Gallic Acid in Zijinsan by HPLC method.Methods Phenomenex Luna 5μ C18（2）100A column was used with methanol-0.1% phosphoric acid （7：93） as mobile phase,UV detection wavelength was at 273nm,and the column temperature was 30℃.Results The linear range of Gallic Acid was 0.082～0.818μg （r=0.9999）.The average recovery rate was 99.1% （RSD=1.68%,n=9）.Conclusion The method is simple,accurate and reliable,and can be used in the quality control of Zijinsan.

关 键 词：HPLC 紫金散 没食子酸 

分 类 号：R284[医药卫生—中药学] R926[医药卫生—中医学]