双丹胶囊质量标准的建立  

Study on Quality Standard for Shuangdan Capsules

作　　者：毕琳琳[1] 缪珊[1] 李穆琼[2] 杨倩[1] 李骅[1] 党碧艳[1] 王四旺[1] 

机构地区：[1]第四军医大学药学系天然药物学教研室,西安710032 [2]第四军医大学药学系药物化学教研室,西安710032

出　　处：《中国药师》2014年第7期1237-1239,共3页China Pharmacist

基　　金：陕西省科技专项项目(编号:2012K19-03-02)

摘　　要：目的：建立双丹胶囊的质量标准.方法：采用TLC法对双丹胶囊中丹酚酸B成分进行鉴别,采用HPLC法测定胶囊中丹皮酚的含量.色谱条件为.Kromasil-C18柱;流动相：甲醇-0.1％磷酸（64∶36）;检测波长274 nm.结果：TLC分离度好,阴性对照无干扰;丹皮酚在26.2～131.0μg· ml-1范围内线性良好（r=0.999 8）,平均回收率为99.59％,RSD为0.85％（n＝6）.结论：该方法简便、准确,可以控制该制剂的质量.Objective：To establish a method for the quality control of Shuangdan capsules.Methods：A TLC method was used in the qualitative identification of salvianolic acid B,and an HPLC method was used to determine the content of paeonol in Shuangdan capsules.A Kromasil-C18 column（250 mm ×4.6 mm,5 μm） was used,the mobile phase was methanol-0.1％ phosphoric acid（64∶ 36）,and the detection wavelength was 274 nm.Results：The linear range of paeonol was 26.2-131.0 μg · ml-1 （r =0.999 8）.The average recovery for paeonol was 99.59％ （RSD =0.85 ％,n =6）.Conclusion：The method is simple and accurate,and suitable for the quality control of Shuangdan capsules.

关 键 词：双丹胶囊 质量标准 丹皮酚 丹酚酸B 

分 类 号：TQ460.72[医药卫生—药物分析学]