三银芪丹颗粒质量标准  

Quality Standard of Sanyin Qidan Granules

作　　者：杨宇珂 刘良裕 崔秀梅 顾选 王建农[1] 付建华[1] YANG Yu-Ke;LIU Liang-Yu;CUI Xiu-Mei;GU Xuan;WANG Jian-Nong;FU Jian-Hua(Institute of Basic Medical Sciences of Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Huayi Pharmaceutical Co.,Ltd.,Beijing 102600,China)

机构地区：[1]中国中医科学院西苑医院基础医学研究所,北京100091 [2]华颐药业有限公司,北京102600

出　　处：《中国药物经济学》2023年第1期102-105,110,共5页China Journal of Pharmaceutical Economics

摘　　要：目的完善三银芪丹颗粒的质量标准。方法采用薄层色谱法(TLC)定性鉴别丹参和三七2味药材,采用高效液相色谱法(HPLC)测定丹参中丹参素钠的含量。色谱条件:资生堂CAPCELL PAK C18色谱柱(250 mm×10 mm,5μm),流动相条件:甲醇-1%醋酸水(3∶97),检测波长为280 nm,流速1.0 ml/min,柱温35℃,进样量为5μl。结果丹参和三七TLC特征斑点清晰,分离度良好,阴性对照无干扰。丹参素钠质量浓度在20~200μg/ml范围内与峰面积线性关系良好,R^(2)=0.9999;加样回收率为103.28%,相对标准偏差(RSD)为1.59%(n=6)。结论所建立的方法准确可靠,专属性强,稳定性及重复性均较好,可用于提升三银芪丹颗粒的质量标准。Objective To establish the quality standard of Sanyin Qidan Granules.Methods Thin layer chromatography(TLC)was used to identify Salvia miltiorrhiza and Panax notoginseng,and the content of Danshensu sodium in Salvia miltiorrhiza was determined by high performance liquid chromatography(HPLC).Chromatographic conditions:Shiseido CAPCELL PAK C18 column(250 mm×10 mm,5μm),the mobile phase was methano-1%acetic acid solution(3:97),the flow rate was 1.0 ml/min,the detection wavelength was 280 nm,the column temperature was 35℃,and the injection volume was 5μl.Results In the established TLC identification of Salvia miltiorrhiza and Panax notoginseng,the component characteristic spots were clear,the separation was good,and the negative control sample had no interference.The concentration of Salvianic acid A sodium was in the range of 20~200μg/ml,which has a good linear relationship with the peak area,R^(2)=0.9999.The average recovery of Salvianic acid A sodium was 103.28%with RSD of 1.59%(n=6).Conclusion The established method is accurate,reliable,specific,stable and can be used for the quality control of Sanyin Qidan Granules.

关 键 词：三银芪丹颗粒 薄层色谱法 高效液相色谱法 丹参素钠 质量标准 

分 类 号：R286.0[医药卫生—中药学]