心可宁胶囊中丹参含量测定研究  

Determination Research of Salvia Miltiorrhiza Bge in XinKeNing Capsule

作　　者：罗疆南 王银红 黄晓燕 李瑞莲 LUO Jiang-nan;WANG Yin-hong;HUANG Xiao-yan;LI Rui-lian(Hunan Institute for Drug Control(Hunan Pharmaceutical Excipients Testing and Inspection Center),Changsha 410001,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Changsha 410001,China)

机构地区：[1]湖南省药品检验研究院(湖南药用辅料检验检测中心),湖南长沙410001 [2]湖南省药品质量评价工程技术中心,湖南长沙410001

出　　处：《海峡药学》2019年第10期81-83,共3页Strait Pharmaceutical Journal

基　　金：2017年国家评价抽验品种心可宁胶囊

摘　　要：目的建立同时测定心可宁胶囊中丹参素、原儿茶醛及丹酚酸B的含量测定方法。方法采用Agilengt TC(2)C18色谱柱(250mm×4.6mm,5μm),以甲醇流动相A,0.1%磷酸为流动相B进行梯度洗脱,检测波长为280nm,流速为1mL·min^-1,柱温为35℃。结果丹参素在44.06ng^4406ng范围内线性关系良好,原儿茶醛在3.028ng^3028ng范围内线性关系良好,丹酚酸B在51.32ng^5132ng范围内线性关系良好。该方法的精密度、稳定性、重复性、加样回收率试验的RSD值均在3.0%以内,平均加样回收率分别为丹参素102.27%,原儿茶醛96.34%,丹酚酸B94.51%。结论该方法准确、简便、灵敏度高,可作为测定心可宁胶囊的丹参三种成分的含量测定方法。OBJECTIVE To establish a method to simultaneous determination of Danshensu,Protocatechuic aldehyde and Salvianolic Acid B in XinKeNing Capsules.METHODS The separation was performed on a Agilengt TC(2)C18 column(250mm×4.6mm,5μm)with gradient elution which methol as mobile phase A,0.1%Phosphoric acid as mobile phase B,the flow rate was 1mL·min^-1.The detection UV wavelength was at 280nm,and the column temperature was 35℃.RESULTS The calibration of Danshengsu was liner in the range of 44.06ng-4406ng,the calibration of Protocatechuic aldehyde was liner in the range of 3.028ng-3028,and the calibration of Salvianolic Acid B was liner in the range of 51.32ng-5132ng.The RSD of precision,solution stability,repeatability,recovery were less than 3%,and the average recovery of Danshengsu,Protocatechuic aldehyde and Salvianolic Acid B was 102.27%,96.34%,94.51%respectively.CONCLUSION The method is simple,rapid and accurate,and can be used for the quality control of XinKening Capsules.

关 键 词：心可宁胶囊 HPLC 丹参素 原儿茶醛 丹酚酸B 丹参 

分 类 号：R927[医药卫生—药学]