高效液相色谱法测定注射用丹参多酚酸中6种水溶性成分的含量  

HPLC determination of six water-soluble chemical constituents in salvianolic acid for injection

作　　者：徐静瑶[1,2] 刘小琳 佟玲 岳洪水 鞠爱春 于治国[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]天津天士力集团天士力研究院,天津300410

出　　处：《中国新药杂志》2015年第14期1599-1603,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2013ZX09402202)

摘　　要：目的:建立分别测定注射用丹参多酚酸中迷迭香酸、紫草酸、丹酚酸B和丹参素钠、原儿茶醛、丹酚酸D 6种水溶性成分的HPLC方法,并对3批注射用丹参多酚酸进行含量测定。方法:色谱柱为Agilent ZORBAX Eclipse Plus C18(250 mm×4.6 mm,5μm);等度洗脱:流动相A为水-甲酸(100∶0.5),流动相B为乙腈-甲醇(100∶3),柱温为30℃;检测波长为288 nm(供迷迭香酸、紫草酸、丹酚酸B的测定);梯度洗脱:流动相为A为水-甲酸(100∶0.2),流动相B为乙腈,柱温为25℃;检测波长为280 nm(供丹参素钠、原儿茶醛、丹酚酸D的测定)。结果:6种成分在实验浓度范围内,峰面积线性关系良好(r≥0.999 3)。重复性、精密度、稳定性、加样回收率结果均符合《中华人民共和国药典》的规定。6种成分的总含量约占67.4%。结论:方法简便、准确,且重复性好,可用于注射用丹参多酚酸中6种成分的含量测定。Objective： To establish an HPLC method to respectively determine the contents of six watersoluble chemical constituents,rosmarinic acid（ RA）,lithospermic acid（ LA）,salvianolic acid B（ Sal B） and sodium danshensu（ DSS）,protocatechuic aldehyde（ PAL） and salvianolic acid D（ Sal D） in salvianolic acid for injection（ SAFI）,and to compare their content discrepancy of SAFI from 3 batches. Methods： The chromatography was performed using an Agilent ZORBAX Eclipse Plus C18（ 250 mm × 4. 6 mm,5 μm） in the isocratic elution mode with a flow rate of 1. 0 m L·min^- 1. For RA,LA and Sal B,mobile phase A was formic acid-water（ 0. 5∶ 100） and B was methanol-acetonitrile（ 3∶ 100）,column temperature was kept at 30 ℃,and the detector was set at 288 nm.For DSS,PAL and Sal D,mobile phase A was formic acid-water（ 0. 2∶ 100） and B was acetonitrile,column temperature was kept at 25 ℃,and the detector was set at 280 nm. Results： All the chemical constituents had good linearity in the designed concentration ranges（ r≥0. 999 3）. The values of average repeatability,precision,stability and recovery met the demand of Chinese Pharmacopoeia. The total contents of six components accounted for67. 4%. Conclusion： The method is simple and accurate for determining the 6 chemical constituents in SAFI.

关 键 词：注射用丹参多酚酸 迷迭香酸 紫草酸 丹酚酸B 丹参素钠 原儿茶醛 丹酚酸D 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]