一测多评法同时测定4种中药注射液中9种丹参酚酸  

Simultaneous determination of nine salvianolic acids in four Chinese herbal injections by QAMS

作　　者：陈影 吴婷[1] 姜超[1] 袭晓昀 张倩[1] 戴国梁[1] 许美娟[1] 居文政[1] CHEN Ying;WU Ting;JIANG Chao;XI Xiao-yun;ZHANG Qian;DAI Guo-liang;XU Mei-juan;JU Wen-zheng(Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China)

机构地区：[1]南京中医药大学附属医院,江苏南京210029

出　　处：《中成药》2021年第3期590-595,共6页Chinese Traditional Patent Medicine

基　　金：国家自然科学基金(81573685);江苏省自然科学基金面上项目(BK20181504);江苏省高层次卫生人才“六个一工程”拔尖人才项目(LGY2019072)。

摘　　要：目的建立一测多评法同时测定丹参注射液(丹参)、丹红注射液(丹参、红花)、冠心宁注射液(丹参、川芎)、香丹注射液(丹参、降香)中丹参素、原儿茶醛、咖啡酸、丹酚酸D、迷迭香酸、紫草酸、丹酚酸B、丹酚酸E、丹酚酸A的含量。方法4种药物50%甲醇稀释液(含0.1%维生素C)的分析采用Agilent ZORBAX SB C_(18)色谱柱(150 mm×4.6 mm,5μm);流动相乙腈⁃0.1%磷酸,梯度洗脱;体积流量0.8 mL/min;柱温30℃;检测波长285 nm。以原儿茶醛为内标,计算其他8种成分的相对校正因子,测定其含量。结果9种成分在各自范围内线性关系良好(r≥0.9992),平均加样回收率90.37%~109.07%,RSD≤5.61%。一测多评法所得结果与外标法接近。结论该方法简便稳定,可用于4种中药注射液的质量控制。AIM To establish a quantitative analysis of multi⁃components by single⁃marker(QAMS)method for the simultaneous content determination of danshensu,protocatechuic aldehyde,caffeic acid,salvianolic acid D,rosmarinic acid,lithospermic acid,salvianolic acid B,salvianolic acid E and salvianolic acid A in Danshen Injection(Salviae miltiorrhizae Radix et Rhizoma),Danhong Injection(Salviae miltiorrhizae Radix et Rhizoma,Carthami Flos),Guanxinning Injection(Salviae miltiorrhizae Radix et Rhizoma,Chuanxiong Rhizoma)and Xiangdan Injection(Salviae miltiorrhizae Radix et Rhizoma,Dalbergiae odoriferae Lignum).METHODS The analyses of 50%methanol diluents(containing 0.1%vitamin C)of these four injections were performed on a 30℃thermostatic Agilent Zorbax SB⁃C_(18) column(150 mm×4.6 mm,5μm),with the mobile phase comprising of acetonitrile⁃0.1%phosphoric acid flowing at 0.8 mL/min in a gradient elution manner,and the detection wavelength was set at 285 nm.Protocatechuic aldehyde was used as an internal standard to calculate the relative correction factors of the other eight constituents,after which the content determination was made.RESULTS Nine constituents showed good linear relationships within their own ranges(r≥0.9992),whose average recoveries were 90.37%-109.07%with the RSDs of less than or equal to 5.61%.The results obtained by QAMS approximated those obtained by external standard method.CONCLUSION This simple and stable method can be used for the quality control of four Chinese herbal injections.

关 键 词：丹参注射液 丹红注射液 冠心宁注射液 香丹注射液 丹参酚酸 一测多评 

分 类 号：R927.2[医药卫生—药学]