摘要
目的:建立SFC-PDA法同时检测丹参饮片中4个脂溶性丹参酮类成分,以及UPLC法同时测定丹参饮片中3个水溶性丹酚酸类成分,以7个成分的测定结果综合评价丹参饮片的质量。方法:采用SFC-PDA法,使用Viridis■HSS SB C18100A(3.0 mm×100 mm,1.8μm)色谱柱,以二氧化碳(A)-[正庚烷-异丙醇(8∶2)(B)]为流动相,梯度洗脱,流速1.5 mL·min^-1,柱温45℃,背压13.8 MPa;采用UPLC-PDA法,使用BEH Shield RP(2.1 mm×100 mm,1.7μm)色谱柱,以乙腈(A)-0.1%磷酸溶液(B)为流动相,梯度洗脱,流速0.4 mL·min^-1,柱温30℃。结果:在建立的色谱条件下,丹参饮片中7个主要成分在各自的液相系统中分离完全,线性良好,精密度、重复性、稳定性及回收率实验结果均符合含量测定要求,同时还比较了用HPLC和SFC 2种方法测定脂溶性成分时的仪器灵敏度,结果为一个数量级。结论:SFC方法快速简便、结果准确,在节省溶剂、减少环境污染的方面具有独特优势,同时采用UPLC方法测定水溶性成分,2种方法可用于丹参饮片的质量分析,同时大大降低检测成本。
Objective:To evaluate the quality of Salvia Miltiorrhiza decoction pieces from difference sources,methods for determining 7 components were established.Among which,lipid-soluble tanshinone components were determined by(SFC-PDA),and 3 water-soluble salvianolic acid components were determined by UPLC.Methods:The SFC-PDA analysis was performed on Viridis■HSS SB C18100 A(3.0 mm×100 mm,1.8μm)column.The mobile phase was Carbon dioxide-n-heptane-isopropanol(8∶2)with isocratic elution mode at a flow rate of 1.5 m L·min^-1.The column temperature was controlled at 45℃and the ABPR pressure was 13.8 MPa.The UPLC-PDA analysis was performed on BEH Shield RP(2.1 mm×100 mm,1.7μm)column,The mobile phase consisted of acetonitrile-0.1%phosphoric acid with gradient elution at a flow rate of 0.4 m L·min^-1.The column temperature was controlled at 30℃.Results:7 main components in Salvia Miltiorrhiza decoction pieces were well separated by SFC and UPLC respectively.Results of linearity,repeatability,stability and recovery met the accept criteria of assay.The sensitivity of fat-soluble components and water-soluble components were comparable in HPLC and SFC system.Conclusion:The SFC method rapid,simple and accurate,which possesses the advantage of solvent saving and environmental friendly.At the same time,the UPLC method is used to determine the water-soluble components.The two methods can be used for analysis the quality of Salvia Miltiorrhiza decoction pieces,and reduce the detection cost remarkably.
作者
张光华
付龙
王京辉
宋彬彬
郭伟
张琳培
钱忠直
ZHANG Guang-hua;FU Long;WANG Jing-hui;SONG Bin-bin;GUO Wei;ZHANG Lin-pei;QIAN Zhong-zhi(ChP-Waters Joint Open Laboratory,Beijing 100061,China;Beijing Institute for Drug Control,Beijing Key Lab.Analysis and Evaluation on Chinese Medicine,Beijing 102206,China;Chinese Pharmacopeia Commission,Beijing 100061,China;R&D Center of Livzon Pharmaceutical Group,Zhuhai 519090,China;China Z.Pharmaceutical Productivity Centre,Beijing 101111,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2020年第5期940-947,共8页
Chinese Journal of Pharmaceutical Analysis
基金
国家药典委员会药品标准制修订研究课题(编号:2018Y005)。
作者简介
通信作者:钱忠直,Tel:(010)82899094,E-mail:goldpharma@chp.org.cn;第一作者:张光华,Tel:18010281185,E-mail:zhangguanghua2014@126.com;第一作者:付龙,Tel:13811805812,E-mail:holluhn@163.com。
