摘要
目的：建立快速灵敏且专属性强的体内分析方法用于研究银丹心脑通软胶囊中丹参酮ⅡA和丹酚酸B的药代动力学研究,为该制剂的临床使用提供参考。方法：采用超高压液相色谱-串联质谱分析法（UPLC-MS/MS）,测定大鼠按2.4 g·kg-1灌胃银丹心脑通软胶囊后不同时间点的血药浓度。质谱采用的扫描方式为多反应离子检测模式,定量分析离子对分别为丹参酮ⅡAm/z 295.0~249.0,丹酚酸B m/z 717.1~519.0和黄芩素m/z 271.1~122.8。通过DAS 2.1.1药动学数据处理软件计算药动学参数。结果：丹参酮ⅡA和丹酚酸B与其他内源性和药源性成分达到了良好分离,线性范围分别为1~100,5~500μg·L-1;平均提取回收率在72.43%~93.92%;准确度在92.65%~106.26%,日内精密度和日间精密度RSD在2.73%~9.87%。丹参酮ⅡA和丹酚酸B的主要药动学参数分别为达峰浓度（Cmax）（38.34±17.35）,（32.00±15.43）μg·L-1;达峰时间（Tmax）分别为（0.25±0.23）,（0.75±0.18）h。结论：UPLC-MS/MS能够快速、灵敏、专属地分析大鼠血浆中丹参酮ⅡA和丹酚酸B的血药浓度,该方法适用于银丹心脑通软胶囊在大鼠体内的药代动力学分析。
Objective： To develop a rapid,reliable and sensitive method of UPLC-MS /MS with an atmospheric-pressure chemical ionization（ APCI） source for determination of tanshinone ⅡAand salvianolic acid B in rat plasma after oral administration of Yindan Xinnaotong soft capsules. Method： UPLC-MS / MS was employed to measure plasma concentration at different time after ig administration of Yindan Xinnaotong soft capsules with2. 4 g ·kg- 1. Analysis was detected by APCI in multiple reaction monitoring（ MRM） mode. Detection of tanshinone ⅡAand salvianolic acid B was using following transitions of m / z 295. 0-249. 0 for tanshinone ⅡA,m/z717. 1-519. 0 for salvianolic acid B and m / z 271. 1-122. 8 for baicalein. DAS 2. 1. 1 software was used to calculate pharmacokinetic parameters. Result： Calibration curve ranges were 1-100 and 5-500 μg·L- 1for tanshinone ⅡA and salvianolic acid B,respectively. Mean recovery of them ranged from 72. 43% to 93. 92%,intra-day and inter-day precisions were in the range of 2. 73%-9. 87% and accuracies were between 92. 65% to 106. 26%. Cmax of tanshinone ⅡAand salvianolic acid B were（ 38. 34 ± 17. 35）,（ 32. 00 ± 15. 43） μg·L- 1,Tmaxof them were（ 0. 25 ± 0. 23）,（ 0. 75 ± 0. 18） h. Conclusion： This method developed in the present study using UPLC-MS /MS is highly sensitive,accurate,rapid and suitable for pharmacokinetic study of tanshinone ⅡAand salvianolic acid B from Yindan Xinnaotong soft capsules in rats.
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2016年第3期76-80,共5页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家“重大新药创制”科技重大专项(2012ZX09201201)
