中国中药杂志

2016, v.41(14) 2727-2731

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Beagle犬口服雷公藤片血浆中雷公藤红素LC-MS/MS测定及药动学研究
LC-MS/MS method for determination of tripterine in plasma:pharmacokinetic study in Beagles

张军;刘史佳;胡杰慧;许美娟;刘子修;周玲;居文政;
ZHANG Jun;LIU Shi-jia;HU Jie-hui;XU Mei-juan;LIU Zi-xiu;ZHOU Ling;JU Wen-zheng;Clinic Pharmacology Laboratory,the Affiliated Hospital of Nanjing University of Chinese Medicine;Applied Biosystems SCIEX Co.,Ltd.;Nanjing University of Chinese Medicine;

摘要(Abstract):

建立Beagle犬血浆中雷公藤红素的LC-MS/MS检测方法,用于Beagle犬口服雷公藤片的药代动力学研究。血浆样品经二氯甲烷提取,色谱条件为Phenomenex Luna C8色谱柱(2.0 mm×50 mm,3μm),流动相为甲醇-乙腈异丙醇溶液(1∶1)-0.1%甲酸15∶55∶30;多反应监测(MRM)雷公藤红素([M+H]+,m/z 451.3/201.1)和内标泼尼松龙([M+H]+,m/z 361.1/147.1);DAS 1.0软件对雷公藤红素药-时曲线进行拟合,并计算药代动力学参数。在0.680 0~136.0μg·L-1,雷公藤红素与内标的峰面积比值与浓度的线性关系良好,定量限为0.680 0μg·L·(-1),日内日间精密度小于6.15%,提取回收率为50.42%~51.65%。Beagle犬口服雷公藤片(1片/kg),血浆中雷公藤红素经时变化符合一室模型(w=1/cc),主要药动学参数分别为Cmax(35.64±9.540)μg·L~(-1),Tmax(2.62±0.69)h,T1/2(2.93±0.29)h,CL(0.308±0.056)L·kg~(-1)·h~(-1),AUC0-12(131.16±31.94)μg·L·h~(-1),AUC0-∞(142.83±37.57)μg·L·h~(-1)。建立的LC-MS/MS分析方法准确灵敏,适于雷公藤片中雷公藤红素药代动力学研究。
To establish a LC-MS/MS method for determination of tripterine in Beagle plasma and study its pharmacokinetics after oral administration of tripterygium tablet. Plasma samples were extracted with dichloromethane and separated on a Phenomenex Luna C8( 2. 0 mm × 50 mm,3 μm) column with methanol-acetonitrile isopropanol( 1∶ 1)-1‰formic acid( 15∶ 55 ∶ 30) as the mobile phase.Tripterine( [M + H]+,m/z 451. 3 /201. 1) and internal standard prednisolone( [M + H]+,m/z 361. 1 /147. 1) were monitored in multiple reaction monitoring( MRM). The concentration-time curves were simulated by drug and statistic software 1. 0 and the pharmacokinetic parameters were calculated. There was a good linear relationship between peak area ratio and concentration of tripterine and internal standard prednisolone within range of 0. 680 0-136. 0 μg·L~(-1). The limit of quantitation was 0. 680 0 μg·L~(-1)and the intraand inter-day precision was within 6. 15%. The absolute recovery rate was between 50. 42% to 51. 65%. The concentration-time curves were consistent with the one-compartment model( w = 1 / cc). The main pharmacokinetic parameters after a single dose were as follows: Cmax( 35. 64 ± 9. 540) μg ·L~(-1),Tmax( 2. 62 ± 0. 69) h,T1 /2( 2. 93 ± 0. 29) h,CL( 0. 308 ± 0. 056) L·kg~(-1)·h~(-1),AUC0-12( 131. 16 ± 31. 94) μg·L·h~(-1),AUC0-∞( 142. 83 ± 37. 57) μg·L·h- 1. The established LC-MS/MS method was proved to be sensitive,accurate and convenient,suitable for the pharmacokinetic study of Tripterygium tablet in Beagle dogs.

关键词(KeyWords): 雷公藤红素;雷公藤片;高效液相色谱-质谱联用;药代动力学
tripterine;Tripterygium tablet;LC-MS/MS;pharmacokinetic study

Abstract:

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基金项目(Foundation): 国家自然科学基金青年基金项目(81403174);; 江苏省自然科学基金面上项目(BK20151602)

作者(Author): 张军;刘史佳;胡杰慧;许美娟;刘子修;周玲;居文政;
ZHANG Jun;LIU Shi-jia;HU Jie-hui;XU Mei-juan;LIU Zi-xiu;ZHOU Ling;JU Wen-zheng;Clinic Pharmacology Laboratory,the Affiliated Hospital of Nanjing University of Chinese Medicine;Applied Biosystems SCIEX Co.,Ltd.;Nanjing University of Chinese Medicine;

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