痧药蟾酥丸中蟾酥的药代动力学研究

Pharmacokinetics of Bufadienolide in Shayao Chansu Pill

目的:进行痧药蟾酥丸Beagle犬急毒药代动力学研究。方法:采用超高效液相色谱-飞行时间质谱(UPLC/TOF MS)建立Beagle犬血浆的代谢指纹谱,测定Beagle犬空白组血浆、对照品、给药组血浆总离子流图谱,并对给药血浆进行方法学验证和药代动力学研究。结果:建立了UPLC/TOF MS方法测定Beagle犬血浆中的蟾酥二烯内酯类化合物,成功地应用于Beagle犬灌胃给予蟾酥丸后血浆的药物动力学研究。结论:本实验为痧药蟾酥丸安全性评价提供了化学依据,为痧药蟾酥丸的临床应用提供参考。

Objective ： To study pharmacokinetics of bufadienolide in Shayao Chansu pill in beagle dogs. Method： Plasma metabolic fingerprint in Beagle dogs was established with UPLC/MS-TOF. The total ion chromatograms in blank plasma, plasma containing control products and plasma obtained from dogs taken Shayao Chansu pill were determined. The plasma containing bufadienolide was methodologically validated and pharmacokinetic study was carried out. Result： The UPLC/MS-TOF method for determining bufadienolide in the Beagle plasma was established, and successfully applied to the pharmacokinetic studies for Beagle plasma after administration of Shayao Chansu pill. Conclusion： The studies provided chemical evidence for safety evaluation of Shayao Chansu pill and references for clinical application of the pill.