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目的:建立血浆中丹参酮ⅡA磺酸钠的分析方法,进行该药物在家兔体内的药代动力学研究。方法:采用乙腈沉淀蛋白法进行血浆样品预处理,以RP-HPLC法测定家兔血浆中丹参酮ⅡA磺酸钠的浓度。色谱柱为Hypersil C18柱(250mm×4.6mm,10μm),流动相为0.01mol·L-1磷酸二氢钾-甲醇-三乙胺(33∶67∶0.5,磷酸调节pH至5.5±0.1),流速为1.0mL·min-1,检测波长271nm。结果:丹参酮ⅡA磺酸钠浓度在0.1～30mg·L-1范围内,与峰面积线性关系良好(r=0.9994),定量限为0.1mg·L-1,样品加样回收率>95%,日内和日间精密度的RSD均<5.0%。家兔静脉注射给药后药物体内处置符合三室模型(W=1)。结论:本文建立的丹参酮ⅡA磺酸钠血药浓度测定方法及所获得的药动学参数,可为丹参酮ⅡA磺酸钠的临床研究提供参考。
Objective: To establish a method for the analysis of sodium tanshinone Ⅱ A sulfonate in plasma and to study the pharmacokinetics of the drug in rabbits. Methods: Plasma samples were pretreated by acetonitrile-precipitated protein method and the concentrations of sodium tanshinone Ⅱ A sulfonate in rabbits plasma were determined by RP-HPLC. The column was Hypersil C18 (250 mm × 4.6 mm, 10 μm). The mobile phase consisted of 0.01 mol·L-1 potassium dihydrogen phosphate-methanol-triethylamine (33:67:0.5, pH adjusted to 5.5 ± 0.1) Flow rate of 1.0mL · min-1, detection wavelength of 271nm. Results: The concentration of sodium tanshinone Ⅱ A was in the range of 0.1-30 mg · L-1, and the linear relationship was good with the peak area (r = 0.9994), the limit of quantification was 0.1 mg · L-1, the sample recovery was> 95% The RSD for intra- and inter-day precision was <5.0%. After intravenous injection of rabbits, the drug was treated in vivo in a three-compartment model (W = 1). Conclusion: The method for determination of tanshinone Ⅱ A sulfonate concentration and the pharmacokinetic parameters established in this paper may provide a reference for the clinical study of tanshinone Ⅱ A sulfonate.