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目的建立大鼠血浆中丹参酮ⅡA浓度的测定方法,考察丹参酮ⅡA自微乳制剂的药动学特征。方法采用乙腈沉淀蛋白进行血浆预处理,以HPLC测定给药后大鼠血浆中丹参酮ⅡA的浓度。色谱柱为Kromasil C18柱(250 mm×4.6 mm,5.0μm),流动相为乙腈-0.01 mol.L-1枸橼酸水溶液(80∶20),流速1.0 mL.min-1,检测波长:270 nm,柱温25℃。比较丹参酮ⅡA自微乳制剂组和混悬液组大鼠血药浓度曲线的差异。结果丹参酮ⅡA在0.102~8.2 mg.L-1内线性关系良好(r=0.998 6),绝对回收率为77.5%~85.6%,相对回收率为88.3%~96.8%,日内和日间精密度RSD均小于15%。丹参酮ⅡA自微乳制剂比丹参酮ⅡA混悬液的AUC值高约2.5倍。结论本法可以准确、灵敏地测定大鼠血浆中丹参酮ⅡA的浓度。将丹参酮ⅡA制成自微乳制剂,能提高其生物利用度。
Objective To establish a method for the determination of tanshinone Ⅱ A concentration in rat plasma and investigate the pharmacokinetics of tanshinone ⅡA microemulsion. Methods Plasma was pretreated with acetonitrile precipitated protein and the concentration of tanshinone Ⅱ A in rat plasma was determined by HPLC. The column was a Kromasil C18 column (250 mm × 4.6 mm, 5.0 μm) with a mobile phase of acetonitrile-0.01 mol·L-1 citric acid (80:20) at a flow rate of 1.0 mL · min-1. The detection wavelength was 270 nm, column temperature 25 ℃. The difference of plasma concentration curve between the tanshinone ⅡA self-microemulsion group and the suspension group was compared. Results Tanshinone ⅡA had a good linear relationship (0.106 ~ 8.2 mg.L-1) (r = 0.998 6), the absolute recovery was 77.5% ~ 85.6% and the relative recovery was 88.3% ~ 96.8%. The intra- and inter- Less than 15%. The tanshinone IIA self-microemulsion formulation has a 2.5-fold higher AUC than tanshinone IIA suspension. Conclusion This method can accurately and sensitively determine the concentration of tanshinone Ⅱ A in rat plasma. Tanshinone Ⅱ A made from self-microemulsion formulations, can improve its bioavailability.