脑忆源片中淫羊藿苷在大鼠血浆中的药动学研究

Pharmacokinetic Studies on Icariin of Naoyiyuan Tablets in Rat Plasma

目的检测脑忆源片中淫羊藿苷在大鼠血浆中的血药浓度,计算其药动学参数。方法采用HPLC法测定不同时间点淫羊藿苷的血药浓度,药-时曲线数据经DAS药动学计算程序处理。色谱柱：Phenomenex lunaC18（150 mm×4.60 mm,5μm）;流动相∶乙腈-水（30∶70）;流速：1 mL.min-1;检测波长：270 nm。结果淫羊藿苷在0.25~13μg/mL之间呈良好的线性关系（r=0.9996）;大鼠灌胃脑忆源片后,淫羊藿苷的药-时曲线符合二室一级吸收模型,主要动力学参数：t1/2α（1.554）h;t1/2β（1.692）h;ka（0.463）h-1;Tmax（3）h;Cmax（4.423875）mg.L-1;AUC0~t（25.877）mg.L-1.h-1;AUC0~∞（25.889）mg.L-1.h-1。结论本法准确、灵敏、简便,适用于淫羊藿苷的血药浓度测定,为含淫羊藿制剂的药动学研究及质量控制提供了参考依据。

Objective To assay the concentration of icariin of Naoyiyuan Tablets in rat plasma,and to investigate its pharmacokinetic parameters.Methods The plasma concentration of icariin was determined by HPLC at different time,and the data of concentration-time curve was calculated by DAS pharmacokinetic program software.A Phenomenex luna C18 column（150 mm × 4.60 mm,5 μm） was used with a mobile phase of acetonitrile-water（30 ∶ 70）.The flow-rate was 1 mL·min-1 and the detection wavelength was 270 nm.Results The calibration curve of icariin was linear in the range of 0.25~13 μg·ml-1（r=0.9996）.The concentration-time profiles of icariin in rats after intragastric administration of Naoyiyuan Tablets were shown to fit the two-compartment model with first-order absorption.The main pharmacokinetic parameters were as follows： t1/2α（1.554）h,t1/2β（1.692）h,ka（0.463）h-1,Tmax（3）h,Cmax（4.423875）mg·L-1,AUC0~t（25.877）mg·L-1·h-1,AUC0~∞（25.889）mg·L-1·h-1.Conclusion This method is accurate,sensitive and simple,and is suitable for the pharmacokinetic studies of icariin.The results will provide certain evidence for quality control of Naoyiyuan Tablets.