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伊痛舒注射乳剂的药动学研究
Study on Pharmacokinetic of Yitongshu Emulsion Injection
【摘要】 目的:建立同时测定大鼠体内藁本内酯和蛇床子素含量的反相高效液相色谱(RP-HPLC)方法,并将此法运用于伊痛舒注射乳剂的药动学研究。方法:色谱柱为Hypersil-C18(250mm×4.6mm,5μm),流动相为乙腈-水(50:50),流速为1.0mL·min-1,检测波长为300nm。结果:藁本内酯和蛇床子素的检测浓度分别在0.13~16.6、0.82~10.5μg·mL-1范围内线性关系良好(r分别为0.9994和0.9996);藁本内酯的日内和日间精密度分别为4.8%~15.6%、10.4%~16.7%,蛇床子素的日内和日间精密度分别为4.9%~11.6%、7.4%~15.9%;方法回收率均>70%。藁本内酯和蛇床子素的Cmax分别为7.30、4.58μg·mL-1,AUC0~分别为t137.26、81.44μg·min·mL-1,AUC0分别为142.23、83.63μg·min·mL-1,t1分别为21.42、19.55h,Ke分别为0.030、0.040·min-1。结∞/2论:该方法可以用于静脉注射给药后伊痛舒注射乳剂的药动学研究。
【Abstract】 OBJECTIVE:To establish RP-HPLC method for simultaneous determination of ligustilide and osthole in rat plasma and pharmacokinetic study of Yitongshu emulsion injection.METHODS:The separation was performed on a Hypersil-C18(250 mm×4.6 mm,5μm) column with the mobile phase consisted of acetonitrile-water (50:50).The detection wavelength was set at 300 nm and the flow rate was 1.0 mL·min-1.Determine its pharmacokinetics of parameters.RESULTS:The linear range of ligustilide and osthole were 0.13-16.6 μg·mL-1(r=0.999 4) and 0.82-10.5 μg·mL-1(r=0.999 6).The RSD of intra-day and inter-day were 4.8%-15.6% and 10.4%-16.7% for ligustilide and 4.9%-11.6% and 7.4%-15.9% for osthole,respectively.The method recoveries for all samples were more than 70%.Cmax of ligustilide and osthole are 7.30 μg·mL-1 and 4.58 μg·mL-1 respectively,AUC0-t are 137.26 μg·min·mL-1 and 81.44 μg·min·mL-1 respectively,AUC0-∞ are 142.23 μg·min·mL-1 and 83.63 μg·min·mL-1 respectively,t1/2 are 21.42 h and 19.55 h respectively,Ke are 0.030·min-1 and 0.040·min-1 respectively.CONCLUSION:The method is suitable for pharmacokinetic study of Yitongshu emulsion injection after intravenous administration.
【Key words】 RP-HPLC; Pharmacokinetic; Yitongshu emulsion injection; Ligustilide; Osthole;
- 【文献出处】 中国药房 ,China Pharmacy , 编辑部邮箱 ,2011年11期
- 【分类号】R285
- 【被引频次】3
- 【下载频次】126