摘要
目的 评价叶下珠配方颗粒、饮片汤剂药动学特性及生物等效性.方法 12 只大鼠随机分为2 组,分别灌胃给予叶下珠配方颗粒、饮片汤剂溶液(0.428 2、2.000 g/kg),于 0.083、0.167、0.25、0.5、0.75、1、2、3、4、8、12、24、36 h采血,UPLC-MS/MS法测定没食子酸、柯里拉京、鞣花酸血药浓度,计算主要药动学参数.再考察这 2种制剂的生物等效性.结果 2 种制剂AUC0～∞、AUC0～t、MRT0～∞、MRT0～t、t1/2、Tmax、CL、Cmax比较,差异无统计学意义(P＞0.05),其Cmax、AUC0～∞比值或对数均数的差值均在 90%置信度下符合生物等效标准.结论 叶下珠配方颗粒、饮片汤剂药动学特性接近,具有生物等效性.
Abstract
AIM To evaluate the pharmacokinetic properties and bioequivalency of Yexiazhu Formula Granules and Decoction.METHODS Twelve rats were randomly assigned into two groups and given intragastric administration of the solutions of Yexiazhu Formula Granules and Decoction(0.428 2,2.000 g/kg),respectively,after which blood collection was made at 0.083,0.167,0.25,0.5,0.75,1,2,3,4,8,12,24,36 h,UPLC-MS/MS was adopted in the plasma concentration determination of gallic acid,corilagin and ellagic acid,and main pharmacokinetic parameters were calculated.Subsequently,the bioequivalency of these two preparations was investigated.RESULTS No significant differences in AUC0-∞,AUC0-t,MRT0-∞,MRT0-t,t1/2,Tmax,CL and Cmax were observable between the two preparations(P＞0.05),whose Cmax,AUC0-∞ ratios or logarithmic mean differences accorded with bioequivalence standard at the 90%confidence level.CONCLUSION Yexiazhu Formula Granules and Decoction demonstrate approximate pharmacokinetic properties and display bioequivalency.
维普
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