复方银黄微型灌肠剂人体内药代动力学研究

Pharmacokinetics Study onYinhuang Compound Microenema in Healthy Volunteers

目的:测定复方银黄微型灌肠剂的药代动力学参数,为临床合理用药提供科学依据。方法:采用高效液相色谱法测定黄芩苷和绿原酸在人体内的血药浓度,采用药动学程序3P97进行统计处理,确定药动学模型及相关药代动力学参数。结果:黄芩苷在人体内呈二室模型分布,其药代动力学参数是:T1/2α=0.325 h,T1/2β=2.370 h,AUC=6.236μg.h/mL,Tm=0.247h,Vd=2.314 L;绿原酸在人体内呈二室模型分布,其药代动力学参数是:T1/2α=0.106 h,T1/2β=1.641 h,AUC=15.138μg.h/mL,Tm=0.267 h,Vd=2.423 L。结论:复方银黄微型灌肠剂经直肠给药后其主要成分黄芩苷和绿原酸在人体内吸收迅速、完全。

Objective:To determine parameters of pharmacokinetics in healthy volunteers,provide a scientific basis for clinical application of Yinhuang compound microenema.Method:HPLC was used to determine the concentrations of chlorogenic acid and baicalin in the plasma samples of healthy volunteers,then analyze these data by the pharmacokinetics program 3P97 to determine the parameters of pharmacokinetics and the compartmental model for both ingredients inYinhuang compound microenema.Result:Baicalin showed two compartment model in healthy volunteers and the main parameters of pharmacokinetics were as follows:T1/2α of 0.325 h,T1/2β of 2.370 h,AUC of 6.236×10^(-3) g·h·L^(-1),Tm of 0.247 h,Vd of 2.314 L;chlorogenic acid showed two compartment model in healthy volunteers and the main parameters of pharmacokinetics were as follows:T1/2α of 0.106 h,T1/2β of 1.641 h,AUC of 1.514×10^(-2)g·h·L^(-1),Tm of 0.267h,Vd of 2.423 L.Conclusion:The main components in Yinhuang compound microenema,baicalin and chlorogenic acid,were absorbed quickly and completely after rectal administration.