中文摘要：

目的：以葛根芩连汤为模型药物,探讨中药复方多效应成分分类整合药代动力学研究方法。方法：SD大鼠灌胃给予20 mL/kg葛根芩连汤,用HPLC-ESI-MS/MS检测11个有效成分的血药浓度。并将这些成分归为黄酮类和生物碱类两类化合物,自定义权重系数,计算葛根芩连汤总黄酮类与总生物碱类化合物在大鼠体内综合血药浓度,建立分类整合药动学研究模型,并用统计矩法得到葛根芩连汤中总黄酮类、总生物碱类化合物在大鼠体内整合药代动力学参数。结果：分类整合的总黄酮类、总生物碱类血浆浓度药时曲线都符合灌胃给药的药物处置规律,整合药动学参数t1/2、AUC0-∝分别为6.08 h、30.00 mg.h.L-1和28.86 h、1.07 mg.h.L-1。结论：分类整合药动学研究模型符合经典药动学模型特征,所获参数能够最大程度上表征中药复方同类成分整体的体内处置规律,为建立中药复方药代动力学研究提供了一种研究方法。

英文摘要：

AIM ： This study was designed to develop and validate a classified and integrated pharmacokinetic approach to assessing the holistic pharmacokinetic properties of traditional Chinese compound recipes using Gegen-Qinlian decoction（GQD） as a model medicine. METHODS ： 11 effective constituents were determined by Triple Quadrupole LC-ESI-MS/MS method after intragastric administration of 20 mL/kg dosage of GQD.An approach of self-defined weighting coefficient has been created to the holistic pharmacokinetic profiles of flavonoids and alkaloids in GQD.The classified and integrated synthetic concentrations were obtained,and then the pharmacokinetic parameters of flavonoids and alkaloids were calculated from non-compartmental model analysis. RESULTS ：Based on the self-defined AUC weighting coefficients integration approach,the holistic pharmacokinetic profiles of both flavonoids and alkaloids were obtained and consistent with regularity of drug disposition in the body.The holistic t 1/2 and AUC 0-∝ of flavonoids were 6.08 h,30.00 mg·h·L-1 and those of alkaloids were 28.86 h,1.07 mg·h·L-1,respectively. CONCLUSION ： A classified and integrated pharmacokinetic approach to describing the holistic pharmacokinetic properties has been successfully developed and validated using GQD as a model traditional Chinese compound recipe.This study would be useful for guiding the holistic pharmacokinetic study in consistence with the intrinsic theory and characteristics of traditional Chinese compound recipe.