基于黄连解毒汤药动学的差异性优化中药复方制备工艺  

Evaluation of Muti-herbs Remedy Prepared Differently based on Pharmacokinetic Variations of Huanglian Jiedu Decoction

作　　者：何凤[1] 顾晓莹[1] 郭立玮[1] 钱志磊[1] 朱华旭[1] 唐于平 

机构地区：[1]南京中医药大学中药复方分离工程重点实验室,南京210029 [2]江苏省方剂重点实验室,南京210029

出　　处：《中国实验方剂学杂志》2012年第10期165-169,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(30873450);江苏省教育厅‘青蓝工程’项目(2008)

摘　　要：目的:以黄连解毒汤为例,基于中药复方药物动力学原理优化中药复方制备工艺。方法:大鼠分别灌胃给予不同制备工艺所得黄连解毒汤全方提取物Ⅰ,Ⅱ,Ⅲ,Ⅳ,于不同时间点采集血浆样品,以黄连解毒汤全方中含量较高的栀子苷为检测指标,采用HPLC测定不同时间点的血药浓度,绘制药-时曲线,应用DAS 2.0软件拟合药动学参数。结果:不同制备工艺所得黄连解毒汤全方提取物中栀子苷的药动学特征相差较大。全方水提取沉淀物组的药-时曲线下面积(AUC)最小且消除最快;全方水提去沉淀物组的AUC(0～∞)与全方水提物组及全方水提醇沉精制物组的AUC(0～∞)相比存在显著性差异(P<0.05);全方水提醇沉精制物组中栀子苷的药-时曲线呈现平缓的趋势;全方水提物组的最大血药浓度(Cmax)最大,但是消除较全方水提醇沉精制物组快。结论:通过不同工艺产物中栀子苷的药代动力学特征的比较,提示中药复方的制备工艺可根据临床给药剂型、给药时间间隔的需求而采用不同的制备工艺,为初步评价中药复方全方的制备工艺研究提供了一种新思路。Objective： To investigate the preparation progresses of muti-herbs remedy, based on pharmacokinetic theory, taken Huanglian Jiedu decoction （HLJDT） example. Method： The plasma samples were collected at different time points, after oral administration of products of HLJDT by four different preparation methods, RP-HPLC was used to determine plasma levels of geniposide which was an index component and higher levels of HLJDT, then concentration-time curve was drawn. And DAS 2.0 software was used to simulate the corresponding pharmacokinetic parameters. Result： Specificity and accuracy of the method were in line with the requirements of biological sample analysis. The analytical results showed that plasma concentration was a larger difference between the oral products made from the same formula HLJDT, but prepared in a different way. The AUC of sediment group of aqueous extract of the muhi-herbs remedy （ IU ） was minimum and elimination of that was fastest; there was a significant difference comparing the AUC（0-∞） between aqueous extract of the multi-herbs remedy without sediment （ II ） and aqueous extract of the multi-herbs remedy （ I ） and the whole side of water extraction and alcohol precipitation refined extract group （IV） （P 〈 0.05 ）; the concentration-time curve of geniposide in sample 1V showed fiat trend ; the Cmax of geniposide in aqueous extract of the multi-herbs remedy was the largest, but elimination of it was more faster than that of sample IV. Conclusion： comparing the pharmacokinetics of the four products prepared by different ways, prompted that the preparation processes of multi- herbs remedy on pharmacokinetics studies could be based on the demands of clinical drug formulations and that of dosing interval, which preliminarily provided a new idea to evaluate preparation processes of multi-herbs remedy.

关 键 词：黄连解毒汤 制备方法 栀子苷 药代动力学 中药复方 

分 类 号：R283.6[医药卫生—中药学] R285.5[医药卫生—中医学]