中文摘要：

目的建立同时测定血浆中丹参素（DSS）、原儿茶酸（PA）及羟基红花黄色素A（HSYA）的HPLC分析方法,研究丹红注射液主要酚酸类成分DSS、PA以及HSYA在正常和寒凝血瘀大鼠中药代动力学行为。方法正常及寒凝血瘀模型大鼠各6只,尾静脉注射丹红注射液。采用HPLC法检测给药后2、5、10、15、20、25、30、40、50、60、90min时血浆中DSS、PA以及HSYA的浓度,流动相为0.2%甲酸水（A）-甲醇（B）,梯度洗脱,梯度波长检测：280nm（0~40 min）,402nm（40~60min）。DAS 3.0软件计算药代动力学参数。结果 DSS和PA呈现二室开放模型,HSYA呈现三室模型。与正常组相比,模型大鼠体内DSS、PA和HSYA的达峰浓度Cmax、DSS的分布半衰期t1/2α、PA和HSYA的消除半衰期t1/2α（t1/2γ）和药时曲线下面积AUC以及总表观分布容积V均增大（P〈0.05）;PA和HSYA的分布半衰期t1/2α和DSS药时曲线下面积AUC均降低（P〈0.05）。结论在寒凝血瘀病理模型下,DSS在体内分布减慢,生物利用度降低;PA和HSYA的分布加快,消除减慢,表观分布容积增大,生物利用度增加,更能发挥好疗效。

英文摘要：

Objective To establish an HPLC method for simultaneous analysis of danshensu（DSS）,protocatechuic acid（PA）and hydroxysafflor yellow A（HSYA）in plasma samples,and to study the pharmacokinetics of DSS,PA and HSYA in DanhongInjection in normal and cold-coagulation and blood-stasis model rats.Methods The cold-coagulation and blood-stasis rat models（n=6）were made by continuous stimulation with ice water for 20days;another 6normal rats served as controls.The concentrations of DSS,PA and HSYA in the plasma were determined by RP-HPLC（0.2%formic acid water[A]-methanol[B],gradient elution,wavelength detection：280nm [0-40min]and 402 nm [40-60min]）at 2,5,10,15,20,25,30,40,50,60,and 90 min after administration of DanhongInjection via the tail vein.The pharmacokinetic parameters were calculated with DAS 3.0software.Results DSS and PA had an open two compartment model and HSYA had an open three compartment model.Compared with the normal groups,the model group had significantly increased maximum plasma concentration（Cmax）of DSS,PA and HSYA,the distribution half-life time（t1/2α）of DSS,and elimination half-life time（t1/2α,t1/2γ）,area under curve（AUC）,and apparent volume（V）of PA and HSYA（P〈0.05）;it also had significantly reduced distribution half-life time（t1/2α）of PA and HSYA and area under curve（AUC）of DSS（P〈0.05）.Conclusion DSS has a lower distribution and bioavailability under the condition of cold-coagulation and blood-stasis,while PA and HSYA show a faster distribution,slower elimination,increased apparent volume and bioavailability,indicating a better clinical effect.