中文摘要：

目的研究羟基红花黄色素A（hydroxysaffior yellow A，HYSA）在人体内的药动学特征。方法12名健康受试者随机分为低、中、高3个剂量组，每组4人，分别脉滴注给予注射用红花黄色素（以羟基红花黄色素A的含量为35，70和140mg计算），采用高效液相色谱法测定给药后不同时间点血浆中羟基红花黄色素A的浓度并计算药动学参数。结果羟基红花黄色素A在体内过程符合二室模型。主要药动学参数如下：pmax分别为（2．02±0．18），（7．42±0．61），（14．48±4．71）mg·L^-1；t1/2β分别为（3．05±0．70），（3．56±0．77），（3．35±0．91）h；AUC0-15分别为（6．79±1．29），（26．75±5．46），（49．81±13．75）mg·h·L^-1。AUC0-∞分别为（7．85±1．07），（28．60±5．51），（53．80±14．85）mg·h·L^-1。结论高、中、低3个单剂量组中羟基红花黄色素A在人体内的消除半衰期较快，AUC0-15，AUC0-∞和ρmax均与剂量呈线性关系。

英文摘要：

OBJECTIVE To study the pharmacokinetics of hydroxysafflor yellow A for intravenous infusion injection in Chinese healthy volunteers. METHODS 12 Healthy volunteers, randomly divided into 3 groups with 4 volunteers in each group, received HSYA at single dose of 35, 70 and 140 mg, respectively. The concentrations of HSYA in human plasma at different time were analyzed by HPLC-UV method. The pharmacokinetic parameters were calculated by the software DAS 2.0. RESULTS The plasma concentration-time curves of the preparation were fitted by a two-compartment model. The main pharmacokinetic parameters were as follows： ρmax were （2.02±0.18） , （7.42±0.61） , （14.48±4.71） mg·L^-1; t1/2β were （3.05±0.70） , （3.56±0.77） , （3.35±0.91）h： AUC0-15 were （6.79± 1.29）, （26.75±5.46）, （49.81 ± 13.75）mg·h·L^-1. AUC0-∞ were（7.85±1.07）, （28.60±5.51）, （53.80±14.85） mg·h·L^-1. CONCLUSION The t1/2β was similar among three dosages and the values of AUC0-15, AUC0-∞, ρmax were linear in the dose range from 35 mg to 140 mg.