论文部分内容阅读
目的研究羟基红花黄色素A(hydroxysafflor 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140 mg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:ρ_(max)分别为(2.02±0.18),(7.42±0.61),(14.48±4.71) mg·L~(-1);t_(1/2β)分别为(3.05±0.70),(3.56±0.77),(3.35±0.91)h;AUC_(0-15)分别为(6.79±1.29),(26.75±5.46),(49.81±13.75)mg·h·L~(-1)。AUC_(0-∞)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,AUC_(0 15),AUC_(0-∞)和ρ_(max)均与剂量呈线性关系。
Objective To study the pharmacokinetics of hydroxysafflor yellow A (HYSA) in human. Methods Twelve healthy subjects were randomly divided into 3 groups (low, middle and high dose groups), 4 in each. Each group was given intravenous injection of safflower yellow pigment (the content of safflower yellow A was 35,70 And 140 mg calculated), the concentration of hydroxysafflor yellow A in plasma at different time points after administration was determined by HPLC, and the pharmacokinetic parameters were calculated. Results Hydroxysafflor yellow A in vivo process in line with the two-compartment model. The main pharmacokinetic parameters were as follows: ρ max were (2.02 ± 0.18), (7.42 ± 0.61) and (14.48 ± 4.71) mg · L -1, respectively, and t 1/2 (3.05 ± (6.76 ± 0.77) and (3.35 ± 0.91) h respectively; AUC 0-15 were (6.79 ± 1.29), (26.75 ± 5.46) and (49.81 ± 13.75) mg · h · L -1 ). AUC_ (0-∞) were (7.85 ± 1.07), (28.60 ± 5.51) and (53.80 ± 14.85) mg · h · L -1, respectively. Conclusion The elimination half-life of hydroxy-safflower yellow A in the three high, middle and low single dose groups is faster in vivo. The linear relationship between AUC_ (0 15), AUC_ (0-∞) and ρ_ (max) .