目的:建立人血浆中羟基红花黄色素A(HSYA)高效液相色谱(HPLC)测定法,考察HSYA在健康女性体内单次和多次给药后药动学。方法:12名健康女性受试者第1天单剂量静滴HSYA70mg,第2天起qd。连续6d,给药后用HPLC测定不同时间血药浓度.求得主要药动学参数。结果:单次和多次静滴HSYA在体内过程符合非房室模型,主要药动学参数:Cmax分别为(5.9±1.6)、(7.8±2.4)mg·L^-1;tmax分别为(1.17±0.29)、(1.00±0.00)h;AUC0-15分别为(23.2±2.5)、(27.2±7.6)mg·L^-1·h;AUC0-∞分别为(23.8±2.8)、(28.6±8.4)mg·L^-1·h;t1/2β分别为(2.96±0.23)、(4.4±1.4)h。结论:qd,连续7d,静滴HSYA70mg,药物在体内无蓄积,受试者耐受性良好。
OBJECTIVE To study the pharmacokinetics of intravenous infusion injection of hydroxysafflor yellow A(HSYA) at multiple-dose and the determination of HSYA in Chinese healthy volunteers. METHODS The plasma samples of 12 healthy volunteers were collected after injecting 70mg intravenous infusion injection of HSYA once a day for 7 days and were deter mined by HPLC method. RESULTS The main pharmacokinetic parameters of HSYA after injection a sing dose(70mg)and multiple-dose were as follow:Cmax were (5. 9± 1.6),(7.8±2.4) mg ·L^-1;AUC0-15were (23.2±2.5),(27.2±7.6) mg ·L^-1; AU0-∞ ,were (23.8±2.8),(28.6±8.4) mg·L^-1·h;tmax were (1. 17±0.29),(1.00±0.00)h;t1/ 2β were (2. 96±0.23),(4.4± 1.4)h. CONCLUSION There are no body cumulation after injecting 70 mg intravenous infusion injection of HSYA once per day for 7 days, the volunteers are safe.