摘要
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 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.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2009年第10期781-783,共3页
Chinese Pharmaceutical Journal
基金
国家自然科学基金资助项目(30672662)
作者简介
田云，女，药师，硕士研究方向：临床药学
通讯作者：文爱东，男，主任药师，教授研究方向：临床药理学Tel／Fax：（029）84773636 E-mail：aidongwen@fmmu．edu．cn
