| 单次静滴人参皂苷-Rd注射液在中国健康志愿者的药代动力学及耐受性 |
| |
| 引用本文： | 邓远辉,曾星,冯怡,刘奕明,杨柳,黄羽,孙静,梁伟雄.单次静滴人参皂苷-Rd注射液在中国健康志愿者的药代动力学及耐受性[J].中国临床药理学杂志,2009,25(2). |
| |
| 作者姓名： | 邓远辉 曾星 冯怡 刘奕明 杨柳 黄羽 孙静 梁伟雄 |
| |
| 作者单位： | 广州中医药大学附属广东省中医院中心实验室;广东省中医药科学院中药药代动力学研究室,广州,510120 |
| |
| 基金项目： | 国家高技术研究发展计划(863计划) |
| |
| 摘 要： | 目的 研究中国健康志愿者单次静滴人参皂苷-Rd(防治脑缺血中药)注射液的药代动力学及耐受性.方法 选12名健康志愿者,按双拉丁方设计分组,每位受试者于3个周期内交叉静脉滴注人参皂苷-Rd注射液10、40、75 mg 3个剂量;用LC/MS/MS法测定血浆人参皂苷-Rd浓度,用DAS软件计算药代动力学参数;试验过程中密切观察药物不良反应.结果 3个剂量(10、40、75 mg)的主要药代动力学参数:Cmax分别为(2.84±0.47)、(10.48±1.74)、(19.34±2.62)mg·L-1,t1/2分别为(19.29±3.44)、(18.41±2.92)、(17.67±2.01)h,AUC0-t分别为(27.26±8.12)、(112.62±24.08)、(208.36±51.36)mg·L-1·h-1,Cmax、AUC0-t与剂量的线性关系良好,随给药剂量的增加基本成比例增加.试验过程中未出现严重不良事件.结论 该药在中国健康受试者的体内过程符合线性药代动力学特征,剂量在10～75 mg内较安全.
|
| 关 键 词： | 人参皂苷-Rd 药代动力学 耐受性 |
Pharmacokinetics and tolerance of single dose intravenous drip of ginsenoside-Rd injection in Chinese healthy volunteers |
| |
| DENG Yuan-hui,ZENG Xing,FENG Yi,LIU Yi-ming,YANG Liu,HUANG Yu,SUN Jing,LIANG Wei-xiong.Pharmacokinetics and tolerance of single dose intravenous drip of ginsenoside-Rd injection in Chinese healthy volunteers[J].The Chinese Journal of Clinical Pharmacology,2009,25(2). |
| |
| Authors: | DENG Yuan-hui ZENG Xing FENG Yi LIU Yi-ming YANG Liu HUANG Yu SUN Jing LIANG Wei-xiong |
| |
| Institution: | 1.Central Laboratory;Guangdong Provincial Hospital of Traditional Chinese Medicine;2.Guangdong Provincial Academy of Chinese Medical Sciences;Guangzhou 510120;China |
| |
| Abstract: | Objective To study the pharmacokinetics and safety of single dose intravenous drip of ginsenoside-Rd injection in Chinese healthy volunteers.Method Twelve healthy volunteers were enrolled and grouped by latin square design,each of whom was administered with single dose intravenous drip of 10 mg,40 mg,and 75 mg ginsenoside-Rd injection in 3 cross periods.The plasma concentrations of ginsenoside-Rd were determined with LC/MS/MS and the pharmacokinetic parameters were calculated with DAS software.Throughout th... |
| |
| Keywords: | ginsenoside-Rd pharmacokinetics tolerance |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
|
