摘要
目的:研究灯盏花素片在中国人体内的药代动力学。方法:2 0名健康志愿者单剂量口服12 0mg灯盏花素片,用高效液相 质谱联用法测定血浆中灯盏乙素总苷元。结果:本实验建立的血药浓度测定方法,血浆中杂质不干扰样品的测定,线性范围为0 .0 12 6～3.2 4mg·L-1;日内和日间精密度均小于12 .0 %。2 0名健康受试者单剂量口服灯盏花素片(12 0mg)后,主要药代动力学参数:Tmax =7.0±2 .3h、Cmax=0 .9±0 .5mg·L-1、AUC0 -tn =5 .6±1.6mg·h·L-1、AUC0 -∞=5 .8±1.6mg·h·L-1、MRT0 -tn=8.0±1.1h、MRT0 -∞=8.6±1.4h。结论:建立的LC MS法适用于灯盏乙素人体药代动力学研究。灯盏花素片口服药代动力学特点是达峰时间较长,约占受试者总人数4 5 %的药时曲线有双峰现象。
AIM: To determination of scutellarin in human plasma by LC-MS method and investigate the pharmacokinetics of breviscapine tablets in Chinese healthy volunteers. METHODS: 20 male healthy volunteers were received a single oral dose of 120 mg breviscapine tablets. The plasma concentration of scutellarin aglycone was determined by HPLC-MS method. RESULTS: The linear range was 3.24- 0.0126 mg·L -1. Within-day RSD and between-day RSD were less than 12%.The main pharmacokinetic parameters were as follows: T_ max was 7.0± 2.3 h, C_ max was 0.9± 0.5 mg·L -1, AUC_ 0-24 h was 5.6± 1.6 mg·h·L -1, AUC_ 0-∞ was 5.8± 1.6 mg·h·L -1, MRT_ 0-24h was 8.0± 1.1 h, and MRT_ 0-∞ was 8.6± 1.4 h. CONCLUSION: This method is sensitive, fast, and accurate, and it can be used for pharmacokinetic studies of scutellarin in humans.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2005年第3期298-301,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
科技部"临床试验关键技术及平台研究"课题资助 (№ 2 0 0 4AA2Z3 766)
