摘要
目的建立测定人血清中甲芬那酸浓度的高效液相色谱检测法,并研究甲芬那酸分散片在健康人体内的药动学特征。方法甲芬那酸血清样品在酸性条件下,用乙腈-乙醚(2:1)混合液萃取。在DiscoveryC_(18)不锈钢分析色谱柱(4.6mm×250mm,5μm)上,以乙腈-水(55:45)(磷酸调pH=3.0)为流动相,流速1.8ml·min^(-1),检测波长280nm。结果测定方法的线性范围0.13～8.28mg·L^(-1),回归方程为ρ=3.903×10^(-6)A-0.01179(r=0.9993),血清中甲芬那酸的最低检测限为20mg·L^(-1)(按信噪比≥3计)。平均方法回收率为(97.30±4.54)%,日内与日间RSD均小于15%。药动学研究表明,甲芬那酸在12名健康人体内的主要药动学参数t_(max),ρ_(max),t_(1/2(Ke))和AUC(0～14h)分别为(1.04±0.50)h,(5.94±2.51)mg·L^(-1)。(2.12±0.69)h和(18.19±4.05)mg·h·L^(-1)。结论本方法具有良好的准确性、精密性和较高的灵敏度、简便快速,适用于甲芬那酸的血药浓度测定和药动学研究的需要。甲芬那酸分散片的药动学特征表现为达峰时间快,生物利用度较高。
OBJECTIVE To establish a simple HPLC assay for determining mefenamic acid in human serum and to study the pharmacokinetic characteristics of mefenamic acid dispersible tablets in healthy volunteers. METHODS The separation was performed on a Diseovery CIS （4.6mm×250 mm, 5μm）spectrum analytical column with the mobile phase consisted of acetonitrile-water （55：45, pH = 3.0） at the flow rate of 1.8 mL·min^-1. The detection wavelength was at 280 nm. RESULTS The linear calibration curve of mefenamic acid in serum was obtained over the range of 0.13 to 8.28 mg·L^-1（ r = 0.999 3）. The average recovery was（97.30±4.54）%. The inter-day and i ntra-day validation did not exceed 15%. The main pharmacokinetic parameters of mefenamic acid dispersible tables were as follows： tmax, ρmax, t1/2（Ke）, AUC（0-14h）were（1.04±0.50）h,（5.94±2.51）mg·L^-1（2.12±0.69）h,（18.19±4.05）mg·h·L^-1,respectively.CONCLUSION The method is accurate and sensitive, simple, rapid, which may be used for blood concentration monitoring and pharmacokinetic study.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2005年第19期1490-1492,共3页
Chinese Pharmaceutical Journal
