摘要
目的:建立测定头孢拉定在人体血浆中浓度的HPI。C法,并计算药动学参数。方法:18名健康志愿者单剂量VI服头孢拉定胶囊500mg,肘静脉取血并分取血浆,用甲醇沉淀血浆蛋白质,采用Hypersil ODS色谱柱(250mm×4.6mm,5μm),以乙腈-水-冰乙酸-三乙胺(10:90:0.14:0.16)作为流动相进行分离,检测波长262nm,流速为1.0mL/min。结果:受试制剂和参比制剂中头孢拉定主要药动学参数:达峰时间tmax为(1.03±0.12)h和(1.03±0.12)h,峰浓度Cmax为(14.26±2.11)μg/mL和(14.13±2.11)μg/mL,消除相半衰期t1/23为(1.13±0.12)h和(1.11±0.12)h,AUC0~∞为(23.41±3.35)μg·h·mL^-1和(23.14±2.92)μg·h·mL^-1。结论:该方法简便、准确、重现性好,适合头孢拉定的血药浓度测定。受试制剂和参比制剂生物等效。
Objective: To study the pharmacokinetics of cefradine capsules and establish a HPLC method for determining the contents of the cefradine in human plasma. Methods: The randomized, crossed-over study was carried out in 18 healthy volunteers. After a single dose of cefradine (500 ms), the plasma drug levels were determined by HPLC method. The column was Hypersil ODS (250 mm×4.6 mm, 5μm) and acetonitrile-water-glacial acetic acid triethylamine (10 : 90 : 0.14 : 0. 16) was the mobile phase. The detection wavelength was 262 nm. The flow rate was 1.0 mL/min. Results: The main pharmacokinetic parameters of test cefradine and reference cefradine were as follows: tmax (1.03 ± 0. 12) h and (1.03 ± 0. 12) h, Cmax (14.26±2.11)μg/mL and (14.13±2.11) μg/mL, t1/2=(1.13±0.12) h and (1.11±0.12) h, AUC0-∞(23.41± 3.35) μg · h· mL^-1 and (23.14±2.92) μg · h· mL^-1. Conclusion:The results show that the two formulations are bioequivalent.
出处
《药学服务与研究》
CAS
CSCD
2006年第4期283-285,共3页
Pharmaceutical Care and Research
关键词
头孢拉定
色谱法
高压液相
血药浓度
药代动力学
cefradine
chromatography, high pressure liquid
plasma concentration
pharmacokinetics