阿魏酸钠片在健康人体中的生物等效性研究  

Pharmacokinetics and bioequivalence of sodium ferulate tablets in human

作　　者：闫冬[1] 赵娜[1] 张希玉[1] 杨亮[1] 马骉 

机构地区：[1]沈阳亿灵医药科技有限公司,沈阳110179 [2]北京赛而生物药业有限公司,北京100078

出　　处：《中国新药杂志》2008年第3期247-250,共4页Chinese Journal of New Drugs

摘　　要：目的:研究阿魏酸钠在健康人体的药动学和生物等效性。方法:采用双交叉随机自身对照试验设计,20例健康男性志愿者分别单剂口服两种阿魏酸钠片(参比制剂和受试制剂)100 mg,应用高效液相-紫外检测法测定血浆中阿魏酸钠的浓度,血药浓度-时间数据经DAS 2.1软件处理后得药动学数据,并进行等效性检验。结果:参比制剂与受试制剂的主要药动学参数分别为Cmax(1 230.3±124.1)和(1 272.6±125.5)μg.L-1,Tmax(25.0±5.9)和(25.3±5.5)m in,t1/2(50.1±19.8)和(46.1±12.6)m in,AUC0-t(72 831.6±11 107.5)和(75 679.8±10 193.4)μg.L-1.m in,AUC0-∞(74 826.4±11 259.6)和(78 149.8±10 709.0)μg.L-1.m in,受试制剂对参比制剂的平均相对生物利用度为(104.9±7.9)%。主要药动学参数进行方差分析和双单侧t检验,Tmax采用非参数检验,结果显示差异无统计学意义。结论:两种阿魏酸钠片具有生物等效性。Objective：To study the pharmacokinetics and the bioequivalence of two kinds of sodium ferulate tablets in human. Methods： In a randomized, crossover and self-control study, 20 healthy male volunteers were orally administrated with single doses （ 100 mg） of the two sodium ferulate tablets. The plasma samples were collected to measure the concentrations by the HPLC-UV method. The plasma concentration-time curves and the bioequivalence of both sodium ferulate tablets were analyzed using DAS 2.1 software. Results： The main pharmacokinetic parameters of the reference and test tablets were as follows ： Cmax were （ 1 230.3± 124.1 ） and （ 1 272.6± 125.5）μg·L^-1; Tmax were （25.0±5.9） and （25.3 ±5.5）min; t1/2 were （50. 1±19.8） and （46. 1±12.6）min; AUC0-∞were （72831.6± 11 107.5） and （75 679.8 ± 10 193.4）μg·L^-1.min; AUC0-∞ were （74 826.4 ±11 259.6） and （78 149.8±10 709.0）μg·L^-1. min; the relative bioavailability of the test tablets was （104.9 ± 7.9 ） %. There were no statistically significant differences in the main parameters of two tablets as analyzed by ANOVA and two- and one-sided t-test. Conclusion： The reference and test sodium ferulate tablets are bioequivalent.

关 键 词：阿魏酸钠 高效液相-紫外检测法 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R972[医药卫生—药学]