地芬尼多口腔崩解片体内代谢探讨

目的：探讨地芬尼多试验药和参比药在健康人体中是否生物等效。方法：采用双周期试验设计，12名健康志愿者分别单次口服地芬尼多试验药和参比药50mg，采用GC—MS方法测定地芬尼多血浓度。用DAS软件计算药物动力学参数，用SPSS软件进行t检验和双因素方差分析。结果：试验药和对照药生物不等效。主要药物动力学参数Ke、t1/2和Cmax在性别因素上存在统计学差异，在剂型因素上无统计学差异；Ka、V／F、AUC0-36和AUC0-∞在剂型因素和性别因素上均不存在统计学差异。结论：单次口服试验药50mg后，不同性别受试者部分药物动力学参数存在差异。

Metabolism of Difenidol Oral Cavity Disintegration Tablet in Vivo

Objective： To discuss the reason about nonbioequivalent of Difenidol testing and referred drugs in healthy volunteers. Method： The crossover design was adopted, 12 healthy volunteers （6 male ＋ 6 female）were received a single dose of testing or referred drug 50 mg respectively. The plasma concentrations were determined by GC-MS method. The primary pharmacokinetic parameters were calculated by DAS software. The t test and the two-ways ANOVA were analyzed by SPSS software. Result： The testing drug and referred drug was nonbioequivalent. The statistic difference of primary pharmacokinetic parameters such as Ke, t1/2 and C was occurred in gender,but none in agent. The others parameters such as Ka, V/F,AUC0-36 and AUC0-∞ showed no statistic difference in gender or agent. Conclusion： With dose of difenidol tablets 50 mg, Some primary pharmacokinetic parameters shows statistic difference in gender.