泮托拉唑肠溶胶囊的人体生物等效性研究

目的评价2种泮托拉唑肠溶胶囊的生物等效性。方法18名健康男性受试者,随机分组,自身交叉口服泮托拉唑肠溶胶囊实验制剂和参比制剂40 mg,采用高效液相色谱法-质谱法测定用药后不同时间的经时血药浓度,以方差分析方法对主要药动学参数AUC0→13、Cmax进行均数的差别检验,以双单侧t检验进行生物等效性判断;对Tmax以非参数检验(符号秩检验)进行生物等效性判断。结果2种泮托拉唑肠溶胶囊实验制剂和参比制剂的药代动力学参数AUC0→13、AUC0→∞、Tmax、Cmax、t1/2分别为7 670.1±2509.6和7 549.6±2 149.9、7 724.4±2 535.1和7 591.2±2 161.2[ng/(h.mL)]、3.0±0.2和3.0±0.2 h、3 107.2±567.0和3 267.2±717.3(ng/mL)、1.1±0.3和1.0±0.2(h)。实验制剂的相对生物利用度为(100.8±10.3)%。方差分析结果表明两种制剂的主要药动学参数AUC0→13、Cmax之间无明显差异。结论2种制剂为生物等效制剂。

BIOEQUIVALENCE OF PANTOPRAZOLE ENTERIC CAPSULES IN HUMAN PLASMA

Objective To evaluate the bioequivalence of Pantoprazole enteric capsules.Methods Eighteen healthy volunteers are randomly divided into two groups,and single oral dose of Pantoprazole at the dose of 40mg of test enteric capsule and reference one are given respectively.The plasma drug time-concentrations of Pantoprazole are determined by high performance liquid chroma-mass spectrography(HPLC-MS).The means of the main pharmacokinetic parameters(AUC_(0→13)、AUC_(0→∞))are analysed by variance,and their bioequivalence is judged by two-one side t-test.The bioequivalence of Tmax is judged by signed rank test.Results The pharmacokinetic parameters AUC_(0→13),AUC_(0→∞),T_(max),C_(max),t_(1/2) of test enteric capsule and reference enteric capsule of the two kind of Pantoprazole is 7670.1±2509.6 and 7549.6 ±2149.9,7724.4±2535.1 and 7591.2±2161.2 [ng/(h·mL)],3.0±0.2 and 3.0±0.2(h),3107.2±567.0 and 3267.2±717.3(ng/mL),1.1±0.3 and 1.0±0.2(h) respectively.The relative bioavailability of test enteric capsule is 100.8±10.3%.The results of analysis of variance show that the main pharmacokinetic parameters(AUC_(0→13),AUC_(0→∞)) are not significantly diferent from two preparations.The results of two-one side t-test and signed rank test show that the two preparations of Pantoprazole are bioequivalent.