泮托拉唑肠溶胶囊人体生物利用度及生物等效性研究

目的研究泮托拉唑肠溶胶囊在健康志愿者体内的生物利用度及生物等效性。方法20例健康志愿者随机交叉口服2种泮托拉唑肠溶胶囊各40mg，采用反相高效液相色谱法测定血中药物浓度。结果健康志愿者口服泮托拉唑肠溶胶囊受试制剂及参比制剂后的峰浓度（Cmax）分别为（3158．81±761．351）ng／mL和（3061．48±644．54）ng／mL，达峰时间（Tmax）分别为（2．3±0．5）h和（2．2±0．5）h，0—12h药时曲线下面积（AUC0-12）分别为（6957．16±2012．73）ng·h／L和（7031．52±2095．4）ng·h／L，血浆半衰期（t1／2）分别为（1．72±0．22）h和（1．78±0．26）h。结论2种泮托拉唑肠溶胶囊在健康志愿者体内的药代动力学参数相似，具有生物等效性。

Investigation of Bioavailability and Bioequivalence of Pantoprazole Enteric-Coated Capsules

Objective To evaluate the bioavailability and bioequivalence of two formulations of Pantoprazole Enteric- Coated Capsules in healthy volunteers. Methods Single oral dose of two Pantoprazole Enteric - Coated Capsules was given to 20 volunteers in an open randomized cross way to study the relative bioavailability. The plasma concentrations were determined by HPLC. Results The pharmacokinetic parameters of test preparation and reference preparation were as follows： Cmax （3 158. 81±761. 351）ng/mL and （3 061.48 ±644. 5g）ng/mL; Tmax： （2. 3 ± 0. 5）h and （2.2 ±0. 5）h; AUC0-12：（6 957. 16 ±2 012.73）ng · h/L and （7 031.52 ±2 095.4）ng · h/L; t1/2： （1.72 ±0. 22）h and （1.78 ±0. 26）h. Conclusion The two formulations are bioequivalent.