泮托拉唑肠溶胶囊人体生物利用度及生物等效性研究  

Investigation of Bioavailability and Bioequivalence of Pantoprazole Enteric-Coated Capsules

作　　者：王永庆[1] 吴春勇[2] 张静[1] 王源园[1] 刘云[1] 邵志高[1] 

机构地区：[1]南京医科大学第一附属医院药剂科,江苏南京210029 [2]中国药科大学,江苏南京210009

出　　处：《中国药业》2009年第3期3-4,共2页China Pharmaceuticals

摘　　要：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。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.

关 键 词：泮托拉唑 生物等效性 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学] R975.2[医药卫生—药学]