泮托拉唑钠肠溶胶囊在健康人体的药代动力学和生物等效性

目的：评价泮托拉唑钠肠溶胶囊在中国健康志愿者体内的药动学和生物等效性。方法：18名健康男性试验者随机分为2组,分别单剂量口服泮托拉唑钠肠溶胶囊试验制剂或参比制剂40mg。7d清洗期后再交叉给药。于服药前（0h）和服药后0.33、0.67、1.00、1.50、2.00、2.50、3.00、3.50、4.00、6.00、8.00、10.00h抽取静脉血。采用高效液相色谱法测定血浆中泮托拉唑的浓度。通过DASVer2.0软件计算主要药动学参数,评价两制剂的生物等效性。结果：泮托拉唑钠肠溶胶囊试验制剂与参比制剂的tmax分别为（2.60±0.67）h和（2.60±0.50）h,Cmax分别为（2767.90±969.20）μg/L和（2864.10±1090.20）μg/L,t1/2分别为（1.80±0.60）h和（1.80±0.50）h,AUC0→t分别为（8071.1±4747.9）μg.h/L和（8272.5±5095.0）μg.h/L,AUC0→∞分别为（8581.60±5255.70）μg.h/L和（8803.30±5639.10）μg.h/L。以AUC0→t计算,试验制剂中泮托拉唑钠对参比制剂的相对生物利用度为（99.40±11.40）%。结论：经方差分析及双单侧t检验,泮托拉唑钠肠溶胶囊试验制剂与参比制剂在中国健康志愿者体内具有生物等效性。

Pharmacokinetics and bioequivalence of Pantoprazole sodium enteric-coated Capsules in healthy volunteers

Objective：To evaluate the pharmacokinetics and bioequivalence of Pantoprazole sodium enteric-coated Capsules in healthy volunteers. Methods：The study was performed in 18 healthy male volunteers according to a randomized 2-way crossover design. The blood samples were collected at 0 h,and 0.33,0.67,1.00,1.50,2.00,2.50,3.00,3.50,4.00,6.00,8.00,10.00 h after taking 40 mg of Pantoprazole sodium enteric-coated Capsules test preparation and reference preparation,and with repeated sampling of the crossover drug administration 7 d after clearance. The concentration of pantoprazole in plasma was determined by HPLC. The pharmacokinetic parameters were calculated and compared statistically to evaluate the relative bioequivalence between the two preparations of pantoprazole sodium by DAS Ver 2.0 software. Results：The major pharmacokinetic parameters of Pantoprazole sodium enteric-coated Capsules test preparation and reference preparation were as follows：tmax were （2.60±0.67） h and （2.60±0.50） h,Cmax were （2 767.90±9 69.20） μg/L and （2 864.10± 1 090.2） μg/L,t1/2 were （1.80±0.60） h and （1.80±0.50） h,AUC0→t were （8 071.10±4 747.90） μg.h/L and （8 272.50±5 095.00） μg.h/L,AUC0→∞ were （8 581.60±5 255.70） μg.h/L and （8 803.30±5 639.10） μg.h/L,respectively. The relative bioavailability of test preparation was （99.40±11.40）%. Conclusion：Statistical analysis showes Pantoprazole sodium enteric-coated Capsules test preparation and reference preparation were bioequivalent in Chinese healthy volunteers.