泮托拉唑肠溶片的健康人体生物等效性研究

目的建立测定人血浆中泮托拉唑的高效液效液相色谱法（HPLC）,研究泮托拉唑肠溶片在男性健康志愿者体内的药动学行为,评价其人体相对生物利用度和生物等效性。方法 18例健康男性志愿者随机分组自身交叉对照试验设计,单剂量口服泮托拉唑肠溶片受试制剂和参比制剂40 mg,HPLC法测定服药后12 h内不同时间血浆中泮托拉唑的浓度,BAPP药动学程序计算相对生物利用度并评价2种制剂生物等效性。结果受制剂试和参比制剂的主要药动学参数：Tmax分别为（3.4±0.6）h和（3.3±0.4）h;Tmax为（3 435.11±1 101.72）μg.L-1和（3 312.37±987.50）μg.L-1;T1/2分别为（1.60±0.31）h和（1.73±0.47）h,药时曲线下面积AUC（0→36 h）分别为（7 805.88±2 390.66）μg.h-1.L-1和（7 459.61±2 641.25）μg.h-1.L-1。受试制剂与参比制剂的相对生物利用度为（107.30±20.20）%。结论建立的分析方法准确灵敏,测得的数据可靠,统计学分析表明2种制剂生物等效。

Bioequivalence study of sinomenone hydrochloride enteric-coated tablets

Objective To establish an HPLC method for determining sinomenone hydrochloride in human plasma,and to investigate the pharmacokinetics and bioequivalence of sinomenone hydrochloride enteric-coated tablets in healthy volunteers.Methods 18 male healthy volunteers were randomized to take a single crossover oral dose of test tablets or reference tablets 40 mg.The concentration of sinomenone hydrochloride in plasma was determined by HPLC.Results The sinomenone hydrochloride main pharmacokinetic parameters of test tablets and reference tablets were as follows：Tmax：（3.4±0.6）h and（3.3±0.4）h;Cmax：（3 435.11±1 101.72）μg·L-1 and（3 312.37±987.50）μg·L-1;T1/2：（1.60±0.31）h and（1.73±0.47）h,AUC（0→36 h）：（7 805.88±2 390.66）μg·h·L-1 and（7 459.61±2 641.25）μg·h·L-1;F was（107.30±20.20）%.Conclusions The established method is sensitive,accurate,and the results are reliable.The test tablets are bioequivalent to the reference tablets.