兰索拉唑片的人体生物等效性研究  

Bioequivalence of Lansoprazole tablets in healthy volunteers

作　　者：贺建昌[1] 徐贵丽[1] 张青[1] 冯恩富[1] 尹玉琴[1] 李星仪[1] 

机构地区：[1]成都军区昆明总医院药学部,云南昆明650032

出　　处：《华西药学杂志》2009年第5期514-516,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的研究兰索拉唑在健康人体内的药物动力学,评价供试制剂和参比制剂的生物等效性。方法20名健康男性志愿者按自身交叉对照设计,单剂量口服30 mg兰索拉唑供试片和参比片。采用HPLC法测定不同时间点血浆中兰索拉唑的药物浓度,用DAS软件处理所得数据,评价其生物等效性。结果兰索拉唑供试制剂和参比制剂的Cmax分别为0.87±0.36、0.95±0.43μg·ml^-1;Tmax分别为3.30±0.97、3.40±0.90 h;T1/2分别为2.42±1.67、1.84±0.99 h;AUC0-24 h分别为3.47±1.81、3.57±2.53μg·ml^-1·h;AUC0-∞分别为4.10±3.31、3.90±3.36μg·ml^-1·h。其相对生物利用度F0～24 h、F0-∞分别为111.8%±55.5%、115.3%±52.9%。结论新建立方法准确、可靠、简便。两制剂具有生物等效性。OBJECTIVE To develop an HPLC method with ultraviolet detector for quantification of Lansoprazole in human plasma and evaluate bioequivalence of two kinds of tablets. METHODS 20 healthy male volunteers were randomly administered with an oral single crossover dose of test or reference Lansoprazole tablets of 30 rag. The plasma samples were then collected from volunteers to measure Lansoprazole concentrations by HPLC. The pharmaeokinetic parameters of Lansoprazole preparations were calculated using DAS 2.0. RESULTS The pharmacokinetic paramcters of reference and test preparations were as follows ： Cmax were 0.87 ± 0.36 and 0.95 ±0.43 μg· ml^-1 ; Tmax were 3.30 ± 0.97 and 3.40 ± 0.90 h ; T1/2 were 2.42 ± 1.67 and 1.84 ± 0.99 h ;AUC0-24h were 3.47 ± 1.81 and 3.57 ±2.53 μg·ml^-1·h;AUC0-h were 4.10 ± 3. 31 and 3.90 ±3.36 μg·ml^-1·h; F0-24h and F0-∞ were 111.8% ±55.5% and 115.3% ± 52.9% , respectively. CONCLUSION A rapid, simple and sensitive HPLC method for determination of Lansoprazole in human plasma has been validated. The statistic analysis shows that the two preparations were bioequivalent.

关 键 词：兰索拉唑 HPLC 药物动力学 生物等效性 

分 类 号：R969[医药卫生—药理学]