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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 study the pharmacokinetics of lansoprazole in healthy volunteers and to evaluate the bioequivalence of test and reference preparations. Methods Twenty healthy male volunteers were randomized to receive a single oral dose of 30 mg of lansoprazole for the test and reference tablets. The plasma concentration of lansoprazole was determined by HPLC at different time points. The data were processed by DAS software and the bioequivalence was evaluated. Results The Cmax of the test preparation and the reference preparation of lansoprazole were 0.87 ± 0.36 and 0.95 ± 0.43μg.ml-1 respectively, the Tmax were 3.30 ± 0.97 and 3.40 ± 0.90 h respectively, and the ratio of T1 / 2 was 2.42 ± 1.67, 1.84 ± 0.99 h; AUC0-24 h were 3.47 ± 1.81,3.57 ± 2.53μg.ml-1.h; AUC0-∞ were 4.10 ± 3.31,3.90 ± 3.36μg.ml-1.h respectively. The relative bioavailability of F0 ~ 24 h, F0-∞ were 111.8% ± 55.5%, 115.3% ± 52.9%. Conclusion The new establishment method is accurate, reliable and easy. The two formulations are bioequivalent.