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目的:研究兰索拉唑肠溶微丸胶囊与兰索拉唑肠溶胶囊的人体生物等效性。方法:20名男性健康志愿者随机交叉单剂量口服兰索拉唑肠溶微丸胶囊(受试制剂)或兰索拉唑肠溶胶囊(参比制剂)30 mg后,采用HPLC法测定血药浓度,用DAS软件计算药动学参数,并评价其生物等效性。结果:单剂量口服受试制剂兰索拉唑肠溶微丸胶囊和参比制剂兰索拉唑肠溶胶囊的主要药动学参数分别为:t_(1/2)(1.93±0.58)、(2.21±0.84)h;t_(max)(1.7±0.4)、(1.7±0.4)h;C_(max)(1067.49±321.71)、(1 034.72±291.14)ng·ml~(-1);AUC_(0-12)(3 655.16±1 635.82)、(3 571.70±l 434.56)"g·h·ml~(-1);AUC_(0-∞)(3 783.13±1 691.29)、(3 735.80±1 541.56)ng·h·ml~(-1)。受试制剂的相对生物利用度为(106.72±13.53)%。结论:2制剂具有生物等效性。
Objective: To study the bioequivalence of lansoprazole enteric-coated pellets and lansoprazole enteric-coated capsules. Methods: Twenty healthy volunteers were randomized to receive a single oral dose of 30 mg oral lansoprazole enteric-coated capsules (test preparation) or lansoprazole enteric-coated capsules (reference preparation) Concentration, pharmacokinetic parameters were calculated using DAS software and their bioequivalence was evaluated. Results: The main pharmacokinetic parameters of Lansoprazole enteric-coated pellets and reference preparation of Lansoprazole enteric-coated capsules were t 1/2 (1.93 ± 0.58), ( 2.21 ± 0.84 h); t max (1.7 ± 0.4), (1.7 ± 0.4) h; C max (1067.49 ± 321.71), (1 034.72 ± 291.14) ng · ml -1; AUC_ ( AUC 0-0 ∞ (3 783.13 ± 1 691.29), (3 735.80 ± 3) 1 541.56) ng · h · ml -1 .The relative bioavailability of the test preparation was (106.72 ± 13.53)% .Conclusion: The preparation has bioequivalence.