论文部分内容阅读
目的评价2种氨氯地平片剂在中国健康志愿者体内的生物等效性。方法24名健康男性受试者,随机分为2组,分别单剂量口服氨氯地平受试制剂或参比制剂10mg。14d清洗期后再交叉给药。于服药前(0h)和服药后2、4、6、8、10、14、24、36、48、72、96、120h抽取静脉血,采用LC-MS/MS法测定血浆中氨氯地平的浓度。利用DAS2.1.1软件计算主要药动学参数,并对2种制剂进行生物等效性评价。结果受试制剂和参比制剂的tmax分别为(6.7±s2.1)h和(6.8±1.8)h,ρmax分别为(7.0±1.3)μg·L-1和(7.3±1.8)μg·L-1,AUC0～120分别为(329±73)μg·h·L-1和(325±83)μg·h·L-1,AUC0～∞分别为(383±96)μg·h·L-1和(369±97)μg·h·L-1。受试制剂的相对生物利用度为(105±24)%。结论2种氨氯地平片剂在中国健康志愿者体内具有生物等效性。
Objective To evaluate the bioequivalence of two amlodipine tablets in Chinese healthy volunteers. Methods Twenty-four healthy male subjects were randomly divided into two groups. One single oral dose of amlodipine test formulation or 10 mg reference formulation respectively. After 14d wash and then cross-administered. Venous blood was drawn before medication (0 h) and at 2, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96 and 120 h after taking the medicine. The plasma levels of amlodipine concentration. The main pharmacokinetic parameters were calculated using DAS2.1.1 software and the bioequivalence of two formulations was evaluated. Results The tmax of test preparation and reference preparation were (6.7 ± s2.1) h and (6.8 ± 1.8) h, respectively, and the values of ρmax were (7.0 ± 1.3) μg · L-1 and (7.3 ± 1.8) μg · L -1 and AUC0 ~ 120 were (329 ± 73) μg · h · L-1 and (325 ± 83) μg · h · L-1, respectively. The AUC0 ~ ∞ were (383 ± 96) μg · h · L- 1 and (369 ± 97) μg · h · L-1. The relative bioavailability of the test preparation was (105 ± 24)%. Conclusion Two kinds of amlodipine tablets have bioequivalence in Chinese healthy volunteers.