论文部分内容阅读
目的:建立阿莫西林血浓度的HPLC测定法,并用于人体生物等效性研究。方法:采用随机双交叉实验设计,20名健康受试者分别口服阿莫西林受试制剂和参比制剂500 mg,HPLC法测定血浆中的阿莫西林浓度。结果:受试制剂和参比制剂的AUC_(0-8)分别为(29.80±4.26)mg·h·L~(-1)、(31.05±4.12)mg·h·L~(-1);AUC_(0-∞)分别为(30.66±4.57)mg·h·L(-1)、(31.86±4.15)mg·h·L~(-1);C_(max)分别为(10.99±1.55)mg·L~(-1)、(10.95±1.64)mg·L~(-1);t_(max)分别为(1.33±0.38)h、(1.31±0.39)h;t_(1/2)分别为(1.52±0.35)h、(1.48±0.41)h。受试制剂的相对生物利用度为(96.2±9.1)%。两制剂的AUC_(0-∞)、C_(max)、t_(max)、t_(1/2)差异无统计学意义(P>0.05)。结论:两制剂具有生物等效性。
Objective: To establish an HPLC method for the determination of amoxicillin in blood and to study its bioequivalence. Methods: A randomized double-crossover design was used. Twenty healthy subjects were orally given 500 mg of amoxicillin and 500 mg of reference formulation respectively. The concentrations of amoxicillin in plasma were determined by HPLC. Results: The AUC_ (0-8) of test preparation and reference preparation were (29.80 ± 4.26) mg · h · L -1 and (31.05 ± 4.12) mg · h · L -1, respectively. The mean AUC_ (0-∞) were (30.66 ± 4.57) mg · h · L -1 and 31.86 ± 4.15 mg · h · L -1, respectively. The C max values were (10.99 ± 1.55) (1.33 ± 0.38) h, (1.31 ± 0.39) h and (t 1/2), respectively, which were respectively higher than those of the control group (mg · L -1, (10.95 ± 1.64) mg · L -1 (1.52 ± 0.35) h, (1.48 ± 0.41) h. The relative bioavailability of the test preparation was (96.2 ± 9.1)%. There was no significant difference in AUC_ (0-∞), C_ (max), t_ (max) and t_ (1/2) between the two preparations (P> 0.05). Conclusion: The two preparations are bioequivalent.