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目的:建立头孢克肟血浓度的HPLC测定法,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名健康受试者口服受试制剂和参比制剂200 mg,用HPLC法测定血浆中的头孢克肟浓度。结果:受试制剂和参比制剂的AUC_(0～24)分别为(27.96±7.34)mg·h·L~(-1)、(28.44±9.24)mg·h·L~(-1);AUC_(0～∞)分别为(28.95±7.50)mg·h·L~(-1)、(29.36±9.47)mg·h·L~(-1);C_(max)分别为(3.27±0.76)mg·L~(-1)、(3.34±0.83)mg·L~(-1);l_(max)分别为(4.0±0.7)h、(4.2±0.7)h;t_(1/2)分别为(4.06±1.01)h、(4.08±0.93)h。受试制剂的相对生物利用度为(100.50±11.60)%。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 cefixime blood concentration in human bioequivalence studies. Methods: A randomized double-crossover design was used. Twenty healthy subjects received 200 mg of test and reference preparations orally, and plasma concentrations of cefixime were determined by HPLC. Results: The AUC_ (0 ~ 24) of test preparation and reference preparation were (27.96 ± 7.34) mg · h · L -1 and (28.44 ± 9.24) mg · h · L -1, respectively. The AUC_ (0 ~ ∞) were (28.95 ± 7.50) mg · h · L -1 and (29.36 ± 9.47) mg · h · L -1, respectively. The C max values were (3.27 ± 0.76 (4.0 ± 0.7) h and (4.2 ± 0.7) h respectively; t 1/2 (t 1) (4.06 ± 1.01) h and (4.08 ± 0.93) h, respectively. The relative bioavailability of the test preparation was (100.50 ± 11.60)%. 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.