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目的:研究头孢地尼分散片在健康人体中的药动学和生物等效性。方法:采用微生物法测定20名健康志愿者单剂量交叉口服400mg头孢地尼分散片(受试制剂)和头孢地尼胶囊(参比制剂)后不同时间血清中的药物浓度。结果:受试制剂与参比制剂药-时曲线均符合一房室开放模型,tmax分别为(3.48±0.53)、(3.60±0.48)h,Cmax分别为(2.10±0.32)、(2.15±0.26)mg·L-1;t1/2ke分别为(2.41±0.39)、(2.33±0.41)h,AUC0~12分别为(9.51±1.65)、(10.05±1.72)mg·h·L-1,AUC0~∞分别为(10.43±1.62)、(11.01±1.81)mg·h·L-1。受试制剂相对于参比制剂的生物利用度为(96.03±14.89)%。结论:两种制剂具有生物等效性。
Objective: To study the pharmacokinetics and bioequivalence of cefdinir dispersible tablets in healthy volunteers. Methods: The serum concentrations of cefdinir dispersible tablets (test preparations) and cefdinir capsules (reference preparations) at different time intervals in 20 healthy volunteers were determined by microbiological method. Results: The drug-time curve of test preparation and reference preparation were in accordance with the one-compartment open model with tmax of (3.48 ± 0.53) and (3.60 ± 0.48) h, respectively, with Cmax of 2.10 ± 0.32 and 2.15 ± 0.26 ) were 2.41 ± 0.39 and 2.33 ± 0.41 h respectively, and AUC0-12 were (9.51 ± 1.65) and (10.05 ± 1.72) mg · h · L-1, respectively ~ ∞ were (10.43 ± 1.62), (11.01 ± 1.81) mg · h · L-1, respectively. The bioavailability of the test formulation relative to the reference formulation was (96.03 ± 14.89)%. Conclusion: Both formulations are bioequivalent.