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目的:研究头孢丙烯分散片的人体药动学以及生物等效性。方法:本研究以成年健康男性体检者共30名为研究对象,随机平均分为两组,一组口服500mg头孢丙烯分散片,设为受试观察组。另一组口服参比制剂,设为参比对照组。利用高效液相色谱法HPLC分别对两组血浆中头孢丙烯的浓度进行定量,计算药动学参数并分析生物等效性。结果:一受试观察组和参比对照组的平均血药浓度分别为4.97±2.13mg/L和4.89±1.57mg/L(P>0.05),不具有差异性。比较两组药动学参数(tmax;Cmax;AUC0-t;AUCO-∞;t1/2;MRT),无显著性统计学差异(P>0.05),计算得出头孢丙烯分散片的相对生物利用度为(97.25±11.3)%。结论:利用高效液相色谱法HPLC分析头孢丙烯分散片的人体药动学方法可行。头孢丙烯分散片与参比制剂在临床上具有生物等效性和安全性。
Objective: To study the pharmacokinetics and bioequivalence of cefprozil dispersed tablets. Methods: In this study, a total of 30 adult healthy male physical examination subjects for the study were randomly divided into two groups, a group of oral 500mg cefprozil dispersible tablets, as the test group. Another group of oral reference preparations, set as a reference control group. The concentrations of cefprozil in plasma were quantified by high performance liquid chromatography (HPLC) respectively. The pharmacokinetic parameters were calculated and the bioequivalence was analyzed. Results: The average plasma concentrations of test group and control group were 4.97 ± 2.13 mg / L and 4.89 ± 1.57 mg / L, respectively (P> 0.05). There was no difference between the two groups. The relative bioavailability of cefprozil dispersible tablets was calculated by comparing the pharmacokinetic parameters (tmax; Cmax; AUC0-t; AUCO-∞; t1 / 2; MRT) Degree was (97.25 ± 11.3)%. Conclusion: The HPLC method for the determination of cefprozil dispersible tablets by human pharmacokinetic method is feasible. Cefprozil dispersible tablets and reference preparations in the clinical bioequivalence and safety.