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目的评价国产头孢地尼干混悬剂与参比头孢地尼胶囊的生物等效性,评价其临床疗效。方法 24名健康男性志愿者交叉口服100 mg的头孢地尼干混悬剂(试验制剂)和头孢地尼胶囊(参比制剂,全泽复),采用UPLC-MS/MS测定血浆中头孢地尼药物浓度。采用WinNonlin 6.3软件处理得到药动学参数并进行统计学分析。结果头孢地尼干混悬剂及参比胶囊的主要药动学参数分别为:ρ_(max)分别为(1 034.78±358.17),(969.71±297.38)ng·mL~(-1);t_(max)分别为(2.98±0.60),(3.44±0.70)h;AUC_(0-12)分别为(4 911.24±1 675.30),(4 522.35±1 600.13)h·ng·mL~(-1);AUC_(0-∞)分别为(5 026.24±1 735.32),(4 680.69±1 699.93)h·ng·mL~(-1);t_(1/2)分别为(1.71±0.23),(1.79±0.39)h。ρ_(max),AUC_(0-12),AUC_(0-∞)的90%置信区间分别为95.6%~115.3%,99.9%~117.2%,99.0%~116.0%。结论头孢地尼干混悬剂与参比头孢地尼胶囊具有生物等效性。
Objective To evaluate the bioequivalence of domestic cefdinir suspension and reference cefdinir capsules and evaluate their clinical efficacy. Methods Twenty-four healthy male volunteers were given 100 mg cefdinir dry suspension (test preparation) and cefdinir capsules (reference preparation, Quanze Fu) crossover. UPLC-MS / MS was used to determine cefdinir Drug concentration. Using WinNonlin 6.3 software to get pharmacokinetic parameters and statistical analysis. Results The main pharmacokinetic parameters of cefdinir suspension and reference capsules were: ρ max (1 034.78 ± 358.17), (969.71 ± 297.38) ng · mL -1; t_ ( max were (2.98 ± 0.60) and (3.44 ± 0.70) h respectively; AUC 0-12 were (4 911.24 ± 1 675.30) and (4 522.35 ± 1 600.13) h · ng · mL -1 ; AUC_ (0-∞) were (5 026.24 ± 1 735.32) and (4 680.69 ± 1 699.93) h · ng · mL -1, respectively; t 1/2 was 1.71 ± 0.23, 1.79 ± 0.39) h. The 90% confidence intervals of ρ max, AUC 0-12 and AUC 0 -∞ were 95.6% -115.3%, 99.9% -117.2% and 99.0% -116.0%, respectively. Conclusion cefdinir suspension and reference cefdinir capsules have bioequivalence.