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目的研究阿奇霉素胶囊及片剂在正常人体内的药动学及相对生物利用度。方法采用3×3拉丁方试验设计,将24名男性健康志愿受试者随机分为3组,分别单次口服阿奇霉素供试制剂与参比制剂。采用HPLC法测定经时血药浓度。用DAS药动学程序处理试验数据,并对试验结果进行方差分析和双单侧t检验。结果阿奇霉素胶囊及片剂的相对生物利用度为:104.1%±10.2%和99.9%±9.8%;阿奇霉素胶囊及片剂供试品和参比品的药时曲线下面积(AUC0→T)分别为:23.27±4.52μg·h·ml-1、23.33±5.76μg·h·ml-1、23.31±7.70μg·h·ml-1;AUC0→∞分别是31.25±5.13μg·h·ml-1、30.59±6.54μg·h·ml-1、29.78±8.15μg·h·ml-1;达峰时间(Tmax)分别为:2.17±0.38h、2.03±0.55h、2.21±0.48h;达峰浓度(Cmax)分别是:1.260±0.109μg·ml-1、1.310±0.138μg·ml-1、1.298±0.087μg·ml-1。结论经统计学分析,制剂间药动学参数差异无显著性意义,阿奇霉素胶囊及片剂与参比制剂具有生物等效性。
Objective To study the pharmacokinetics and relative bioavailability of azithromycin capsules and tablets in normal human. Methods A total of 24 healthy volunteers were randomly divided into 3 groups according to 3 × 3 Latin square design. One single oral azithromycin test preparation and reference preparation respectively. Determination of serum concentration by HPLC. The DAS pharmacokinetic program was used to process the experimental data and the test results were analyzed for variance and double unilateral t-test. Results The relative bioavailability of azithromycin capsules and tablets was 104.1% ± 10.2% and 99.9% ± 9.8%, respectively. The area under the curve of drug concentration (AUC0 → T) for azithromycin capsules and tablets were : 23.27 ± 4.52μg · h · ml-1, 23.33 ± 5.76μg · h · ml-1, 23.31 ± 7.70μg · h · ml-1; AUC0 → ∞ were 31.25 ± 5.13μg · h · ml- 30.59 ± 6.54μg · h · ml-1,29.78 ± 8.15μg · h · ml-1; the peak time (Tmax) were 2.17 ± 0.38h, 2.03 ± 0.55h and 2.21 ± 0.48h respectively; Cmax) were 1.260 ± 0.109 μg · ml -1, 1.31 0 ± 0.138 μg · ml -1, 1.298 ± 0.087 μg · ml -1, respectively. Conclusion According to the statistical analysis, there is no significant difference in the pharmacokinetic parameters between the two preparations. The bioavailability of azithromycin capsules and the tablets and the reference preparations are bioequivalent.