克拉霉素分散片在健康人体内的相对生物利用度

目的：研究克拉霉素分散片在健康人体内的相对生物利用度，评价其生物等效性。方法：采用微生物法测定9名受试者单剂量交叉口服500mg克拉霉素分散片和片剂后不同时间血清中药物浓度，用3P87程序软件处理血药浓度-时间数据。结果：2制剂体内过程均符合一室模型，Cmax分别为(3．09±0．29)mg·L-1和(2．98±0．37)mg·L-1；Tmax分别为(1．37±0．35)h和(1．56±0．42)h；T1/2分别为(4．±0．92)h和(4．09±0．71)h；AUC为(22．6±3．6)mg·h·L-1和(23．00±3．90)mg·h·L-1，被试制剂的相对生物利用度为(98．7±10．9)％(82．5％～117．4％)。结论：2种制剂具有生物等效性。

Relative bioavailability of clarithromycin in healthy volunteers

Aim: To study the relative bioavailahility of clarithromycin disperse tablet. Methods: The clarithromycin concen-tration in serum were determined by microbiology method after a single oral dose of clarithromycin disperse tablet and clar-ithromycin tablet were respectively given to 9 volunteers in an open randomized cross-over test. Data of serum level-time were pro-cessed with 3P87 software. Results:The concentration-time curves of clarithromycin disperse tablet and tablet fitted to one-com-partment open model. The Cmax was (3.09±0.29) mg·L-1 and (2.98±0.37) mg·L-1, Tmax was (1.37±0.35) h and (1.56±0.42) h, T1/2 was (4.07±0.92) h and (4.09±0.71) h, AUC was (22.6±3.6) mg·h·L-1 and (23.0±3.90) mg·h·L-1 of clarithromycin disperse tablet and clarithromycin tablet, respectively. The pharmacokinetic parameters obtained from ourstudies showed no significant difference between two formulations. Compared with reference formulation, the relative bioavailahilitywas (98.7 ± 10.9)%(82.5% ～ 117.4% )of clarithromycin disperse tablet. Conclusion: The results suggest that the two formu-lations were bioequivalent.