罗红霉素颗粒剂在健康人体内的相对生物利用度

目的：研究罗红霉素颗粒剂在健康人体内的相对生物利用度。方法：采用微生物法测定8名志愿者单剂量交叉口服300mg罗红霉素颗粒剂和片剂后不同时间血清中的药物浓度。结果：二者药-时曲线均符合二室模型，Cmax分别为(11．40±1．60)mg·L-1和(9．65±1．26)mg·L-1；Tmax分别为(1．36±0．24)h和(1．71±0．27)h；T1/2分别为(12．88±0．88)h和(13．46±0．95)h；AUC是(111．18±18．44)mg·h·L-1和(108．91±16．94)mg·h·L-1，罗红霉素颗粒剂的相对生物利用度为(102．08±8．02)％(88．01％～5．53％)。结论：2种制剂具有生物等效性。

Relative bioavailability of roxithromycin granule in healthy volunteers

Aim: To study the relative bioavailability of roxithromycin granule. Methods: The roxdthromycin concentrationsin serum were determined by microbiological method after a single oral dose of roxithromycin granule and roxithromycin tablet wererespectively given to 8 volunteers in an open randomized cross-over test. Results: The concentration-time curves of roxithromycingranule and tablet fitted to a two-compartment open model. The Cmax was ( 11. 40 ± 1.60 ) mg· L- 1 and ( 9.65 ± 1.26) mg· L- 1;Tmax was (1.36±0.24) h and (1.71 ±0.27) h; T1/2 was (12.88±0.88) h and (13.46±0.95) h;AUC was (111.18± 18.44)mg·h·L-1 and (108.91 ± 16.94) mg·h·L- 1,of roxithromycin granule and roxithromaycin tablet respectively. The pharmacokineticparameters obtained from our studies showed no significant difference between two formulations ( P > 0.05). The relative bioavail-ability was ( 102.08 ± 8.02 ) % (88.01% ～ 115.53 % ) of roxithromycin granule. Conclusion: The results of statistical analysis suggest that the two fonnulations be bioequivalent.