摘要
目的研究阿奇霉素片受试制剂与参比制剂人体相对生物利用度及药代动力学。方法18名健康受试者自身交叉单剂量口服阿奇霉素受试制剂和参比制剂各500 mg,定时取血,用微生物法测定血药浓度。结果阿奇霉素片受试制剂与参比制剂的血药浓度时间曲线基本一致,符合一级吸收二房室模型。受试制剂与参比制剂的主要药动学参数分别为:消除半衰期t1/2β:(36.48±9.45)h,(38.10±9.39)h;Tmax:(2.39±0.61)h,(2.44±0.61)h;Cmax:(509.10±106.08)μg/L,(505.20±89.91)μg/L。药代动力学参数经配对t检验,差异均无显著性意义(P>0.05)。两种制剂的药时曲线下面积(AUC0-t)平均值分别为:受试制剂(9 080±1 339)(μg.h)/L,参比制剂:(9 308±1 390)(μg.h)/L;受试制剂的相对生物利用度为(98.0±10.1)%。结论受试制剂阿奇霉素与参比制剂生物等效。
Objective To study the pharmacokinetics and bioavailabilites of azithromycin tablets （tested） and tablets （reference）. Methods A single dose of 500 mg azithromycin was given, in a randomized, two-way crossover study, in 18 healthy male volunteers. The concentrations in plasma were determined by microbiological assay. Results Both concentration time curves of tests and reference products fitted to a two compartment open model with a first order absorption. The main pharma- cokinetic parameters were as follows t1 h 2β, （36.48± 9.45 ） h, （38.10 ±9.39） h; T （ 2.39 ± 0. 61 ） h, （ 2.44± 0.61 ） h; C （509.10±06.08） μg/L, （505.20±89.91） μg/L, respectively. There was no significant difference in pharmacokinetic parameters between two preparations （P〉0.05）. The relative bioavailability of the tested tablets was （98.0± 10.1） %. Conclusion The results of statistical analysis showed that two formulations are bioequivalent.
出处
《华中科技大学学报（医学版）》
CAS
CSCD
北大核心
2006年第5期672-674,共3页
Acta Medicinae Universitatis Scientiae et Technologiae Huazhong
