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对12 名健康男性志愿者单剂量空腹口服供试品阿奇霉素分散片及对照品阿奇霉素胶囊进行了药代动力学研究。采用微生物法测定受试者服药后不同时间点血尿药物浓度,计算其药代动力学参数及相对生物利用度。结果表明两药体内过程均符合血管外一级吸收的二房室模型。Cm ax分别为(036±014)和(033±012) m g/L,t1/2β分别为(4182±479)和(3931±601)h,AUC分别为(540±188)和(539±191) h·m g/L,两者间差别均无统计学意义(P> 005)。与对照品比较,供试品阿奇霉素分散片的相对生物利用度为(10040±663)% 。口服阿奇霉素分散片144 h 尿药排出率为给药量的1109% 。
Pharmacokinetic studies of 12 healthy male volunteers with single-dose fasting oral azithromycin dispersible tablets and reference substance azithromycin capsules were conducted. The microbiological method was used to determine the drug concentration of hematuria at different time points after taking the drug, and the pharmacokinetic parameters and relative bioavailability were calculated. The results show that the two drugs in vivo processes are in line with the extravascular absorption of a two-compartment model. Cm ax were (036 ± 014) and (033 ± 012) m g / L, respectively. The t1 / 2β were (4182 ± 479) and (3931 ± 6 01) h and AUC were (540 ± 188) and (539 ± 191) h · m g / L, respectively. There was no significant difference between the two groups (P> 005). Compared with the control, the relative bioavailability of azithromycin dispersible tablets was (10040 ± 663)%. Oral azithromycin dispersible tablets 144 h urinary drug delivery rate of 11 09%.