琥乙红霉素颗粒的人体生物利用度和生物等效性研究  

Bioavailability and bioequivalence of erythromycin ethylsuccinate granules in healthy volunteers

作　　者：曾桂雄[1] 钟国平[1] 王雪丁[1] 黄丽慧[1] 黄民[1] 

机构地区：[1]中山大学药学院临床药理研究所,广州510080

出　　处：《中国感染与化疗杂志》2006年第4期228-230,共3页Chinese Journal of Infection and Chemotherapy

摘　　要：目的研究琥乙红霉素颗粒在健康人体内的药动学与生物等效性。方法20例受试者随机交叉单剂量口服琥乙红霉素颗粒受试制剂或参比制剂各500 mg,以微生物法测定人体血浆药物浓度。结果受试制剂与参比制剂的药动学参数如下：T_(max)分别为(0．86±0．22)h和(0．80±0．13)h,C_(max)分别为(2．13±0．64)和(2．16±0．61)mg/L,t_(1/2)分别为(2．04±0．2)和(1．97±0．4)h,AUC_(?)分别为(4%±1．73)和(4．63±1．52)mg·h/L。受试制剂与参比制剂比较,相对生物利用度(F)为(109．1±22．8)%。结论经生物等效性检验,受试颗粒剂与参比颗粒制剂具有生物等效性。Objective To study the bioavailability and bioequivalence of erythromycin ethylsuccinate granules in healthy male volunteers. Methods In a randomized two-period crossover study, 20 healthy male volunteers received single 500 mg test and reference formulations of erythromycin ethylsuccinate granules. The plasma concentrations of erythromycin were assayed by microbiological method. Results The parameters of test and reference preparations were as follows： Tmax（0.86 ± 0.22） and （0.80 ±0.13）h, Cmax（2.13 ± 0.64）and （2. 16 ± 0.61） mg/L, t1/2 （2. 04 ± 0. 2） and （1.97± 0.4） h, AUC0-t（4.96 ± 1.73） and （4.63 ± 1.52） mg·h/L, respectively. There was no significant difference between the two preparations. The relative hioavailability of the test granules was （109.1± 22.8）%. Conclusions The two preparations of erythromycin ethylsuccinate granules are bioequivalent.

关 键 词：琥乙红霉素颗粒 藤黄微球菌 生物利用度 生物等效性 

分 类 号：R96[医药卫生—药理学]