摘要
目的:对罗红霉素颗粒剂的药物动力学与相对生物利用度进行研究.方法:采用微生物法测定8名志愿者单剂量po 300mg罗红霉素颗粒剂与片剂的血药浓度,计算两者的药物动力学参数与相对生物利用度.结果:两者药-时曲线以一级吸收双室模型拟合较好,两者的c—分别为(6.64土0·80)与(6.44土0·89)μg/ml;t_(max)_分别为(1.60土0.45)与(2.00土0.34)h;T_1/2分别为(14. 78士0.99)与(14.00士1.60)h;AUC_o_oo～分别为(100.03士18.40)与(99.01士19.21)μg·h/ml,统计学处理表明两者无显著性差异(P>0.05).结论:罗红霉素颗粒剂与片剂为生物等效制剂,罗红霉素颗粒剂的相对生物利用度为101·56%.
AIM : To study the pharmacokinetics and relative bioavailability of ro-xithromycin granules. METHODS: The roxithromycin concentrations in plasma were deter-mined by bioassay method following a single oral dose of 300mg roxithromycin granules and roxithromycin tablets were respectively given to 8 volunteers according to a crossover de-sign. RESULTS : The concentration-time curves of roxithromycin granules and roxithromycin tablets were conformed to two compartments open model with a first order absorption. The c_(max)was(6. 64±0. 80) and(6. 44±0. 89)μg/ml;the t_(max)was (1. 60±0. 45) and( 2. 00±0. 34)h; the T_(1/2(β) was (14. 78±0. 99) and (14. 00±1. 60)h,respectively. The AUC_(0→∞) was (100. 03±18.40)and(99. 01±19. 21)μg ·h/ml, respectively. There was no significant difference bet-ween 2 formulations (P>0. 05). CONCLUSION:These two formulations are bioequivalent. The relative bioavailability of roxithromycin granules to the imported tablets is 101. 56%.
出处
《中国临床药学杂志》
CAS
1998年第6期273-275,共3页
Chinese Journal of Clinical Pharmacy
