盐酸克林霉素棕榈酸酯分散片在健康人体的药代动力学和生物等效性  

Pharmacokinetics and bioequivalent of clindamycin palmitate hydrochloride dispersible tablet in healthy volunteers

作　　者：车宁[1] 殷琦[1] 李可欣[1] 孙春华[1] 

机构地区：[1]卫生部北京医院药学部,北京100730

出　　处：《中国临床药理学杂志》2005年第4期279-281,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究单次口服盐酸克林霉素棕榈酸酯分散片后的药代动力学及其生物等效性。方法用开放、随机、自身交叉的给药方案,20名健康志愿者单次口服盐酸克林霉素棕榈酸酯被试制剂或参比制剂,微生物法测定血清中药物浓度,计算2制剂的药代动力学参数并进行生物等效性评价。结果被试制剂与标准参比制剂在人体内的吸收、分布、代谢行为相似,2者的AUC0-t分别为(10.28±1.75),(10.75±2.11)mg·h·L-1;tmax分别为(1.25±0.34),(1.21±0.38)h;Cmax分别为(2.24±0.43),(2.18±0.61)mg·L-1;t1/2Ke分别为(3.27±0.40),(3.11±0.38)h,被试制剂的相对生物利用度为(96.70±11.30)%,经方差分析和双单侧检验,无显著性差异(P<0.05)。结论2制剂为生物等效制剂。Objective To study the pharmacokinetics and bioequivalence of clindamycin palmitate hydrochloride dispersible tablet in 20 healthy male volunteers. Methods A single oral dose 300mg clindalycin palmitate hydrochloride of reference or test drugs was given to each volunteer according to an open, randomized, cross -over study. The drug concentrations in plasma were determined by microbial method. Results The main pharmacokinetics parameters of nateglinide were as the following ： AUC0-t were （ 10.28 ±1.75）mg · h · L^-1 and （10.75 ±2.11）mg · h · L^-1, Cmax were （2.24 ±0.43） mg· L^-1 and （2.18±0.61） mg· L^-1, tmax were （1.25±0.34） h and （1.21 ±0.38）h, t1/2ke were（3.27 ±0.40）h and （3.11 ±0.38）h for test and reference, respectively. The relative bioavailability was （96.7 ＋ 11.3） %. Conclusion The results of statistical analysis showed that two formulations were bioequivalent.

关 键 词：盐酸克林霉素棕榈酸酯 药代动力学 生物等效性 微生物法 生物等效性评价 药代动力学参数 盐酸克林霉素 棕榈酸酯 分散片 健康人体 

分 类 号：R969.1[医药卫生—药理学] R971.9[医药卫生—药学]