中国医院用药评价与分析2016，Vol.16Issue(7)：874-877,4.DOI:10.14009/j.issn.1672-2124.2016.07.004
拉米夫定胶囊和片剂在健康人体内的药动学和生物等效性研究Δ
Pharmacokinetics and Bioequivalence of Lamivudine Capsules and Tablets in Healthy VolunteersΔ
摘要
Abstract
OBJECTIVE:To establish the LC-MS/MS method for the determination of lamivudine in plasma and to evaluate the pharmacokinetics and bioequivalence of Lamivudine capsules and tablets in healthy volunteers . METHODS:A single oral dose (100 mg of Lamivudine capsules and tablets ) was given to 24 healthy volunteers in a randomized crossover study .The plasma concentration of lamivudine was determined by LC-MS/MS method .The pharmacokinetic parameters were calculated and the bioequivalence of the two formulations were evaluated by DAS 3.0 program.RESULTS:After a single dose , the pharmacokinetic parameters of Lamivudine capsules and tablets were as follows:Tmax:(1.05 ±0.43) h and (1.01 ±0.38) h; Cmax:(979.05 ±267.25) ng/ml and (1 023.59 ±340.14) ng/ml;t1/2:(9.55 ±4.64) h and (8.95 ±4.68) h; AUC0-t:(3 799.15 ±1 103.26) ng· h/ml and (3 727.14 ± 1 083.10) ng· h/ml;AUC0-∞:(3 881.94 ±1 135.72) ng· h/ml and (3 811.56 ±1 103.61) ng· h/ml respectively. The 90% confidential interval of AUC0-t , AUC0-∞ and Cmax was 95.4%-109.8 %, 95.3%-109.5% and 86.1%-109.1%, respectively.The relative bioavailability of Lamivudine capsules and tablets was ( 104.8 ±25.8 )%. CONCLUSIONS: The method can be used in the pharmacokinetics and bioequivalence of Lamivudine capsules and tablets, and the two preparations were bioequivalent .关键词
拉米夫定/药动学/生物等效性/LC-MS/MSKey words
Lamivudine/Pharmacokinetics/Bioequivalence/LC-MS/MS分类
医药卫生引用本文复制引用
赵明明,李国飞,邱枫,孙亚欣,肇丽梅..拉米夫定胶囊和片剂在健康人体内的药动学和生物等效性研究Δ[J].中国医院用药评价与分析,2016,16(7):874-877,4.基金项目
“重大新药创制”科技重大专项十二五第二批项目 （）
