硫酸特布他林胶囊人体药代动力学和相对生物利用度研究  

THE PHARMACOKINETICS AND RELATIVE BIOAVAILABILITY OF TERBUTALINE CAPSULE IN HEALTHY VOLUNTEERS

作　　者：王建新[1,2] 陈得光[1,2] 李铜铃 秦永平[1,2] 邹远高 李[1,2] 

机构地区：[1]华西医科大学药学院 [2]华西医科大学附一院临床药理研究所

出　　处：《中国临床药理学杂志》1999年第4期273-276,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：本实验采用反相高效液相色谱法测定１０名志愿受试者单剂量口服５ｍｇ硫酸特布他林胶囊或片剂后，血清中特布他林浓度变化情况，经３Ｐ８７药动学程序处理，结果表明：以特布他林计的药时曲线下面积ＡＵＣ０→∞分别为５４．１３±１４．６８μｇ·ｈ·Ｌ－１和５３．９９±１５．９９μｇ·ｈ·Ｌ－１，达峰时间Ｔｍａｘ分别为２．９５±０．４９ｈ和３．００±０．６４ｈ，峰浓度Ｃｍａｘ分别为６．５４±１．９１μｇ·Ｌ－１和６．６７±２．４３μｇ·Ｌ－１，Ｔ１／２分别为２．６５±０．３０ｈ和２．６２±０．３６ｈ。以配对Ｔ检验和双单侧Ｔ检验对两种制剂的上述药代动力学参数进行统计分析，均无显著性差异，说明两种制剂为生物等效制剂。以硫酸特布他林片为标准参比制剂，硫酸特布他林胶囊的相对生物利用度为１００．４３±９．２６％。The pharmacokinetics and relative bioavailability of terbutaline sulphate capsule was studied in 10 healthy male volunteers. A single oral dose of 5 mg terbutaline sulphate capsule or tablet(Bricanyl) was given to each volunteer according to an open randomized crossover design. The concentration of terbutaline in serum was determined by HPLC with UV-detector. The main pharmacokinetic parameters of terbutaline were: AUC0→∞ 54.13±14.68 μg·h·L-1and 53.99±15.99 μg·h·L-1, Tmax 2.95±0.49 h and 3.00±0.64 h, Cmax 6.54±1.91 μg·L-1 and 6.67±2.43 μg·L-1, T1/2 2.65±0.30 h and 2.62±0.36 h。The relative bioavailability of the drug was 100.43±9.26% ,The results of statistical analysis show that two formulations are bioequivalent.

关 键 词：硫酸特布他林 药代动力学 相对生物利用度 

分 类 号：R974[医药卫生—药品] R969.1[医药卫生—药学]