替米沙坦3种制剂的人体生物等效性研究  

Human bioequivalence study of three kinds of telmisartan preparations

作　　者：郑鹏程[1] 李铜铃[1] 许小红[1] 张蓉琴[1] 鄢琳[1] 程强[1] 

机构地区：[1]四川大学华西药学院临床药学教研室,四川成都610041

出　　处：《中国新药与临床杂志》2005年第7期536-539,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:比较国产替米沙坦片及胶囊与进口替米沙坦片的相对生物利用度。方法:24名健康男性受试者采用3种制剂3周期随机交叉试验设计。反相高效液相色谱法测定单剂量口服80mg国产替米沙坦片、替米沙坦胶囊、进口替米沙坦片后的替米沙坦血药浓度。3P87程序计算药动学参数,AUC,cmax对数转换后进行方差分析并计算90%可信区间。结果:国产替米沙坦片、替米沙坦胶囊、进口替米沙坦片的主要药动学参数分别为:cmax(703±s209),(703±196),(707±202)μg·L-1;tmax(0.88±0.15),(0.91±0.18),(0.85±0.13)h;AUC0～84(17863±7223),(17995±7207),(17950±7616)μg·h·L-1;AUC0～∞(20587±7309),(20732±7129),(20960±7420)μg·h·L-1;MRT(35±5),(35±5),(36±6)h;t1/2:(25±4),(25±4),(26±5)h。结论:国产替米沙坦片、替米沙坦胶囊、进口替米沙坦片具有生物等效性。AIM: To compare the bioavailability of domestic telmisartan tablets and capsules with imported telmisartan tablets. METHODS: This was an open randomized,three periods crssover study on twenty-fo ur healthy male volunteers. A reversed-phas e high performance liquid chromatography was used for the concentration determin ation of telmi sartan in serum after a single oral dose of 80 mg telmisartan tablets,capsules a nd imported telmisartan tablets in a crossover design. RESULTS: The phar macokine tic parameters of domestic telmisartan tablets,capsules and imported telmisarta n tablets were as follows: c_(max)(703±209),(703±196),(707±202)μg·L~ (-1);t_(max)(0.88±(0.15)),((0.91)± 0.18),(0.85±(0.13)h);AUC_(0-84)((17 863)±(7 223)),(17 9 95± 7 207),(17 950±(7 616))μg·h·L^(-1);AU C_(0-∞) (20 587±7 309),((20 732)±(7 129)),(20 960±7 420)μg·h·L^(-1);(MRT(35±5)),(35±5),(36±6)h;t _(1/2) :(2 5±(4)),(25±(4)),(26±5)h. CONCLUSION: Domestic telmisartan tablets and capsules are bioequivalent with the imported telmisartan tablets.

关 键 词：替米沙坦 片剂 胶囊 色谱法 高压液相 生物利用度 治疗等效 

分 类 号：R972.4[医药卫生—药品] R969.1[医药卫生—药学]