摘要
本文制备了双氯芬酸钠缓释片 ,研究了缓释片和普通肠溶片的药物动力学和生物利用度。采用HPLC法测定了两种制剂血浆中的药物浓度。结果表明 ,12名健康志愿受试者单剂量口服 10 0 mg双氯芬酸钠缓释片后 ,血药浓度 -时间曲线存在双峰 ,tmax分别为 ( 4 .0 2± 1.96) h和 ( 10 .60± 2 .17) h,Cmax分别为 ( 34 6.95±14 6.84 ) ng/ml和 ( 4 65.58± 2 4 5.38) ng/m l,均比肠溶片峰浓度低。缓释片的相对生物利用度为 ( 95.1±10 .8) %
The diclofenac sodium sustained release tablets(DS SRT) were prepared The pharmacokinetics and bioavailability of DS SRT were evaluated using diclofenac sodium enteric coated tablets(DS ECT) as the reference stantdard The plasma concentrations of the two preparations were determined by HPLC method The results showed that the concentration time profile produced double peak phenomenon after the oral administration of a 100 mg single dose of DS SRT The t max for the DS SRT(4 02±1 96) h and (10 60±2 17) h were significantly different from the corresponding value for the DS ECT The C max for the DS SRT were (346 95±146 84)ng/ml and (465 58±245 38)ng/ml, respectively The C max of the DS SRT was significantly much lower than the DS ECT(2782 09±553 62) ng/ml The relative bioavailability of the DS SRT was found to be 95 1% compared with the conventional product
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1999年第6期431-434,共4页
Journal of China Pharmaceutical University
关键词
双氯芬酸钠
缓释片
体外释放度
药物动力学
Diclofenac sodium
Sustained release tablets
Dissolution in vitro
Pharmacokinetics
Bioavailability
