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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) %
In this paper, diclofenac sodium sustained-release tablets were prepared, the pharmacokinetics and bioavailability of sustained-release tablets and ordinary enteric-coated tablets were studied. The plasma concentration of the two preparations was determined by HPLC. The results showed that 12 healthy volunteers oral administration of diclofenac sodium sustained release tablets after a single dose, the plasma concentration - time curve of double peaks, tmax were (4.20 ± 1.96) h and (10.60 ± 2 .17) h and Cmax were (34 6.95 ± 14 6.84) ng / ml and (65.58 ± 2 4 5.38) ng / ml, respectively. The relative bioavailability of sustained-release tablets was (95.1 ± 10.8)%