口服单剂量茶碱缓释片的人体生物等效性评价  

Evaluation of Bioequivalence Assessment after Single Dose Theophylline Sustained-release Tablets in Healthy Volunteers

作　　者：楼永海[1] 胡大平[1] 孙渊[1] 叶君飞[1] 陈赛贞[1] 

机构地区：[1]浙江省台州医院临床药学室,浙江台州317000

出　　处：《中国药业》2004年第6期30-31,共2页China Pharmaceuticals

摘　　要：目的研究两种国产茶碱缓释片在12名健康志愿者体内的药物动力学和相对生物利用度,并进行生物等效性评价。方法根据交叉试验方法口服单剂量200mg的两种茶碱缓释片,采用反相高效液相色谱法测定血清中茶碱的浓度。结果口服单剂量200mg试验品AUC,Cmax,Tmax,t1/2分别为(57.72±14.00)mg·h/L,(2.51±0.44)mg/L,(6.17±1.59)h,(19.44±5.94)h;对照品为(50.23±11.89)mg·h/L,(2.28±0.43)mg/L,(5.83±1.80)h,(16.52±5.28)h。结论两种国产茶碱缓释制剂的AUC0→36经双、单侧t检验,存在显著性差异,而Cmax,Tmax无显著性差异。Objective:To study the pharmacokinetics and relative bioavailability of 2 domestic theophylline sustained-release tablets in 12 healthy volunteers,Methods:A single oral dose of 200 mg were given according to a crossover design,The theophylline concentrations in plasma were determined by RP-HPLC,Results:In the single dose of 200 mg experiment tablets the AUC,Cmax,Tmax and t1/2 of the subject were(57.72±14.00)mg·h/L,(2.51±0.44)mg/L,(6.17±1.59)h,(19.44±5.94)h;the standard tablets were (50.23±11.89)mg·h/L,(2.28±0.43)mg/L,(5.83±1.80)h,(16.52±5.28)h,Conclusion:The results of AUC0→36 showed significant difference between two kinds of sustained-release tablets,but Cmax and Tmax showed no significant difference,

关 键 词：茶碱 反相高效液相色谱 生物利用度 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R974.3[医药卫生—药学]