帕罗西汀片在健康志愿者体内的生物等效性  

Bioequivalence of paroxetine tablets in healthy volunteers

作　　者：林治光[1] 李华芳[1] 翁毅仁[1] 庄冬梅[1] 蒋继承[1] 朱砾[1] 顾牛范[1] 

机构地区：[1]上海市精神卫生中心生化药理室,上海200030

出　　处：《中国临床药学杂志》2005年第4期231-233,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的评价2种国产盐酸帕罗西汀片剂的生物等效性。方法采用自身交叉试验方法。20名健康志愿者顿服40mg盐酸帕罗西汀片后,在规定时间内采血。以HPLC法测定血清药物浓度;以3P87药动学软件计算主要药动学参数,并评价2种国产帕罗西汀片之间的生物等效性。结果受试制剂和参比制剂的主要药动学参数tmax分别为(5.3±2.0)、(5.5±2.0)h;cmax分别为(31.0±12.1)(、30.2±12.3)μg.L-1;AUC0→t分别为(727.9±306.6)、(719.8±316.7)μg.h.L-1;T1/2分别为(19.7±7.3)(、19.2±7.0)h。2制剂间参数比较,P>0.05,受试制剂相对于参比制剂的相对生物利用度为(103.80±16.99)%。结论2种帕罗西汀片剂为生物等效制剂。AIM To evaluate the bioequivalence between two kinds of paroxetine tablets.METHODS A single (oral) dose of 40 mg paroxetine tablet was given respectively to 20 healthy volunteers in an open randomized cross-over test for comparison of relative bioavailability in human. Paroxetine serum concentration was determined by HPLC.(RESULTS)The main pharmacokinetic parameters were as follows: t_(max) of test preparation and reference preparation were (5.3±(2.0))h and (5.5±(2.0))h,c_(max) were (31.0±12.1) μg·L^(-1) and (30.2±12.3) μg·L^(-1), AUC_(0→t) were (727.9±(306.6)) μg·h·L^(-1) and (719.8 ±316.7) μg·h·L^(-1),T_(1/2) were (19.7±7.3) h and (19.2±7.0)h , respectively. There were no statistical differences of all parameters between two preparations (P>0.05). The mean relative bioavailability of test preparation versus reference preparation was (103.8±16.99)%. The test preparation was bioquivalent to reference preparation.CONCLUSION The results show that two preparation are bioequivalent.

关 键 词：盐酸帕罗西汀 生物等效性 高效液相色谱法 

分 类 号：R96[医药卫生—药理学]