盐酸昂丹司琼口崩片与普通片的生物等效性研究  

Bioavailability and Bioequivalence of Ondansetron Orally Disintegrating Tablets and Conventional Tablets

作　　者：汪杨[1] 吴伟[1] 黄敏[1] 胡弢[1] 孙宁云[1] 阙俐[1] 

机构地区：[1]复旦大学药学院药剂学教研室,上海200032

出　　处：《复旦学报（医学版）》2005年第1期55-58,共4页Fudan University Journal of Medical Sciences

摘　　要：目的 对昂丹司琼口崩片和普通片进行生物利用度和生物等效性评价。方法 20名健康男性志愿者 随机分成2组,单剂量交叉口服盐酸昂丹司琼口崩片1片(8 mg／片)和普通片2片(枢丹片,4 mg／片),于一定时 间采集血样,用高效液相色谱-紫外检测法测定16 h内的血浆药物浓度。经统计得到有关参数,3P97软件进行 方差分析与生物等效性判断。结果 口崩片和普通片的峰浓度(cmax)为(35.67±8.944)和(35.81±10.03)ng／ mL,达峰时间(tmax)为(1.509±0.790 7)和(1.525±0.580 4)h;0至∞时间药时曲线下面积(AUC0-∞)为(265.2 ±101.5)和(272.6±114.2)ng.h／mL,,0至16 h药时曲线下面积(AuC0-t)为(230.2±77.99)和(230.7±83. 59)ng·h／mL。两种制剂的主要药动学参数cmax,AUC0-t经对数转换后进行方差分析及双单侧检验并计算90％ 置信区间,表明两种制剂生物等效。盐酸昂丹司琼口崩片平均相对生物利用度为102.0％。结论 口崩片与普 通片具有生物等效性。Purpose To study the bioavailability and bioequivalence of Ondansetron orally disintergrating tablet (test formulation) and conventional tablet (reference formulation) . Methods Test or reference tablets 8 mg were given to 20 male health volunteers with a randomized two-way crossover design. The drug levels in plasma were assayed by HPLC. The pharmacokinetic parameters of the two tablets were calculated with the 3P97 software. Results Pharmacokinetic parameters of orally disintegrating tablet and conventional tablet were as following: Cmax(35.67±8.944) and (35.81±10.03)ng/mL,tmax(1.509±0.790 7) and (1.525±0.580 4)h,AUC0-∞(265.2±101.5) and (272.6±114.2)ng·h/mL, (AUC0-t(230.2±77.99) and (230. 7±83. 59 )ng·h/mL, respectively. The mean relative bioavailability of test product vs. reference was 102.0% . Analysis of variance and two one-sided t-test showed that there were no significant difference between the two formulations. Conclusions Two formulations were bioequivalent.

关 键 词：盐酸昂丹司琼 生物等效性研究 AUC 制剂 单剂量 峰浓度 相对生物利用度 紫外检测 高效液相色谱 方差分析 

分 类 号：R969.1[医药卫生—药理学] R975.4[医药卫生—药学]