乌苯美司片剂、胶囊剂在中国健康人体药动学及生物等效性研究  

Pharmacokinetics and Relative Bioavailability of Ubenimex Tablets and Capsules in Chinese Healthy Volunteers

作　　者：张淑慧[1] 孙颖光[1] 马杰[1] 赫立恩[1] 

机构地区：[1]河北省人民医院药学部,石家庄050051

出　　处：《中国药学杂志》2010年第3期210-213,共4页Chinese Pharmaceutical Journal

摘　　要：目的评价乌苯美司片剂、胶囊剂在中国人群中的生物等效性。方法采用液相色谱-质谱联用法测定20名健康受试者口服30 mg乌苯美司后血浆中的乌苯美司浓度。采用统计软件计算药动学参数,并评价其生物等效性。结果乌苯美司片剂、胶囊剂的药动学参数AUC0-12 h分别为(3921.9±600.7)和(3879.2±626.7)μg.h.L-1,实测mρax为(2702.4±431.0)和(2582.8±514.8)μg.L-1,实测tmax为(0.58±0.26)和(0.79±0.25)h,t1/2为(2.5±0.5)和(2.1±0.5)h。乌苯美司片剂、胶囊剂的相对生物利用度为(101.5±8.0)%。结论经统计学分析,乌苯美司片剂、胶囊剂具有生物等效性。OBJECTIVE To evaluate the bioequivalence of ubenimex tablets and capsules. METHODS A single oral dose of 30 mg ubenimex tablets or capsules was given to 20 healthy volunteers in a randomized crossover study. The concentrations of ubenimex were determined by HPLC-MS/MS method. RESULTS The main pharmaeokinetic parameters of two products were as follows： AUC0-12 h （3 921. 9 ±600. 7） and （3 879. 2±626. 7） μg·h·L^-1 , pmax, （2 702. 4 ±431. 0） and （2 582. 8±514. 8） μg·L^-1, tmax（0. 58 ±0. 26） and （0. 79 ± 0. 25 ） h, t 1/2 （2. 5 ± 0. 5 ） and （2. 1± 0. 5 ） h, respectively. The relative bioavailability of ubenimex tablets and capsules was （101.5 ±8.0）%. There were no significant differences on the pharmacokinetic parameters between the two preparations（ P 〉 0. 05）. CONCLUSION The results of statistical analysis demonstrated that the two preparations were bioequivalent.

关 键 词：乌苯美司 液相色谱-质谱法 生物等效性 生物利用度 药动学 

分 类 号：R969.1[医药卫生—药理学]