安吡昔康胶囊的人体生物等效性  

Study on bioequivalence of ampiroxicam capsules in Chinese healthy volunteers

作　　者：刘晓燕[1] 曲婷婷[1] 刘焕君[2] 王本杰[2] 魏春敏[2] 李小利[2] 郭瑞臣[2] 

机构地区：[1]山东大学药学院药剂学 [2]山东大学齐鲁医院临床药理研究所,山东济南250012

出　　处：《中国医院药学杂志》2007年第11期1538-1541,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的：进行试验制剂安吡昔康胶囊与参比制剂安吡昔康片的单剂双交叉人体生物等效性考察。方法：采用高效液相色谱法测定安吡昔康代谢物吡罗昔康血浓度，以DAS软件计算吡罗昔康主要药动学参数，评价两制剂的生物等效性。结果：安吡昔康试验制剂和参比制剂活性代谢物吡罗昔康主要药动学参数t1／2分别为（44．7±9.0）h和（46．2±13.0）h，了k分别为（7．7±2．2）h和（7．2±1．6）h，Cmax分别为（2．6±0．5）mg·L^-1和（2．6±0．5）mg·L^-1，AUC0-144分别为（187．3±32．1）mg·L^-1·h和（188．7±30.0）mg·L^-1·h，AUC0-∞分别为（216．6±36．6）mg·L^-1·h和（219．1±40．2）mg·L^-1·h。试验制剂人体相对生物利用度（100．2±15．9）％。结论：安吡昔康试验制剂和参比制剂中吡罗昔康主要药动学参数周期间和剂型间无显著性差异，为生物等效制剂。OBJECTIVE To investigate the bioequivalence of ampiroxicam capsule and tablet. METHODS An HPLC method was used to separate the active metabolite of ampiroxicam in plasma after liquid-liquid extraction and detected at ultraviolet wavelength of 360 nm. The main pharmacokinetic parameters were calculated and evaluated by DAS 2. 0. RESULTS The main pharmacokinetic parameters of ampiroxicam capsule and tablet, characterized as piroxicam, were as follows, t1/2 （44.7±9.0） h and （46.2±13.0）h, Tmax（7.7±2.2）h and （7.2±1.6）h,Cmax（2.6±0. 5）mg·L^-1 and （2.6±0.5）mg·L^-1,AUC0-144（187.3±32.1）mg·L^-1·h and （188.7±30.0）mg·L^-1·h,AUC0-∞ （216.6±36.6）mg·L^-1·h and （219.1±40.2）mg·L^-1·h,respec-tively. The relative bioavailability of ampiroxicam capsule was （100.2±15.9）%. CONCLUSION The ampiroxicam capsule and tablet were bioequivalent,and its main pharmacokinetic parameters had no significant difference.

关 键 词：安吡昔康 吡罗昔康 生物等效性 高效液相色谱法 

分 类 号：R971[医药卫生—药品]