奥沙普秦肠溶片HPLC测定法及其人体生物等效性研究  

The bioequivalence of oxaprozin enteric tablet in healthy volunteers measured with HPLC

作　　者：夏春华[1] 徐文炜[1] 熊玉卿[1] 章新晶[1] 

机构地区：[1]江西医学院临床药理研究所,江西南昌330006

出　　处：《中国药理学通报》2006年第3期366-368,共3页Chinese Pharmacological Bulletin

摘　　要：目的建立一种HPLC检测法,以测定人体血浆中奥沙普秦的药物浓度,并对两种奥沙普秦肠溶片生物等效性进行评价。方法18名健康受试者单剂量交叉口服400 mg奥沙普秦供试制剂或参比制剂后不同时间点采血,采用HPLC法测定其浓度,计算其药动学参数和相对生物利用度,评价两制剂的生物等效性。结果奥沙普秦供试制剂与参比制剂AUC0-240 h分别为(2852.86±871.00)和(2992.84±854.02)μg.L-1.h,实测Cm ax分别为(33.48±11.36)和(32.70±7.30)μg.L-1,实测Tm ax分别为(12.1±5.7)和(13.8±5.8)h,T12ke分别为(57.11±8.51)h和(60.98±7.97)h。两制剂主要药动学参数经统计学分析差异无显著性。结论该方法简便灵敏,两制剂具有生物等效性。Aim An HPLC method was established for the study on pharmacokinetics and bioequivalence of oxaprozin enteric tablet in healthy volunteers. Methods The oxaprozin in plasma was determined using HPLC method following a single oral dose of 400 mg of oxaprozin given respectively to 18 healthy male volun teers in an open randomized crossover design. The pharmacokinetic parameters and relative bioavailability were calculated to evaluate the bioequivalence of 2 tablet and reference tablet were（2852. 86 ± 871.00）and （2992.84 ±854.02） μg·L^-1 . h, Cmax were （33.48±11.36）and （32.70±7.30）μg·L^-1,T1/2kc were（12. 1 ± 5.7）and （13.8±5.8） h,T1/2kc were （57. 11 ± 8.51 ） and （ 60. 98 ± 7.97 ） h, respectively. These main pharmacokinetie parameters obtained showed no statistically significant difference between the 2 products. Conclusion The method is simple and sensitive. Both preparations are bioequivalent.

关 键 词：奥沙普秦 HPLC 药代动力学 生物等效性 

分 类 号：R446.1[医药卫生—诊断学] R452[医药卫生—临床医学]