精氨洛芬片剂与颗粒剂在健康受试者体内的生物等效性  

Bioequivalence of arginine ibuprofen tablets and granules in Chinese healthy volunteers

作　　者：许俊羽[1] 梁雁[1] 赵侠[1] 周颖[1] 赵东方[1] 张慧琳[1] 田硕涵[1] 路敏[1] 刘晓[1] 向倩[1] 崔一民[1] 

机构地区：[1]北京大学第一医院药剂科,北京100034

出　　处：《中国临床药理学杂志》2009年第3期215-218,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究精氨洛芬(非甾体抗炎药)片剂与颗粒剂在中国健康志愿者体内的生物等效性。方法20名健康男性受试者分别随机交叉口服精氨洛芬片(试验制剂)及其颗粒(参比制剂)0.4 g,用HPLC-UV法测定给药后不同时间点的血浆布洛芬浓度;用DAS程序对试验数据进行统计处理,评价2种制剂的生物等效性。结果试验制剂和参比制剂的药代动力学参数如下:Cmax分别为(50.60±9.12)、(50.53±8.58)mg.L-1,tmax分别为(0.51±0.20)、(0.34±0.11)h,AUC0-t分别为(118.63±21.42)、(115.75±20.23)mg.h.L-1,AUC0-∞分别为(121.18±22.18)、(118.55±21.83)mg.h.L-1。试验制剂与参比制剂AUC0-t之比和Cmax之比的90%可信区间分别为97.5%～107.6%和93.3%～107.2%。结论试验制剂和参比制剂吸收程度等效(AUC0-t,AUC0-∞和Cmax均生物等效性);但吸收速度不等效(tmax不等效)。Objective To study the bioequivalence of arginine ibuprofen tablets and its granules in Chinese healthy volunteers. Methods A single oral dose of 0. 4 g arginine ibuprofen tablets （test） and arginine ibuprofen granules （reference） were given to 20 healthy male volunteers. Ibuprofen concentrations in plasma were determined by HPLC-UV method. The parameters of pharmacokinetics were calculated by DAS program. The bioequivalence of the two formulations were analyzed. Results The main pharmacokinetic parameters of test and reference drug were as follows： the Cmax were （50. 60 ±9. 12 ） , （50. 53 ±8.58） mg.L^-1; the tmax were （0.51±0.20） , （0.34±0.11 ） h; the AUC0-t were （118.63±21.42） , （115.75 ±20.23） mg.h.L^-1; the AUC0-∞ were （121.18±22.18） , （118.55±21.83） mg.h.L^-1. The 90% confident interval for AUC0-t-ratio and Cmax-ratio of the mean values of test to reference formulations were 97.5% - 107.6% and 93.3% - 107.2%, respectively. Conclusion The test and the reference were bioequivalent in absorption degree but were not in rate.

关 键 词：布洛芬 精氨酸 生物等效性 高效液相色谱-紫外法 

分 类 号：R969.1[医药卫生—药理学] R976[医药卫生—药学]