布洛芬软胶囊的人体生物等效性研究

目的:以巨化集团公司制药厂生产的布洛芬泡腾片为参比制剂,评价恩必普药业有限公司生产的布洛芬软胶囊的人体生物等效性。方法:18名健康男性受试者按两制剂两周期的交叉试验设计口服单剂量400mg的受试制剂和参比制剂后,采用高效液相色谱法测定血浆中布洛芬的浓度,使用DAS1.0软件计算药代动力学参数并进行生物等效性统计分析。结果:受试制剂和参比制剂的cmax分别为(50.45±7.08)和(45.18±8.01)μg/ml;tmax分别为(0.48±0.21)和(0.68±0.31)h;AUC0-10h分别为(135.26±20.9)和(140.26±21.72)μg.ml-1.h-1;AUC0-∞分别为(139.85±21.45)和(145.46±23.93)mg.ml-1.h-1;t1/2分别为(2.06±0.26)和(2.04±0.25)h。受试制剂的相对生物利用度为(96.98±10.52)%(AUC0-16h,A/AUC0-10h,R×100%)。结论:两种制剂具有生物等效性。

Pharmacokinetic and Bioequivalence of Ibuprofen Soft Capsules in Healthy Volunteers

Objective：To study pharmacokinetics of ibuprofen soft capsules in healthy human subjects and its bioequivalence. Methods： In a randomized crossover study, 18 healthy male volunteers were given a single oral dose of 400mg ibuprofen. The concentration of ibuprofen in plasma was determined by HPLC. The pharmacokinetic parameters were processed by DAS program for statistic analysis. Results： The pharmacokinetic parameters of the test and reference preparations were as follows：cmax were （50. 45±7. 08）and （45. 18±8. 01）μg · ml^- 1; tmax were（0. 48±0. 21）and（0. 68 ±0. 31）h;AUC0-10h were （135.26±20. 9）and （140. 26±21.72）μg · ml^- 1 ;AUC0-∞were （139. 85±21： 45） and （145. 46±23. 93）μg · ml^- 1 ;t1/2 were （2.06±0. 26） and （2. 04±0. 25） h, respectively. The relative bioavaitability of the test preparations was （96. 98± 10. 52）. Conclusion： The two preparations were bioequivalent.