摘要
目的:评价国产氯雷他定胶囊与进口片剂在健康人体生物等效性。方法:采用双周期自身对照交叉试验设计,20名健康志愿者单次口服40mg供试制剂和参比制剂,采用固相萃取反相HPLC,测定血浆中氯雷他定的浓度。结果:氯雷他定片剂和胶囊的AUC0-∞分别为(57.3±20.7)μg.h.L-1和(60.1±23.7)μg.h.L-1,AUC0-8分别为(56.5±20.8)μg.h.L-1和(59.2±23.8)μg.h.L-1,Cmax分别为(22.9±5.1)μg.h.L-1和(22.9±5.4)μg.L-1,tmax分别为(0.93±0.20)h和(1.06±0.25)h,t1/2分别为(1.3±0.4)h和(1.2±0.4)h,氯雷他定胶囊相对于进口片剂生物利用度为(105.0±12.3)%,经方差分析,双单侧t检验差异均无显著性。结论:氯雷他定胶囊与片剂生物等效。
OBJECTIVE To evaluate the bioequivalence of loratadine capsules in Chinese healthy volunteers. METHODS A single oral dose 40 mg of two loratadine preparations, reference and test preparation was given to 20 volunteers in a randomized cross-over study. The concentration of loratadine in plasma was determined by solid phase extract HPLC. RESULTS The main pharmacokinetic parameters of two preparations reference and test preparations were as follows： AUG0→∞ were （57. 3 ± 20. 7） and （60. 1 ± 23.7）μg·h·L^-1 , AUC0-8 were （56. 5 ± 20. 8） and （59. 2 ± 23.8）μg·h·L^-1 ,Cmax were （22. 9 ± 5.1 ） and （22. 9 ± 5. 4） μg·h·L^-1, tmax were （0. 93 ± 0. 20） and （ 1.06 ± 0. 25） h, tmax were （ 1.3 ± 0. 4） and （ 1.2 ± 0. 4） h, respectively. The relative bioavailability was （105. 0 ± 12. 3） %. CONCLUSION The results of two one-side test statistical analysis .show that the two formulations are bioequivalent.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2007年第10期1390-1392,共3页
Chinese Journal of Hospital Pharmacy
