摘要
目的 评价两种环孢素胶囊 (丽珠环明胶囊与新山地明胶囊 )的生物等效性。方法 以随机分组自身对照、间隔 1周交叉试验设计法 ,用反相高效液相色谱技术测定环孢素血浓度 ,在 10名健康男性志愿受试者身上比较单剂量po 30 0mg丽珠环明胶囊和新山地明胶囊后的药动学参数和相对生物利用度。结果 丽珠环明胶囊的药 时曲线与新山地明胶囊的药 时曲线极其相似 ,其AUC0→ 2 4 分别为 :(70 5 1.4± 10 84.2 )和 (6 918.5± 6 93.4)ng·h·mL-1;cmax分别为 :(15 19.88± 2 19.84)和 (15 19.6 9±2 33.6 8)ng·mL-1;t1/ 2α分别为 (1.2 8± 0 .38)和 (1.2 3± 0 .40 )h ;t1/ 2 β分别为 (9.80± 3.18)和 (9.71± 4.87)h ;tmax分别为 :(1.45± 0 .2 8)和 (1.30± 0 .35 )h ,经统计分析 ,各药动学参数均无显著性差异。丽珠环明胶囊相对于新山地明胶囊的相对生物利用度为(10 2 .0± 13 .7) %。
OBJECTIVE To evaluate the bioequivalence of two kinds of cyclosporine capsules.METHODS 300mg single oral dose of cyclosporine Livzon capsule and Sandimmun Neoral capsule were given to 10 volunteers in an open randomized crossover way to study the pharmacokinetics and relative bioavailability.Cyclosporine concentrations in blood were assayed by RP HPLC method.RESULTS The relative bioavailability of cyclosporine Livzon capsule was (102.0±13.7)%.The time concentration curve of cyclosporine Livzon capsule was similar to that of Sandimmun Neoral capsule, and their AUC 0→24 were (7051.4±1084.2) and (6918.5±693.4) ng·h·mL -1 ; c max were (1519.88±219.84) and (1519.69±233.68) ng·mL -1 ; t 1/2α were (1.28±0.38)and (1.23±0.40)h; t 1/2β were (9.80±3.18)and (9.71± 4.87 )h; t max were (1.45±0.28) and (1.30±0.35) h,respectively.The result of statistical analysis on above parameters showed that there was no significant difference between cyclosporine Livzon capsule and Sandimmun Neoral capsule.CONCLUSION The two formulations were bioequivalent.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2001年第3期180-182,共3页
Chinese Pharmaceutical Journal
