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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) %。结论 丽珠环明胶囊与新山地明胶囊具有生物等效性
Objective To evaluate the bioequivalence of two cyclosporine capsules (Livzon Huanming Capsule and Xin Shan Di Ming Capsule). Methods A randomized crossover study was designed to test the cyclosporine blood concentration by reversed-phase high-performance liquid chromatography (RP-HPLC). A randomized crossover study was conducted in 10 healthy male volunteers to compare the single dose po 30 0mg Pharmacokinetic Parameters and Relative Bioavailability of Capsules and Jojoba Capsules. Results The pharmacokinetic profile of Livzon Huan Ming Capsule was very similar to the drug profile of Xin Shan Di Ming Capsule. The AUC0 → 24 were (70 5 1.4 ± 10 84.2) and (6 918.5 ± 6 93.4) ng · h · mL-1; cmax were (15 19.88 ± 2 19.84) and (15 19.6 9 ± 2 33.6 8) ng · mL-1, respectively; t1 / 2α were (1.2 8 ± 0.38) and (1.2 3 ± 0 .40) h; t1 / 2 β were (9.80 ± 3.18) and (9.71 ± 4.87) h, respectively; tmax was 1.45 ± 0.28 and 1.30 ± 0.35 h, respectively. The pharmacokinetic parameters were not significantly different. The relative bioavailability of Livzon Huan Ming Capsule to Xin Shan Di Ming Capsule was (102.0 ± 13.7)%. Conclusions Lizhu Huanming Capsule has the bioequivalence with Xin Shan Di Ming Capsule