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目的:考察国产环孢素(田可胶囊)的临床药动学参数,以便临床安全、合理的使用:方法:6例健康志愿者单剂量口服田可胶囊,用FPIA法检测其全血浓度。结果:田可胶囊的药动学参数为:α=(0.49±0.54)h-1,β=(0 14+0.08)h-1,ka=(1.93±3.06)h-1,t1.2α=(2.8±1.96)h,t1.2β=(10.73±14.55)h,t1/2ka=(1.26±1.07)h,AUC=(6.76±1.84)mg·h·L-1,Cl=(0.056±0.021)L·h-1,Tp=(2.89±1.57)h,Cmax=(669.57±218.36)mg·L-1。结论:田可胶囊的药动学参数个体差异较大,需临床注意,做到个体化给药。
Objective: To investigate the clinical pharmacokinetic parameters of domestic cyclosporine (Tian Ke Capsule) for clinical safe and reasonable use: Methods: Six healthy volunteers were given oral dose of Tian Ke Capsule and their whole blood concentration was measured by FPIA. Results: The pharmacokinetic parameters of Tian Ke Capsule were as follows: α = (0.49 ± 0.54) h-1, β = (0 14 +0.08) h-1, ka = (6.7 ± 1.84) mg · h · L-1, Cl = (0.056 ± 0.021), t1.2β = (10.73 ± 14.55) h, t1 / 2ka = ) L · h-1, Tp = (2.89 ± 1.57) h, Cmax = (669.57 ± 218.36) mg · L-1. Conclusion: The pharmacokinetic parameters of Tian Ke Capsule vary greatly and require clinical attention and individualized administration.