亚叶酸钙片的人体生物利用度及生物等效性研究

Relative Bioavailability and Bioequiavailability of Calcium Folinate Tablets in Healthy Volunteers

目的:研究亚叶酸钙片在健康受试者体内的相对生物利用度和生物等效性。方法:采用两制剂双周期随机交叉试验设计,18名男性健康受试者单剂量口服亚叶酸钙片或参比片剂75 mg,用HPLc测定血浆亚叶酸浓度。采用3P97药动学程序进行数据处理。结果:试验片剂与参比片剂的AUC_(0-24h)分别为(4 608.68±806.72)ng·ml～·h和(4 868.73±909.83)ng·ml^(-1)·h;C_(max)分别为(484.82±72.87)ng·ml^(-1)和(499.50±108.19)ng·ml^(-1);T_(max)分别为(2.33±0.30)h和(2.47±0.27)h。结论:两种制剂主要药动学参数均无显著性差异。与参比片剂相比,试验片剂的相对生物利用度为(96.48±18.60)%,两者具有生物等效性。

Objective： To study the relative bioavailability and bioequiavailability of calcium folinate tablets in 18 healthy volunteers. Method ： The randomized two-period crossover design was used, 18 healthy volunteers were orally administered with 75 mg calcium folinate tablets or reference, respectively. Leucovorin in plasma was determined by HPLC, and the data were processed with 3P97 pharmacokinetic program. ResuLt： The pharmacokinetic parameters of the two tabletes were as follows： A UC0-24h were （4608.68 ± 806.72 ） ng·ml^-1· h and （4868.73 ±909.83 ）ng·ml^-1·h, Cmax were （484.82 ± 72.87 ） ng·ml^-1 and （499.50 ±108.19 ） ng·ml^-1, Tmax were （2.33 ± 0.30） h and （2.47 ± 0.27 ） h, respectively. Conclusion： The differences of their main pharmacokinetic parameters were not statistically significant （P 〉 0.05 ）. Compared with reference formulations, the relative bioavailability of the test is （96.48 ±18.60） % （AUC0-24h） ,then the test and reference formulations are bioequivalent.