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目的:研究两种氯雷他定片在健康受试者体内的生物等效性。方法:20名男性健康志愿者随机交叉单次口服受试和参比氯雷他定片40 mg后,采用HPLC法测定氯雷他定的血浓度,用3P97软件计算其药动学参数和相对生物利用度,评价两种制剂的生物等效性。结果:单次口服受试制剂和参比制剂40 mg后,其主要药动学参数C_(max)分别为(39.54±13.24)和(41.21±11.26)μg·L~(-1),t_(max)分别为(1.13±0.40)和(1.12±0.33)h,t_(1/2)分别为(2.70±1.14)和(2.99±1.08)h,AUC_(0→10)分别为(123.06±43.09)和(135.10±38.74)μg·L~(-1)·h,AUC_(0→∞)分别为(135.45±50.24)和(151.05±42.80)μg·L~(-1)·h,受试制剂相对于参比制剂的生物利用度为90.12%±15.29%。两制剂的AUC、C_(max)经对照较换后进行方差分析、双单侧t检验和(1- 2α)%置信区间法统计分析,差异无统计学意义(P>0.05)。结论:两种制剂具有生物等效性。
Objective: To study the bioequivalence of two loratadine tablets in healthy volunteers. Methods: Twenty male healthy volunteers were randomized to receive a single oral dose of 40 mg of loratadine and oral loratadine. The blood concentration of loratadine was determined by HPLC. The pharmacokinetic parameters were calculated by 3P97 software and relative Bioavailability, bioequivalence of both formulations was evaluated. RESULTS: The main pharmacokinetic parameters Cmax of single oral formulation and reference formulation were (39.54 ± 13.24) and (41.21 ± 11.26) μg · L -1, t_ ( max were (1.13 ± 0.40) and (1.12 ± 0.33) h respectively, t 1/2 was 2.70 ± 1.14 and 2.99 ± 1.08 h respectively, and AUC 0-0 10 was 123.06 ± 43.09 ) And (135.10 ± 38.74) μg · L -1 · h · AUC 0-0∞ were (135.45 ± 50.24) and (151.05 ± 42.80) μg · L -1 · h, respectively The bioavailability of the formulation relative to the reference formulation was 90.12% ± 15.29%. The AUC and Cmax of the two preparations were compared by analysis of variance, double unilateral t-test and (1- 2α)% confidence interval statistical analysis, the difference was not statistically significant (P> 0.05). Conclusion: Both formulations are bioequivalent.