摘要
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 kinds of loratadine tablets in healthy volunteers. Method： A single oral dose of 40 mg loratadine and test or reference preparations was given to 20 healthy male volunteers in an open randomized crossover design. Loratadine concentrations in plasma were determined by HPLC method. The pharmacokinetic parameters and relative bioavailability were calculated by 3 P97 program to evaluate the bioequivalence of two preparations. Result： The main pharmacokinetic parameters of the test and the reference preparation were as follows ： Cmax were （ 39.54 ± 13.24 ） μg·L^-1 and （ 41.21 ± 11.26 ） μg·L^-1, tmax were （ 1. 13 ± 0.40 ） h and （ 1.12 ± 0.33 ） h, t1/2 were （ 2.70 ± 1.14 ） h and （ 2.99 ± 1.08 ） h, AUC0→10 were （ 123.06 ± 43.09 ） μg·L^-1·h and （ 135.10 ±38.74） μg·L^-1·h,AUC0→∞ were （ 135.45 ±50.24） μg·L^-1·h and（ 151.05 ±42.80） μg·L^-1·h,respectively. The relative bioavailability of test to reference preparation were 90.12% ± 15.29%. Conclusion： The result demonstrated that the two preparations of loratadine were bioequivalent by analysis of variance, two-one sided test and 90 % confidential interal.
出处
《中国药师》
CAS
2007年第11期1071-1073,共3页
China Pharmacist
