摘要
目的:通过高效液相-质谱联用(HPLC-MS/MS)法检测人血浆中氯雷他定的浓度,研究健康受试者口服氯雷他定受试软胶囊和参比片的人体相对生物利用度和生物等效性。方法:18名男性健康志愿者随机交叉分别单剂量口服受试制剂和参比制剂40mg,采用HPLC-MS/MS法测定血浆中药物浓度,通过方差分析和双单侧t检验比较2种制剂的AUC0→24、AUC0→∞、Cmax、tmax。结果:受试制剂和参比制剂的主要药动学参数为AUC0→24分别为(218.6±84.4)和(199.5±71.0)μg·h·L-1,AUC0→∞分别为(226.7±87.5)和(205.7±73.2)μg·h·L-1,Cmax分别为(71.9±23.7)和(69.8±23.9)μg·L-1,tmax分别为(0.97±0.36)和(1.04±0.32)h,t1/2分别为(5.2±2.1)和(5.2±1.7)h。结论:2种氯雷他定制剂生物等效,受试制剂和参比制剂的相对生物利用度为(111.8±25)%。
JRJECTIVE To study the relative bioavailability and bioequivalence of different formulations containing lorata- dine. METHODS A randomized, crossed-over study was conducted in 18 healthy male volunteers by a single dose of 40 mg loratadine of different formulations. The pharmacokinetic parameters as AUG,24 ,AUG0→∞ ,Cmax and tmax were compared by sta- tistical analysis. RESULTS The main pharmacokinetie parameters of test and reference preparations were as follows： AUC0→24 were （218. 6 ± 84. 4） and （199. 5 ± 71.0）μg·h·-1, AUG0→∞ were（226. 7 ± 87. 5） and （205.7 ± 73. 2） μg·h·-1 , Cmax were （71.9 ± 23. 7） and （69. 8 ± 23.9）μg.L 1, tmax were （0. 97 ± 0. 36） and （1.04 ± 0. 32）h, 6/2 were （5. 2 ± 2. 1） and （5. 2 ± 1.7）h. CONCLUSION The results show that the two formulations are bioequivalent. The relative bioavailability of loratadine capsules is （111.8±25）%.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2008年第18期1559-1562,共4页
Chinese Journal of Hospital Pharmacy
