摘要
目的:比较深圳市海滨制药有限公司研制的氯雷他定片(受试制剂)和上海先灵葆雅制药有限公司生产的氯雷他定片(商品名:开瑞坦,参比制剂)在健康人体内的药代动力学过程,并评价两制剂的生物等效性。方法:20例健康男性受试者随机交叉单次口服氯雷他定片40mg后,采用固相萃取反向HPLC法测定氯雷他定血浆浓度,进行有关生物利用度研究,并评价二者的生物等效性。结果:单次口服参比与受试氯雷他定片40mg后,主要药代动力学参数Cmax分别为34.9±16.6μg·L与33.5±17.4μg·L－1tmax分别为0.76±0.24h与0.75±0.26h,t(1/2)分别为1.63±0.48h与l.73±0.49 h,AUCO-tn 分别为 53.7±25.9μg·h·L-1与48.8±21.0μg·h·L－1,AUC0→∞分别为58.5±28.0μg·h·L－1与54.6±23.8μg·h·L－1。受试制剂相对对参比制剂的生物利用度F为94.5%±14.5%。结论:统计分析结果显示,受试制剂与参比制剂生物等效。
OBJECTIVE: To study the pharmacokinetics and bioequivdent ofloratadine in healthy Volunteers. METHODS:A single oral dose 40mg loratadine ofreference or test preparations was given to healthy male volunteers according toan open randomized crossover study.The plasma concentrations of loratadine weredetermined by a RP HPLC method. The pharmacokinetic parameters and biovailabilityof test preparation were compared with reference preparation. RESULTS: The mainpharmacokinetic parameters of the reference and the test preparation were as follows:Cmax were 34.9±16.6μg.L-1and 33.5±l7.4μg.L-1; tmax were 0.76±0.24h and 0.75±0.26h;t(1/2)were l.63±0.48h and l.73±0.49h;AUC0-tn were 53.7±25.9μg.h.L-1 and48.8±2l.0μg.h.L-1; AUC0→∞were 58.5±28.0μg.h.L-1 and 54.6±23.8μg.h.L-1, Therelative bioavailability of reference to test preparation was 94.5 %±l4.5 %.CONCLUSION: The results of statistics analysis showed that the referencepreparation and the test preparation were bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2002年第2期105-108,共4页
The Chinese Journal of Clinical Pharmacology
