摘要
目的研究非诺贝特双层渗透泵片在犬体内的药动学特征,并评价受试制剂和参比制剂的生物等效性。方法采用LC-MS测定比格犬体内的血药浓度,采用DAS 2.1.1软件计算药动学参数。结果受试制剂和参比制剂血浆中非诺贝特酸的Cmax分别为(1 100.0±771.2)、(924.3±564.0)ng/mL,tmax分别为(6.7±8.5)、(2.5±0.5)h,AUC0-t分别为(17 841.1±12220.7)、(17 615.5±12 870.2)ng·h/mL;t1/2分别为(17.7±8.2)、(16.4±3.3)h,MRT0-t分别为(24.7±4.0)、(24.5±5.2)h,受试制剂中非诺贝特酸的平均相对生物利用度为(104.7±12.4)%。结论受试制剂非诺贝特渗透泵片和参比制剂非诺贝特缓释胶囊具有生物等效性。
Objective To study the pharmacokinetics of Fenofibrate Double-layer Osmotic Pump Tablets and evaluate the bioequivalence between tested preparation and reference preparation in Beagle＇s dogs. Methods The concentration of fenofibric acid in plasma was determined by LC-MS. Also, the pharmacokinetic parameters of Fenofibrate Double-layer Osmotic Pump Tablets in vivo were calculated by pharmacokinetic software DAS 2.1.1. Results The main pharmacokinetic parameters of the tested preparation and reference preparation were as follows. The CmaxWere （1 100.0 ± 771.2） and （924.3 ± 564.0） ng/L, tmax were （6.7 ± 8.5） and （2.5 ± 0.5） h, AUC0-4 were （17 841.1 ± 12 220.7） and （17 615.5 ± 12 870.2） ng.h/mL, 4/2 were （17.7 ± 8.2） and （16.4 ± 3.3） h, MRTo.t were （24.7 ± 4.0） and （24.5 ± 5.2） h, the relative bioavailability of fenofibric acid in the tested preparation was （104.7 ± 12.4）%. Conclusion The test preparation and reference preparations are bioequivalent.
出处
《现代药物与临床》
CAS
2014年第6期594-598,共5页
Drugs & Clinic
基金
国家重点基础研究发展计划(973计划)项目(2012CB724001)
关键词
非诺贝特渗透泵片
非诺贝特缓释胶囊
生物利用度
药动学
Fenofibrate Double-layer Osmotic Pump Tablets
Fenofibrate Sustained Release Capsules
bioavailability
pharmacokinetics
