2种萘哌地尔片的人体生物等效性研究  

Bioequivalence of 2 Kinds of Naftopidil Tablets in Healthy Volunteers

作　　者：黄天文[1] 文隽[2] 李艳[1] 潘文[1] 雷宇[1] 

机构地区：[1]广西壮族自治区肿瘤医院,南宁530021 [2]广西中医学院第一附属医院,南宁530023

出　　处：《中国药房》2013年第2期141-143,共3页China Pharmacy

摘　　要：目的:比较2种萘哌地尔片的人体药动学参数、生物利用度,评价二者的生物等效性。方法:18名男性健康志愿者随机交叉单剂量口服50mg受试制剂或参比制剂,采用高效液相色谱法测定血浆中萘哌地尔浓度,并用3p97程序对试验数据进行统计处理。结果:单剂量口服萘哌地尔片受试制剂及参比制剂50mg的药动学参数分别为:t1/2(6.77±2.90)、(6.75±3.39)h,tmax(1.10±1.10)、(1.10±1.10)h,cmax(216.71±98.38)、(199.24±91.62)mg/L,AUC0-24h(546.74±299.13)、(561.01±307.52)mg·h/L,AUC0-∞(594.23±319.57)、(608.90±342.46)mg·h/L。萘哌地尔片受试制剂的相对生物利用度为(99.0±12.5)%。结论:2种萘哌地尔片具有生物等效性。ABSTRACT OBJECTIVE： To compare the pharmacokinetics and bioavailability between 2 kinds of Naftopidil tablets, and to evaluate the bioequivalence of 2 preparations. METHODS： In randomized crossover design, a single oral dose of 50 mg test preparation and reference preparation were given in 18 healthy male volunteers, and the plasma concentrations of naftopidil were determined by HPLC. The data were analyzed by 3p97 program. RESULTS： The pharmacokinetic parameters of test preparation and reference preparation after single dose of oral administration were as follows： t1/2 were （6.77 ± 2.90） h and （6.75 ± 3.39） h; tmax were （1.10 ± 1.10） h and （1.10 ± 1.10） h;cmax were （216.71 ± 98.38）mg/Land （199.24 ± 91.62）mg/L;AUC0-24h were （546.74 ± 299.13） mg·h/L and （561.01 ± 307.52）mg·h/L;AUC0-∞ were （594.23 ± 319.57）mg·h/L and （608.90 ± 342.46）mg·h/L. The relative bioavailability of test preparation was （99.0 ± 12.5）% o CONCLUSON： 2 kinds of Naftopidil tablets are bioequivalent.

关 键 词：萘哌地尔 生物利用度 生物等效性 高效液相色谱法 药动学 

分 类 号：R969.1[医药卫生—药理学] R972.4[医药卫生—药学]