摘要
目的测定地高辛口服溶液在兔体内的药动学参数,计算相对于片剂生物利用度。方法新西兰兔8只,雌雄各半,分为两组,分别灌服地高辛口服液和地高辛片剂60"g/kg。给药后于耳缘静脉采血0.7 ml。2周后,两组互换给药剂型,采血后血样经离心处理后取血清用荧光偏振免疫分析法测定血药浓度;使用DAS2.0程序计算药动学参数,用SPSS11.0进行统计学处理,并进行生物等效性评价。结果地高辛口服液的药动学参数为:AUC0-24 h(11.5±3.5)"g.h.L-1,Tmax(1.0±0.3)h,Cmax(1.8±1.1)"g.L-1,t1/2(6.2±3.1)h。2种制剂药动学参数除Tmax外,差异均无统计学意义(P>0.05);地高辛口服液的相对片剂的生物利用度为(96±18)%。结论地高辛口服液比片剂在兔体内吸收更快;2种制剂具基本生物等效性。
Objectives To study the pharmacokinetics and relative bio-availability of solution and tablet of digoxin in rabbits. Methods Eight rabbits, half the male and half the female, were divided into two groups randomly. Digoxin of 60 μg/kg was administered to animals from one group and plasma concentration of digoxin was determined in 8 rabbits after digoxin administration. Digoxin plasma concentration was determined by fluorescence polarization immunoassay. Pharmacokinetics parameters were calculated using DAS 2.0 software and statistics analysis was performed by SPSS 11.0 software. Results The main pharmacokinetic parameters of digoxin solution as follows ： AUC0-24h （11.5±3.5） μg·h·L^-1, Tmax （1.0±0.3） h, Vd （1.8±1.1） μg· L^-1, t1/2 （6.2±3.1） h. The relative bioavailability of the digoxin （ solution vs tablet） was （96±18） %. Conclusions Digoxin oral solution can be rapidly absorbed more than that in tablet in rabbits. The two digoxin formulations can be considered as bioequivalent.
出处
《岭南心血管病杂志》
2008年第3期215-216,共2页
South China Journal of Cardiovascular Diseases
关键词
地高辛
口服液
血药浓度
药动学
相对生物利用度
Digoxin
Oral solution
Blood concentration
Pharmacokinetics
Relative bio-availability
