摘要
目的:比较A、B两厂复方卡托普利片的生物利用度和药代动力学。方法:9名健康志愿者随机交叉口服单剂量30mg复方卡托普利片,以对溴苯乙酰基溴(PBPB)为衍生化试剂,采用反相高效液相色谱法。结果:测得A、B药厂生产的复方卡托普利片剂在血浆中Cap浓度达峰时间分别为(0.94±0.13)h和(1.00±0.15)h;达峰浓度Cmax分别为(92.03±27.36)ng/ml、(74.67±19.29)ng/ml;药时曲线下面积(AUC)分别为(252.78±68.14)ng/(h·L)、(251.19±50.13)ng/(h·L)。血药浓度—时间曲线符合二房室模型。结论:以A厂复方卡托普利片为标准算得B厂复方卡托普利片中卡托普利的相对生物利用度(F)为99.37%。
OBJECTIVES:To compare the bioavailability and pharmacokinetics of captopril between products of two factories.METHODS:An open randomized crossover study was carried out in 9 healthy volunteers who received a single oral dose of 30mg captopril,taking β bromophenacyl bromide as ramification.Drug concentrations in plasma were assayed by HPLC method.RESULTS:The concentration time course after medication conformed to a 2 compartment open model with a first order absorption.The pharmacokinetic parameters of Captopril of A and B medicine factories were:Tmax(0.94±0.13)h,(1.00±0.15)h,Cmax(92.03±27.36)ng/ml,(74.67±19.29)ng/ml,AUC(252.78±68.14)ng/(h·L),(251.19±50.13)ng/(h·L)respectively.CONCLUSIONS:The results showed that the bioavailability for the testing tablet was 99.37%,the two formulations were bioequivalent.
出处
《中国药房》
CAS
CSCD
1999年第3期125-126,共2页
China Pharmacy