卡托普利片剂在人体内相对生物利用度的研究  

Study on the relative bioavailability of Captopril tablets

作　　者：张卫[1] 肖继红[1] 赵健嫦 许富强[1] 

机构地区：[1]广东省江门市第二人民医院,广东江门529000

出　　处：《华西药学杂志》2005年第3期230-232,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的研究两种卡托普利片剂的人体相对生物利用度。方法按照随机交叉试验设计,22名男性健康志愿者分别po卡托普利和开搏通各25mg,采用液相色谱-质谱联用方法测定血浆中卡托普利的浓度,采用NDST程序对药动学参数进行方差分析和双单侧t检验。结果两种制剂在受试者体内的药动学参数Cmax分别为20.99±11.03、22.08±10.64mg·L-1;t1/2分别为1.87±0.11、1.93±0.11h;tmax分别为0.83±0.28、0.85±0.23h;AUC0-∞分别为63.23±16.80、65.10±14.15mg·h·L-1,受试制剂对参比制剂的相对生物利用度为97.13%。结论两种制剂具有生物等效性。OBJECTIVE To study the relative bioavailability of two kinds of Captopril tablets in human. METHODS 22 healthy male volunteers were randomly divided into A and B groups, 25 mg of Captopril tablets and preparations Capoten tablets were given,respectively. The concentrations of captopril in the plasma were determined by HPLC-MS. The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test.RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follow: C_~max was 20.99±11.03 and 22.08±10.64 mg·L^-1 ;t_~1/2 was 1.87±0.11 and 1.93±0.11 mg·h·L^-1 ;t_~max was 0.83±0.28 and ~0.85±0.23 mg·h·L^-1 ;AUC_~0-∞ was 63.23±16.80 and 65.10±14.15mg·h·L^-1 , respectively.And the relative bioavailability of the test tablets was 103.5%±13.3%. CONCLUSION The two tablets are bioequivalent.

关 键 词：卡托普利 片剂 人体内 人体相对生物利用度 液相色谱-质谱联用 药动学参数 交叉试验设计 双单侧t检验 健康志愿者 生物等效性 方差分析 NDST 制剂 开搏通 受试者 

分 类 号：R972.4[医药卫生—药品] R927.2[医药卫生—药学]