赖诺普利/氢氯噻嗪复方片在中国健康志愿者中的药代动力学研究(英文)  

Pharmacokinetics of the combined preparation of lisinopril and hydrochlorothiazide on Chinese healthy volunteers

作　　者：韦阳[1] 孙莹莹[1] 王恪申[1] 孙丹利[1] 郑名友[1] 

机构地区：[1]浙江省医学科学院,浙江杭州310013

出　　处：《药学学报》2011年第8期955-961,共7页Acta Pharmaceutica Sinica

摘　　要：本研究描述了赖诺普利/氢氯噻嗪复方片在中国健康人体内的药代动力学特征。9名受试对象分别服用高、中、低3种剂量的复方片剂,结果表明,两种药物的AUC和Cmax都随着剂量的增加显著增加,但3种剂量间AUC/Dose、Cmax/Dose和tmax无明显差别。赖诺普利和氢氯噻嗪在涉及剂量范围内呈线性代谢特征。8名健康受试者在多次服用赖诺普利/氢氯噻嗪复方片后,与第1次服药比较,达稳态后的赖诺普利的AUC、Cmax和Cmin有所增加,其中AUC和Cmax显著增加;氢氯噻嗪的AUC、Cmax、Cmin和tmax有所增加,其中AUC和Cmin显著增加。达稳态后,赖诺普利的波动指数(FI)为2.29,浓度较为平稳,而氢氯噻嗪的波动指数FI为4.09,浓度相对波动较大。The aim of the present study,performed on two different groups of volunteers,is to characterize the pharmacokinetics of lisinopril/hydrochlorothiazide combined tablet.After administration of high,medium and low doses of lisinopril/hydrochlorothiazide combined tablets,AUC and Cmax of two compounds both increase significantly with increase of dose.Neither normalized AUC/Dose nor Cmax/Dose has significant difference between every two tested dose groups.The similar results can be observed as for the parameters of tmax.Lisinopril and hydrochlorothiazide are both eliminated with linear characteristics.After repeated administration of lisinopril/hydrochlorothiazide combined tablets,AUC,Cmax and Cmin of lisinopril in the steady state increase.AUC and Cmin increase significantly.As for hydrochlorothiazide,AUC,Cmax,Cmin,and tmax also increase in steady state.AUC and Cmin increase significantly.Administered with the test medication,lisinopril has an fluctuation index（FI） value of 2.29 and reaches a relative steady concentration.But hydrochlorothiazide has an FI value of 4.09 with relatively large fluctuating concentrations.

关 键 词：赖诺普利 氢氯噻嗪 药代动力学 

分 类 号：R969[医药卫生—药理学]