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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。
This study describes the pharmacokinetics of lisinopril / hydrochlorothiazide in Chinese healthy volunteers. Nine subjects took high, medium and low doses of three kinds of compound tablets, the results showed that the two drugs AUC and Cmax with the dose increased significantly, but the three doses of AUC / Dose, Cmax / Dose and tmax no significant difference. Lisinopril and hydrochlorothiazide are linearly metabolized over the dose range involved. Eight healthy volunteers treated with lisinopril / hydrochlorothiazide after multiple tablets, compared with the first administration, steady-state lisinopril after AUC, Cmax and Cmin increased, where AUC and Cmax The AUC, Cmax, Cmin and tmax of hydrochlorothiazide increased, and the AUC and Cmin increased significantly. After reaching steady state, lisinopril had a fluctuating index (FI) of 2.29 and a relatively stable concentration, while the hydrochlorothiazide fluctuating index FI was 4.09, with a relatively fluctuating concentration.