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

韦 阳  孙莹莹  王恪申  孙丹利  郑名友

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

韦阳孙莹莹王恪申孙丹利郑名友

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

HUI Yang

摘要

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C_max都随着剂量的增加显著增加, 但3种剂量间AUC/Dose、C_max/Dose和t_max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、C_max和C_min有所增加, 其中AUC和C_max显著增加; 氢氯噻嗪的AUC、C_max、C_min和t_max有所增加, 其中AUC和C_min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。

Abstract:
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 C_max of two compounds both increase significantly with increase of dose. Neither normalized AUC/Dose nor C_max/Dose has significant difference between every two tested dose groups. The similar results can be observed as for the parameters of t_max. Lisinopril and hydrochlorothiazide are both eliminated with linear characteristics. After repeated administration of lisinopril/hydrochlorothiazide combined tablets, AUC, C_max and C_min of lisinopril in the steady state increase. AUC and C_min increase significantly. As for hydrochlorothiazide, AUC, C_max, C_min, and t_max also increase in steady state. AUC and C_min 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.

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