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目的:研究液相色谱-质谱法测定人血浆中的复方赖诺普利,并分析高蛋白高脂肪食物对其药动学的影响。方法:采用随机双周期交叉设计,12名健康受试者(男女各半)随机分为2组,Ⅰ组空腹服复方赖诺普利片1片(每片含赖诺普利10．0 mg,氢氯噻嗪12．5 mg),Ⅱ组进食后服复方赖诺普利片1片,交叉间隔为1 wk。结果:空腹和进食单剂量口服受试制剂:赖诺普利的tmax分别为(7．3±s 1．2)和(7．5±1．0)h;cmax分别为(42±7)和(33±10)μg·L-1;t1／2分别为(13．7±2．0)和(12．5±2．2)h; MRT分别为(20±3)和(19．9±2．5)h;AUC0～72分别为(545±147)和(493±125)μg·h·L-1。氢氯噻嗪的tmax分别为(2．8±0．7)和(4．6±1．1)h;cmax分别为(82±23)和(77±13)μg·L-1;t1/2分别为(8．6±1．8)和(8．4±1．7)h;MRT分别为(10．4±2．0)和(11．6±1．6)h;AUC0～48分别为(680±281)和(684±83)μg·h·L-1。结论:该方法选择性强、灵敏度高、操作简便,适用于复方赖诺普利制剂的临床药动学研究;进食高脂肪、高蛋白的食物会影响赖诺普利的达峰浓度和氢氯噻嗪的达峰时间。
OBJECTIVE: To study the determination of compound lisinopril in human plasma by liquid chromatography-mass spectrometry (HPLC-MS) and to analyze the influence of high-protein and high-fat food on its pharmacokinetics. Methods: Twelve randomized crossover design, 12 healthy subjects (male and female half) were randomly divided into two groups. Group Ⅰ was treated with an oral compound lisinopril tablet (each tablet containing lisinopril 10.0 mg , Hydrochlorothiazide 12.5 mg). The rats in group Ⅱ were treated with 1 unit of compound lisinopril tablets at intervals of 1 wk. RESULTS: The tmax of lisinopril was (7.3 ± s 1.2) and (7.5 ± 1.0) h, respectively; the cmax was (42 ± 7) And (33 ± 10) μg · L-1, respectively; t1 / 2 was (13.7 ± 2.0) and (12.5 ± 2.2) h respectively; MRT was (20 ± 3) and 9 ± 2.5) h; AUC0 ~ 72 were (545 ± 147) and (493 ± 125) μg · h · L-1, respectively. The tmax of hydrochlorothiazide were (2.8 ± 0.7) and (4.6 ± 1.1) h, respectively, and the values of cmax were (82 ± 23) and (77 ± 13) μg · L -1 (8.6 ± 1.8) and (8.4 ± 1.7) h respectively; MRT was (10.4 ± 2.0) and (11.6 ± 1.6) h respectively; AUC0-48 (680 ± 281) and (684 ± 83) μg · h · L-1. Conclusion: This method is selective, sensitive and easy to operate. It is suitable for clinical pharmacokinetics study of compound lisinopril. Eating high fat and high protein foods will affect the peak concentration of lisinopril and the effect of hydrochlorothiazide Peak time.