论文部分内容阅读
目的研究注射用盐酸尼非卡兰在健康人体的药动学。方法24名健康志愿者,男女各半,按体重配对,随机分为3组,以奥硝唑为内标,采用HPLC-UV测定尼非卡兰0.3,0.4mg·kg-1单次静脉推注和0.4mg·kg-1静脉推注后0.4mg·kg-1·h-1连续静脉输注6h给药尼非卡兰经时血浓度,采用DAS2.0程序计算其主要药动学参数。结果志愿者注射用盐酸尼非卡兰0.3,0.4mg·kg-1静脉推注,0.4mg·kg-1负荷剂量后0.4mg·kg-1·h-1连续6h静脉输注,尼非卡兰ρmax分别为(230.95±54.02),(358.62±73.98)和(444.30±88.12)μg·L-1;t1/2分别为(1.55±0.38)、(1.344±0.19)和(1.35±0.23)h;AUC0-t分别为(193.53±45.19),(285.61±46.57)和(2609.02±498.20)μg·h·L-1。结论血浆内源性物质不干扰尼非卡兰测定,方法简单,操作方便;尼非卡兰静脉注射给药人体内呈线性药动学特征;整个试验过程顺利,静脉推注和静脉输注给药志愿者无不良反应发生。
Objective To study the pharmacokinetics of nifedipine hydrochloride for injection in healthy volunteers. Methods Twenty-four healthy volunteers, male and female, were divided into three groups according to their body weight. Ornidazole was used as an internal standard. The contents of nifedipine 0.3 and 0.4 mg · kg -1 were determined by HPLC-UV. Note: The 0.4 mg · kg-1 0.4mg · kg-1 intravenous bolus injection of 6mg continuous intravenous infusion of nifedal cardine blood concentration, using the DAS2.0 program to calculate the main pharmacokinetic parameters . Results The volunteers were injected intravenously with 0.3, 0.4 mg · kg -1 of nifedipine hydrochloride and 0.4 mg · kg -1 · h -1 after the 0.4 mg · kg -1 loading dose for 6 h, (Ρmax) were (230.95 ± 54.02), (358.62 ± 73.98) and (444.30 ± 88.12) μg · L-1, respectively, and were 1.55 ± 0.38, 1.344 ± 0.19 and 1.35 ± 0.23 h ; AUC0-t were (193.53 ± 45.19), (285.61 ± 46.57) and (2609.02 ± 498.20) μg · h · L-1, respectively. Conclusions Plasma endogenous substances do not interfere with the determination of nifeducalyse. The method is simple and easy to operate. The pharmacokinetics of nifeducin administered intravenously in the human body is linear. The whole experiment is carried out smoothly, intravenously and intravenously Drug volunteers no adverse reactions occur.