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目的观察健康受试者空腹及高脂高热量饮食情况下口服褪黑素缓释片的药代动力学特征。方法 10名健康受试者单剂量、自身交叉口服褪黑素缓释片2 mg。用HPLC-MS/MS法测定人血浆中褪黑素的浓度,用DAS 3.2.3计算主要药代动力学参数。结果空腹与进食后的主要药代动力学参数如下:C_(max)分别为(1.40±0.68),(1.13±0.38)ng·m L~(-1);t_(1/2)分别为(2.53±1.10),(2.64±1.85)h;t_(max)分别为(1.28±0.85),(2.28±1.52)h;AUC_(0-10h)分别为(4.69±2.21),(4.09±1.58)ng·m L~(-1)·h;AUC_(0-∞)分别为(4.98±2.45),(4.32±1.64)ng·m L~(-1)·h。结论高脂高热量饮食可降低褪黑素缓释片在人体内吸收程度,并延迟吸收速度。
Objective To observe the pharmacokinetics of oral melatonin sustained-release tablets in healthy subjects under fasting and high-fat and high-calorie diet. Methods Ten healthy volunteers were given a single dose of 2 mg melatonin sustained-release tablets. The concentration of melatonin in human plasma was determined by HPLC-MS / MS and the main pharmacokinetic parameters were calculated using DAS 3.2.3. Results The main pharmacokinetic parameters after fasting and eating were as follows: C max were (1.40 ± 0.68) and (1.13 ± 0.38) ng · m L -1, t 1/2 was (2.69 ± 2.21) and (4.09 ± 1.58) AUC_ (0-10h) were significantly higher than that of the control group (2.53 ± 1.10) and (2.64 ± 1.85) h respectively; t max was 1.28 ± 0.85 and 2.28 ± 1.52 h, ng · m L -1 · h and AUC 0 -∞ were 4.98 ± 2.45 and 4.32 ± 1.64 ng · m L -1 · h, respectively. Conclusion High fat and high calorie diet can reduce the absorption of melatonin sustained release tablets in the human body, and delay the absorption rate.