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目的研究健康志愿者服用刺葡萄籽油后对匹伐他汀药动学的影响。方法用自身前后对照随机交叉的试验方法,筛选8名健康受试者,男女各半,一组连续7d口服匹伐他汀钙片,另一组连续7d同时口服刺葡萄籽油软胶囊和匹伐他汀钙片,洗脱2周后,两组交叉服用药物。用HPLC-MS/MS测定血浆匹伐他汀的浓度,用DAS2.0软件计算药动学参数。结果联用刺葡萄籽油软胶囊和匹伐他汀钙片与单用匹伐他汀钙片的主要药动学参数:AUC分别为(152.9±66.26)和(135.556±76.133)μg·h·L-1,ρmax分别为(33.51±15.121)和(33.109±21.324)μg·L-1,tmax分别为(0.688±0.259)和(0.875±0.443)h,t1/2分别为(15.76±12.118)和(11.753±6.892)h,CL分别为(15.4±1.764)和(17.106±5.027)L·h-1。结论在健康受试者体内连续服药时,除半衰期延长外,刺葡萄籽油对匹伐他汀的其他主要药动学参数未产生显著性影响。
Objective To study the effect of grape seed oil on the pharmacokinetics of pitavastatin in healthy volunteers. Methods Eight randomly selected healthy subjects were screened by randomized crossover test before and after treatment. One group was treated with pitavastatin calcium continuously for 7 days and the other group was administered with grape seed oil soft capsule and pterygium simultaneously for 7 days. Statin calcium tablets, two weeks after elution, the two groups crossed to take the drug. The concentration of plasma pitavastatin was determined by HPLC-MS / MS and the pharmacokinetic parameters were calculated by DAS 2.0 software. Results The main pharmacokinetic parameters (AUC) were (152.9 ± 66.26) and (135.556 ± 76.133) μg · h · L -1, respectively, for the combination of prickly ash seed oil capsules and pitavastatin calcium tablets with pitavastatin calcium tablets. 1, ρmax were (33.51 ± 15.121) and (33.109 ± 21.324) μg · L-1, tmax was (0.688 ± 0.259) and (0.875 ± 0.443) h respectively, t1 / 2 was (15.76 ± 12.118) and 11.753 ± 6.892) h, CL were (15.4 ± 1.764) and (17.106 ± 5.027) L · h-1, respectively. Conclusions In healthy volunteers, in addition to prolonging the half-life, grape seed oil has no significant effect on other major pharmacokinetic parameters of pitavastatin.