饮食对谱圣康口服液在健康人体的药代动力学的研究  

Effect of diet on the pharmacokinetic of Picika oral solution in healthy human

作　　者：段锋[1] 朱珍真[1] 毕京峰[1] 陈本超[1] 陈贞[1] 张丽[1] 姬慧[1] 郎丽巍[1] 王敏[1] 魏振满[1] 

机构地区：[1]中国人民解放军第三〇二医院新药临床试验中心,北京100039

出　　处：《中国临床药理学杂志》2016年第3期227-229,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究饮食对谱圣康口服液在健康受试者体内的药代动力学变化及影响。方法试验用随机、自身对照设计。12例受试者随机分为2组,每组6例,分别于空腹和进食后服用谱圣康口服液60 m L,给药前后按不同点采集血浆样品,测定血药和尿液浓度并计算药代动力学参数。结果受试者空腹和进食后服用谱圣康口服液后,活性成分三萜皂苷CKL-A03在血浆中的药代动力学参数分别为:t_(1/2)为(126.13±74.04),(104.81±68.44)min;t_(max)为(53.75±10.03),(58.75±11.89)min;C_(max)分别为(3.06±0.86),(3.81±2.82)μg·L^(-1);AUC_(0-t)分别为(268.81±84.25),(355.03±177.82)μg·L^(-1)·min。尿液中CKL-A03的t_(1/2)分别为(1.14±0.12),(1.24±0.16)h。结论饮食可能对谱圣康的吸收和在体内的消除速度均有影响。Objective To study the influence of diet on the pharmacoki- netic of Picika oral solution in healthy subjects. Methods This study taken random, before and after self - control design. Twelve subjects were randomly divided into 2 groups, each group was 6 cases, then they were given Picika oral solution 60 mL respectively before and after meal. Before and after administration, blood and urine samples were collected at different points, the plasma and urine concentration was measured and pharmacokinetic parameters were calculated. Results Before and after administration of Picika oral solution 60 mL, the drug pharmacokinetic parameters of active ingredients - CKL - A03 were listed as follows ： t1/2 was （126. 13 ± 74.04 ）, （104.81 ± 68.44 ） min; tmax were （53.75 ± 10. 03） and （58.75± 11.89） min; Cmax were （3.06 ±0. 86） and （3.81 ±2.82）ug·L-1; AUC0-1, were （268.81 ±84.25） and （355.03 ± 177.82）ug·L-1 min in plasma respectively, tl/2 was （1.14 ± 0.12）, （1.24 ± 0.16） h in the urine respectively. Conclusion Diet may affect the absorption and eliminate speed of the drug.

关 键 词：谱圣康口服液 饮食试验 药代动力学 Ⅰ期临床试验 自身对照 

分 类 号：R979.5[医药卫生—药品] R969.1[医药卫生—药学]