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学科主题: 药剂学
题名:
地塞米松棕榈酸酯注射液在中国健康受试者的药代动力学研究
其他题名: Pharmacokinetic study of dexamethasone palmitate injection in Chinese healthy volunteers
作者: 梁雁; 许俊羽; 赵侠; 周颖; 孙培红; 张慧琳; 崔一民
关键词: 地塞米松棕榈酸酯注射液 ; 药代动力学 ; 液相色谱-串联质谱 ; dexamethasone palmitate injection ; pharmacokinetic ; LC-MS/MS
刊名: 中国临床药理学杂志
发表日期: 2015
DOI: 10.13699/j.cnki.1001-6821.2015.16.017
期: 16, 页:1613-1617
收录类别: 中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型: Journal Article
摘要: 目的:研究健康受试者单剂量静脉注射两种地塞米松棕榈酸酯的药代动力学。方法用开放、双周期随机交叉给药方案,10名健康受试者单剂量静脉注射两种地塞米松棕榈酸酯1 mL,用LC-MS/MS法测定血浆中地塞米松棕榈酸酯、地塞米松和尿样中的地塞米松,计算其主要药代动力学参数。结果9名受试者完成全部试验。单剂量静脉注射地塞米松棕榈酸酯受试制剂和参比制剂后,地塞米松棕榈酸酯的主要药代动力学参数:AUC0-tn分别为(951.57±341.39),(955.03±434.42) ng ? mL-1? h;AUC0-∞分别为(954.83±341.82),(957.85±433.95)ng? mL-1? h;cmax分别为(681.33±307.91),(622.00±205.71) ng? mL-1;t1/2分别为(0.73±0.05),(0.76±0.18)h。单剂量静脉注射地塞米松棕榈酸酯受试制剂和参比制剂后,地塞米松的主要药代动力学参数:AUC0-tn分别为(179.11±27.99),(199.18±26.90) ng? mL-1? h;AUC0-∞分别为(208.35±37.54),(237.45±45.52) ng? mL-1? h;cmax分别为(26.17±3.19),(32.44±2.74) ng? mL-1;tmax分别为(2.00±1.09),(1.56±0.64) h,t1/2分别为(3.74±1.02),(4.30±1.46)h。48 h地塞米松的尿中累积排泄率分别为(3.58±1.07)%和(3.93±1.23)%。结论两种制剂的主要药代动力学参数无显著性差异。 Objective To study the pharmacokinetics of dexamethasone palmitate injection in Chinese healthy volunteers.Methods A single administration of 1 mL dexamethasone palmitate injection of test and reference formulation was given to 10 healthy volunteers by intravenous injection according to an open, randomized, cross-over study.The con-centrations of dexamethasone palmitate and dexamethasone in plasma and urine were determined by LC-MS/MS method, the pharmacokinetic pa-rameters were calculated.Results Nine healthy volunteers had comple-ted the full clinical trail.The main pharmacokinetic parameters of dexa-methasone palmitate were as follows.AUC0-tn were (951.57 ±341.39), (955.03 ±434.42)ng? mL-1? h, AUC0-∞ were(954.83 ±341.82), (957.85 ±433.95 ) ng? mL-1? h, cmax were ( 681.33 ±307.91 ) , ( 622.00 ± 205.71 ) ng ? mL-1 , t1/2 were ( 0.73 ± 0.05 ) , (0.76 ±0.18)h for test and reference formulation, respectively.The main pharmacokinetic parameters of dexamethasone were as follows. AUC0-tn were ( 179.11 ±27.99 ) , ( 199.18 ±26.90 ) ng? mL-1? h, AUC0-∞ were(208.35 ±37.54), (237.45 ±45.52) ng? mL-1? h, cmax were (26.17 ±3.19), (32.44 ±2.74) ng? mL-1, tmax were(2.00 ±1.09), (1.56 ±0.64)h, t1/2 were(3.74 ±1.02), (4.30 ±1.46)h for test and refer-ence formulation, respectively. Cumulative 48 h urine excretion accounted for ( 3.58 ± 1.07 )% and (3.93 ±1.23)%, respectively.Conclusion There is no significant difference between the main pharmacokinetic parameters of two formulations of dexamethasone palmitate injection.
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/43839
Appears in Collections:北京大学第一临床医学院_药剂科_期刊论文

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作者单位: 北京大学第一医院药剂科,北京,100034

Recommended Citation:
梁雁,许俊羽,赵侠,等. 地塞米松棕榈酸酯注射液在中国健康受试者的药代动力学研究[J]. 中国临床药理学杂志,2015(16):1613-1617.
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