苯环喹溴铵鼻喷雾剂和布地奈德鼻喷雾剂联合用药在人体内的药代动力学相互作用  

Pharmacokinetic interaction between bencycloquidium bromide nasal spray and budesonide nasal spray in healthy volunteers

作　　者：钟水生[1] 罗柱[2] 孙鲁宁[1] 恩格百特[1] 梁茂植[2] 丁黎[1] 

机构地区：[1]中国药科大学药物分析教研室,南京210009 [2]四川大学华西医院临床药理研究室,成都610041

出　　处：《中国药科大学学报》2013年第5期447-450,共4页Journal of China Pharmaceutical University

基　　金：国家"重大新药创制"科技重大专项资助项目(No.2009ZX09102-059)~~

摘　　要：考察苯环喹溴铵鼻喷雾剂(BCQB)与布地奈德鼻喷雾剂(BUD)联用时在人体内的药代动力学相互作用。采用随机、两周期、序贯交叉、多次给药试验设计,12名男性健康受试者随机分成两组:Ⅰ组受试者序贯单次鼻腔给药BCQB180μg,连续给药BCQB 6 d(一天4次,每次180μg),联合给药(BCQB 180μg和BUD 256μg);Ⅱ组受试者序贯单次鼻腔给药BUD 256μg,连续给药BUD 7 d(一天1次,每次256μg),联合给药(BUD 256μg和BCQB 180μg)。一周清洗期后两组交换给药方式继续进行试验。采用LC-MS/MS法分别测定受试者给药后血浆中苯环喹溴铵与布地奈德的血药浓度。计算BCQB和BUD单用及联用两种用药方式下的药代动力学参数c max、AUC、t max,并进行统计分析。结果表明,BCQB与BUD联合用药不存在显著的体内药代动力学相互作用。The pharmacokinetic interaction between bencycloquidium bromide nasal spray（BCQB）and budesonide nasal spray（BUD）in human was investigated. 12 male volunteers were randomly divided into two groups according to an open, randomized, two-period, two-way crossover design. In period 1, Group I took single dose BCQB 180 μg, multiple doses BCQB（180 μg, four times daily for 6 days）and combined dose（BCQB 180 μg and BUD 256 μg）; Group II took single dose BUD 256 μg, multiple doses BUD（256 μg, once daily for 7 days）and combined dose（BCQB 180 μg and BUD 256 μg）, successively. After a wash-out time of 7 days, the two groups exchanged their administration processes in period 2. Plasma concentration of bencycloquidium bromide and budesonide were measured by LC-MS/MS, respectively. The pharmacokinetic parameters, cmax, AUC and tmax, were calculated and statistically analyzed. Results showed that there was no obvious pharmacokinetic interaction between BUD and BCQB when they were administered jointly to healthy volunteers.

关 键 词：苯环喹溴铵 布地奈德 药代动力学 药物相互作用 LC—MS MS 鼻喷雾剂 

分 类 号：R969.1[医药卫生—药理学]