布洛伪麻胶囊中布洛芬对伪麻黄碱血药浓度的影响  

Effect of ibuprofen in ibuprofen-ephedrine capsule on ephedrine in plasma

作　　者：华晓东[1] 芮菁[1] 唐元泰[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2017年第3期1-4,共4页Tianjin Pharmacy

摘　　要：目的:分别口服给予比格狗伪麻黄碱胶囊(单方)和布洛伪麻胶囊,观察布洛伪麻胶囊中其他成分对伪麻黄碱血药浓度的影响。方法:口服给予比格狗伪麻黄碱胶囊(单方)和布洛伪麻胶囊(按伪麻黄碱计均为45 mg/粒)后,在不同时间点采血,用HPLC方法测定血浆中的伪麻黄碱含量,并进行药物的生物等效性比较。结果:布洛伪麻组给药后伪麻黄碱主要的药代动力学参数为:峰浓度(0.12±0.08)μg/ml,t_(1/2α)和t_(1/2β)分别为(1.27±0.98)和(4.66±4.05)h;AUC0~t为0.80μg·h/ml[95%可信限(0.28-1.32)]。伪麻黄碱(单方)给药后伪麻黄碱的峰浓度为(0.12±0.04)μg/ml,t_(1/2α)和t_(1/2β)分别为(1.64±1.36)和(2.11±1.14)h;AUC_(0~t)为0.72μg·h/ml[95%可信限(0.370-1.07)]。用方差分析和双向单侧t-检验法考查结果并进行统计学分析,结果表明两组动物分别口服给予伪麻黄碱(单方)与布洛伪麻后,体内的伪麻黄碱具有相似的药代动力学特征,药物的吸收、分布及消除过程均无明显差异。用DAS软件进行统计分析,布洛伪麻胶囊相对于伪麻黄碱(单方)的生物利用度为111%。其相对生物利用度落在80%~120%范围内,符合生物等效性原则。结论:伪麻黄碱(单方)和布洛伪麻口服给予比格狗后,两种制剂中的伪麻黄碱具有相似的药代动力学特征,未受布洛伪麻胶囊中其他成分的影响。Objective ： To study the influence of ibuprofen in ibuprofen - ephedrine capsules on ephedrine in plasma. Methods ： Ephedrine and ephedrine - ibuprofen compound capsules were administered orally to the dogs at a dose of 45 mg of ephedrine, respectively. The ephedrine concentrations in plasma at various time points were determined by HPLC. Results： The concentration - time curves of two preparations fitted to two compartment open model. The main pharmacokinetic parameters were as follows ： Cmax （ 0.12 ± 0.08 ） , （ 0. 12 ± 0.04 ） μg/ml ; AUC 0.80,0.72μg. h/ml. The pharmacokinetic parameters obtained from our study showed no significant difference between the two products （ P 〉 0.05 ） , By content calibration relative bioequivalenee of ephedrine was 111%. Conclusion： The results suggests that the the two preparations are bioequivalent.

关 键 词：布洛伪麻胶囊 伪麻黄碱 血药浓度 生物等效性 HPLC 

分 类 号：R969.2[医药卫生—药理学]