【摘要】 目的研究布洛伪麻软胶囊在健康人体内的药物动力学及相对生物利用度。方法采用HPLC法测定20名健康男性受试者口服布洛伪麻软胶囊和洛芬伪麻片后不同时间血浆中布洛芬和盐酸伪麻黄碱的质量浓度,并求出主要药物动力学参数。结果血浆中布洛芬的tmax分别为(1.4±0.9)和(2.6±1.2)h,ρmax分别为(43.7±10.2)和(35.6±8.8)mg.L-1,t1/2均为(2.4±0.5)h,AUC0-15分别为(177.9±39.7)和(165.1±42.2)mg.h.L-1;盐酸伪麻黄碱的tmax分别为(1.3±0.2)和(1.2±0.2)h,ρmax分别为(296.6±98.8)和(269.5±82.5)μg.L-1,t1/2分别为(5.4±0.4)和(5.4±0.3)h,AUC0-24分别为(1.943±0.394 1)和(1.952±0.399 5)mg.h.L-1;布洛芬的相对生物利用度为(107.8±8.3)%,盐酸伪麻黄碱的相对生物利用度为(99.5±5.4)%。结论根据双单侧检验表明两种制剂具有生物等效性。更多还原

【Abstract】 Objective To study the pharmacokinetics and relative bioavailability of ibuprofen and pseudoephedrine soft capsules.Methods An HPLC method was developed for the determination of the plasma concentrations of ibuprofen and pseudoephedrine in 20 healthy Chinese male volunteers following a single dose of ibuprofen and pseudoephedrine soft capsules(test formulation) and compound ibuprofen tablets(reference formulation),and the main pharmacokinetic parameters were calculated.Results The main pharmacokinetic parameters of ibuprofen in plasma samples were:tmax=(1.4±0.9)and(2.6±1.2)h,ρmax=(43.7±10.2)and(35.6±8.8)mg·L-1,t1/2=(2.4±0.5)and(2.4±0.5)h,AUC0-15=(177.9±39.7)and(165.1±42.2)mg·h·L-1.The main pharmacokinetic parameters of pseudoephedrine were:tmax=(1.3±0.2)and(1.2±0.2)h,ρmax=(296.6±98.8)and(269.5±82.5)μg·L1,t1/2=(5.4±0.4)and(5.4±0.3)h,AUC0-24=(1.943±0.394 1)and(1.952±0.399 5)μg·h·L-1.The value of relative bioavailability of ibuprofen and pseudoephedrine were(107.8±8.3)% and(99.5±5.4)% respectively.Conclusions The data of AUC and ρmax are log-transformed before analysis of variance(ANVOA),The results of two one-side t-test show that two preparations were bioequivalent.The statistical results show two products had bioequivalence in vivo.更多还原