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目的评价复方氯扑伪麻缓释片中的氯雷他定、对乙酰氨基酚和伪麻黄碱的药动学特点。方法采用LC-MS/MS法测定血浆中的氯雷他定、对乙酰氨基酚和伪麻黄碱浓度并用非房室模型计算药动学参数。结果8名受试者口服单剂量的复方氯扑伪麻缓释片后氯雷他定、对乙酰氨基酚和伪麻黄碱的AUC_(0→t)分别为:(18.04±13.81)、(26 455.42±5 245.72)、(3 703.16±487.26)μg·h·L~(-1);ρ_(max)分别为(6.81±4.98)、(3 918.75±816.17)和(423.63±49.55)μg·L~(-1);t_(max)分别为(0.91±0.30)、(4.13±1.13)和(5.25±0.89)h;t_(1/2)分别为(3.71±1.72)、(5.34±2.02)和(11.81±5.08)h。多剂量给药后氯雷他定、对乙酰氨基酚和伪麻黄碱的AUC~(ss)分别为:(63.26±39.58)、(49 226.51±11 103.51)和(11 046.73±12 642.36)μg·h·L~(-1);ρ_(max)分别为(6.36±3.31)、(5 733.75±1 099.06)和(576.38±136.48)μg·L~(-1);ρ_(min)分别为(1.08±0.74)、(1 890.63±350.06)和(247.88±71.35)μg·L~(-1);t_(max)分别为(1.13±0.55)、(2.31±0.88)和(3.38±1.06)h;ρ_(av)分别为(3.72±2.00)、(3 812.19±576.16)和(412.13±94.01)μg·L~(-1);DF分别为(143.02±26.11)、(99.54±21.74)和(80.07±18.09)%。结论单剂量和多剂量给药后,氯雷他定、对乙酰氨基酚和伪麻黄碱的药动学参数基本没有明显变化。
Objective To evaluate the pharmacokinetics of loratadine, paracetamol and pseudoephedrine in compound chlorpromazine sustained-release tablets. Methods Plasma loratadine, paracetamol and pseudoephedrine concentrations were determined by LC-MS / MS and pharmacokinetic parameters were calculated using a non-compartmental model. Results The AUC_ (0 → t) values of loratadine, paracetamol and pseudoephedrine were (18.04 ± 13.81) and (26 455.42 ± 5 245.72), (3 703.16 ± 487.26) μg · h · L -1 and ρ max were (6.81 ± 4.98), (3 918.75 ± 816.17) and (423.63 ± 49.55) μg · L -1 -1 and t_ (max) were (0.91 ± 0.30), (4.13 ± 1.13) and (5.25 ± 0.89) h respectively; t 1/2 was 3.71 ± 1.72 and 5.34 ± 2.02, respectively 11.81 ± 5.08) h. The AUC ~ (ss) of loratadine, paracetamol and pseudoephedrine were (63.26 ± 39.58), (49 226.51 ± 11 103.51) and (11 046.73 ± 12 642.36) μg · h · L -1 and ρ max respectively were (6.36 ± 3.31), (5 733.75 ± 1 099.06) and (576.38 ± 136.48) μg · L -1, respectively; ρ min were (1.08 ± (1.13 ± 0.55), (2.31 ± 0.88) and (3.38 ± 1.06) h, respectively; (p <0.74), (1890.63 ± 350.06) and (247.88 ± 71.35) μg · L -1 (av) were (3.72 ± 2.00), (3 812.19 ± 576.16) and (412.13 ± 94.01) μg · L -1, respectively; DF were 143.02 ± 26.11, 99.54 ± 21.74 and 80.07 ± 18.09)%. Conclusion The pharmacokinetic parameters of loratadine, paracetamol and pseudoephedrine did not change significantly after single-dose and multi-dose administration.