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目的评价2种氨麻苯美片的人体生物等效性。方法20名健康受试者按两制剂双周期交叉试验设计口服2种氨麻苯美片后,采用高效液相色谱-质谱法测定血浆中伪麻黄碱、O-去甲右美沙芬和苯海拉明的浓度,采用高效液相色谱-紫外法测定血浆中对乙酰氨基酚的浓度,使用DAS1.0软件计算各药动学参数并进行生物等效性统计分析。结果参比制剂和受试制剂中对乙酰氨基酚的ρmax分别为(6.16±1.24)和(6.04±1.03)mg.L-1,tmax分别为(1.31±0.69)和(1.50±0.70)h,AUC0-16 h分别为(29.17±6.67)和(28.76±6.29)mg.h.L-1;伪麻黄碱的ρmax分别为(210.0±30.3)和(214.6±35.7)μg.L-1,tmax分别为(2.33±1.08)和(2.23±1.19)h,AUC0-24 h分别为(1 887.4±364.3)和(1 936.8±444.3)μg.h.L-1;苯海拉明的ρmax分别为(84.4±24.6)和(92.2±29.2)μg.L-1,tmax分别为(2.75±1.11)和(2.98±1.06)h,AUC0-36 h分别为(819.2±284.7)和(937.5±391.4)μg.h.L-1;O-去甲右美沙芬的ρmax分别为(6.63±2.90)和(6.00±2.15)μg.L-1,tmax分别为(2.73±0.92)和(2.58±1.05)h,AUC0-24 h分别为(42.79±13.02)和(40.24±11.92)μg.h.L-1。以AUC0-t计算,受试制剂中对乙酰氨基酚、伪麻黄碱、苯海拉明和右美沙芬的相对生物利用度分别为(99.1±9.6)%,(102.7±13.5)%,(114.3±25.3)%和(95.6±17.3)%。结论统计分析结果表明,2种氨麻苯美片具有生物等效性。
Objective To evaluate the bioequivalence of two kinds of Aminopram tablets. Methods Twenty healthy subjects were enrolled in the study. Two kinds of aminophenazone tablets were orally administered after the two-drug crossover test was conducted. The contents of pseudoephedrine, O-demethoxam and diphenhydramine in plasma were determined by high performance liquid chromatography-mass spectrometry The concentrations of paracetamol in plasma were determined by HPLC-UV method. The pharmacokinetic parameters were calculated by DAS 1.0 software and bioequivalence statistical analysis was performed. Results The pmax of acetaminophen in the reference preparation and the test preparation were (6.16 ± 1.24) and (6.04 ± 1.03) mg.L-1, respectively, and the tmax were 1.31 ± 0.69 and 1.50 ± 0.70 h, (29.17 ± 6.67) and (28.76 ± 6.29) mg.hL-1 for AUC0-16 h and (210.0 ± 30.3) and (214.6 ± 35.7) μg.L-1 for pseudoephedrine, respectively ± 1.08) and (2.23 ± 1.19) h respectively, and the AUC0-24 h were (1 887.4 ± 364.3) and (1 936.8 ± 444.3) μg.hL-1, respectively; the ρmax of diphenhydramine were (84.4 ± 24.6) and (92.2 ± 29.2) μg.L-1, tmax were (2.75 ± 1.11) and (2.98 ± 1.06) h respectively, and AUC0-36 h were (819.2 ± 284.7) and (937.5 ± 391.4) μg.hL- The ρmax of O-desmethyl dextromethorphan were (6.63 ± 2.90) and (6.00 ± 2.15) μg.L-1, respectively, with tmax of (2.73 ± 0.92) and (2.58 ± 1.05) (42.79 ± 13.02) and (40.24 ± 11.92) μg.hL-1, respectively. The relative bioavailability of acetaminophen, pseudoephedrine, diphenhydramine and dextromethorphan in the tested formulations were (99.1 ± 9.6)%, (102.7 ± 13.5)%, (114.3 ± 25.3)%, % And (95.6 ± 17.3)%. Conclusion The results of statistical analysis show that the two kinds of aminophenol tablets have bioequivalence.