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ρ_max分别为(6.16±1.24)和(6.04±1.03) mg·L-1, t_max分别为(1.31±0.69)和(1.50±0.70)h，AUC_{0-16 h}分别为(29.17±6.67)和(28.76±6.29) mg·h·L-1；伪麻黄碱的ρ_max分别为(210.0±30.3)和(214.6±35.7)μg·L-1，t_max分别为(2.33±1.08)和(2.23±1.19)h，AUC_{0-24 h}分别为(1 887.4±364.3)和(1 936.8±444.3)μg·h·L-1；苯海拉明的ρ_max分别为(84.4±24.6)和(92.2±29.2)μg·L-1，t_max分别为(2.75±1.11 )和(2.98±1.06) h，AUC_{0-36 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ρ_max分别为(6.63±2.90)和(6.00±2.15) μg·L-1，t_max分别为(2.73±0.92)和(2.58±1.05)h，AUC_{0-24 h}分别为(42.79±13.02)和(40.24±11.92)μg·h·L-1。以AUC_0-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 bioequivalence of two paracetamol, dextromethorphan hydrochloride, pseudoephedrine hydrochloride and diphenhydramine hydrochloride tablets in healthy volunteers. METHODS In randomized crossover design, a single dose of test formula and reference formula was given to 20 healthy male volunteers. Dextrorphan, pseudoephedrine and diphenhydramine were measured by LC-MS/MS, paracetamol by HPLC-UV. RESULTS After a single oral administration test formula and reference formula, the main pharmacokinetic parameters of paracetamol were as follows:ρ_max (6.16±1.24) and (6.04±1.03) mg·L-1, t_max (1.31±0.69) and (1.50±0.70)h，AUC_{0-16 h} (29.17±6.67) and (28.76±6.29 )mg·h·L-1. Pharmacokinetic parameters of pseudoephedrine were as follows:ρ_max (210.0±30.3) and (214.6±35.7)μg·L-1，t_max (2.33±1.08) and (2.23±1.19)h，AUC_{0-24 h} (1 887.4±364.3) and (1 936.8±444.3)μg·h·L-1. Pharmacokinetic parameters of diphenhydramine were as follows: ρ_max (84.4±24.6) and (92.2±29.2)μg·L-1，t_max (2.75±1.11 ) and (2.98±1.06)h，AUC_{0-36 h} (819.2±284.7) and (937.5±391.4) μg·h·L-1. Pharmacokinetic parameters of dextrorphan were as follows: ρ_max (6.63±2.90) and (6.00±2.15) μg·L-1，t_max (2.73±0.92) and (2.58±1.05)h，AUC_{0-24 h} (42.79±13.02) and (40.24±11.92) μg·h·L-1.The relative bioavailability of paracetamol, pseudoephedrine, diphenhydramine and dextromethorphan were (99.1±9.6)%, (102.7±13.5)%, (114.3±25.3)% and (95.6±17.3)%, respectively. CONCLUSION The results of statistical analysis demonstrated that the two preparations were bioequivalent.