对乙酰氨基酚软胶囊与片剂的人体相对生物利用度研究

Relative Bioavailability of Paracetamol Soft Capsules and Tablets in Human

20名健康男性志愿者交叉口服对乙酰氨基酚的软胶囊与片剂,采用HPLC法测定血浆中对乙酰氨基酚的浓度。单剂量口服600mg软胶囊与500mg片剂后,血浆中Cmax分别为(8.7±1.9)和(7.7±1.6)μg/ml,tmax分别为(0.86±0.42)和(0.75±0.30)h,t1/2分别为(3.05±0.30)和(3.06±0.36)h,AUC0→12h分别为(32.13±8.61)和(27.25±6.02)μg·h·ml–1,AUC0→∞分别为(34.28±9.73)和(29.00±6.76)μg·h·ml–1。经非参数秩和检验、双单侧t检验后,两制剂具有生物等效性。软胶囊的相对生物利用度为(98.2±12.5)%。

According to a randomized crossover design, twenty healthy male volunteers were orally taken 600mg paracetamol soft capsules and 500mg paracetamol tablets. The concentrations of paracetamol in plasma were determined by HPLC. The pharmacokinetic parameters were Cmax （8.7 ± 1.9） and （7.7 ± 1.6） μg/ml, tmax （0.86 ± 0.42） and （0.75 ± 0.30） h, t1/2 （3.05 ± 0.30） and （3.06 ± 0.36） h, AUC0→12h （32.13 ± 8.61 ） and （27.25 ± 6.02）μg·h·ml^-1, AUC0→∞ （34.28±9.73） and （29.00±6.76）μg·h·ml^-1, for paracetamol soft capsules and tablets, respectively. The results of rank test and two one-side t test showed that two preparations were bioequivalent. The relative bioavailability of paracetamol soft capsules was （98.2±12.5） %.