复方对乙酰氨基酚维生素C分散片在健康人体药物动力学和相对生物利用度

Pharmacokinetics and Bioequivalence of Compound Paracetamol and Vitamin C Tablet in Healthy Volunteers

目的:研究复方对乙酰氨基酚维生素C分散片在健康人体的药物动力学和相对生物利用度。方法:用随机分组自身对照方法,20名健康志愿者分别单次剂量服用复方对乙酰氨基酚维生素C分散片与参比制剂泡腾片,HPLC法检测对乙酰氨基酚和维生素C的血浓度,采用DAS1.0程序计算药物动力学参数并进行生物等效性评价。结果:分散片与泡腾片中,对乙酰氨基酚的AUC_(O→t)分别为(39.74±9.76)和(39.83±6.76)mg·h·L^(-1),AUC_(O→∞)分别为(41.43±10.25)和(40.88±7.13)mg·h·L^(-1);C_(max)分别为(10.57±2.45)和(10.27±1.75)mg·L^(-1);t_(max)分别为(0.52±0.34)和(0.75±0.51)h;维生素C的AUC_(O-t)分别为(91.35±28.29)和(89.47±23.10)mg·h·L^(-1),C_(max)分别为(7.71±1.80)和(7.53±2.15)mg·L^(-1);t_(max)分别为(2.36±0.91)和(2.36±0.85)h;分散片平均相对生物利用度分别为(102.94±15.96)%(以对乙酰氨基酚计算)和(100.09±12.75)%(以维生素C计算)。结论:分散片和参比制剂具有生物等效性。

Objective ： To study the pharmacokinetics and bioavailability of two formulations of compound paracetamol and vitamin C tablet. Method： A single oral dose of two formulations was given to 20 healthy volunteers in an open randomized cross-over study. Plasma level of paracetamol and vitamin C were determined by HPLC, the pharmacokinetic parameters were calculated and the bioequivalence of the two formulations was evaluated by DAS 1.0. Result ： The pharmacokinetic parameters of paracetamol of the two formulations were as followed ： AUC0→t were （ 39.74 ± 9.76 ） and （ 39.83 ± 6.76 ） mg · h · L ^- 1, AUC0→∞ were （ 41.43 ± 10.25 ） and （40.88±7.13）mg·h·L^-1,Cawere （10.57±2.45） and （10.27±1.75）mg· h· L^ -1 , tmax were （ 0. 52 ± 0. 34 ） and （0.75±0.51 ） h, respectively. The pharmacokinetic parameters of vitamin of the two formulaions were as followed： AUC0→t, were（ 91.35 ± 28. 29）and （89.47 ±23.10）mg · h · L^-1 ,Cmax were（7.71 ± 1.80）and （7.53 ±2.15）mg · L^-1 ,tmax were （2.36 ±0.91 ）and （2.36 ± 0.85 ） h,respectively, the relative bioavailability were （ 102.94 ± 15.96 ） % for paracetamol and （ 100.09± 12.75 ） % for vitamin C. Conclusion： The two formulations （test and reference） were bioequivalence.