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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 relative bioavailability of acetaminophen vitamin C dispersible tablets in healthy volunteers. Methods: A randomized controlled group of 20 healthy volunteers were given a single dose of acetaminophen vitamin C dispersible tablets and reference preparation effervescent tablets, respectively. The blood concentrations of acetaminophen and vitamin C were measured by HPLC. Pharmacokinetic parameters were calculated using the DAS 1.0 program and bioequivalence was evaluated. Results: The AUC_ (O → t) of acetaminophen in dispersible tablets and effervescent tablets were (39.74 ± 9.76) and (39.83 ± 6.76) mg · h · L -1, respectively. The AUC_ (O → ∞ ) Were (41.43 ± 10.25) and (40.88 ± 7.13) mg · h · L -1, respectively. The maximal C max values were (10.57 ± 2.45) and (10.27 ± 1.75) mg · L -1 ; t_ (max) were (0.52 ± 0.34) and (0.75 ± 0.51) h respectively; AUC_ (Ot) of vitamin C were 91.35 ± 28.29 and 89.47 ± 23.10 mg · h · L -1, , And (max) were (7.71 ± 1.80) and (7.53 ± 2.15) mg · L -1, respectively; t max was 2.36 ± 0.91 and 2.36 ± 0.85 h respectively; Bioavailability was (102.94 ± 15.96)% (calculated as acetaminophen) and (100.09 ± 12.75)% (calculated as vitamin C), respectively. Conclusion: Dispersible tablets and reference preparations are bioequivalent.