Retaco P, González M, Pizzorno M T, Volonté M G
Departamento de Ciencias Biológicas, Facultad de Ciencias Exactas, Universidad Nacional de La Plata, Argentina.
Eur J Drug Metab Pharmacokinet. 1996 Oct-Dec;21(4):295-300. doi: 10.1007/BF03189730.
A bioavailability study of two lots of paracetamol tablets was carried out in 5 healthy volunteers, using a crossover aleatory design, and drug monitoring in urine and saliva by high performance liquid chromatography (HPLC). Results were correlated with those obtained in an in vitro dissolution study. Statistical evaluation of bioavailability parameters indicates that the two formulations may be considered bioequivalent, in spite of differences found during early stages of the absorption process, which were preventable according to an in vitro dissolution study.
采用交叉随机设计,在5名健康志愿者身上对两批扑热息痛片剂进行了生物利用度研究,并通过高效液相色谱法(HPLC)对尿液和唾液中的药物进行监测。将结果与体外溶出度研究所得结果进行关联。生物利用度参数的统计评估表明,尽管在吸收过程的早期阶段发现了差异,但根据体外溶出度研究,这些差异是可以预防的,这两种制剂仍可被视为生物等效。