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目的:研究氨酚曲马多片在中国健康志愿者体内的药动学。方法:12名健康志愿者,男女各半,采用3×3拉丁方设计,分别顿服氨酚曲马多片(盐酸曲马多37.5 mg+对乙酰氨基酚325 mg)1,2,3片。反相HPLC-UV法检测对乙酰氨基酚、曲马多及其代谢物M1的含量,并采用3P97药动学软件估算药动学参数,Cmax和Tmax采用实测值计算,AUC0～tn采用梯形法计算。结果:口服不同剂量氨酚曲马多片后,对乙酰氨基酚、曲马多及其代谢物M1药-时曲线拟合结果均符合一室模型,各剂量组的Cmax和AUC0～24随剂量增加而增大。结论:在给药剂量范围内氨酚曲马多单次给药后的Cmax和AUC0～24与剂量的线性关系尚不能得出明确结论。
Objective: To study the pharmacokinetics of paracetamol tramadol tablets in Chinese healthy volunteers. Methods: Twelve male and female volunteers were enrolled in this study. Each of the three healthy volunteers was enrolled in a 3 × 3 Latin square design. One, two or three tablets of paracetamol tramadol (37.5 mg tramadol hydrochloride and 325 mg paracetamol) were dosed daily. The contents of paracetamol, tramadol and its metabolite M1 were determined by reversed-phase HPLC-UV method. The pharmacokinetic parameters were estimated by 3P97 pharmacokinetic software. The calculated values of Cmax and Tmax were calculated by using the trapezoidal method Calculate. Results: After the oral administration of paracetamol and tramadol tablets, the results of paracetamol, tramadol and their metabolites M1-time curves fitted the one-compartment model. The Cmax and AUC0-24 of each dose group were significantly lower than those of the control group Increase and increase. CONCLUSION: The linear relationship between Cmax and AUC0 ~ 24 and dose after single dose of trastuzumab in the dose range can not reach a clear conclusion.