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目的:研究吡罗昔康贴片在中国健康志愿者体内连续给药的药动学。方法:11名健康受试者连续使用吡罗昔康贴片,每2天1次,每次1片(48mg),连续使用14d,HPLC法测定血液中吡罗昔康的浓度,用DAS软件进行数据处理,计算药动学参数。结果:连续使用吡罗昔康贴片第10天,其血药浓度已达稳态。主要药动学参数tmax为(43.8±15.5)h,Cmax为(40.6±11.3)μg·L-1,t1/2为(62.3±23.7)h,AUC0-τ和AUC0-∞分别为(4177.3±1376.0)μg·L-1·h和(5867.9±2768.7)μg·L-1·h,波动度为1.09±0.24。和受试者单次使用同等剂量贴片的药动学参数值进行组间t检验,结果差异无统计学意义。结论:吡罗昔康贴片按每2天1次,每次1片试验方案给药,在国人体内不产生蓄积现象,且受试者情况良好未发生任何不良反应。
Objective: To study the pharmacokinetics of piroxicam patch for continuous administration in Chinese healthy volunteers. Methods: Eleven healthy volunteers were treated with piroxicam patch continuously for 1 day (48mg) once every 2 days for 14 days. The concentration of piroxicam in blood was determined by HPLC, and the data were processed by DAS software. Pharmacokinetic parameters were calculated. Results: On the tenth day after continuous use of piroxicam patch, the plasma concentration reached steady state. The main pharmacokinetic parameters tmax was (43.8 ± 15.5) h, Cmax was (40.6 ± 11.3) μg · L-1, t1 / 2 was (62.3 ± 23.7) h and AUC0-τ and AUC0-∞ were (4177.3 ± 1376.0) μg · L-1 · h and (5867.9 ± 2768.7) μg · L-1 · h with a volatility of 1.09 ± 0.24. And subjects using a single dose of the same dose patch pharmacokinetic parameters t-test between groups, the results showed no significant difference. CONCLUSION: Piroxicam patch is administered once every 2 days for 1 tablet each time. It does not accumulate in the body of the human and the subjects are in good condition without any adverse reactions.