氢可酮对对乙酰氨基酚药动学的影响研究

目的研究氢可酮对对乙酰氨基酚药动学的影响。方法选20名健康男性志愿者,随机分为2个试验组,每组10人。每组志愿者每次试验时分别口服1片受试制剂或参比制剂,2次用药间隔7 d。用高效液相色谱-质谱-质谱联用方法分别测定血浆中对乙酰氨基酚的浓度。结果受试制剂和参比制剂的主要药动学参数Cmax分别为（6 315.29±1 586.70）μg/L和（5 689.51±1 516.40）μg/L,Tmax均为（0.65±0.42）h和（0.72±0.48）h,T1/2分别为（4.14±1.17）h和（4.47±1.09）h,AUC0-24分别为（20 968.57±5 786.33）μg/L和（19 936.78±6 381.11）μg/L,AUC0-∞分别为（21 280.00±5 847.28）μg/L和（20 424.08±6 462.00）μg/L。2种制剂Cmax、Tmax、T1/2、AUC均没有统计学意义。结论氢可酮对对乙酰氨基酚的吸收、分布和代谢没有影响,氨酚氢可酮片可在临床上安全使用。

Effect of Hydrocodone on Pharmacokinetics of Acetaminophen

Objective To investigate the effect of hydrocodone on pharmccokinetics of acetaminophen. Methods A total of 20healthy male volunteers were randomly divided into 2 groups,10 people in each group. They took a pill of test preparation or reference preparation respectively,and the treatment interval was 7 d. The blood concentrations of acetaminophen were determined by HPLC-MS /MS. Results The main pharmacokinetic parameters of test preparation or reference preparation were as follows： Cmaxwere（ 6 315. 29±1 586. 70） and（ 5 689. 51±1 516. 40） μg /L,Tmaxwere（ 0. 65± 0. 42） and（ 0.72± 0. 48） h,T1 /2were（ 4. 14±1. 17） and（ 4. 47±1. 09） h,AUC0-24were（ 20 968. 57±5 786. 33） and（ 19 936. 78±6381. 11） μg /L,AUC0-∞were（ 21 280. 00±5 847. 28） and（ 20 424. 08±6 462. 00） μg /L. Cmax,Tmax,T1 /2and AUC of the 2 preparation were no statistical significance. Conclusion There were no effect of hydrocodone on absorption,distribution and metabolism of acetaminophen. Hydrocodone bitartrate and acetaminophen tablet can be used in clinical safely.