目的　研究中国健康成年男性志愿者连续口服D 聚甘酯片的药动学。方法　选择经体检及实验室检查均正常的健康成年男性志愿者。 12名受试者连续口服D 聚甘酯片 10d ,每日一次 ,每次 4 0 0mg。应用免疫荧光比浊法测定给药后不同时间点血浆的部分凝血活酶时间 (aPTT) ,据随行测定的aPTT 血浆浓度标准曲线 ,计算相应的血药浓度。采用 3P97软件进行数据处理 ,分别求出首次给药和末次给药后药动学参数 ,以及达稳态时间、稳态浓度、累积比和波动系数。结果　依据aPTT结果计算D 聚甘酯血浆浓度 ,在 0 .0 5～ 10mg·L-1浓度范围内呈良好的线性关系 (r =0 .995 7) ;最低检测浓度为 0 .0 5mg·L-1,回收率在 91.4 8%～ 10 5 .6 7%之间 ,日内、日间RSD小于 13%。受试者连续口服D 聚甘酯片 ,于给药后第 7天血药浓度达到稳态 ,平均稳态血药浓度cav为 (0 .4 4 2± 0 .0 6 7)mg·L-1,达稳态后血药浓度 时间曲线下面积AUCss为 (10 .6 0 2± 1.6 0 5 )mg·h·L-1,累积比R为 1.2 6 1± 0 .0 31,波动系数FI为 1.5 5 4± 0 .0 6 1。首次与末次给药后主要药动学参数cmax分别为 (1.0 4 1± 0 .10 7)和 (1.4 0 1± 0 .12 5 )mg·L-1;t1/2 β分别为 (18.934± 1.76 0 )和 (19.977± 1.0 98)h ;tmax分别为 (1.0 39± 0 .0 96 )和(0 Objective To study the pharmacokinetics of continuous oral D-polyglycerol tablets in healthy adult male volunteers in China. Methods Healthy adult male volunteers who had normal physical examination and laboratory test were selected. 12 subjects consecutive oral D-polyglycerol tablets 10d, once daily, each 400mg. The plasma thromboplastin time (aPTT) at different time points after administration was measured by immunofluorescence turbidimetry. The corresponding plasma concentration was calculated according to the standard curve of aPTT plasma concentration. Data were processed using 3P97 software to determine the pharmacokinetic parameters after the first administration and the last administration, as well as the steady-state time, steady-state concentration, cumulative ratio and fluctuation coefficient respectively. Results According to the aPTT results, the plasma concentration of D-polyglycerol was calculated and showed a good linear relationship (r = 0.995 7) at a concentration range of 0.05 ~ 10 mg · L-1. The lowest detection limit was 0. 05 mg · L -1, the recovery rate was between 91.4 8% ~ 105.67%, and the intra-day and inter-day RSD was less than 13%. Subjects continuously oral D-polyglycerol tablets, the blood concentration reached steady state on the 7th day after administration, the average steady-state plasma concentration of cav was (0.44 ± 0.607) mg · L- 1, the area under the plasma concentration-time curve after reaching the steady state AUCss was (10.6 ± 2.0) mg · h · L-1, the cumulative ratio R was 1.2 6 1 ± 0.31 and the fluctuation coefficient FI Is 1.5 5 4 ± 0 .0 6 1. The main pharmacokinetic parameters (cmax) were (1.04 1 ± 0.10 7) and (1.4 0 1 ± 0.125) mg · L-1 after the first and last administration respectively; t1 / 2 β were (18.934 ± 1.76 0) and (19.977 ± 1.098) h respectively; tmax was (1.039 ± 0.096) and (0