【摘要】 目的研究中国健康男性志愿者单次静滴D-聚甘酯注射液(抗拴塞药)的药代动力学。方法选27名健康男性志愿者,随机分成3组,分别接受单次静滴D-聚甘酯注射液100,200,300 mg。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),计算相应的血药浓度,用 3P97软件计算药代动力学参数。结果血药浓度-时间曲线符合二房室模型,3组的药代动力学参数β、t1/2β、CL无显著性差异,与给药剂量无关,3组 AUC0-39 h随给药剂量的加大而增加;但300 mg组AUC0-39h／dose和C0／dose 与另2组差异有统计学意义。结论在100—200 mg内,D-聚甘酯注射液的体内过程,基本符合线性动力学特征。更多还原

【Abstract】 Objective To investigate the pharmacokinetics of a single dose D - polymannuronicate injection in Chinese healthy male volunteers. Methods Twenty seven healthy volunteers were divided into 3 groups randomly , The aPTT of plasma samples collected from the volunteers after iv 100,200,300 mg D - polymannuronicate injection respectively were determined by the immuno - fluorescence turbidity method. The pharma-cokinetcs parameters were calculated by 3P97 software. Results The plasma concentration - time curve fits two compartment model after iv D -polymannuronicate injection 100,200 ,300 mg. There were no significant difference in pharmacokinetic parameters β, t1/2β, CL between the three groups. But AUC0-39h increased with dose rising. There were significant difference in AUC0-39h/dose and C0/dose between 300 mg group and other two groups, while there was no significant difference between 100 mg group and 200 mg group. Conclusion The results showed that the process of the drug in the dosage range of 100 ~ 200 mg in human body fit linear dynamic feature.更多还原