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首页> 外文期刊>Asian journal of drug metabolism and pharmacokinetics >Pharmacokinetics of multi-dose D-polymannuronicate tablets in Chinese healthy volunteers
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Pharmacokinetics of multi-dose D-polymannuronicate tablets in Chinese healthy volunteers

机译：多剂量D-聚甘露糖醛酸酯在中国健康志愿者中的药代动力学

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To investigate the pharmacokinetics of multi-dose D-polymannuronicate tablet in Chinese healthy malevolunteers. Methods The protocol was designed according to GCP principle after ethics committee passed. It's necessary that all volunteers sign the informed consents. 12 volunteers passed health and laboratory examinations took orally D-polymannuronicate 400mg once a day for 10 days. The activated part thromboplastin time (aPTT) assay was determined by immuno-fluoresence turbidity method and the plasma concentrations were determined by the accompanily aPTT-plasma concentration standard curve and pharmacokinetic parameters of the first and the last dosing were calculated by 3P97 software. Results The plasma concentrations were in well linearity(r=0.9957) in 0.05approx10mg L~(-1) by aPTT method. The recovery was between 91.48%~105.67% and the RSD of within-day and between-day were less than 13%. The steady concentration was achieved after the volunteers took D-polymannuronicate for 7 days. The mean steady plasma concentration (CAV) was 0.442+-0.067mg L~(-1) , The AUC_(ss), accumulation rate R and the fluctation coefficient FI were 10.602+-1.605mg L~(-1)centre noth~(-1), 1.261+-0.031, 1.554+-0.061 respectively. The main parameters of D-polymannuronicate after the first and the last dosing such as C_(max), T_(1/2beta), T_(max) V/F, CL were 1.041+-0.107mgL~(-1) and 1.401+-0.125mg L~(-1), 18.934+-1.760h and 19.977+-1.098h, 1.039+-0.096h and 0.969+-0.109h, 202.167+-19.187L and 160.220+-22.274L, 33.553+-5.038L h~(-1) and 24.807+-3.875Lcentre not h~(-1) respectively. The AUC_(0-infinity) of the first dosing was 12.195+-1.912mg h~(-1) L~(-1) and the AUC_(0-t) after the last dosing was 10.602+-1.605 mg L~(-1)centre not h~(-1). Conclusion The steady concentration was achieved after the healthy volunteers took multi-dose D-polymannuronicate of 400 mg a day for 7 days and there is no accumulation in vivo for 10 days. No correlated- adverse effects took place except elongation of aPTT. Once a day administration of D-polymannuronicate was recommended.
机译：研究多剂量D-聚甘露糖醛酸酯在中国健康男性志愿者中的药代动力学。方法伦理委员会通过后，根据GCP原则设计方案。所有志愿者都必须签署知情同意书。 12名通过健康和实验室检查的志愿者每天口服一次D-聚甘露糖醛酸酯400mg，持续10天。通过免疫荧光浊度法测定活化部分凝血活酶时间（aPTT），并通过相应的aPTT-血浆浓度标准曲线确定血浆浓度，并通过3P97软件计算第一次和最后一次给药的药代动力学参数。结果aPTT法测定血浆浓度在0.05〜10mg L〜（-1）时呈线性良好（r = 0.9957）。回收率在91.48％〜105.67％之间，日内和日间RSD小于13％。志愿者服用D-聚甘露糖醛酸酯7天后达到稳定浓度。平均稳定血浆浓度（CAV）为0.442 + -0.067mg L〜（-1）中心，AUC_（ss），累积速率R和波动系数FI为10.602 + -1.605mg L〜（-1）中心。 （-1），1.261 + -0.031、1.554 + -0.061。第一次和最后一次给药后D-聚甘露糖醛酸酯的主要参数如C_（max），T_（1 / 2beta），T_（max）V / F，CL为1.041 + -0.107mgL〜（-1）和1.401 + -0.125mg L〜（-1），18.934 + -1.760h和19.977 + -1.098h，1.039 + -0.096h和0.969 + -0.109h，202.167 + -19.187L和160.220 + -22.274L，33.553 +- 5.038L h〜（-1）和24.807 + -3.875Lcentre不是h〜（-1）。第一次给药的AUC_（0-无穷大）为12.195 + -1.912mg h〜（-1）L〜（-1），最后一次给药后的AUC_（0-t）为10.602 + -1.605mg L〜（ -1）中心不是h〜（-1）。结论健康志愿者每天服用400毫克D-聚甘露糖醛酸酯多剂量达7天，体内10天无累积，达到了稳定的浓度。除aPTT延长外，未发生相关不良反应。建议每天一次使用D-聚甘露糖醛酸酯。

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