摘要
目的:建立测定注射用重组人甲状旁腺素(rhPTH)(1-84)血药浓度的方法并对其药动学进行研究,为rhPTH(1-84)Ⅰ期临床试验提供准确的测定方法。方法:采用放射免疫分析(RIA)法,以甲状腺素放射免疫试剂盒(ELISA-rhPTH)测定rhPTH(1-84)血药浓度。结果:rhPTH(1-84)血药浓度在24～520pg/ml范围内线性关系良好(r=0.9989),最低定量限为10pg/ml;血浆提取回收率为86.7%～92.8%;日内RSD<7%,日间RSD<9%;血浆样本-80℃贮存80d稳定性良好。患者皮下注射2.0μg/kgrhPTH(1-84)后的主要药动学参数分别为:tmax(0.63±0.28)h、cmax(146.55±46.35)pg/ml,AUC0-10h(532.36±132.54)pg/ml。结论:本法特异性好、灵敏度高、操作简便。
OBJECTIVE： To establish a method for the determination of plasma concentration of recombinant human parathy- roid hormone （rhPTH） （1-84） for injection and study its pharmacokinetics, to provide method for clinical trial of rhPTH （1-84）. METHODS： By radioimmunoassay （RIA）, plasma concentrations of rhPTH （1-84） were determined with ELISA-PTH kit. RE- SULTS： The linear ranges of rhPTH（1-84） were 24-520 pg/ml（r=0.998 9）. The lowest detection limit was 10 pg/ml. The extrac- tion recoveries in plasma were 86.7%-92.8% ; intra-day RSD was less than 7% and inter-day RSD was less than 9%. The plasma samples were stored for 80 days at -80% with good stability. Main pharmacokinetic parmaeters of rhPTH（1-84） after subcutane- ous injection of 2.0 μg/kg were tmax（0.63 ± 0.28）h,Cmax（146.55 ± 46.35）pg/ml,AUC0-10h（532.36 ± 132.54）pg/ml. CONCLUSION： The method is specific, sensitive and simple. KEY WORDS Radioimmunoassay; Recombinant human parathyroid hormones （1-84） for injection; Plasma; Stability; Pharma- cokinetics
出处
《中国药房》
CAS
CSCD
2013年第6期516-518,共3页
China Pharmacy
