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血浆中环孢素的测定:单克隆抗体特异性放射免疫分析与液相色谱法的比较

Determination of cyclosporine in plasma: specific radioimmunoassay with a monoclonal antibody and liquid chromatography compared.

作者信息

Vernillet L, Keller H P, Le Bigot J F, Humbert H

机构信息

Pharmaceutical Research Center, Sandoz SARL, Rueil-Malmaison, France.

出版信息

Clin Chem. 1989 Apr;35(4):608-11.

PMID:2649276
Abstract

A radioimmunoassay of cyclosporine (Sandimmune) involving use of a mouse monoclonal antibody was tested to monitor specifically the parent drug in plasma. The cyclosporine concentrations obtained by RIA were compared with those obtained by the HPLC method. For the RIA method, the within- and between-assay CVs are less than 6%, the limit of detection is about 10 micrograms/L for a 50-microL sample of plasma. For the HPLC method, the within- and between-assay CVs are less than 20%, the limit of detection is about 15 micrograms/L for a 1-mL sample of plasma. The concentrations by RIA correlated well with those by HPLC in samples from patients receiving bone-marrow (n = 39), heart (n = 52), or liver (n = 51) transplants. In all indications, the ratio of values by RIA to those by HPLC for these samples remained stable and close to 1 during the drug-monitoring period, i.e., for up to 202 days. Therefore, the specific RIA can be used instead of HPLC to measure the parent drug in plasma.

摘要

对一种涉及使用小鼠单克隆抗体的环孢素(山地明)放射免疫分析法进行了测试,以专门监测血浆中的母体药物。将放射免疫分析法获得的环孢素浓度与通过高效液相色谱法获得的浓度进行比较。对于放射免疫分析法,批内和批间变异系数均小于6%,对于50微升血浆样本,检测限约为10微克/升。对于高效液相色谱法,批内和批间变异系数均小于20%,对于1毫升血浆样本,检测限约为15微克/升。在接受骨髓移植(n = 39)、心脏移植(n = 52)或肝脏移植(n = 51)的患者样本中,放射免疫分析法测得的浓度与高效液相色谱法测得的浓度相关性良好。在所有适应症中,在药物监测期间,即长达202天内,这些样本的放射免疫分析法值与高效液相色谱法值的比值保持稳定且接近1。因此,特异性放射免疫分析法可用于替代高效液相色谱法来测量血浆中的母体药物。

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