Grasela D M, Rocci M L, Vlasses P H
Division of Clinical Pharmacology, Jefferson Medical College, Philadelphia, Pennsylvania 19107.
J Pharmacokinet Biopharm. 1987 Dec;15(6):601-13. doi: 10.1007/BF01068415.
The purposes of the present investigation were (i) to directly compare in man, indocyanine green (ICG) plasma concentrations analyzed by high performance liquid chromatography (HPLC) vs. spectrophotometry; (ii) to evaluate whether the pharmacokinetic parameters generated for ICG from a clinical study are assay-dependent; (iii) to examine whether the method of pharmacokinetic analysis affects the magnitude of any assay-related differences observed in ICG's pharmacokinetic parameters; and (iv) to evaluate whether assay methodology and/or method of pharmacokinetic analysis affect the conclusions derived from a clinical study employing ICG as a marker for hepatic blood flow (HBF). Plasma samples obtained from a clinical study designed to assess the effects of cimetidine and posture on HBF were analyzed by spectrophotometry and HPLC. The spectrophotometric method overestimated ICG plasma concentrations when compared to HPLC. This finding is consistent with the observations of others suggesting the presence of a chemical impurity in the commercial ICG preparation. Data generated by the spectrophotometric method produced lower ICG clearance and HBF estimates and a longer ICG half-life regardless of the method of pharmacokinetic analysis. The method of pharmacokinetic data analysis had no effect on any pharmacokinetic parameter. The experimental conclusions derived from the clinical study were not affected by either analytical methodology or method of data analysis.
（i）在人体中直接比较通过高效液相色谱法（HPLC）与分光光度法分析的吲哚菁绿（ICG）血浆浓度；（ii）评估临床研究中为ICG生成的药代动力学参数是否依赖于检测方法；（iii）检查药代动力学分析方法是否会影响在ICG药代动力学参数中观察到的任何与检测相关差异的大小；以及（iv）评估检测方法和/或药代动力学分析方法是否会影响以ICG作为肝血流量（HBF）标志物的临床研究得出的结论。通过分光光度法和HPLC分析了从一项旨在评估西咪替丁和体位对HBF影响的临床研究中获得的血浆样本。与HPLC相比，分光光度法高估了ICG血浆浓度。这一发现与其他人的观察结果一致，表明市售ICG制剂中存在化学杂质。无论药代动力学分析方法如何，分光光度法产生的数据得出的ICG清除率和HBF估计值较低，ICG半衰期较长。药代动力学数据分析方法对任何药代动力学参数均无影响。临床研究得出的实验结论不受分析方法或数据分析方法的影响。
