生物学的同等性とバイオアベイラビリティのジャーナル

概要

Hemolysis of Blood Samples has no Significant Impact on the Results of Pharmacokinetic Data

Jie Zhao, Quancheng Kan, Jianguo Wen, Yidong Li, Yunqiao Sheng, Li Yang, Jason Wu and Shengjun Zhang

Purpose: This study examined whether hemolyzed blood samples affect the pharmacokinetic (PK) profile. Methods: A validated LC-MS/MS method was used to analyze both hemolyzed and non-hemolyzed plasma samples obtained from healthy volunteers to whom Clopidogre, Methylprednisolone and Ropinirole were administrated orally in three independent bioequivalence (BE) studies. Results: The drug concentrations of hemolyzed and non-hemolyzed plasma samples, were, respectively: clopidogrel (n=12) 862.57 ± 860.16 (ng/mL) and 920.61 ± 959.14 (ng/mL); Methylprednisolone (n=10) 155.21 ±33.60 (ng/mL) and 160.01 ± 29.9 (ng/mL); Ropinirole (n=16) 1322.87 ± 392.96 (ng/mL) and 1151.42 ± 299.91 (ng/mL). The drug concentrations between hemolyzed and non-hemolyzed plasma samples did not yield a significant difference (P>0.05). Conclusions: The measurable plasma concentrations of the test drugs were not significantly different from those of normal non-hemolyzed plasma samples, suggesting that there was no impact on the accuracy of PK profile of the three test drugs.