Vancomycin (VAN) has a narrow therapeutic window and variable pharmacokinetic properties, which require timely monitoring of plasma concentration to adjust the dosage for better effectiveness. A sensitive and quantitative immunochromatographic method was developed to detect VAN in plasma. The linear response range of the method to detect plasma VAN was 1.25-50 μg/mL. The intra-and inter-assay coefficients were 4.68% and 8.81%, respectively, while the recovery was 89.10%-98.32%. The clinical comparative experiment results demonstrated a good correlation (r > 0.90) between the fluorescent immunochromatographic strip test and the mass spectrum. In this study, a simple, rapid, and high-sensitivity immunochromatographic method was established for detecting VAN, which helped establish the basis for further application of monitoring plasma concentration.
To evaluate the pharmacokinetic properties and bioequivalence of 2 oral formulations of domperidone in healthy Chinese subjects, a randomized, open-label, 2-way crossover study was conducted under fasting and fed states. All 96 healthy subjects were randomized to receive a single oral dose of a 10-mg generic domperidone tablet (test) or branded domperidone tablet (reference). Blood samples were collected at specified time intervals and analyzed for domperidone using liquid chromatography-tandem mass spectrometry. In the fasting test, 90% CIs of geometric mean ratios were 86.7% to 105.8% for maximum concentration, 96.7% to 106.1% for area under the concentration-time curve (AUC) from time 0 to the time of the last measurable plasma concentration, and 97.1% to 106.1% for AUC from time 0 extrapolated to infinity. In the fed test, the 90% CIs were 90.8% to 121.1%, 99.7% to 109.4%, and 99.4% to 109.1%, respectively. All 90% CIs were within the bioequivalence range of 80% to 125%, indicating that the 2 formulations were bioequivalent. In addition, the values of time to maximum concentration, terminal-phase elimination half-life, and AUC were significantly higher in the fed group than in the fasting group, suggesting that a high-fat meal slowed down the absorption and elimination of domperidone and significantly increased domperidone exposure.
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