基于生理药代动力学模型对盐酸莫西沙星有效性的研究

Evaluation on the efficacy of moxifloxacin hydrochloride based on physiological pharmacokinetic models

本研究基于生理药代动力学理论,建立和验证盐酸莫西沙星的体内药代模型,计算不同剂型在体内包括静脉血及肺、脾等不同器官的药物浓度-时间曲线,通过相应药代动力学参数结果与相关病原菌的最小抑菌浓度的比较,量化评价本品种及其制剂的有效性水平。结果表明,盐酸莫西沙星制剂在相应器官的抗感染有效性水平基本一致,品种制剂的生理药代动力学模型可以更为准确地描述抗感染药物在体内的吸收、分布、代谢和排泄过程,适用于这类药物的有效性评价工作,为相应科研与科学监管工作提供有力的研判依据。

This study is to establish and validation in vivo models of moxifloxacin based on the theory of physiologically based pharmacokinetics(PBPK),and then to predict the distribution of moxifloxacin in human venous return and organ such as lung,spleen and so on.The efficacy of moxifloxacin and its pharmaceutical preparations were quantified by comparing the pharmacokinetic parameters with the minimum inhibitory concentration of related pathogenic bacterium.The results showed that the anti-infection efficacy of pharmaceutical moxifloxacin preparation in the corresponding organs was basically the same.The PBPK model of moxifloxacin preparations can be more accurately described the pharmacokinetic of anti-infective drugs in human,it is suitable for the efficacy evaluation of anti-infective drugs and provides a strong basis for the corresponding scientific research and scientific supervision.