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新型冻干两性霉素B卵磷脂基油包水微乳剂与两性霉素B脱氧胆酸盐在动物模型中的比较药代动力学及安全性

Comparative pharmacokinetics and safety of a novel lyophilized amphotericin B lecithin-based oil-water microemulsion and amphotericin B deoxycholate in animal models.

作者信息

Brime Begona, Frutos Paloma, Bringas Pilar, Nieto Ana, Ballesteros M Paloma, Frutos Gloria

机构信息

Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, Complutense University of Madrid, Spain.

出版信息

J Antimicrob Chemother. 2003 Jul;52(1):103-9. doi: 10.1093/jac/dkg266. Epub 2003 Jun 12.

Abstract

Amphotericin B (AmB) has been a most effective systemic antifungal agent, but its use is circumscribed by the dose-limiting toxicity of the conventional micellar dispersion formulation Fungizone (D-AmB). To lower AmB-associated toxicity, AmB may be integrated into oil-in-water lecithin-based microemulsions. The present study compares the pharmacokinetic characteristics of D-AmB with the alternative formulation of AmB in microemulsion (M-AmB), which has proved effective in a murine candidiasis model. Both formulations were given by intravenous bolus: D-AmB 1 mg/kg, and M-AmB 0.5, 1 or 2 mg/kg. The pharmacokinetics of D-AmB and M-AmB have several differences, specifically with regard to the respective Cmax and AUC0- infinity values. Elimination of AmB from serum was biphasic for both M-AmB and D-AmB. Single-dose D-AmB (1 mg/kg) achieved a Cmax of 3.89 +/- 0.48 mg/L and an AUC0- infinity of 32.28 +/- 7.31 mg.h/L, whereas single-dose M-AmB (1 mg/kg) by comparison achieved a lower Cmax (2.92 +/- 0.54 mg/L) and a lower AUC0- infinity (21.89 +/- 5.17 mg.h/L). To evaluate the safety of M-AmB, a multiple-dose toxicity study was performed in groups of 10 mice, each receiving D-AmB 1 mg/kg, or M-AmB 1, 1.5, 2 or 3 mg/kg. The findings suggest that, in comparison with D-AmB, M-AmB produces no histologically demonstrable renal lesions, or changes in clinical chemistry.

摘要

两性霉素B(AmB)一直是一种非常有效的全身性抗真菌药物,但其使用受到传统胶束分散制剂Fungizone(D-AmB)剂量限制性毒性的限制。为了降低与AmB相关的毒性,可将AmB整合到水包油型卵磷脂基微乳剂中。本研究比较了D-AmB与微乳剂中AmB的替代制剂(M-AmB)的药代动力学特征,M-AmB已在小鼠念珠菌病模型中证明有效。两种制剂均通过静脉推注给药:D-AmB为1mg/kg,M-AmB为0.5、1或2mg/kg。D-AmB和M-AmB的药代动力学有几个差异,特别是在各自的Cmax和AUC0-无穷大值方面。M-AmB和D-AmB从血清中的消除均为双相。单剂量D-AmB(1mg/kg)的Cmax为3.89±0.48mg/L,AUC0-无穷大为32.28±7.31mg·h/L,而相比之下,单剂量M-AmB(1mg/kg)的Cmax较低(2.92±0.54mg/L),AUC0-无穷大也较低(21.89±5.17mg·h/L)。为了评估M-AmB的安全性,对每组10只小鼠进行了多剂量毒性研究,每组小鼠分别接受1mg/kg的D-AmB或1、1.5、2或3mg/kg的M-AmB。研究结果表明,与D-AmB相比,M-AmB不会产生组织学上可证实的肾脏病变或临床化学变化。

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