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由发酵产生的多组分抗生素物质:对监管机构、重症患者和仿制药的影响。

Multicomponent antibiotic substances produced by fermentation: implications for regulatory authorities, critically ill patients and generics.

机构信息

Department of Clinical Microbiology, Ampath National Laboratory Services, Suite 9C, Milpark Hospital, 9 Guild Road, Parktown West, 2193 Johannesburg, South Africa.

Department of Critical Care, Charlotte Maxeke Johannesburg Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

出版信息

Int J Antimicrob Agents. 2014 Jan;43(1):1-6. doi: 10.1016/j.ijantimicag.2013.06.013. Epub 2013 Aug 3.

DOI:10.1016/j.ijantimicag.2013.06.013
PMID:23920094
Abstract

Teicoplanin and polymyxin E (colistin) are antibiotics consisting of multiple, closely related subcomponents, produced by fermentation. The principal components comprise a complex mixture of chemically related, active substances (teicoplanin A(2-1)-A(2-5) and polymyxin E(1-2), respectively), which might be required to be present in specific ratios to ensure optimal antibacterial and clinical efficacy. These subcomponents differ in their fatty acid and amino acid composition and, as such, the lipophilic and protein binding characteristics differ between components. This has therapeutic implications for critically ill patients, as the volume of distribution of the teicoplanin A2 and polymyxin E analogues at the onset of an intravenous infusion may impact on expected pharmacokinetics and influence outcome.

摘要

替考拉宁和多黏菌素 E(黏菌素)是由发酵产生的由多个密切相关的亚组分组成的抗生素。主要成分由化学相关的、活性物质(分别为替考拉宁 A(2-1)-A(2-5)和多黏菌素 E(1-2))的复杂混合物组成,为确保最佳的抗菌和临床疗效,可能需要以特定比例存在。这些亚组分在脂肪酸和氨基酸组成上有所不同,因此,各个组分的亲脂性和蛋白结合特性也有所不同。这对重症患者具有治疗意义,因为静脉输注开始时替考拉宁 A2 和多黏菌素 E 类似物的分布容积可能会影响预期的药代动力学并影响结果。

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Multicomponent antibiotic substances produced by fermentation: implications for regulatory authorities, critically ill patients and generics.由发酵产生的多组分抗生素物质:对监管机构、重症患者和仿制药的影响。
Int J Antimicrob Agents. 2014 Jan;43(1):1-6. doi: 10.1016/j.ijantimicag.2013.06.013. Epub 2013 Aug 3.
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