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将各种哌拉西林/他唑巴坦仿制药产品与当代品牌(Zosyn,惠氏)制剂进行体外效价评估。

In vitro potency evaluations of various piperacillin/tazobactam generic products compared with the contemporary branded (Zosyn, Wyeth) formulation.

作者信息

Jones Ronald N, Fritsche Thomas R, Moet Gary J

机构信息

JMI Laboratories, North Liberty, IA 52317, USA.

出版信息

Diagn Microbiol Infect Dis. 2008 May;61(1):76-9. doi: 10.1016/j.diagmicrobio.2007.12.010. Epub 2008 Jan 24.

Abstract

Twenty-three generic intravenous piperacillin/tazobactam products were compared for in vitro activity to the branded formulation (Zosyn, Wyeth, Philadelphia, PA) by disk diffusion and incremental broth microdilution assay methods. All but 1 lot demonstrated significantly decreased activity (-5 to -35%), necessitating further investigations regarding the chemical purity, potency, and therapeutic equivalence of these products worldwide. The average -16% activity across all generic lots was equivalent to underdosing piperacillin/tazobactam by 2.6 g daily for serious clinical infections (4.5 g Q6 h).

摘要

通过纸片扩散法和递增肉汤微量稀释法,对23种通用型静脉注射哌拉西林/他唑巴坦产品与品牌制剂(Zosyn,惠氏,宾夕法尼亚州费城)进行了体外活性比较。除1批产品外,所有产品均表现出活性显著降低(-5%至-35%),这使得有必要在全球范围内对这些产品的化学纯度、效价和治疗等效性进行进一步研究。所有通用批次产品的平均活性降低16%,相当于在治疗严重临床感染时(每6小时4.5克),每日哌拉西林/他唑巴坦的给药剂量不足2.6克。

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