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Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products for intravenous administration

机译:不同商业抗生素产品静脉内给药抗菌活性的体外比较研究

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Background The antimicrobial resistance is a global problem, probably due to the indiscriminate and irrational use of antibiotics, prescriptions for incorrect medicines or incorrect determinations of dose, route and/or duration. Another consideration is the uncertainty of patients receiving antibiotics about whether the quality of a generic medicine is equal to, greater than or less than its equivalent brand-name drug. The antibiotics behaviors must be evaluated in vitro and in vivo in order to confirm their suitability for therapeutic use. Methods The antimicrobial activities of Meropenem and Piperacillin/Tazobactam were studied by microbiological assays to determine their potencies (content), minimal inhibitory concentrations (MICs), critical concentrations and capacity to produce spontaneous drug-resistant mutants. Results With respect to potency (content) all the products fulfill USP requirements, so they should all be considered pharmaceutical equivalents. The MIC values of the samples evaluated (trade marks and generics) were the same for each strain tested, indicating that all products behaved similarly. The critical concentration values were very similar for all samples, and the ratios between the critical concentration of the standard and those of each sample were similar to the ratios of their specific antibiotic contents. Overall, therefore, the results showed no significant differences among samples. Finally, the production of spontaneous mutants did not differ significantly among the samples evaluated. Conclusions All the samples are pharmaceutical equivalents and the products can be used in antimicrobial therapy.
机译:背景技术抗菌素耐药性是一个全球性的问题,可能是由于滥用抗生素和不合理地使用抗生素,处方不正确的药物或错误确定剂量,途径和/或持续时间所致。另一个考虑因素是接受抗生素治疗的患者对于仿制药质量是否等于,大于或小于其同等品牌药品的不确定性。必须在体外和体内评估抗生素的行为,以确认其在治疗上的适用性。方法采用微生物学方法研究美洛培南和哌拉西林/他唑巴坦的抗菌活性,以确定其功效(含量),最低抑菌浓度(MIC),临界浓度和产生自发抗药性突变体的能力。结果关于效力(含量),所有产品均符合USP要求,因此应将所有产品均视为等效药物。对于每种测试菌株,所评估样品(商标和通用名)的MIC值均相同,表明所有产品的行为均相似。所有样品的临界浓度值非常相似,标准品的临界浓度与每个样品的临界浓度之比与其特定抗生素含量的比率相似。因此,总的来说,结果表明样品之间没有显着差异。最后,自发突变体的产生在所评估的样品之间没有显着差异。结论所有样品均为药物当量,产品可用于抗菌治疗。

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